DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Rejections under 112(b)
Applicant's arguments and amended claim set, filed 12/15/25, have been fully considered but they are not persuasive. Applicant argues that the limitation “a thermoplastic including a filler defining a density to make the marker visible on the image of the marker taken by the imager” in claim 16, lines 2-3 is definite. However, this limitation encompasses any thermoplastic including any filler of any density at any level of radiation without imposing any upper limit or lower limit on the density of the filler. The open-ended numerical range claimed does not have an upper limit or lower limit and no density of the filler is disclosed in the applicant’s originally filed specification, drawings, or claims. Therefore, a PHOSITA in view of the specification and drawings would be unable to ascertain the scope of the cited term and claim limitation. See MPEP 2173.05(c).
Rejections under 103
Applicant’s arguments with respect to claim(s) 1-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claims 1-2 and 4-10 are rejected under 35 U.S.C. 103 over Russell in further view of Beekley ’19 in further view of Park. Claim 3 is rejected under 35 U.S.C. 103 over Russell in further view of Beekley ’19 in further view of Park in further view of Russell ’06. Claim 11 is rejected under 35 U.S.C. 103 over Russell in further view of Beekley ’19 in further view of Park in further view of Traboulsi. Claim 12 is rejected under 35 U.S.C. 103 over Russell in further view of Beekley ’19 in further view of Park in further view of Jessop. Claim 13 is rejected under 35 U.S.C. 103 over Russell in further view of Beekley ’19 in further view of Park in further view of Isaacson. Claim 15 is rejected under 35 U.S.C. 103 over Russell in further view of Beekley ’19 in further view of Park. Claim 16 is rejected under 35 U.S.C. 103 over Russell in further view of Beekley ’19 in further view of Park in further view of Isaacson. Claims 17 and 19 are rejected under 35 U.S.C. 103 over Russell in further view of Beekley ’19 in further view of Park in further view of Jessop. Claim 18 is rejected under 35 U.S.C. 103 over Russell in further view of Beekley ’19 in further view of Park in further view of Jessop in further view of Russell ’06.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Such claim limitation(s) is/are:
“first means” in claim 14, line 3;
“second means” in claim 14, line 6; and
“third means” in claim 14, line 10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Corresponding structure appears to described in specification paragraph [0019]. Thus, “first means” is interpreted as covering “adhesive” and equivalents thereof; “second means” is interpreted as covering “an axially-elongated, line-shaped marker” as equivalents thereof, and “third means” is interpreted as covering “a foam spacer” and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3-5, 13, 16, and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation “at a level of radiation used by the imager” in claim 3, line 3 and “at the level of radiation used by the imager” in claim 3, line 5 encompasses any level of radiation without imposing any upper or lower limit on the level of radiation. The open-ended numerical range claimed does not have an upper limit or a lower limit and no level of radiation is disclosed in the applicant’s originally filed specification, drawings, or claims. Therefore, a PHOSITA in view of the specification and drawings would not consider any level of radiation to be inherently supported by the discussion in the original disclosure as the claim reads literally on undisclosed embodiments. See MPEP 2163.05 III.
The limitation “of at least about 1/2 millimeter” in claim 4, line 3 encompasses any distance “of at least about 1/2 millimeter.” This term does not impose any upper limit on the thickness of the foam spacer. The open-ended numerical range claimed does not have an upper limit, while turning to the applicant’s specification (U.S. Pub. No. 2022/0160456), in paragraph [0015] applicant appears to set out an upper limit of “about 1 millimeter” but does not recite such in the claims. Therefore, a PHOSITA in view of the specification and drawings would not consider thickness of the spacer greater than 1 millimeter to be inherently supported by the discussion in the original disclosure as the claim reads literally on embodiments outside the disclosed range. See MPEP 2163.05 III.
The limitation “a thermoplastic defining a density to make the marker visible on an image of the marker taken by the imager” in claim 13, lines 2-3 encompasses any thermoplastic with any density at any level of radiation without imposing any upper limit or lower limit on the density of the thermoplastic. The open-ended numerical range claimed does not have an upper limit or lower limit and no density of the thermoplastic is disclosed in the applicant’s originally filed specification, drawings, or claims. Therefore, a PHOSITA in view of the specification and drawings would not consider any thermoplastic with any density to be inherently supported by the discussion in the original disclosure as the claim reads literally on undisclosed embodiments. See MPEP 2163.05 III.
