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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/26/26 has been entered.
Response to Arguments
Overview
In brief, Applicant’s independent claims 1, 14, and 17 recite at least a deformable, linear marker supported upon an axially-extending, radiolucent, adhesive-backed foam spacer, the foam spacer comprising a plurality of axially-spaced, laterally-extending portions and a flexible, elastic/stretchy, and compressible foam (e.g., Fig. 9).
In brief, Applicant admits (U.S. PGPub. No. 2022/0160456 [0003]-[0011]) that the prior art encompasses at least a deformable, linear marker supported upon an axially-extending, radiolucent, adhesive-backed spacer, the spacer comprising a plurality of axially-spaced, laterally-extending portions and a flexible material (e.g., Fig. 1). Comparing between the Applicant admitted prior art and the independent claims appears to indicate that the alleged inventive concept is the selected spacer material: a flexible, elastic/stretchy, and compressible foam.
In brief, the references of record teach at least the following features:
Russell ‘461 teaches a deformable, linear marker supported upon a plurality of axially-spaced, laterally-extending radiolucent, adhesive-backed pads (e.g., Fig. 1).
Beekley ’19 teaches a deformable, linear marker supported upon an axially-extending radiolucent, adhesive-backed spacer, the spacer comprising a plurality of axially-spaced, laterally-extending portions and a flexible, elastic/stretchy, and compressible material (e.g., Fig. 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis”).
Park teaches a deformable marker supported upon a radiolucent, adhesive-backed foam spacer, the foam spacer comprising a flexible and compressible foam (e.g., Fig. 5B).
Jones teaches a deformable electrode supported on a radiolucent, adhesive-backed foam spacer, the foam spacer comprises a flexible and elastic foam (e.g., Fig. 1).
Jessop teaches a marker supported on a radiolucent, adhesive-backed foam spacer, the foam spacer comprises a flexible and compressible foam (e.g., Fig. 1).
112(a) Rejections
Applicant’s arguments, see Remarks and Amended Claim Set, filed 6/26/26, with respect to the rejection of claims 3-5, 13, 16, and 18 under 35 U.S.C. 112(a) have been fully considered and are persuasive. The rejection of claims 3-5, 13, 16, and 18 under 35 U.S.C. 112(a) has been withdrawn.
112(b) Rejections
Applicant’s arguments, see Remarks and Amended Claim Set, filed 6/26/26, with respect to the rejection of claims 3-5, 13, 16, and 18 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 3-5, 13, 16, and 18 under 35 U.S.C. 112(b) has been withdrawn.
103 Rejections
Applicant's arguments filed 6/26/26 have been fully considered but they are not persuasive.
Regarding the Park reference, Applicant argues that
Park teaches away from the claimed invention by preventing the upper surface of the foam structure 506 from flexing, stretching, or conforming to the contour of the skin, and thereby preventing the radiographic marker supported on the foam spacer from flexing and conforming to the contour of the skin as well, as recited in the amended independent claims. Remarks at 14.
First, in response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant attacks Park individually for not teaching both a deformable marker and a flexible, stretchable, conforming foam spacer. However, Park is not relied upon to teach a deformable marker, rather Russell ‘461 and Beekley ’19 are relied upon to teach a deformable marker. Applicant must address the combination of references and cannot attack Park individually for features for which it is not cited. Therefore, on this ground alone, Applicant’s arguments are improper and unpersuasive.
Second, in arguendo, in response to Applicant's argument that the top surface of the foam deformable structure would be unable to be flexible, stretchable, and/or conforming due to the attachment of a rigid marker to the top surface, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Again, Park is not relied upon to teach a deformable marker, rather Russell ‘461 and Beekley ’19 are relied upon to teach a deformable marker. It is improper analysis for Applicant to require the bodily incorporation of not only the foam deformable structure of Park but also the rigid marker of Park when analyzing the obviousness of combining Park’s teaching of a flexible and conformable foam deformable spacer with Russell ‘461 and Beekley ‘19’s combined teaching of a deformable marker supported on a flexible, stretchable, and conforming spacer. Therefore, on this ground alone, Applicant’s arguments are improper and unpersuasive.
Third, in arguendo, in response to Applicant’s argument that Park teaches away from the claimed invention because the top surface of the foam deformable structure would be unable to be flexible, stretchable, and/or conforming due to the attachment of a rigid marker to the top surface, Applicant improperly excludes the teachings of the embodiment of Park paragraphs [0056]-[0060] and Figs. 6A-6B. Remarks at 14-16.
Paragraph [0059] states that
device 601 may not comprise a rigid structure. In particular, in one example base structure 602 may bend in one or more directions. For example, base structure 602 may substantially conform to one or more areas of curvature of the human body onto which it is a fixed.
Paragraph [0059] explictly teaches that, contrary to Applicant’s contention, the marker/device and the base structure is not rigid and can bend and/or conform to the curvature of the body.
Paragraph [0056] states that
Accordingly, device 601 may be similar in one or more aspects described herein to one or more of device 100, 200, 300, 400, and/or 500.
Paragraph [0056] explictly teaches that any of the aspects of device 500 (described in paragraphs [0052]-[0055] and Figs. 5A-5B) can be combined with those of device 601 (described in paragraphs [0056]-[0060] and Figs. 6A-6B).
Further, as admitted by the Applicant, paragraphs [0052]-[0055] disclose that one of the aspects of device 500 is a foam deformable structure which is provided below the base structure along the top surface of the deformable structure. Therefore, contrary to Applicant’s contention, even if Park were relied upon to teach both the foam deformable structure and the deformable marker, Park explictly teaches both a foam deformable structure with a top surface supporting and attached to a deformable marker. Therefore, Applicant’s argument is not persuasive.
In addition, Applicant provides no evidence to establish a teaching away by Park.
"A reference may be said to teach away when a person of ordinary skill, upon reading the reference ... would be led in a direction divergent from the path that was taken by the applicant." In re Haruna, 249 F .3d 1327, 1335 (Fed. Cir. 2001) (quoting Tee Air, Inc. v. Denso Mfg. Mich. Inc., 192 F.3d 1353, 1360 (Fed. Cir. 1999)); see In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (holding that, to teach away, the prior art must "criticize, discredit, or otherwise discourage the solution claimed").
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.")
First, there is no suggestion in Park that the base structure is required to be rigid. In fact, as discussed above, Park explictly states that the base structure is not required to be rigid. Second, there is no suggestion in Park that the foam deformable structure’s top surface is required to be attached to a rigid base structure. In fact, as discussed above, Park explictly contemplates using any of the aspects of the device 500 including the foam deformable structure as part of device 601, wherein the foam deformable structure’s top surface would be attached to a non-rigid, bendable, conforming base structure. As there are no teachings in Park that criticizes, discredits, or otherwise discourages the solution claimed, i.e., a flexible, elastic/stretchy, conformable top surface of a foam spacer, Applicant’s argument is not persuasive.
Regarding the Jessop reference, Applicant argues that “Jessop teaches using a foam layer that ‘resists compression,’ and therefore teaches away from the claimed invention.” Remarks at 16. Applicant provides no evidence to establish a teaching away by Jessop.
First, there is no suggestion in Jessop that the foam spacer is not flexible, elastic, and compressible as alleged by the Applicant. Applicant’s argument rises and falls with the premise that the functionality described in col.3, lines 51-57 criticizes, discredits, or otherwise discourages the solution claimed, i.e., a flexible, elastic/stretchy, conformable foam spacer. Jessop col. 3, lines 51-57 reads:
The foam from which the foam ring 12 is formed is selected so as to minimize absorption of imaging radiation, while at the same time providing a layer having a thickness extent 13 which resists compression. In this way the shape of the protruding anatomical structure being marked is preserved at least insofar as it does not extend beyond the thickness extent of the supporting layer.
This passage provides that a possible function of the foam ring is to absorb compressive forces acting upon the foam ring such that the compressive force acting on the protruding anatomical structure is reduced or eliminated. This functionality requires the foam ring to be conformable/compressible such that it absorbs the compressive forces acting on the foam ring and does not transmit them to the protruding anatomical structure. On this ground alone Applicant’s argument is fatally flawed as the feature Applicant alleges teaches away in fact requires some conformability/compressibility of the foam ring to function. Therefore, Applicant’s arguments are not persuasive.
Moreover, in arguendo, Jessop at col. 4, lines 9-13 explictly states that the foam ring is compliant, i.e, conforms/compresses. Jessop col. 4, lines 9-13 reads:
The foam used in the illustrated embodiment is a physically blown nitrogen-expanded closed-cell foam of polyethylene copolymer resin such as LD45 foam available commercially from Zotefoam, Inc. of Hackettstown, N.J. However, great variation in the properties of the foam is possible; depending for example on the stiffness desired, better preserving the shape of the protruding structure, or compliance desired, for example to increase comfort to the patient.
This passage provides that the stiffness or compliance desired for the foam ring can be varied, for example, to increase comfort to the patient by increasing the compliance of the foam ring. On this ground alone Applicant’s argument is fatally flawed as the teachings of Jessop that it is desirable for patient comfort for the foam ring to be compliant is in stark contradiction to Applicant’s allegation that Jessop requires the foam ring to be rigid/non-conforming. Therefore, Applicant’s arguments are not persuasive.
As detailed in infra rejections: claims 1-2 and 4-10 are rejected over the combination of Russell ‘461, Beekley ’19, Park, and Jones; claim 3 is rejected over the combination of Russell ‘461, Beekley ’19, Park, Jones, and Russell ’706; claim 11 is rejected over the combination of Russell ‘461, Beekley ’19, Park, Jones, and Traboulsi; claim 12 is rejected over the combination of Russell ‘461, Beekley ’19, Park, Jones, Traboulsi, and Jessop; claim 13 is rejected over the combination of Russell ‘461, Beekley ’19, Park, Jones, and Isaacson; claims 14-16 are rejected over the combination of Russell ‘461, Beekley ’19, Park, and Jones; claims 17 and 19-20 are rejected over the combination of Russell ‘461, Beekley ’19, Park, and Jones; and claim 18 is rejected over the combination of Russell ‘461, Beekley ’19, Park, Jones, and Russell ’706.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Russell ‘461 & Burns (Reissued U.S. Patent No. 36,461), hereinafter “Russell ‘461,” in further view of Beekley (“Discover Beekley TomoSpot Skin Markers for 3D Breast Tomosynthesis” September 2019), hereinafter “Beekley ‘19,” with additional evidence from Searing (U.S. Design Patent No. D879,963) and Axis Imaging News (“Product Showcase: Skin Markers Geared Toward Women with Sensitive Skin” 2006), hereinafter “Axis,” in further view of Park (U.S. Pub. No. 2018/0098820), hereinafter “Park,” in further view of Jones (U.S. Pub. No. 2012/0253162), hereinafter “Jones.”
Regarding claim 1, Russell ‘461 discloses an imaging marker for use in connection with an imager (marker system visible when imaged with a radiation imager, Col. 2, lines 39-56; note that the limitation “for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker and therefore does not have patentable weight as it does not result in a structural difference, MPEP 2111.02 II.), wherein the imaging marker is adhesively attachable and conformable to a contoured surface of the skin of a person to be imaged by the imager in connection with an imaging procedure (adhesive pads releasably adhere to the surface of the subject, Abstract; marker system is applied to the skin of the subject, Col. 4, lines 14-25; non-adhesive side of adhesive pad is attached to marker wire and adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16; marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25; marker wire is bendable, Abstract, Col. 2, lines 39-56; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25; marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25; see also bending of the marker wire system in Fig. 4; marker system visible when imaged with a radiation imager, Col. 2, lines 39-56; note that the limitation “a person to be imaged by the imager in connection with an imaging procedure” is merely a purpose and/or intended use for the claimed marker and therefore does not have patentable weight as it does not result in a structural difference, MPEP 2111.02 II.), the imaging marker can be subjected to forces during the imaging procedure, and the imaging marker is configured to prevent such forces from detaching the imaging marker from the skin (adhesive pads releasably adhere to the surface of the subject, Abstract; continuous row of adhesive pads along the length of the marker wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; marker wire visible when imaged with a radiation imager, Abstract, Col. 2, lines 39-56; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25; i.e., the adhesive and adhesive pad prevents forces exerted on the adhesive pad from detaching the adhesive pad from the skin during imaging; see also bending of the marker wire system in Fig. 4), the imaging marker comprising:
a linear-shaped marker (“line of wire”, Abstract; marker can be bent into a line, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear, Figs. 1 & 4) that is visible on an image of the marker taken by the imager in connection with an imaging procedure (marker wire visible when imaged with a radiation imager, Abstract, Col. 2, lines 39-56), wherein the linear-shaped marker is flexible and conformable to the contoured surface of the skin (marker wire is bendable, Abstract, Col. 2, lines 39-56; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25; marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25; see also bending of the marker wire system in Fig. 4), and defines an underside (marker wire defines an underside that is attached to the adhesive pads, Col. 2, line 66 – Col. 3, line 16) and an elongated axis (“line of wire”, Abstract; marker can be bent into a line thereby defining an elongated axis, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear and thereby defines an elongated axis, Figs. 1 & 4); and
an adhesive-backed spacer (adhesive pad with an adhesive side, Col. 2, line 66 – Col. 3, line 16) wherein the spacer defines a first surface and a second surface located on an opposite side of the spacer relative to the first surface (the adhesive pad has a top surface below and attached to the marker wire and a bottom surface which has an adhesive, Col. 2, line 66 – Col. 3, line 16), the marker is supported on and attached to the first surface (the marker wire is supported on and attached to the top surface of the adhesive pad, Col. 2, line 66 – Col. 3, line 16), the adhesive is located on the second surface (the adhesive pad has a bottom surface which has an adhesive, Col. 2, line 66 – Col. 3, line 16), the spacer defines a thickness between the first and second surfaces (continuous row of adhesive pads along the length of the marker wire which has a thickness between the top and bottom surface of each adhesive pad, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55), the adhesive is configured to releasably attach the spacer to the contoured surface of the skin with the imaging marker located on an opposite side of the spacer relative to the skin (adhesive pads releasably adhere to the surface of the subject, Abstract; marker system is applied to the skin of the subject, Col. 4, lines 14-25; non-adhesive side of adhesive pad is attached to marker wire and adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16; marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25), wherein the spacer is between the linear marker and the adhesive (non-adhesive side of adhesive pad is attached to marker wire and adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16; “line of wire”, Abstract; marker can be bent into a line, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear, Figs. 1 & 4), and defines a plurality of laterally-extending portions (each of the adhesive pads extends laterally from the marker wire, Figs. 1 & 4), wherein a plurality of the laterally-extending portions are located on opposite sides of the elongated axis relative to each other (each of the adhesive pads extends laterally from the marker wire in opposing directions, Figs. 1 & 4) and are axially spaced relative to each other along the elongated axis (continuous row of adhesive pads along the length of the marker wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; each of the adhesive pads are axially spaced relative to each other along the elongated axis of the marker wire, Figs. 1 & 4), and the spacer, including the first and second surfaces thereof, is configured to upon releasable adhesive attachment of said spacer with a deformed linear-shaped marker to the skin with the spacer in contact with and adhesively attached to and substantially conformed to the contoured surface of the skin, each of the first and second surfaces of the spacer is configured to respond to forces to thereby prevent such forces exerted on the spacer during the imaging procedure from detaching the spacer from the contoured surface of the skin during the imaging procedure (adhesive pads releasably adhere to the surface of the subject, Abstract; continuous row of adhesive pads along the length of the marker wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; marker wire visible when imaged with a radiation imager, Abstract, Col. 2, lines 39-56; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25; marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25; i.e., the adhesive and adhesive pad prevents forces exerted on the adhesive pad from detaching the adhesive pad from the skin during imaging; see also bending of the marker wire system in Fig. 4).
However, while Russell ‘461 discloses the spacer is an adhesive pad that is made of paper or plastic (adhesive pad is made of paper or plastic, Col. 2, line 66 – Col. 3, line 16) and that the spacer adhesive prevents forces exerted on the spacer from detaching the spacer from the skin during imaging, only the marker wire is disclosed as being opaque and appearing in the radiographic image (Col. 2, lines 39-56), and only the adhesive pad is disclosed as being in contact with the subject marker (continuous row of adhesive pads along the length of the marker wire and the adhesive pads can be any size and shape appropriate to support the wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; adhesive pads releasably adhere to the surface of the subject, Abstract), the adhesive pad is between the adhesive and the linear marker, a plurality of axially-spaced, laterally-extending portions of the adhesive pad as detailed above, and the marker system is configured to flex at least between the axially-spaced, laterally-extending portions (marker wire system is bendable along its elongated axis, Abstract, Col. 2, lines 39-56, Col. 3, lines 38-49; see also bending of the marker wire system in Fig. 4), Russell ‘461 does not appear to explictly disclose the imaging marker can be subjected to at least one of compressive or tensile forces during the imaging procedure, and the imaging marker is configured to prevent such forces from detaching the imaging marker from the skin; an adhesive-backed, flexible, elastic, and compressible foam spacer comprising a flexible, elastic, and compressible foam material that is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the imaging procedure; the flexible, elastic and compressible foam spacer, including the first and second surfaces thereof, is conformable to the contoured surface the skin with the linear-shaped marker, and the foam spacer spaces substantially the entirety of the underside of the marker away from the contoured surface of the skin, wherein the foam spacer defines an axially-elongated foam portion extending along the elongated axis of the linear-shaped marker between the linear-shaped marker and the adhesive; and the foam spacer, including the first and second surfaces thereof, is configured to flex, stretch, and compress, to thereby deform with deformation of the linear-shaped marker; and each of the first and second surfaces of the foam spacer is configured to stretch in response to tensile forces exerted thereon or compress in response to compressive forces exerted thereon, to thereby prevent such forces exerted on the foam spacer during the imaging procedure from detaching the foam spacer from the contoured surface of the skin during the imaging procedure.
However, in the same field of endeavor of radiography markers, Beekley ‘19 teaches the imaging marker can be subjected to at least one of compressive or tensile forces during the imaging procedure, and the imaging marker is configured to prevent such forces from detaching the imaging marker from the skin (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; backing material is adhesive for application to scars, P.2; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression and that sticks better during positioning and compression with the material bending and expanding within the patient’s breast during compression and is releasably attached to the skin);
an adhesive-backed, flexible, elastic, and compressible spacer comprising a flexible and compressible material (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression) that is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the imaging procedure (Figure 3 demonstrates that the adhesive backing of the Beekley TomoSpot scar marker is translucent/radiolucent/invisible on the radiography image of the linear marker taken by a CT imager and only the line marker portion of the device appears in radiography images, Fig. 3; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is translucent/radiolucent/invisible on an image taken by a mammography imager); the flexible, elastic and compressible spacer, including the first and second surfaces thereof, is conformable to the contoured surface the skin with the linear-shaped marker (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression), and the spacer spaces substantially the entirety of the underside of the marker away from the contoured surface of the skin (Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises a marker line supported by an adhesive backing material along both the axially-elongated portion and the axially-spaced, laterally-extending portions, note that in the original color version of this document, the hummingbird design pattern of the adhesive backing is visible through the see-through line marker in both the axially-elongated portion and the axially-spaced, laterally-extending portions, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence, Searing U.S. Design Patent No. D879,963 Figures 1 and 2 further demonstrates that for the Beekley TomoSpot scar marker, the backing material supports the marker line along both the axially-elongated portion and the axially-spaced, laterally-extending portions), wherein the spacer defines an axially-elongated portion extending along the elongated axis of the linear-shaped between the linear-shaped marker and the adhesive marker (Figure 7 demonstrates that the Beekley TomoSpot scar marker comprises a marker line supported by an adhesive backing material defining an axially-elongated portion extending along the elongated axis of the marker line, note that in the original color version of this document, the hummingbird design pattern of the adhesive backing is visible through the see-through line marker in the axially-elongated portion, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence, Searing U.S. Design Patent No. D879,963 Figures 1 and 2 further demonstrates that for the Beekley TomoSpot scar marker, the backing material supports the marker line in the axially-elongated portion); and the spacer, including the first and second surfaces thereof, is configured to flex, stretch, and compress, to thereby deform with deformation of the linear-shaped marker (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; ; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression); and, upon releasable adhesive attachment of said spacer in contact with and adhesively attached to and substantially conformed to the contoured surface of the skin, each of the first and second surfaces of the spacer is configured to stretch in response to tensile forces exerted thereon or compress in response to compressive forces exerted thereon, to thereby prevent such forces exerted on the spacer during the imaging procedure from detaching the spacer from the contoured surface of the skin during the imaging procedure (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; backing material is adhesive for application to scars, P.2; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression and that sticks better during positioning and compression with the material bending and expanding within the patient’s breast during compression and is releasably attached to the skin).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Beekley ‘19’s known technique of an adhesive pad shape having both an axially-elongated portion and axially-spaced, laterally-extending portions to Russell ‘461’s known adhesive pad shape to improve patient comfort under compression by preventing pinching of the patient’s skin. See, e.g., Beekley ‘19, P.2. See also MPEP 2141 III. (C).
However, while Russell ‘461 discloses a deformable linear-shaped marker and the spacer is an adhesive pad with a first and second surface that is made of paper or plastic and Beekley ‘19 teaches a deformable linear-shaped marker and that the spacer adhesive pad material is translucent/radiolucent/invisible in radiography images and is flexible, elastic, compressible, and stretchy as detailed above, Russell ‘461 in further view of Beekley ‘19 does not appear to teach the adhesive pad is a foam spacer comprising a flexible, elastic, and compressible foam material that is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the imaging procedure, and the foam spacer, including the first and second surfaces thereof, is configured to and the foam spacer, including the first and second surfaces thereof, is configured to flex, stretch, and compress, to thereby deform with deformation of the marker and, upon releasable adhesive attachment of said foam spacer with a deformed marker to the skin with the foam spacer in contact with and adhesively attached to and substantially conformed to the contoured surface of the skin, each of the first and second surfaces of the foam spacer is configured to stretch in response to tensile forces exerted thereon or compress in response to compressive forces exerted thereon, to thereby prevent such forces exerted on the foam spacer during the imaging procedure from detaching the foam spacer from the contoured surface of the skin during the imaging procedure.
However, in the same field of endeavor of radiography markers, Park teaches an adhesive-backed, flexible, and compressible foam spacer comprising a flexible and compressible foam material (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e, is flexible and conformable, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]) that is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the imaging procedure (deformable structure spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; deformable structure is not radiopaque and does not appear in generated radiological image, Figs. 6A-6B, 7, 11A-11D, 15A-15B, 16; see also [0056]; note that the limitation “the image of the marker taken by the imager in connection with the imaging procedure” is merely a purpose and/or intended use for the claimed spacer and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “the imager” is not part of the claimed “imaging marker”), the flexible and compressible foam spacer, including the first and second surfaces thereof, is conformable to the contoured surface of the skin with the marker (deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), and the foam spacer including the first and second surfaces thereof, is configured to flex and compress to thereby deform with deformation of the marker (deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]) and, upon releasable adhesive attachment (adhesive layer is configured to temporarily and removably bond to the skin, [0051], see also [0053], Fig. 5B) of said foam spacer with a deformed marker to the skin with the foam spacer in contact with and adhesively attached to and substantially conformed to the skin (deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]; adhesive layer is configured to temporarily and removably bonded to the skin, [0051], see also [0053], Fig. 5B), each of the first and second surfaces of the foam spacer is configured to compress in response to compressive forces exerted thereon, to thereby prevent such forces exerted on the foam spacer during the imaging procedure from detaching the foam spacer from the contoured surface of the skin during the imaging procedure (adhesive layer is configured to temporarily and removably bonded to the skin, [0051], see also [0053], Fig. 5B; radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]; deformable structure spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; deformable structure is not radiopaque and does not appear in generated radiological image, Figs. 6A-6B, 7, 11A-11D, 15A-15B, 16, see also [0056]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056], i.e., the conforming, flexible deformable structure and the adhesive on the deformable structure prevents forces exerted on the deformable structure from detaching the deformable structure from the skin during imaging including when the base structure and marker support by the top surface of the deformable structure are deformed and when the skin has a curvature/contour).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Park’s known technique of an adhesive, flexible foam layer for adhering to and conforming to the surface of the subject’s skin to Russell ‘461 in further view of Beekley ‘19’s known linear radiography marker with an adhesive layer to achieve the predictable result that such an adhesive, flexible foam layer provides for conformation to the undulations of the uneven surface of the skin without failure of the spacer material. See e.g., Park, [0054]-[0055].
However, while Russell ‘461 in further view of Beekley ’19 in further view of Park teaches an adhesive-backed, flexible, and compressible foam spacer, Russell ‘461 in further view of Beekley ’19 in further view of Park does not appear to explictly teach the foam spacer is elastic, the foam spacer, including the first and second surfaces thereof, is configured to stretch, and each of the first and second surfaces of the foam spacer is configured to stretch in response to tensile forces exerted thereon.
However, in the same field of endeavor of adhesive-backed support pads and solving substantially the same problem of providing a stretchable adhesive-backed support pad, Jones teaches an adhesive-backed, flexible, elastic foam spacer (foam backing pad has a bottom surface upon which a pressure sensitive adhesive is included and is configured to elastically stretch, [0032]-[0033]; electrode and backing pad are configured to adhere and flexibly conform to skin contours, [0009], [0031]-[0033]), the flexible and elastic foam spacer, including the first and second surfaces thereof, is conformable to the contoured surface of the skin with the device (top surface and bottom surface of the foam backing pad are configured to flex and elastically stretch to thereby deform with deformation of the electrode, [0009], [0031]-[0033]), and the foam spacer, including the first and second surfaces thereof, is configured to flex and stretch to thereby deform with deformation of the device (top surface and bottom surface of the foam backing pad are configured to flex and elastically stretch to thereby deform with deformation of the electrode, [0009], [0031]-[0033]), and each of the first and second surfaces of the foam spacer is configured to stretch in response to tensile forces exerted thereon to thereby prevent such forces exerted on the foam spacer during the imaging procedure from detaching the foam spacer form the contoured surface of the skin during the imaging procedure (top surface and bottom surface of the foam backing pad are configured to elastically stretch in response to tensile forces exerted thereon, [0032]-[0033]; see also electrode and backing pad adhered and flexibly conforming to skin contours, [0009], [0031]-[0033]; see also electrode and backing pad being radiolucent during an imaging procedure, [0005], [0009], i.e., the conforming, flexible, stretchable, foam backing pad and the adhesive on the bottom surface of the backing pad prevents forces exerted on the backing pad from detaching the backing pad during imaging).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Jones’ known technique of an adhesive-backed, flexible, elastic, stretchable foam layer for adhering to and conforming to the contoured surface of the subject’s skin to Russell ‘461 in further view of Beekley ’19 in further view of Park’s known linear radiography marker with an adhesive-backed, flexible, conformable foam adhesive layer to achieve the predictable result that providing an elastically stretchable foam layer allows for the layer to remain attached and conform to the contours of the subject’s body during initial attachment and during body positioning changes when the subject is in motion. See, e.g., Jones, [0031]-[0032].
Regarding claim 2, Russell ‘461 discloses the spacer defines a plurality of pairs of laterally-extending portions extending laterally on opposite sides of the elongated axis relative to each other (continuous row of adhesive pads along the length of the marker wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; each of the adhesive pads are axially spaced relative to each other along the elongated axis of the marker wire and extends laterally from the marker wire in opposing directions, Figs. 1 & 4).
However, while Russell ‘461 discloses the spacer is an adhesive pad as detailed above, Russell ‘461 does not appear to explictly disclose the spacer defines relatively narrow-width portions extending between axially-spaced pairs of laterally-extending portions.