The limitation “a thermoplastic including a filler defining a density to make the marker visible on the image of the marker taken by the imager” in claim 16, lines 2-3 encompasses any thermoplastic including any filler of any density at any level of radiation without imposing any upper limit or lower limit on the density of the filler. The open-ended numerical range claimed does not have an upper limit or lower limit and no density of the filler is disclosed in the applicant’s originally filed specification, drawings, or claims. Therefore, a PHOSITA in view of the specification and drawings would not consider any thermoplastic including any filler of any density to be inherently supported by the discussion in the original disclosure as the claim reads literally on undisclosed embodiments. See MPEP 2163.05 III.
The limitation “transmitting radiation through the imaging marker at a level at which the marker portion is partially radiopaque, partially radiolucent to the transmitted radiation and the spacer is translucent or radiolucent to the transmitted radiation” in claim 18, lines 2-4 encompasses any level of radiation without imposing any upper or lower limit on the level of radiation. The open-ended numerical range claimed does not have an upper limit or a lower limit and no level of radiation is disclosed in the applicant’s originally filed specification, drawings, or claims. Therefore, a PHOSITA in view of the specification and drawings would not consider any level of radiation to be inherently supported by the discussion in the original disclosure as the claim reads literally on undisclosed embodiments. See MPEP 2163.05 III.
Claim 5 is rejected as depending from rejected claim 4.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-5, 13, 16, and 18 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The limitation “at a level of radiation used by the imager” in claim 3, line 3 and “at the level of radiation used by the imager” in claim 3, line 5 encompasses any level of radiation without imposing any upper or lower limit on the level of radiation. The open-ended numerical range claimed does not have an upper limit or a lower limit and no level of radiation is disclosed in the applicant’s originally filed specification, drawings, or claims. Therefore, a PHOSITA in view of the specification and drawings would be unable to ascertain the scope of the cited term and claim limitation. See MPEP 2173.05(c).
The limitation “of at least about 1/2 millimeter” in claim 4, line 3 encompasses any distance “of at least about 1/2 millimeter.” This term does not impose any upper limit on the thickness of the foam spacer. The open-ended numerical range claimed does not have an upper limit, and, therefore, a PHOSITA in view of the specification and drawings would be unable to ascertain the scope of the cited term and claim limitation. See MPEP 2173.05(c). It is noted that turning to the applicant’s specification (U.S. Pub. No. 2022/0160456), in paragraph [0015] applicant appears to set out an upper limit of “about 1 millimeter” but does not recite such in the claims.
The limitation “a thermoplastic defining a density to make the marker visible on an image of the marker taken by the imager” in claim 13, lines 2-3 encompasses any thermoplastic with any density at any level of radiation without imposing any upper limit or lower limit on the density of the thermoplastic. The open-ended numerical range claimed does not have an upper limit or lower limit and no density of the thermoplastic is disclosed in the applicant’s originally filed specification, drawings, or claims. Therefore, a PHOSITA in view of the specification and drawings would be unable to ascertain the scope of the cited term and claim limitation. See MPEP 2173.05(c).
The limitation “a thermoplastic including a filler defining a density to make the marker visible on the image of the marker taken by the imager” in claim 16, lines 2-3 encompasses any thermoplastic including any filler of any density at any level of radiation without imposing any upper limit or lower limit on the density of the filler. The open-ended numerical range claimed does not have an upper limit or lower limit and no density of the filler is disclosed in the applicant’s originally filed specification, drawings, or claims. Therefore, a PHOSITA in view of the specification and drawings would be unable to ascertain the scope of the cited term and claim limitation. See MPEP 2173.05(c).
The limitation “transmitting radiation through the imaging marker at a level at which the marker portion is partially radiopaque, partially radiolucent to the transmitted radiation and the spacer is translucent or radiolucent to the transmitted radiation” in claim 18, lines 2-4 encompasses any level of radiation without imposing any upper or lower limit on the level of radiation. The open-ended numerical range claimed does not have an upper limit or a lower limit and no level of radiation is disclosed in the applicant’s originally filed specification, drawings, or claims. Therefore, a PHOSITA in view of the specification and drawings would be unable to ascertain the scope of the cited term and claim limitation. See MPEP 2173.05(c).