However, in the same field of endeavor of radiography markers, Beekley ‘19 teaches the spacer defines relatively narrow-width portions extending between axially-spaced pairs of laterally-extending portions (Figure 7 demonstrates that Beekley TomoSpot scar markers comprise a marker line supported by an adhesive backing defining an axially-elongated portion with relatively narrow-width portions compared to the laterally-extending portions extending along the elongated axis of the marker lines, Fig. 7, note that in the original color version of this document, the hummingbird design pattern of the adhesive backing is visible through the see-through line marker in the axially-elongated portion, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence, Searing U.S. Design Patent No. D879,963 Figures 1 and 2 further demonstrates that for the Beekley TomoSpot scar marker, the backing material supports the marker line in the axially-elongated portion).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Beekley ‘19’s known technique of an adhesive pad shape having both an axially-elongated portion and axially-spaced, laterally-extending portions to Russell ‘461’s known adhesive pad shape to improve patient comfort under compression by preventing pinching of the patient’s skin. See, e.g., Beekley ‘19, P.2. See also MPEP 2141 III. (C).
However, while Russell ‘461 discloses the spacer is an adhesive pad that is made of paper or plastic as detailed above, Russell ‘461 in further view of Beekley ‘19 does not appear to explictly disclose the adhesive pad is made of foam.
However, in the same field of endeavor of radiopaque markers, Park teaches the adhesive pad is made of foam (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Park’s known technique of an adhesive, flexible foam layer for adhering to and conforming to the surface of the subject’s skin to Russell ‘461 in further view of Beekley ‘19’s known linear radiography marker with an adhesive layer to achieve the predictable result that such an adhesive, flexible foam layer provides for conformation to the undulations of the uneven surface of the skin without failure of the spacer material. See e.g., Park, [0054]-[0055].
Regarding claim 4, Russell ‘461 discloses the spacer extends between the linear-shaped marker and the adhesive (“line of wire”, Abstract; marker can be bent into a line, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear, Figs. 1 & 4; non-adhesive side of adhesive pad is attached to marker wire and adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16), and a thickness between the first and second surfaces thereof (continuous row of adhesive pads along the length of the marker wire which has a thickness between the top and bottom surface of each adhesive pad, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55).
However, while Russell ‘461 discloses the spacer is an adhesive pad that is made of paper or plastic and Beekley ‘19 teaches the spacer covers substantially the entirety of the underside of the marker as detailed above, Russell ‘461 in further view of Beekley ‘19 does not appear to explictly teach the adhesive pad is made of foam and the thickness between the first and second surfaces thereof is at least about 1/2 millimeter.
However, in the same field of endeavor of radiopaque markers, Park teaches the adhesive pad is made of foam (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]) that extends between the linear-shaped marker and the adhesive, and the thickness between the first and second surfaces thereof is at least about 1/2 millimeter (device deployment guide is a linear shaped marker, Figs. 14A-14B; deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure may be between 0.5-15mm thick, [0054]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Park’s known technique of an adhesive, flexible foam layer for adhering to and conforming to the surface of the subject’s skin to Russell ‘461 in further view of Beekley ‘19’s known linear radiography marker with an adhesive layer to achieve the predictable result that such an adhesive, flexible foam layer provides for conformation to the undulations of the uneven surface of the skin without failure of the spacer material. See e.g., Park, [0054]-[0055].
Regarding claim 5, Russell ‘461 discloses the spacer defines a thickness between the first and second surfaces thereof (“line of wire”, Abstract; marker can be bent into a line, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear, Figs. 1 & 4; non-adhesive side of adhesive pad is attached to marker wire and adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16; continuous row of adhesive pads along the length of the marker wire which has a thickness between the top and bottom surface of each adhesive pad, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55).
However, while Russell ‘461 discloses the spacer is an adhesive pad that is made of paper or plastic and Beekley ‘19 teaches the spacer covers substantially the entirety of the underside of the marker as detailed above, Russell ‘461 in further view of Beekley ‘19 does not appear to explictly teach the adhesive pad is made of foam that defines a thickness between the first and second surfaces thereof of about ½ millimeter to about 1 millimeter.
However, in the same field of endeavor of radiopaque markers, Park teaches the adhesive pad is made of foam (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]) that defines a thickness between the first and second surfaces thereof of about ½ millimeter to about 1 millimeter (device deployment guide is a linear shaped marker, Figs. 14A-14B; deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure may be between 0.5-15mm thick, [0054]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Park’s known technique of an adhesive, flexible foam layer for adhering to and conforming to the surface of the subject’s skin to Russell ‘461 in further view of Beekley ‘19’s known linear radiography marker with an adhesive layer to achieve the predictable result that such an adhesive, flexible foam layer provides for conformation to the undulations of the uneven surface of the skin without failure of the spacer material. See e.g., Park, [0054]-[0055].
Regarding claim 6, Russell ‘461 discloses the thickness between the first and second surfaces thereof (“line of wire”, Abstract; marker can be bent into a line, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear, Figs. 1 & 4; non-adhesive side of adhesive pad is attached to marker wire and adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16; continuous row of adhesive pads along the length of the marker wire which has a thickness between the top and bottom surface of each adhesive pad, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55).
However, while Russell ‘461 discloses the spacer is an adhesive pad that is made of paper or plastic and Beekley ’19 teaches the spacer covers substantially the entirety of the underside of the marker as detailed above, Russell ‘461 in further view of Beekley ‘19 does not appear to explictly teach the adhesive pad is made of foam wherein the thickness between the first and second surfaces thereof is uniform.
However, in the same field of endeavor of radiopaque markers, Park teaches the adhesive pad is made of foam (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]), wherein the thickness between the first and second surfaces thereof is uniform. (device deployment guide is a linear shaped marker, Figs. 14A-14B; deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure may be between 0.5-15mm thick, i.e., a uniform thickness, [0054]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Park’s known technique of an adhesive, flexible foam layer for adhering to and conforming to the surface of the subject’s skin to Russell ‘461 in further view of Beekley ‘19’s known linear radiography marker with an adhesive layer to achieve the predictable result that such an adhesive, flexible foam layer provides for conformation to the undulations of the uneven surface of the skin without failure of the spacer material. See e.g., Park, [0054]-[0055].
Regarding claim 7, Russell ‘461 discloses the adhesive coating extends substantially throughout the second surface of the spacer (the adhesive pad has a top surface below and attached to the marker wire and a bottom surface which has an adhesive, Col. 2, line 66 – Col. 3, line 16).
However, Russell ‘461 in further view of Beekley ‘19 does not appear to explicitly teach the adhesive defines an adhesive coating extending substantially through the second surface of the foam spacer.
However, in the same field of endeavor of radiopaque markers, Park teaches the adhesive pad is made of foam (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]) the adhesive defines an adhesive coating extending substantially through the second surface of the foam spacer (adhesive layer covers entirety of back surface of deformable structure and deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053])
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Park’s known technique of an adhesive, flexible foam layer for adhering to and conforming to the surface of the subject’s skin to Russell ‘461 in further view of Beekley ‘19’s known linear radiography marker with an adhesive layer to achieve the predictable result that such an adhesive, flexible foam layer provides for conformation to the undulations of the uneven surface of the skin without failure of the spacer material. See e.g., Park, [0054]-[0055].
Regarding claim 8, Russell ‘461 discloses the imaging marker is mounted on a releasable liner, and the releasable liner is releasably attached to the adhesive (adhesive pads are releasable adhered to base tape, Abstract; see also removal of adhesive pads from base tape, Col. 3, lines 38-49).
Regarding claim 9, Russell ‘461 discloses the marker defines a continuous linear shape extending along the elongated axis (“line of wire”, Abstract; marker can be bent into a line thereby defining an elongated axis, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear and thereby defines an elongated axis, Figs. 1 & 4), and the releasable liner defines an axially-elongated shape extending along the elongated axis of the linear marker (elongated base tape, Abstract; base tape is a single longitudinal strip with the marker wire running along the length of the tape, Col. 2, lines 39-56; see also Figure 1 demonstrating that tape, #12, and marker wire, #23, run along the same elongated axis, Fig. 1).
Regarding claim 10, Russell ‘461 discloses the linear marker and releasable backing are configured to be torn, cut, or separated at desired locations to form individual imaging markers therefrom at desired lengths (marker wire and tape can be cut to any desired length, Col. 1, lines 41-45, Col. 3, lines 38-49).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Russell in further view of Beekley ’19 (with additional evidence from Searing and Axis) in further view of Park in further view of Jones as applied to claim 1 above, and further in view of Russell (U.S. Pub. No. 2006/0072706), hereinafter “Russell ‘706.”
Regarding claim 3, Russell discloses the imager generates images by transmitting radiation (marker wire visible when imaged with a radiation imager to generate images, Abstract, Col. 2, lines 39-56), the marker is formed by at least one radiopaque portion on the image taken by the imager in connection with the imaging procedure (marker wire visible when imaged with a radiation imager due to being radiopaque, Abstract, Col. 2, lines 39-56).
However, while Russell discloses the spacer is an adhesive pad as detailed above, Russell does not appear to explictly disclose the spacer is translucent or radiolucent on the image taken by the imager in connection with the imaging procedure.
However, in the same field of endeavor of radiography markers, Beekley ’19 teaches the spacer is translucent or radiolucent on the image taken by the imager in connection with the imaging procedure (Figure 3 demonstrates that the adhesive backing of the Beekley TomoSpot scar marker is translucent or radiolucent on the radiography image of the linear marker taken by a CT imager and only the line marker portion of the device appears in radiography images, Fig. 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Beekley ‘19’s known technique of an adhesive pad shape having both an axially-elongated portion and axially-spaced, laterally-extending portions to Russell’s known adhesive pad shape to improve patient comfort under compression by preventing pinching of the patient’s skin. See, e.g., Beekley ‘19, P.2. See also MPEP 2141 III. (C).
However, while Russell discloses the spacer is an adhesive pad that is made of paper or plastic as detailed above, Russell in further view of Beekley does not appear to explictly disclose the adhesive pad is made of foam that is substantially radiolucent on the image taken by the imager in connection with the imaging procedure.
However, in the same field of endeavor of radiopaque markers, Park teaches the adhesive pad is made of foam (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]) that is translucent or radiolucent on the image taken by the imager in connection with the imaging procedure (deformable structure spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; deformable structure is not radiopaque and does not appear in generated radiological image, Figs. 6A-6B, 7, 11A-11D, 15A-15B, 16; see also [0056]; note that the limitation “the image of the marker taken by the imager in connection with the imaging procedure” is merely a purpose and/or intended use for the claimed spacer and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “the imager” is not part of the claimed “imaging marker”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Park’s known technique of an adhesive, flexible foam layer for adhering to and conforming to the surface of the subject’s skin to Russell in further view of Beekley ‘19’s known linear radiography marker with an adhesive layer to achieve the predictable result that such an adhesive, flexible foam layer provides for conformation to the undulations of the uneven surface of the skin without failure of the spacer material. See e.g., Park, [0054]-[0055].
However, while Russell discloses a linear radiopaque marker as detailed above, Russell in further view of Beekley ‘19 in further view of Park in further view of Jones does not appear to teach the marker is formed by at least one radiopaque portion that is at least partially radiopaque, partially radiolucent on the image taken by the imager in connection with the imaging procedure.
However, in the same field of endeavor of radiography markers, Russell ‘706 teaches the marker is formed by at least one radiopaque portion that is at least partially radiopaque, partially radiolucent on the image taken by the imager in connection with the imaging procedure (a marker that is partially radiolucent, partially radiopaque at the specified energy level of x-ray radiation used by the radiographic imager during the radiographic imaging examination, Abstract).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Russell ‘706’s known technique of adjusting marker densities and thicknesses to alter the radiation absorption of the marker to Russell in further view of Beekley ‘19 in further view of Park in further view of Jones’s known marker densities and thicknesses to achieve the predictable result of improving the ability to simultaneously view anatomical features and the marker line by selecting a marker density and thickness matched with the x-ray radiation energy such that the marker casts a legible shadow without obscuring anatomical detail present in the underlying tissue. See e.g., Russell ‘706, Abstract. See also MPEP 2141 III. (C).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Russell ‘461 in further view of Beekley ‘19 (with additional evidence from Searing and Axis) in further view of Park in further view of Jones as applied to claim 1 above, and further in view of Traboulsi (U.S. Pub. No. 2010/0276056), hereinafter “Traboulsi.”
Regarding claim 11, while Russell ‘461 in further view of Beekley ‘19 in further view of Park in further view of Jones teaches a foam spacer as detailed above, Russell ‘461 in further view of Beekley ’19 in further view of Park in further view of Jones does not appear to teach the foam of the foam spacer is a thermoplastic or thermoset foam.
However, in solving substantially the same problem of providing a comfortable patient contact surface during irradiation, Traboulsi teaches the foam of a foam spacer is a thermoplastic or thermoset foam (resilient layer is a foam spacer made of thermoplastic foam, [0037]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Traboulsi’s known technique of using thermoplastic foam adhesive pad material to Russell ‘461 in further view of Beekley ’19 in further view of Park in further view of Jones’s known foam adhesive pad material to achieve the predictable result of improving the comfort of the patient by providing a foam material that is safe for use with patients and will not irritate the user. See e.g., Traboulsi, [0037]. See also MPEP 2141 III. (C).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Russell ‘461 in further view of Beekley ‘19 (with additional evidence from Searing and Axis) in further view of Park in further view of Jones in further view of Traboulsi as applied to claim 11 above, further in view of Jessop et al. (U.S. Patent No. 6,269,148), hereinafter “Jessop.”
Regarding claim 12, Russell ‘461 in further view of Beekley ’19 in further view of Park in further view of Jones does not appear to explictly teach the foam of the foam spacer is a closed-cell foam.
However, in the same field of endeavor of radiopaque markers, Jessop teaches the foam of the foam spacer is a closed-cell foam (foam adhesive pad, Col. 2, line 54 – Col. 3, line 13; see also Col. 3, line 51 – Col. 4, line 24; foam is closed-cell foam, Col. 4, lines 5-24; see also claim 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Jessop’s known foam adhesive pad material to Russell ‘461 in further view of Beekley ‘19 in further view of Park’s known adhesive pad material to achieve the predictable result of improving the comfort of the patient by allowing for selection of a foam pad material with a desired level of compliance. See, e.g., Jessop, Col. 4, lines 5-24. See also MPEP 2141 III. (C).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Russell ‘461 in further view of Beekley ‘19 (with additional evidence from Searing and Axis) in further view of Park in further view of Jones as applied to claim 1 above, further in view of Isaacson et al. (U.S. Pub. No. 2019/0209809), hereinafter “Isaacson.”
Regarding claim 13, while Russell ‘461 discloses a linear-shaped marker (“line of wire”, Abstract; marker can be bent into a line, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear, Figs. 1 & 4) visible on an image of the marker taken by the imager in connection with the imaging procedure (marker wire visible when imaged with a radiation imager, Abstract, Col. 2, lines 39-56), Russell ‘461 in further view of Beekley ‘19 in further view of Park does not appear to teach the marker is made of a thermoplastic including a filler defining a density to make the marker visible on an image of the marker taken by the imager in connection with the imaging procedure.
However, in the same field of endeavor of radiography markers, Isaacson teaches the marker is made of a thermoplastic including a filler defining a density to make the marker visible on an image of the marker taken by the imager in connection with the imaging procedure (linear stripe markers made of a thermoplastic polymer material including a radiopaque filler thereby rendering the marker visible under x-ray imaging, [0024]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Isaacson’s known technique for a filled thermoplastic marker material to Russell ‘461 in further view of Beekley ‘19 in further view of Park’s known marker material to achieve the predictable result of improving the image contrast and sharpness of the x-ray image by allowing the tailoring of the type and/or amount of the filler in the thermoplastic marker. See e.g., Isaacson, [0024]. See also MPEP 2141 III. (C).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Russell ‘461 in further view of Beekley ’19 (with additional evidence from Searing and Axis), in further view of Park in further view of Jones.
Regarding claim 14, Russell ‘461 discloses an imaging marker for use in connection with an imager (marker system visible when imaged with a radiation imager, Col. 2, lines 39-56; note that the limitation “for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker and therefore does not have patentable weight as it does not result in a structural difference, MPEP 2111.02 II.), wherein the imaging marker is adhesively attachable and conformable to a contoured surface of the skin of a person to be imaged by the imager in connection with an imaging procedure (adhesive pads releasably adhere to the surface of the subject, Abstract; marker system is applied to the skin of the subject, Col. 4, lines 14-25; non-adhesive side of adhesive pad is attached to marker wire and adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16; marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25; marker wire is bendable, Abstract, Col. 2, lines 39-56; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25; marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25; see also bending of the marker wire system in Fig. 4; marker system visible when imaged with a radiation imager, Col. 2, lines 39-56; note that the limitation “a person to be imaged by the imager in connection with an imaging procedure” is merely a purpose and/or intended use for the claimed marker and therefore does not have patentable weight as it does not result in a structural difference, MPEP 2111.02 II.), the imaging marker can be subjected to forces during the imaging procedure, and the imaging marker is configured to prevent such forces from detaching the imaging marker from the skin (adhesive pads releasably adhere to the surface of the subject, Abstract; continuous row of adhesive pads along the length of the marker wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; marker wire visible when imaged with a radiation imager, Abstract, Col. 2, lines 39-56; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25; i.e., the adhesive and adhesive pad prevents forces exerted on the adhesive pad from detaching the adhesive pad from the skin during imaging; see also bending of the marker wire system in Fig. 4), the imaging marker comprising:
first means for releasably attaching the imaging marker to the contoured surface of the skin (adhesive on adhesive pads releasably adheres to the surface of the subject, Abstract; marker system is applied to the skin of the subject, Col. 4, lines 14-25; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25; marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25; note that the limitation “for releasably attaching…” is merely a purpose and/or intended use for the claimed marker system and therefore does not have patentable weight as it does not result in a structural difference from the releasable adhesive and the adhesive pad applied to the skin, MPEP 2111.02 II.)), wherein the surface of the skin defines a contour (adhesive pads releasably adhere to the surface of the subject, Abstract; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25) and a scar or other anatomical feature also defining a contour (marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25);
second means visible on an image of the marker taken by the imager in connection with the imaging procedure (marker wire visible when imaged with a radiation imager, Abstract, Col. 2, lines 39-56) and forming a line-shaped image (“line of wire”, Abstract; marker can be bent into a line, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear, Figs. 1 & 4), wherein the second means is for flexing (marker wire system is bendable along its elongated axis, Abstract, Col. 2, lines 39-56, Col. 3, lines 38-49; see also bending of the marker wire system in Fig. 4; note that the limitation “for flexing” is merely a purpose and/or intended use for the claimed marker system and therefore does not have patentable weight as it does not result in a structural difference from the bendable wire marker, MPEP 2111.02 II.) and substantially conforming to the contour of the skin (adhesive pads releasably adhere to the surface of the subject, Abstract; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25) and for following the contour of the scar or other anatomical feature on the skin (marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25; note that the limitation “for substantially conforming…” is merely a purpose and/or intended use for the claimed marker system and therefore does not have patentable weight as it does not result in a structural difference from the bendable wire marker, MPEP 2111.02 II.); and
third means located between the first and second means (non-adhesive side of adhesive pad is attached to marker wire and adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16) for spacing the underside of the second means away from the skin (non-adhesive side of adhesive pad is below and attached to the marker wire placed atop the adhesive pad, Col. 2, line 66 – Col. 3, line 16; continuous row of adhesive pads along the length of the marker wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; note that the limitation “for spacing…” is merely a purpose and/or intended use for the claimed marker system and therefore does not have patentable weight as it does not result in a structural difference from the bendable wire marker, MPEP 2111.02 II.), for substantially conforming to the contour of the skin (adhesive pads releasably adhere to the surface of the subject, Abstract; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25; see also bending of the marker wire system in Fig. 4; note that the limitation “for substantially conforming…” is merely a purpose and/or intended use for the claimed marker system and therefore does not have patentable weight as it does not result in a structural difference from the adhesive and the adhesive pad applied to the skin, MPEP 2111.02 II.) and following the contour of the scar or other anatomical feature on the skin (marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25; note that the limitation “[for] following…” is merely a purpose and/or intended use for the claimed marker system and therefore does not have patentable weight as it does not result in a structural difference from the adhesive and the adhesive pad applied to the skin, MPEP 2111.02 II.), and for preventing forces exerted thereon in conforming to and following the contours from detaching the first means from the skin (adhesive pads releasably adhere to the surface of the subject, Abstract; continuous row of adhesive pads along the length of the marker wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; marker wire visible when imaged with a radiation imager, Abstract, Col. 2, lines 39-56; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25; i.e., the adhesive and adhesive pad prevents forces exerted on the adhesive pad from detaching the adhesive pad from the skin during imaging; see also bending of the marker wire system in Fig. 4; note that the limitation “for preventing forces… from detaching the first means from the skin” is merely a purpose and/or intended use for the claimed marker system and therefore does not have patentable weight as it does not result in a structural difference from the adhesive and the adhesive pad applied to the skin, MPEP 2111.02 II.), wherein the first means defines a first surface and a second surface located on an opposite side of the first means relative to the first surface (the adhesive has a top surface along the bottom surface of the adhesive pad and a bottom surface that is releasably adhered to the skin and/or scar, Abstract; Col. 4, lines 14-25; see also the adhesive pad has a top surface below and attached to the marker wire and a bottom surface which has an adhesive, Col. 2, line 66 – Col. 3, line 16), the second means is supported on and attached to the first surface (the marker wire is supported on and attached to the top surface of the adhesive pad which is attached to the top surface of the adhesive, Col. 2, line 66 – Col. 3, line 16), the first means is located on the second surface (the adhesive pad has a bottom surface which has an adhesive, Col. 2, line 66 – Col. 3, line 16), and the first and second surfaces of the third means respond to forces to thereby prevent said forces exerted on the third means during the imaging procedure from detaching the third means and second means supported thereon from the contoured surface of the skin (adhesive pads releasably adhere to the surface of the subject, Abstract; continuous row of adhesive pads along the length of the marker wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; marker wire visible when imaged with a radiation imager, Abstract, Col. 2, lines 39-56; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25; marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25; i.e., the adhesive and adhesive pad prevents forces exerted on the adhesive pad from detaching the adhesive pad from the skin during imaging; see also bending of the marker wire system in Fig. 4).
However, while Russell ‘461 discloses applying the marker adhesive pads of the marker system to the surface of the skin and along a scar and that the marker is line-shaped and the marker system is configured to flex as detailed above, and further that the third means is an adhesive pad that is made of paper or plastic (adhesive pad is made of paper or plastic, Col. 2, line 66 – Col. 3, line 16), only the marker wire is disclosed as being opaque and appearing in the radiographic image (Col. 2, lines 39-56), and only the adhesive pad is disclosed as being in contact with the subject marker (continuous row of adhesive pads along the length of the marker wire and the adhesive pads can be any size and shape appropriate to support the wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; adhesive pads releasably adhere to the surface of the subject, Abstract), Russell ‘461 does not appear to explictly disclose the imaging marker can be subjected to at least one of compressive or tensile forces during the imaging procedure, and the imaging marker is configured to prevent such forces from detaching the imaging marker from the skin; the surface of the skin defines a curvilinear contour and a scar or other anatomic feature also defining a curvilinear contour; the second means forming a line-shaped image thereof in the image; and the third means defined by a flexible, elastic and compressible foam located between the first and second means that is translucent, radiolucent, or invisible on the image of the marker taken by the imager in connection with the imaging procedure for spacing substantially the entirety of the underside of the second means away from the skin, for flexing with deformation of the second means, for substantially conforming to the curvilinear contour of the skin and following the curvilinear contour of the scar or other anatomical feature on the skin, and for preventing forces exerted thereon in flexing with deformation of the second means and flexibly conforming to and following the curvilinear contours from detaching the first means from the skin; the third means, including the first and second surfaces thereof is conformable to the contoured surface of the skin with the second means and the first and second surfaces of the third means are stretchable in response to tensile forces exerted thereon or compressible in response to compressive forces exerted thereon to thereby prevent said forces exerted on the third means during the imaging procedure from detaching the third means and second means supported thereon from the contoured surface of the skin.
However, in the same field of endeavor of radiography markers, Beekley ‘19 teaches the imaging marker can be subjected to at least one of compressive or tensile forces during the imaging procedure, and the imaging marker is configured to prevent such forces from detaching the imaging marker from the skin (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; backing material is adhesive for application to scars, P.2; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression and that sticks better during positioning and compression with the material bending and expanding within the patient’s breast during compression and is releasably attached to the skin);
the surface of the skin defines a curvilinear contour and a scar or other anatomic feature also defining a curvilinear contour (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the surface of the skin of the breast defining a curvilinear contour along the surgical scar, Fig. 3; the Beekley TomoSPOT scar marker is for application to scars, P.2);
the second means forming a line-shaped image thereof in the image (Figure 3 demonstrates that the adhesive backing of the Beekley TomoSpot scar marker is translucent, radiolucent or invisible on the radiography image of the linear marker taken by a CT imager and only the line marker portion of the device appears in radiography images, Fig. 3);
the third means defined by a flexible, elastic and compressible material (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression) located between the first and second means (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin, Fig. 7) that is translucent, radiolucent, or invisible on the image of the marker taken by the imager in connection with the imaging procedure (Figure 3 demonstrates that the adhesive backing of the Beekley TomoSpot scar marker is translucent/radiolucent/invisible on the radiography image of the linear marker taken by a CT imager and only the line marker portion of the device appears in radiography images, Fig. 3; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is translucent/radiolucent/invisible on an image taken by a mammography imager) for spacing substantially the entirety of the underside of the second means away from the skin (Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises a marker line supported by an adhesive backing material along both the axially-elongated portion and the axially-spaced, laterally-extending portions, note that in the original color version of this document, the hummingbird design pattern of the adhesive backing is visible through the see-through line marker in both the axially-elongated portion and the axially-spaced, laterally-extending portions, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence, Searing U.S. Design Patent No. D879,963 Figures 1 and 2 further demonstrates that for the Beekley TomoSpot scar marker, the backing material supports the marker line along both the axially-elongated portion and the axially-spaced, laterally-extending portions; note that the limitation “for spacing…” is merely a purpose and/or intended use for the claimed marker system and therefore does not have patentable weight as it does not result in a structural difference from the adhesive and the adhesive pad applied to the skin, MPEP 2111.02 II.), for flexing with deformation of the second means (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; note that the limitation “for flexing” is merely a purpose and/or intended use for the claimed marker system and therefore does not have patentable weight as it does not result in a structural difference from the adhesive and the adhesive pad applied to the skin, MPEP 2111.02 II.; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression), for substantially conforming to the curvilinear contour of the skin (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; note that the limitation “for substantially conforming…” is merely a purpose and/or intended use for the claimed marker system and therefore does not have patentable weight as it does not result in a structural difference from the adhesive and the adhesive pad applied to the skin, MPEP 2111.02 II. note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression) and following the curvilinear contour of the scar or other anatomical feature on the skin (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the surface of the skin of the breast defining a curvilinear contour along the surgical scar, Fig. 3; the Beekley TomoSPOT scar marker is for application to scars, P.2; note that the limitation “for following…” is merely a purpose and/or intended use for the claimed marker system and therefore does not have patentable weight as it does not result in a structural difference from the adhesive and the adhesive pad applied to the skin, MPEP 2111.02 II.; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression), and for preventing forces exerted thereon in flexing with deformation of the second means and flexibly conforming to and following the curvilinear contours from detaching the first means from the skin (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; backing material is adhesive for application to scars, P.2; note that the limitation “for preventing forces… from detaching the first means from the skin” is merely a purpose and/or intended use for the claimed marker system and therefore does not have patentable weight as it does not result in a structural difference from the adhesive and the adhesive pad applied to the skin, MPEP 2111.02 II.; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression); the third means, including the first and second surfaces thereof is conformable to the contoured surface of the skin with the second means (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression) and the first and second surfaces of the third means are stretchable in response to tensile forces exerted thereon or compressible in response to compressive forces exerted thereon to thereby prevent said forces exerted on the third means during the imaging procedure from detaching the third means and second means supported thereon from the contoured surface of the skin (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; backing material is adhesive for application to scars, P.2; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression and that sticks better during positioning and compression with the material bending and expanding within the patient’s breast during compression and is releasably attached to the skin).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Beekley ‘19’s known technique of an adhesive pad shape having both an axially-elongated portion and axially-spaced, laterally-extending portions to Russell ‘461’s known adhesive pad shape to improve patient comfort under compression by preventing pinching of the patient’s skin. See, e.g., Beekley ‘19, P.2. See also MPEP 2141 III. (C).
However, while Russell ‘461 discloses a deformable linear-shaped marker and the spacer is an adhesive pad with a first and second surface that is made of paper or plastic and Beekley ‘19 teaches a deformable linear-shaped marker and that the spacer adhesive pad material is translucent/radiolucent/invisible in radiography images and is flexible, elastic, compressible, and stretchy as detailed above, Russell ‘461 in further view of Beekley ‘19 does not appear to teach the third means defined by a flexible, elastic, and compressible foam located between the first and second means that is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the imaging procedure; the third means, including the first and second surfaces thereof is conformable to the contoured surface of the skin with the second means and the first and second surfaces of the third means are stretchable in response to tensile forces exerted thereon or compressible in response to compressive forces exerted thereon to thereby prevent said forces exerted on the third means during the imaging procedure from detaching the third means and second means supported thereon from the contoured surface of the skin.
However, in the same field of endeavor of radiography markers, Park teaches the third means defined by a flexible and compressible foam located between the first and second means (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e, is flexible and conformable, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]) that is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the imaging procedure (deformable structure spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; deformable structure is not radiopaque and does not appear in generated radiological image, Figs. 6A-6B, 7, 11A-11D, 15A-15B, 16; see also [0056]; note that the limitation “the image of the marker taken by the imager in connection with the imaging procedure” is merely a purpose and/or intended use for the claimed spacer and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “the imager” is not part of the claimed “imaging marker”); the third means, including the first and second surfaces thereof is conformable to the contoured surface of the skin with the second means (deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]) and the first and second surfaces of the third means are compressible in response to compressive forces exerted thereon to thereby prevent said forces exerted on the third means during the imaging procedure from detaching the third means and second means supported thereon from the contoured surface of the skin (adhesive layer is configured to temporarily and removably bonded to the skin, [0051], see also [0053], Fig. 5B; radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]; deformable structure spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; deformable structure is not radiopaque and does not appear in generated radiological image, Figs. 6A-6B, 7, 11A-11D, 15A-15B, 16, see also [0056]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056], i.e., the conforming, flexible deformable structure and the adhesive on the deformable structure prevents forces exerted on the deformable structure from detaching the deformable structure from the skin during imaging including when the base structure and marker support by the top surface of the deformable structure are deformed and when the skin has a curvature/contour).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Park’s known technique of an adhesive, flexible foam layer for adhering to and conforming to the surface of the subject’s skin to Russell ‘461 in further view of Beekley ‘19’s known linear radiography marker with an adhesive layer to achieve the predictable result that such an adhesive, flexible foam layer provides for conformation to the undulations of the uneven surface of the skin without failure of the spacer material. See e.g., Park, [0054]-[0055].
However, while Russell ‘461 in further view of Beekley ’19 in further view of Park teaches an adhesive-backed, flexible, and compressible foam spacer, Russell ‘461 in further view of Beekley ’19 in further view of Park does not appear to explictly teach the third means defined by an elastic foam; and the first and second surfaces of the third means are stretchable in response to tensile forces exerted thereon or compressible in response to compressive forces exerted thereon to thereby prevent said forces exerted on the third means during the imaging procedure from detaching the third means and second means supported thereon from the contoured surface of the skin.
However, in the same field of endeavor of adhesive-backed support pads and solving substantially the same problem of providing a stretchable adhesive-backed support pad, Jones teaches the third means defined by a flexible and elastic foam located between the first means and second means (foam backing pad has a top surface attached to a flexible electrode and a bottom surface upon which a pressure sensitive adhesive is included and is configured to elastically stretch, [0032]-[0033]; electrode and backing pad are configured to adhere and flexibly conform to skin contours, [0009], [0031]-[0033]); the third means, including the first and second surfaces thereof is conformable to the contoured surface of the skin with the second means (top surface and bottom surface of the foam backing pad are configured to flex and elastically stretch to thereby deform with deformation of the electrode, [0009], [0031]-[0033]) and the first and second surfaces of the third means are stretchable in response to tensile forces exerted thereon to thereby prevent said forces exerted on the third means during the imaging procedure from detaching the third means and second means supported thereon from the contoured surface of the skin (top surface and bottom surface of the foam backing pad are configured to elastically stretch in response to tensile forces exerted thereon, [0032]-[0033]; see also electrode and backing pad adhered and flexibly conforming to skin contours, [0009], [0031]-[0033]; see also electrode and backing pad being radiolucent during an imaging procedure, [0005], [0009], i.e., the conforming, flexible, stretchable, foam backing pad and the adhesive on the bottom surface of the backing pad prevents forces exerted on the backing pad from detaching the backing pad during imaging).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Jones’ known technique of an adhesive-backed, flexible, elastic, stretchable foam layer for adhering to and conforming to the contoured surface of the subject’s skin to Russell ‘461 in further view of Beekley ’19 in further view of Park’s known linear radiography marker with an adhesive-backed, flexible, conformable foam adhesive layer to achieve the predictable result that providing an elastically stretchable foam layer allows for the layer to remain attached and conform to the contours of the subject’s body during initial attachment and during body positioning changes when the subject is in motion. See, e.g., Jones, [0031]-[0032].
Regarding claim 15, Russell ‘461 discloses the first means is an adhesive (adhesive pad with an adhesive side, Col. 2, line 66 – Col. 3, line 16), the second means is an axially-elongated, line-shaped marker (“line of wire”, Abstract; marker can be bent into a line thereby defining an elongated axis, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear and thereby defines an elongated axis, Figs. 1 & 4), and the third means is a spacer (adhesive pads, Abstract, Col. 2, line 66 – Col. 3, line 16), wherein the spacer is between the line-shaped marker and the adhesive (non-adhesive side of adhesive pad is attached to marker wire and adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16; “line of wire”, Abstract; marker can be bent into a line, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear, Figs. 1 & 4) and a plurality of laterally-extending portions (each of the adhesive pads extends laterally from the marker wire, Figs. 1 & 4) located on opposite sides of the elongated axis relative to each other (each of the adhesive pads extends laterally from the marker wire in opposing directions, Figs. 1 & 4) and axially-spaced relative to each other along the elongated axis (continuous row of adhesive pads along the length of the marker wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; each of the adhesive pads are axially spaced relative to each other along the elongated axis of the marker wire, Figs. 1 & 4).
However, Russell ‘461 does not appear to disclose the spacer defines an axially-elongated portion extending along the elongated axis of the line-shaped marker between the line-shaped marker and the adhesive, and a plurality of laterally-extending portions located on opposite sides of the elongated axis relative to each other and axially-spaced relative to each other along the elongated axis to thereby define bridges located between laterally-extending portions.
However, in the same field of endeavor of radiography markers, Beekley ’19 teaches the spacer defines an axially-elongated portion extending along the elongated axis of the line-shaped marker between the line-shaped marker and the adhesive (Figure 7 demonstrates that the Beekley TomoSpot scar marker comprises a marker line supported by an adhesive backing material defining an axially-elongated portion extending along the elongated axis of the marker line, note that in the original color version of this document, the hummingbird design pattern of the adhesive backing is visible through the see-through line marker in the axially-elongated portion, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence, Searing U.S. Design Patent No. D879,963 Figures 1 and 2 further demonstrates that for the Beekley TomoSpot scar marker, the backing material supports the marker line in the axially-elongated portion), and a plurality of laterally-extending portions located on opposite sides of the elongated axis relative to each other and axially-spaced relative to each other along the elongated axis to thereby define bridges located between laterally-extending portions (Figure 7 demonstrates that Beekley TomoSpot scar markers comprise a marker line supported by an adhesive backing defining an axially-elongated portion with relatively narrow-width portions compared to the laterally-extending portions extending along the elongated axis of the marker lines, Fig. 7, note that in the original color version of this document, the hummingbird design pattern of the adhesive backing is visible through the see-through line marker in the axially-elongated portion, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence, Searing U.S. Design Patent No. D879,963 Figures 1 and 2 further demonstrates that for the Beekley TomoSpot scar marker, the backing material supports the marker line in the axially-elongated portion).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Beekley ‘19’s known technique of an adhesive pad shape having both an axially-elongated portion and axially-spaced, laterally-extending portions to Russell ‘461’s known adhesive pad shape to improve patient comfort under compression by preventing pinching of the patient’s skin. See, e.g., Beekley ‘19, P.2. See also MPEP 2141 III. (C).
However, Russell ‘461 in further view of Beekley ’19 does not appear to teach the adhesive pad is made of foam.
However, in the same field of endeavor of radiopaque markers, Park teaches the adhesive pad is made of foam (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Park’s known technique of an adhesive, flexible foam layer for adhering to and conforming to the surface of the subject’s skin to Russell ‘461 in further view of Beekley ‘19’s known linear radiography marker with an adhesive layer to achieve the predictable result that such an adhesive, flexible foam layer provides for conformation to the undulations of the uneven surface of the skin without failure of the spacer material. See e.g., Park, [0054]-[0055].
Regarding claim 16, Russell ‘461 discloses the spacer defines a thickness between the first and second surfaces (“line of wire”, Abstract; marker can be bent into a line, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear, Figs. 1 & 4; non-adhesive side of adhesive pad is attached to marker wire and adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16; continuous row of adhesive pads along the length of the marker wire which has a thickness between the top and bottom surface of each adhesive pad, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55) and is configured to space the line-shaped marker away from the contoured surface of the skin (“line of wire”, Abstract; marker can be bent into a line, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear, Figs. 1 & 4; non-adhesive side of adhesive pad is attached to marker wire and adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16; continuous row of adhesive pads along the length of the marker wire which has a thickness between the top and bottom surface of each adhesive pad, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55).
However, while Russell ‘461 discloses the spacer is an adhesive pad that spaces the line-shaped marker away from the contoured surface of the skin, Russell ‘461 may not explictly disclose that the spacer is configured to substantially space the line-shaped marker away from the contoured surface of the skin.
However, in the same field of endeavor of radiography markers, Beekley ‘19 teaches the spacer defines a thickness between the first and second surfaces and is configured to substantially space the line-shaped marker away from the contoured surface of the skin (Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin with a thickness of the spacer material between the top and bottom surfaces, Fig. 7; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises a marker line supported by an adhesive backing material along both the axially-elongated portion and the axially-spaced, laterally-extending portions, note that in the original color version of this document, the hummingbird design pattern of the adhesive backing is visible through the see-through line marker in both the axially-elongated portion and the axially-spaced, laterally-extending portions, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence, Searing U.S. Design Patent No. D879,963 Figures 1 and 2 further demonstrates that for the Beekley TomoSpot scar marker, the backing material supports the marker line along both the axially-elongated portion and the axially-spaced, laterally-extending portions).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Beekley ‘19’s known technique of an adhesive pad shape having both an axially-elongated portion and axially-spaced, laterally-extending portions to Russell ‘461’s known process using an adhesive pad shape to improve patient comfort under compression by preventing pinching of the patient’s skin. See, e.g., Beekley ‘19, P.2. See also MPEP 2141 III. (C).
However, while Russell ‘461 discloses the spacer is an adhesive pad that is made of paper or plastic and Beekley ’19 teaches the spacer is configured to substantially space the line-shaped marker away from the contoured surface of the skin as detailed above, Russell ‘461 in further view of Beekley ‘19 does not appear to explictly teach the adhesive pad is made of foam that defines a uniform thickness.
However, in the same field of endeavor of radiopaque markers, Park teaches the adhesive pad is made of foam (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]), wherein the foam spacer defines a uniform thickness between the first and second surfaces and is configured to substantially uniformly space the marker away from the contoured surface of the skin (device deployment guide is a linear shaped marker, Figs. 14A-14B; deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure may be between 0.5-15mm thick, i.e., a uniform thickness, [0054]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Park’s known technique of an adhesive, flexible foam layer for adhering to and conforming to the surface of the subject’s skin to Russell ‘461 in further view of Beekley ‘19’s known linear radiography marker with an adhesive layer to achieve the predictable result that such an adhesive, flexible foam layer provides for conformation to the undulations of the uneven surface of the skin without failure of the spacer material. See e.g., Park, [0054]-[0055].
Claims 17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Russell ‘461 in further view of Beekley ’19 (with additional evidence from Searing and Axis) in further view of Park in further view of Jones.
Regarding claim 17, Russell ‘461 discloses a method (imaging a marker system, Col. 2, lines 39-56) comprising:
(i) preparing an imaging marker for attachment to a surface of the skin of a subject to be imaged (removing the tape from the marker, cutting the marker to the desired length, bending the marker to a desired shape for application to the skin of the subject, Col. 3, lines 38-49), wherein the surface of the skin defines a contour (adhesive pads releasably adhere to the surface of the subject, Abstract; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25) and a scar or other anatomical feature also defining a contour (marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25), the imaging marker includes a flexible (marker wire is bendable, Abstract, Col. 2, lines 39-56) line-shaped marker portion (“line of wire”, Abstract; marker can be bent into a line thereby defining an elongated axis, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear and thereby defines an elongated axis, Figs. 1 & 4) that is visible on an image of the marker taken by an imager in connection with an imaging procedure (marker wire visible when imaged with a radiation imager, Abstract, Col. 2, lines 39-56), an adhesive-backed spacer (adhesive pad with an adhesive side, Col. 2, line 66 – Col. 3, line 16), wherein the spacer defines a first surface and a second surface located on an opposite side of the spacer relative to the first surface (the adhesive pad has a top surface below and attached to the marker wire and a bottom surface which has an adhesive, Col. 2, line 66 – Col. 3, line 16), the line-shaped marker is supported on and attached to the first surface the marker wire is supported on and attached to the top surface of the adhesive pad, Col. 2, line 66 – Col. 3, line 16), the adhesive is located on the second surface (the adhesive pad has a bottom surface which has an adhesive, Col. 2, line 66 – Col. 3, line 16), and an image of the marker is taken by the imager in connection with the imaging procedure (marker wire visible when imaged with a radiation imager, Abstract, Col. 2, lines 39-56), and the preparing includes flexing (marker wire system is bendable along its elongated axis, Abstract, Col. 2, lines 39-56, Col. 3, lines 38-49; see also bending of the marker wire system in Fig. 4) and substantially conforming the line-shaped marker portion to the contour of the skin (adhesive pads releasably adhere to the surface of the subject, Abstract; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25) and substantially conforming to the contour of the skin (adhesive pads releasably adhere to the surface of the subject, Abstract; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25) and causing the line-shaped marker portion to substantially follow the contour of the scar or other anatomical feature on the skin (marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25);
(ii) adhesively attaching the foam spacer to the surface of the skin with the spacer in contact with the skin (adhesive pads releasably adhere to the surface of the subject, Abstract; continuous row of adhesive pads along the length of the marker wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; marker wire visible when imaged with a radiation imager, Abstract, Col. 2, lines 39-56; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25), and in connection with such attaching, causing the spacer and the line-shaped marker portion to substantially follow the contour of the scar or other anatomical feature on the skin (adhesive pads releasably adhere to the surface of the subject, Abstract; continuous row of adhesive pads along the length of the marker wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; marker wire visible when imaged with a radiation imager, Abstract, Col. 2, lines 39-56; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25; marker system is applied to the skin of the subject at the scar, Col. 4, lines 14-25);
(iii) imaging with the imager the marker portion of the imaging marker such that the marker portion is visible (marker wire visible when imaged with a radiation imager, Abstract, Col. 2, lines 39-56); and
(iv) during the releasably attaching and imaging of steps (ii) and (iii), the spacer, including the first and second surfaces thereof, absorbing forces exerted thereon during the following of the contours, and thereby preventing the spacer from detaching form the skin during the releasably attaching and imaging of steps (ii) and (iii) (adhesive pads releasably adhere to the surface of the subject, Abstract; continuous row of adhesive pads along the length of the marker wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; marker system can be bent into any desired shape for applying to subject, Col. 2, lines 39-56, Col. 3, lines 38-49; marker system is applied to the skin of the subject, Col. 4, lines 14-25; i.e., the adhesive and adhesive pad prevents forces exerted on the adhesive pad from detaching the adhesive pad from the skin during imaging; see also bending of the marker wire system in Fig. 4).
However, while Russell ‘461 discloses applying the marker adhesive pads of the marker system to the surface of the skin and along a scar and that the marker is line-shaped and the marker system is configured to flex to match a contour of the skin and scar as detailed above, and further that the spacer is an adhesive pad that is made of paper or plastic (adhesive pad is made of paper or plastic, Col. 2, line 66 – Col. 3, line 16), only the marker wire is disclosed as being opaque and appearing in the radiographic image (Col. 2, lines 39-56), and only the adhesive pad is disclosed as being in contact with the subject marker (continuous row of adhesive pads along the length of the marker wire and the adhesive pads can be any size and shape appropriate to support the wire, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55; adhesive pads releasably adhere to the surface of the subject, Abstract), Russell ‘461 does not appear to disclose the surface of the skin defines a curvilinear contour and a scar or other anatomical feature also defining a curvilinear contour; an adhesive-backed spacer comprising a flexible, elastic and compressible material; the spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the imaging procedure; (ii) adhesively attaching the spacer to the surface of the skin with the spacer in contact with and substantially conforming to the skin, and in connection with such attaching, substantially conforming the spacer, including the first and second surfaces thereof, to the curvilinear contour of the skin, and causing the spacer and the line-shaped marker portion to substantially follow the curvilinear contour of the scar or other anatomical feature on the skin; (iii) imaging with the imager the marker portion of the imaging marker and at least the portion of the person underlying the marker such that the marker portion is visible and the foam spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager; and (iv) during the releasably attaching and imaging steps, the foam material, including the first and second surface thereof, absorbing forces exerted thereon during the flexible conforming to and following of the curvilinear contours by stretching in response to tensile forces exerted thereon or compressing in response to compressive forces exerted thereon, and thereby preventing the foam spacer from detaching from the skin during the releasably attaching and imaging steps.
However, in the same field of endeavor of radiography markers, Beekley ‘19 teaches the surface of the skin defines a curvilinear contour and a scar or other anatomical feature also defining a curvilinear contour (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the surface of the skin of the breast defining a curvilinear contour along the surgical scar, Fig. 3; the Beekley TomoSPOT scar marker is for application to scars, P.2; note that while not relied upon in this rejection and provided as additional evidence, Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT include scar markers); an adhesive-backed spacer (Figure 3 demonstrates that the Beekley TomoSpot scar marker conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; backing material is adhesive for application to scars, P.2; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that sticks better during positioning and compression with the material bending and expanding within the patient’s breast during compression and is releasably attached to the skin) comprising a flexible, elastic and compressible material (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression); the spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the imaging procedure (Figure 3 demonstrates that the adhesive backing of the Beekley TomoSpot scar marker is translucent/radiolucent/invisible on the radiography image of the linear marker taken by a CT imager and only the line marker portion of the device appears in radiography images, Fig. 3; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is translucent/radiolucent/invisible on an image taken by a mammography imager), and the preparing includes flexing and substantially conforming the line-shaped marker portion to the curvilinear contour of the skin (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression) and causing the line-shaped marker portion to substantially follow the curvilinear contour of the scar or other anatomical feature on the skin (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the surface of the skin of the breast defining a curvilinear contour along the surgical scar, Fig. 3; the Beekley TomoSPOT scar marker is for application to scars, P.2; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression);
(ii) adhesively attaching the spacer to the surface of the skin with the spacer in contact with and substantially conforming to the skin (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression), and in connection with such attaching, substantially conforming the spacer, including the first and second surfaces thereof, to the curvilinear contour of the skin (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression), and causing the spacer and the line-shaped marker portion to substantially follow the curvilinear contour of the scar or other anatomical feature on the skin (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the surface of the skin of the breast defining a curvilinear contour along the surgical scar, Fig. 3; the Beekley TomoSPOT scar marker is for application to scars, P.2; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression);
(iii) imaging with the imager the marker portion of the imaging marker and at least the portion of the person underlying the marker such that the marker portion is visible (Figure 3 demonstrates that the adhesive backing of the Beekley TomoSpot scar marker is translucent/radiolucent/invisible on the radiography image of the linear marker taken by a CT imager and only the line marker portion of the device appears in radiography images of the person, Fig. 3; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is translucent/radiolucent/invisible on an image taken by a mammography imager) and the spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager (Figure 3 demonstrates that the adhesive backing of the Beekley TomoSpot scar marker is translucent/radiolucent/ invisible on the radiography image of the linear marker taken by a CT imager and only the line marker portion of the device appears in radiography images, Fig. 3; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is translucent/radiolucent/invisible on an image taken by a mammography imager); and
(iv) during the releasably attaching and imaging steps, the foam material, including the first and second surface thereof, absorbing forces exerted thereon during the flexible conforming to and following of the curvilinear contours Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression) by stretching in response to tensile forces exerted thereon or compressing in response to compressive forces exerted thereon, and thereby preventing the foam spacer from detaching from the skin during the releasably attaching and imaging steps (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; backing material is adhesive for application to scars, P.2; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression and that sticks better during positioning and compression with the material bending and expanding within the patient’s breast during compression and is releasably attached to the skin).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Beekley ‘19’s known technique of an adhesive pad shape having both an axially-elongated portion and axially-spaced, laterally-extending portions to Russell ‘461’s known process using an adhesive pad shape to improve patient comfort under compression by preventing pinching of the patient’s skin. See, e.g., Beekley ‘19, P.2. See also MPEP 2141 III. (C).
However, while Russell ‘461 discloses a deformable linear-shaped marker and the spacer is an adhesive pad with a first and second surface that is made of paper or plastic and Beekley ‘19 teaches a deformable linear-shaped marker and that the spacer adhesive pad material is translucent/radiolucent/invisible in radiography images and is flexible, elastic, compressible, and stretchy as detailed above, Russell ‘461 in further view of Beekley ‘19 does not appear to teach the adhesive pad is an adhesive-backed foam spacer comprising a flexible, elastic and compressible foam material; the foam spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the imaging procedure; adhesively attaching the foam spacer to the surface of the skin with the foam spacer in contact with and substantially conforming to the skin, and in connection with such attaching, substantially conforming the foam spacer, including the first and second surfaces thereof, to the curvilinear contour of the skin and causing the foam spacer and the marker portion to substantially follow the curvilinear contour of the scar or other anatomical feature on the skin; and during the releasably attaching and imaging steps, the foam material, including the first and second surface thereof, absorbing forces exerted thereon during the flexible conforming to and following of the curvilinear contours by stretching in response to tensile forces exerted thereon or compressing in response to compressive forces exerted thereon, and thereby preventing the foam spacer from detaching from the skin during the releasably attaching and imaging steps.
However, in the same field of endeavor of radiography markers, Park teaches an adhesive-backed foam spacer comprising a flexible and elastic foam material (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e, is flexible and conformable, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]); the foam spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the imaging procedure (deformable structure spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; deformable structure is not radiopaque and does not appear in generated radiological image, Figs. 6A-6B, 7, 11A-11D, 15A-15B, 16; see also [0056]);
(ii) adhesively attaching the foam spacer to the surface of the skin with the foam spacer in contact with and substantially conforming to the skin (deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), and in connection with such attaching, substantially conforming the foam spacer, including the first and second surfaces thereof, to the curvilinear contour of the skin and causing the foam spacer and the marker portion to substantially follow the curvilinear contour of the scar or other anatomical feature on the skin (deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]);
(iii) imaging with the imager the marker portion of the imaging marker and at least the portion of the person underlying the marker such that the marker portion is visible (radiopaque marker element is visible in radiographic image, [0056]), and the foam spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager (deformable structure spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; deformable structure is not radiopaque and does not appear in generated radiological image, Figs. 6A-6B, 7, 11A-11D, 15A-15B, 16; see also [0056]); and
(iv) during the releasably attaching and imaging of steps (ii) and (iii) (adhesive layer is configured to temporarily and removably bond to the skin, [0051], see also [0053], Fig. 5B; radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]), the foam material, including the first and second surface thereof, absorbing forces exerted thereon during the flexible conforming to and following of the curvilinear contours (deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]; adhesive layer is configured to temporarily and removably bonded to the skin, [0051], see also [0053], Fig. 5B) by compressing in response to compressive forces exerted thereon, and thereby preventing the foam spacer from detaching from the skin during the releasably attaching and imaging of steps (ii) and (iii) (adhesive layer is configured to temporarily and removably bonded to the skin, [0051], see also [0053], Fig. 5B; radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]; deformable structure spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; deformable structure is not radiopaque and does not appear in generated radiological image, Figs. 6A-6B, 7, 11A-11D, 15A-15B, 16, see also [0056]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056], i.e., the conforming, flexible deformable structure and the adhesive on the deformable structure prevents forces exerted on the deformable structure from detaching the deformable structure from the skin during imaging including when the base structure and marker support by the top surface of the deformable structure are deformed and when the skin has a curvature/contour).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Park’s known technique of an adhesive, flexible foam layer for adhering to and conforming to the surface of the subject’s skin to Russell ‘461 in further view of Beekley ‘19’s known process using a linear radiography marker with an adhesive layer to achieve the predictable result that such an adhesive, flexible foam layer provides for conformation to the undulations of the uneven surface of the skin without failure of the spacer material. See e.g., Park, [0054]-[0055].
However, while Russell ‘461 in further view of Beekley ’19 in further view of Park teaches an adhesive-backed, flexible, and compressible foam spacer, Russell ‘461 in further view of Beekley ’19 in further view of Park does not appear to explictly teach the foam spacer comprises an elastic foam material; and during the releasably attaching and imaging of steps (ii) and (iii), the foam material, including the first and second surface thereof, absorbing forces exerted thereon during the flexible conforming to and following of the curvilinear contours by stretching in response to tensile forces exerted thereon, and thereby preventing the foam spacer from detaching from the skin during the releasably attaching and imaging of steps (ii) and (iii).
However, in the same field of endeavor of adhesive-backed support pads and solving substantially the same problem of providing a stretchable adhesive-backed support pad, Jones teaches an adhesive-backed foam spacer comprising a flexible and elastic foam material (foam backing pad has a bottom surface upon which a pressure sensitive adhesive is included and is configured to elastically stretch, [0032]-[0033]; electrode and backing pad are configured to adhere and flexibly conform to skin contours, [0009], [0031]-[0033]);
(ii) adhesively attaching the foam spacer to the surface of the skin with the foam spacer in contact with and substantially conforming to the skin (foam backing pad has a bottom surface upon which a pressure sensitive adhesive is included and is configured to elastically stretch, [0032]-[0033]; electrode and backing pad are configured to adhere and flexibly conform to skin contours, [0009], [0031]-[0033]; top surface and bottom surface of the foam backing pad are configured to flex and elastically stretch to thereby deform with deformation of the electrode, [0009], [0031]-[0033]), and in connection with such attaching, substantially conforming the foam spacer, including the first and second surfaces thereof, to the curvilinear contour of the skin and causing the foam spacer and the device portion to substantially follow the curvilinear contour of the scar or other anatomical feature on the skin (top surface and bottom surface of the foam backing pad are configured to flex and elastically stretch to thereby deform with deformation of the electrode, [0009], [0031]-[0033]; electrode and backing pad are configured to adhere and flexibly conform to skin and body/anatomical contours, [0009], [0031]-[0033]);
(iv) during the releasably attaching and imaging of steps (ii) and (iii), the foam material, including the first and second surface thereof, absorbing forces exerted thereon during the flexible conforming to and following of the curvilinear contours by stretching in response to tensile forces exerted thereon, and thereby preventing the foam spacer from detaching from the skin during the releasably attaching and imaging of steps (ii) and (iii) ((foam backing pad has a bottom surface upon which a pressure sensitive adhesive is included and is configured to elastically stretch, [0032]-[0033]; top surface and bottom surface of the foam backing pad are configured to elastically stretch in response to tensile forces exerted thereon, [0032]-[0033]; see also electrode and backing pad adhered and flexibly conforming to skin contours, [0009], [0031]-[0033]; see also electrode and backing pad being radiolucent during an imaging procedure, [0005], [0009], i.e., the conforming, flexible, stretchable, foam backing pad and the adhesive on the bottom surface of the backing pad prevents forces exerted on the backing pad from detaching the backing pad during imaging).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Jones’ known technique of an adhesive-backed, flexible, elastic, stretchable foam layer for adhering to and conforming to the contoured surface of the subject’s skin to Russell ‘461 in further view of Beekley ’19 in further view of Park’s known process of using a linear radiography marker with an adhesive-backed, flexible, conformable foam adhesive layer to achieve the predictable result that providing an elastically stretchable foam layer allows for the layer to remain attached and conform to the contours of the subject’s body during initial attachment and during body positioning changes when the subject is in motion. See, e.g., Jones, [0031]-[0032].
Regarding claim 19, while Russell ‘461 discloses applying the marker to a scar as detailed above and cutting the imaging marker to any desired length (marker wire and tape can be cut to any desired length, Col. 1, lines 41-45, Col. 3, lines 38-49), Russell ‘461 does not appear to explictly disclose the scar or other anatomical feature defines a length, and cutting the imaging marker to a length approximately equal to or greater than the length of the scar or other anatomical feature.
However, in the same field of endeavor of radiography markers, Beekley ‘19 teaches the scar or other anatomical feature defines a length (Figure 3 demonstrates that the scar defines a length along the skin of the patient’s breast, Fig. 3), and cutting the imaging marker to a length approximately equal to or greater than the length of the scar or other anatomical feature (Figure 3 demonstrates that the Beekley TomoSPOT marker line has been cut to match the length of the surgical scar, Fig. 3)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Beekley ‘19’s known technique of an adhesive pad shape having both an axially-elongated portion and axially-spaced, laterally-extending portions to Russell ‘461’s known process of using an adhesive pad shape to improve patient comfort under compression by preventing pinching of the patient’s skin. See, e.g., Beekley ‘19, P.2. See also MPEP 2141 III. (C).
Regarding claim 20, Russell ‘461 discloses the spacer defines a thickness between the first and second surfaces (“line of wire”, Abstract; marker can be bent into a line, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear, Figs. 1 & 4; non-adhesive side of adhesive pad is attached to marker wire and adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16; continuous row of adhesive pads along the length of the marker wire which has a thickness between the top and bottom surface of each adhesive pad, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55), and step (ii) includes the spacer spacing the line-shaped marker from the skin (“line of wire”, Abstract; marker can be bent into a line, Col. 3, lines 38-49; Figures 1 and 4 demonstrate that the marker wire is linear, Figs. 1 & 4; non-adhesive side of adhesive pad is attached to marker wire and adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16; continuous row of adhesive pads along the length of the marker wire which has a thickness between the top and bottom surface of each adhesive pad, Col. 2, line 66 – Col. 3, line 16; see also Col. 1, lines 48-55).
However, while Russell ‘461 discloses the spacer is an adhesive pad that spaces the line-shaped marker away from the contoured surface of the skin, Russell ‘461 may not explictly disclose that the spacer substantially spacing the line-shaped marker from the skin.
However, in the same field of endeavor of radiography markers, Beekley ’19 teaches the spacer defines a thickness between the first and second surfaces and step (ii) includes the spacer substantially spacing the line-shaped marker from the skin (Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin with a thickness of the spacer material between the top and bottom surfaces, Fig. 7; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises a marker line supported by an adhesive backing material along both the axially-elongated portion and the axially-spaced, laterally-extending portions, note that in the original color version of this document, the hummingbird design pattern of the adhesive backing is visible through the see-through line marker in both the axially-elongated portion and the axially-spaced, laterally-extending portions, Fig. 7; note that while not relied upon in this rejection and provided as additional evidence, Searing U.S. Design Patent No. D879,963 Figures 1 and 2 further demonstrates that for the Beekley TomoSpot scar marker, the backing material supports the marker line along both the axially-elongated portion and the axially-spaced, laterally-extending portions).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Beekley ‘19’s known technique of an adhesive pad shape having both an axially-elongated portion and axially-spaced, laterally-extending portions to Russell ‘461’s known process using an adhesive pad shape to improve patient comfort under compression by preventing pinching of the patient’s skin. See, e.g., Beekley ‘19, P.2. See also MPEP 2141 III. (C).
However, while Russell ‘461 discloses the spacer is an adhesive pad that is made of paper or plastic and Beekley ’19 teaches the spacer is configured to substantially space the line-shaped marker away from the contoured surface of the skin as detailed above, Russell ‘461 in further view of Beekley ‘19 does not appear to explictly teach the adhesive pad is made of foam that defines a uniform thickness.
However, in the same field of endeavor of radiopaque markers, Park teaches the adhesive pad is made of foam (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]), wherein the foam spacer defines a uniform thickness between the first and second surfaces, and step (ii) includes the foam spacer substantially uniformly spacing the line-shaped marker from the skin (device deployment guide is a linear shaped marker, Figs. 14A-14B; deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure may be between 0.5-15mm thick, i.e., a uniform thickness, [0054]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Park’s known technique of an adhesive, flexible foam layer for adhering to and conforming to the surface of the subject’s skin to Russell ‘461 in further view of Beekley ‘19’s known process of using a linear radiography marker with an adhesive layer to achieve the predictable result that such an adhesive, flexible foam layer provides for conformation to the undulations of the uneven surface of the skin without failure of the spacer material. See e.g., Park, [0054]-[0055].
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Russell in further view of Beekley ‘19 in further view of Park in further view of Jones as applied to claim 17 above, and further in view of Russell ‘706.
Regarding claim 18, Russell discloses the imaging includes transmitting radiation through the imaging marker wherein the marker portion is radiopaque (marker wire visible when imaged with a radiation imager to generate images, Abstract, Col. 2, lines 39-56).
However, while Russell discloses the spacer is an adhesive pad that is made of paper or plastic as detailed above, Russell does not appear to explictly disclose that the spacer is translucent or radiolucent on the image of the marker portion taken by the imager.
However, in the same field of radiography markers, Beekley ’19 teaches the spacer is translucent or radiolucent on the image of the marker portion taken by the imager (Figure 3 demonstrates that the adhesive backing of the Beekley TomoSpot scar marker is translucent or radiolucent on the radiography image of the linear marker taken by a CT imager and only the line marker portion of the device appears in radiography images, Fig. 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Beekley ‘19’s known technique of an adhesive pad shape having both an axially-elongated portion and axially-spaced, laterally-extending portions to Russell’s known process using an adhesive pad shape to improve patient comfort under compression by preventing pinching of the patient’s skin. See, e.g., Beekley ‘19, P.2. See also MPEP 2141 III. (C).
However, while Russell discloses the spacer is an adhesive pad that is made of paper or plastic as detailed above, Russell in further view of Beekley does not appear to explictly disclose the adhesive pad is made of foam wherein the foam spacer is translucent or radiolucent on the image of the marker portion taken by the imager.
However, in the same field of endeavor of radiopaque markers, Park teaches the adhesive pad is made of foam (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]) wherein the foam spacer is translucent or radiolucent on the image of the marker portion taken by the imager (deformable structure spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; deformable structure is not radiopaque and does not appear in generated radiological image, Figs. 6A-6B, 7, 11A-11D, 15A-15B, 16; see also [0056]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Park’s known technique of an adhesive, flexible foam layer for adhering to and conforming to the surface of the subject’s skin to Russell in further view of Beekley ‘19’s known process of using a linear radiography marker with an adhesive layer to achieve the predictable result that such an adhesive, flexible foam layer provides for conformation to the undulations of the uneven surface of the skin without failure of the spacer material. See e.g., Park, [0054]-[0055].
However, while Russell discloses a linear radiopaque marker as detailed above, Russell in further view of Beekley ‘19 in further view of Park in further view of Jones does not appear to teach the marker portion is partially radiopaque, partially radiolucent.
However, in the same field of endeavor of radiography markers, Russell ‘706 teaches the marker is formed by at least one radiopaque portion that is at least partially radiopaque, partially radiolucent on the image taken by the imager in connection with the imaging procedure (a marker that is partially radiolucent, partially radiopaque at the specified energy level of x-ray radiation used by the radiographic imager during the radiographic imaging examination, Abstract).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Russell ‘706’s known technique of adjusting marker densities and thicknesses to alter the radiation absorption of the marker to Russell in further view of Beekley ‘19 in further view of Park in further view of Jones’s known process employing marker densities and thicknesses to achieve the predictable result of improving the ability to simultaneously view anatomical features and the marker line by selecting a marker density and thickness matched with the x-ray radiation energy such that the marker casts a legible shadow without obscuring anatomical detail present in the underlying tissue. See e.g., Russell ‘706, Abstract. See also MPEP 2141 III. (C).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jessop et al. (U.S. Pub. No. 2004/0116802) (“Jessop ‘04”) discloses, for example, the features of claim 1 of an imaging marker (medical imaging marker, [0017]) for use in connection with an imager (x-ray imaging, [0017]), comprising:
a linear-shaped marker (formable wire-like marking body structure, [0043], Fig. 5C) that is visible on an image of the marker taken by the imager in connection with an imaging procedure (at least partially radiopaque marking body visible in x-ray images, [0013], [0016]-[0017]), wherein the linear-shaped marker is flexible (carrier is moldable, malleable, soft, elastomeric, and/or bendable as desired, [0040], [0043]) and defines an underside (Figure 3 shows the wire-like marking body structure having a top surface, Fig. 3; formable wire-like marking body structure is disposed above an adhesive substrate, [0043], Fig. 3; marking body has a bottom surface disposed above the top surface of an adhesive, the bottom surface of the adhesive is above a to surface of an attachment substrate, [0032], Fig. 1) and an elongated axis (formable wire-like marking body structure defines an elongated axis, Fig. 1);
an adhesive (adhesive substrate, [0043], Fig. 5C; attachment substrate has a bottom surface upon which an adhesive layer is disposed, [0032], Fig. 1); and
a spacer (adhesive substrate, [0043], Fig. 5C; attachment substrate, [0032], Fig. 1) wherein the spacer is located between the adhesive and the marker (adhesive substrate, [0043], Fig. 5C; attachment substrate is between the marking body and the adhesive layer, [0032], Fig. 1), and defines a thickness between the adhesive and substantially the entirety of the underside of the marker (adhesive substrate covers substantially the entirety of the underside of the formable wire-like marking body structure, [0043], Fig. 5C; attachment substrate has a thickness that separates substantially the entirety of the underside of the marking body from the adhesive layer, [0032], Fig. 1) the adhesive is configured to releasably attach the imaging marker to a surface of a person's skin undergoing the imaging procedure at an interface of the imaging marker and the skin (adhesive layer is releasably attached to a backing layer, the backing layer being removed to attach the attachment substrate to the skin, [0032]; adhesive layer is releasably attached to the skin, [0033]), and the spacer spaces substantially the entirety of the underside of the marker away from the skin (adhesive substrate covers substantially the entirety of the underside of the formable wire-like marking body structure, [0043], Fig. 5C; attachment substrate has a thickness that separates substantially the entirety of the underside of the marking body from the adhesive layer, the adhesive layer being attached to the skin, [0032], Fig. 1), wherein the spacer defines an axially-elongated portion extending along the elongated axis of the linear marker between the linear marker and the adhesive (adhesive substrate covers substantially the entirety of the underside of the formable wire-like marking body structure including the portions along the elongated axis of the formable wire-like marking body structure, [0043], Fig. 5C; See also attachment substrate has a thickness that separates substantially the entirety of the underside of the marking body from the adhesive layer, [0032], Fig. 1), and a plurality of laterally-extending portions (adhesive substrate forms a plurality of laterally-extending portions, Fig. 5C), wherein a plurality of the laterally-extending portions are located on opposite sides of the elongated axis relative to each other (adhesive substrate forms a plurality of laterally-extending portions that form opposing portions, Fig. 5C), at least a portion of a plurality of the laterally-extending portions are axially spaced relative to each other along the elongated axis (adhesive substrate forms a plurality of laterally-extending portions that have gaps between the laterally-extending portions, Fig. 5C), and the spacer is configured to flex, at least between the axially-spaced, laterally-extending portions (adhesive substrate is configured to allow the wire-like structure to be bendable, [0043]; Figure 5C demonstrates that the formable wire-like marking body structure and adhesive substrate is flexed in multiple directions at least between the axially-spaced, laterally-extending portions, Fig. 5C), to thereby allow the spacer to flex with deformation of the linear-shaped marker (adhesive substrate is configured to allow the wire-like structure to be bendable, [0043]; Figure 5C demonstrates that the formable wire-like marking body structure and adhesive substrate is flexed in multiple directions, Fig. 5C) and to, upon releasable adhesive attachment of said imaging marker with a deformed linear-shaped marker to the skin with the spacer substantially conformed to the skin prevent forces exerted on the spacer from detaching the spacer from the skin during the imaging procedure (adhesive layer is releasably attached to a backing layer, the backing layer being removed to attach the attachment substrate to the skin, [0032]; adhesive layer is releasably attached to the skin, [0033]; adhesive substrate is configured to allow the wire-like structure to be bendable, [0043]; Figure 5C demonstrates that the formable wire-like marking body structure and adhesive substrate is flexed in multiple directions at least between the axially-spaced, laterally-extending portions, Fig. 5C).
Jessop ’04 further discloses adjusting the density of the carrier and filler of the marking body to make the marking body partially radiopaque, partially radiolucent ([0012]-[0014], [0016]-[0017], [0034]-[0035]).
Joseph et al. (U.S. Patent No. 7,602,883) discloses an imaging marker for radiographic imaging including a partially radiopaque, partially radiolucent marker substantially entirely disposed atop a marker substrate using adhesive and the marker substrate bottom surface having an adhesive for adhering and conforming to the skin of the patient at a region of interest to mark the region of interest in the radiographic image.
Beekley (“CT Treatment Planning: Accuracy in Treatment Planning Affects the Efficacy of Treatment” 2016) discloses the Beekley CT-SPOT and S-SPOT line marker system comprising a radiopaque line marker atop a spacer adhesive pad layer that is adhered to the skin of the patient along anatomical landmarks such as scars and flex to follow the curvilinear contour of the skin and scar surface that when imaged with a radiography imager only the line marker is visible in the radiography image. As admitted by the applicant on page 9 of the Remarks filed 29 March 2024, Beekley teaches that a PHOSITA in at least 2016 would expect a linear marker to be “[1] flexible, [2] contour to the skin, and [3] clearly denote the area of concern in imaging and CT simulation [4] without lifting or coming off” (Beekley, P.1, ¶5) (numbering added). Beekley further teaches that each of these expectations are achieved with the CT-SPOT and/or S-SPOT line markers by mirroring/paralleling each of these expectations in that Beekley’s markers “are [1] flexible and [2] contour easily around corners. [4] With a medical-grade, latex-free adhesive, it provides the ‘just right’ stick that radiation therapists value. [3] The non-metallic line images brightly on every slice that it appears on during simulation while also reducing artifact and streaking.” (Beekley, P.1, ¶10) (numbering added).
MacLennan (“DCIS Treatment with Conformal Breast Tangents and Field in Field Dose Shaping” 2015) discloses the application of Beekely CT-SPOT line marker system comprising a radiopaque line marker atop a spacer adhesive pad layer that is adhered to the skin of the patient along anatomical landmarks such as scars and flex to following the curvilinear contour of the skin and scar surface that when imaged with a radiography imager only the line marker is visible in the radiography image.
Russell (U.S. Patent No. 5,232,452) discloses the application of a line marker system comprising a radiopaque line marker atop a spacer adhesive pad layer that is adhered to the skin of the patient along anatomical landmarks such as scars and are bendable to follow the contour of the skin and scar surface that when imaged with a radiography imager only the line marker is visible in the radiography image.
Russell (U.S. Patent No. 5,383,233) discloses the application of marker system comprising a partially radiopaque, partially radiolucent marker atop a spacer adhesive pad layer this is adhered to the skin of the patient on anatomical landmarks and that when imaged with a radiography imager only the marker is visible in the radiography image.
Beekley (“Conventional Simulation” 2016) discloses the application of Beekely T-SPOT line marker system comprising a radiopaque line marker atop a spacer adhesive pad layer that is adhered to the skin of the patient along anatomical landmarks such as scars and flex to following the curvilinear contour of the skin and scar surface that when imaged with a radiography imager only the line marker is visible in the radiography image.
Apostolidis (U.S. Design Patent No. 767,138) discloses a line marker system comprising a line marker region atop a spacer layer.
Apostolidis (U.S. Design Patent No. 702,839) discloses a pellet marker system comprising a single pellet marker region atop a spacer layer.
Jones et al. (U.S. Pub. No. 2012/0253,162), Gadsby et al. (U.S. Pub. No. 2003/0074042 and U.S. Pub. No. 2003/0004558), and Grayzel et al. (U.S. Patent No. 4,102,331) disclose radiolucent, foam adhesive pads for adhering and conforming to the surface of the skin of a patient during radiographic imaging.
Beekley (“Innovative Medical Products” 2016) discloses Beekley linear and pellet TomoSPOT, pellet N, X, Y, and V-SPOT, linear S-SPOT, linear, pellet, and crosshair CT-SPOT, and linear T-SPOT markers comprising a marker, a spacer, and adhesive that flexibly and removably adhere to the skin.
CT-SPOT crosshair in an “X” formation for use in 3-point setups by applying the adhesive markers to the patient’s skin and imaging the patient such that only the non-metallic “X” marker shows up in the radiology image.
Beekley (“CT Treatment Planning: Finding the Zero Slice” 2016) discloses the Beekley CT-SPOT crosshair marker comprising a marker, a spacer, and adhesive that flexibly and removably adhere to the skin. CT-SPOT crosshair in an “X” formation for use in 3-point setups by applying the adhesive markers to the patient’s skin and imaging the patient such that only the non-metallic “X” marker shows up in the radiology image.
Beekley (“Our Best Practice with Crosshair Skin Markers for Three Point Set-Ups in CT Simulation” 2015) discloses the Beekley CT-SPOT crosshair marker comprising a marker, a spacer, and adhesive that flexibly and removably adhere to the skin. CT-SPOT crosshair in an “X” formation for use in 3-point setups by applying the adhesive markers to the patient’s skin and imaging the patient such that only the non-metallic “X” marker shows up in the radiology image.
Park (U.S. Pub. No. 2019/0261894) discloses a radiopaque imaging marker with a radiopaque marker portion, a radiolucent spacer made of foam of a thickness greater than 1mm, and a radiolucent adhesive backing layer for releasable attachment to the skin of a patient during radiological imaging.
Russell (U.S. Patent No. 7,263,159) discloses the application of marker system comprising a partially radiopaque, partially radiolucent marker atop a spacer adhesive pad layer this is adhered to the skin of the patient on anatomical landmarks and that when imaged with a radiography imager only the marker is visible in the radiography image.
Dzierlatka (U.S. Design Patent No. 688,373) discloses a pellet marker system comprising a single pellet marker region atop a spacer layer.
Boutte (U.S. Design Patent No. 683,020) discloses a pellet marker system comprising a single pellet marker region atop a spacer layer.
Dzierlatka (U.S. Design Patent No. 643,928) discloses a pellet marker system comprising a single pellet marker region atop a spacer layer.
Dzierlatka (U.S. Design Patent No. 627,469) discloses a pellet marker system comprising a single pellet marker region atop a spacer layer.
Traboulsi (U.S. Pub. No. 2010/0113860) discloses a crosshair marker system comprising a crosshair marker region atop a spacer layer with adhesive for releasably adhering to the subject’s skin.
Dzierlatka (U.S. Design Patent No. 602,590) discloses a pellet marker system comprising a single pellet marker region atop a spacer layer.
Dzierlatka (U.S. Design Patent No. 559,985) discloses a pellet marker system comprising a single pellet marker region atop a spacer layer.
Archambault (U.S. Design Patent No. 552,735) discloses a pellet marker system comprising a single pellet marker region atop a spacer layer.
PDC Healthcare (“Introducing New Spee-D-Mark 3D Breast Tomo Markers” 2018) discloses the application of PDC Healthcare Spee-D-Mark breast tomography markers including a radiopaque linear scar marker atop a radiolucent spacer adhesive pad that is adhered to the skin of the patient along anatomical landmarks such as scars and flex to following the curvilinear contour of the skin and scar surface that when imaged with a radiography imager only the line marker is visible in the radiography image.
PDC Healthcare (“Medical Records, Imaging & Supplies Catalog” 2014) discloses the application of PDC Healthcare Spee-D-Mark/Spee-D-Line, Radiopaque and Radiolucent – No Burnout, markers including a radiopaque linear scar marker atop a super stretchy radiolucent spacer adhesive pad that is adhered to the skin of the patient along anatomical landmarks such as scars and flex to following the curvilinear contour of the skin and scar surface that when imaged with a radiography imager only the line marker is visible in the radiography image.
PDC Healthcare (“Quick Reference Guide to Mammography Skin Markers” 2017) discloses the application of scar markers including a radiopaque linear scar marker atop a radiolucent spacer adhesive pad that is adhered to the skin of the patient along anatomical landmarks such as scars and flex to following the curvilinear contour of the skin and scar surface that when imaged with a radiography imager only the line marker is visible in the radiography image.
Beekley Medical (“TenderTouch Cushioned Tape for Thermoplastic Masks” 2019) and (“How Comfort Influences Patient’s Compliance to RT Treatments” 2019) discloses an adhesive foam spacer that can be placed beneath a crosshair marker or other structure such as a therapy mask and defines a thickness between the adhesive and the crosshair marker, the adhesive is configured to releasably attach the marker to a surface of a person’s skin undergoing the procedure at an interface of the marker and the skin, and the foam spacer spaces substantially the entirety of the underside of the marker away from the skin, wherein the foam spacer defines an axially-elongated portion extending along an elongated axis between the marker and the adhesive, and a plurality of laterally-extending portions, wherein a plurality of the laterally-extending portions are located on opposite sides of the elongated axis relative to each other, at least a portion of a plurality of the laterally-extending portions are axially spaced relative to each other along the elongated axis, and the foam spacer is configured to flex, at least between the axially-spaced, laterally-extending portions, to thereby allow the spacer to flex with deformation of the marker and to, upon releasable adhesive attachment of said marker with a deformed linear-shaped marker to the skin with the foam spacer substantially conformed to the skin, prevent forces exerted on the foam spacer from detaching the foam spacer from the skin during the procedure.
Beekley (“Innovative Medical Products” 2013) discloses Beekley linear and pellet TomoSPOT, pellet N, X, Y, and V-SPOT, linear S-SPOT, linear, pellet, and crosshair CT-SPOT, and linear T-SPOT markers comprising a marker, a spacer, and adhesive that flexibly and removably adhere to the skin.
CT-SPOT crosshair in an “X” formation for use in 3-point setups by applying the adhesive markers to the patient’s skin and imaging the patient such that only the non-metallic “X” marker shows up in the radiology image.
Beekley (“Defining Treatment Fields in Breast Conservation Therapy” 2019) discloses the application of Beekely CT-SPOT line marker system comprising a radiopaque line marker atop a spacer adhesive pad layer that is adhered to the skin of the patient along anatomical landmarks such as scars and flex to following the curvilinear contour of the skin and scar surface that when imaged with a radiography imager only the line marker is visible in the radiography image.
Beekley (“Supine vs. Prone Breast Treatment Planning” 2018) discloses the application of Beekely CT-SPOT line marker system comprising a radiopaque line marker atop a spacer adhesive pad layer that is adhered to the skin of the patient along anatomical landmarks such as scars and flex to following the curvilinear contour of the skin and scar surface that when imaged with a radiography imager only the line marker is visible in the radiography image.
Beekley (“Digital Breast Tomosynthesis: A Planning Guide to Integrating the Latest Advancement into your Imaging Center” 2014) discloses the application of Beekely TOMO-SPOT line marker system comprising a radiopaque line marker atop a spacer adhesive pad layer that is adhered to the skin of the patient along anatomical landmarks such as scars and flex to following the curvilinear contour of the skin and scar surface that when imaged with a radiography imager only the line marker is visible in the radiography image.
Beekley (“How One Radiation Oncologist Delineates Superficial Landmarks and Scars in CT Treatment Planning” 2018) discloses the application of Beekely CT-SPOT line marker system comprising a radiopaque line marker atop a spacer adhesive pad layer that is adhered to the skin of the patient along anatomical landmarks such as scars that when imaged with a radiography imager only the line marker is visible in the radiography image.
Beekley (“How Linear Markers used in Radiation Oncology Treatment Planning can Affect Accuracy and Efficacy” 2017) discloses the application of Beekely CT-SPOT line marker system comprising a radiopaque line marker atop a spacer adhesive pad layer that is adhered to the skin of the patient along anatomical landmarks such as scars and flex to following the curvilinear contour of the skin and scar surface that when imaged with a radiography imager only the line marker is visible in the radiography image.
Beekley (“Overcoming Challenges with Temporary Set-Up Marks in Radiation Oncology” 2016) discloses the Beekley crosshair marker comprising a marker, a spacer, and adhesive that flexibly and removably adhere to the skin.
Radiation Products Design Inc. (“Marking – Film, Skin & Tattoo, Fiducial Markers” 2019) discloses the application of Suremark Wire linear marker system comprising a radiopaque line marker atop a spacer adhesive pad layer where the spacer adhesive pad layer defines a thickness between the adhesive and the line marker, and the spacer spaces substantially the entirety of the underside of the marker, wherein the foam spacer defines an axially-elongated portion extending along an elongated axis between the marker and the adhesive, and a plurality of laterally-extending portions, wherein a plurality of the laterally-extending portions are located on opposite sides of the elongated axis relative to each other, at least a portion of a plurality of the laterally-extending portions are axially spaced relative to each other along the elongated axis.
Clare et al. (U.S. Patent No. 5,295,482) discloses a medical electrode with a foam spacer of a thickness greater than 1mm, an adhesive backing layer, and a releasable liner for releasable attachment to the skin of a patient.
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/Johnathan Maynard/Examiner, Art Unit 3798
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