Claim 5 is rejected as depending from rejected claim 4.
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 & Burns (Reissued U.S. Patent No. 36,461), hereinafter “Russell,” 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.”
Regarding claim 1, Russell 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.), 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 (marker wire is bendable, Abstract, Col. 2, lines 39-56) 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 adhesive is located on an opposite side of the spacer relative to the marker (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 the spacer supports the marker thereon (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) and defines a thickness between the adhesive and the underside of the marker (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), the adhesive is configured to releasably attach the spacer to a surface of a person's skin undergoing the imaging procedure 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), 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), at least a portion of a plurality of the laterally-extending portions 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 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 the skin, prevent forces exerted on the spacer from detaching the spacer from 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; 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 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 does not appear to explictly disclose the spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the imaging procedure, the spacer covers substantially the entirety of the underside of the marker, the spacer defines an axially-elongated portion extending along the elongated axis of the linear marker between the linear marker and the adhesive, and the 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 linear-shaped marker and releasable adhesive attachment of said foam 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 skin.
However, in the same field of endeavor of radiography markers, Beekley ‘19 teaches 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), the spacer supports the marker thereon and covers substantially the entirety of the underside of the marker (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), the spacer spaces substantially the entirety of the underside of the marker away from the skin (Figure 7 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), the spacer defines an axially-elongated portion extending along the elongated axis of the linear 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 is configured to flex at least between the axially-spaced, laterally-extending portions, to thereby allow the spacer to flex 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; 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 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 skin, prevent forces exerted on the spacer from detaching the spacer from 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; 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).
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 and Beekley ‘19 teaches that the adhesive pad material is translucent/radiolucent/invisible in radiography images as detailed above, Russell in further view of Beekley ‘19 does not appear to explictly disclose the adhesive pad is made of foam 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 is configured to flex to thereby allow the spacer to flex with deformation of the marker and to, upon releaseable adhesive attachment of said 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, prevent forces exerted on the foam spacer from detaching the foam spacer from the skin during 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, 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”), and the foam spacer is configured to flex to thereby allow the spacer to flex with deformation of the marker (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]) and to, upon releaseable adhesive attachment (adhesive layer is configured to temporarily and removably bond to the skin, [0051], see also [0053], Fig. 5B) of said 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]; adhesive layer is configured to temporarily and removably bond to the skin, [0051], see also [0053], Fig. 5B), prevent forces exerted on the foam spacer from detaching the foam spacer from the skin during the imaging procedure (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]; 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, i.e., the conforming, flexible spacer and the adhesive on the spacer prevents forces exerted on the spacer from detaching the spacer from the skin 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 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].
Regarding claim 2, Russell 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 discloses the spacer is an adhesive pad as detailed above, Russell does not appear to explictly disclose the spacer defines relatively narrow-width portions located 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 located 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’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 ‘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 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 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 defines a thickness between an underside of the linear-shaped marker and the adhesive (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),
However, while Russell 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 in further view of Beekley ‘19 does not appear to explictly teach the adhesive pad is made of foam that defines a thickness of 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]), extends between the linear-shaped marker and the adhesive, and defines a thickness between an underside of the linear-shaped marker and the adhesive of 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 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 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 discloses the spacer defines a thickness between the underside of 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; 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),
However, while Russell 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 in further view of Beekley ‘19 does not appear to explictly teach the adhesive pad is made of foam that defines a thickness 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 underside of the linear-shaped marker and the adhesive within the range 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 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 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 discloses the thickness between the underside of 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; 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).
However, while Russell 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 in further view of Beekley ‘19 does not appear to explictly teach the adhesive pad is made of foam that defines a substantially 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 thickness between the underside the linear-shaped marker and the adhesive is substantially 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 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 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 discloses the adhesive extends substantially throughout the underside of and underlies the spacer (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).
However, Russell in further view of Beekley ‘19 does not appear to explicitly teach the adhesive defines an adhesive coating extending substantially through the underside of and underlying 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]) with an adhesive that defines an adhesive coating extending substantially throughout the underside of and underlying 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])
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].
Regarding claim 8, Russell 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 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 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) in further view of Park as applied to claim 1 above, and further in view of Russell (U.S. Pub. No. 2006/0072706), hereinafter “Russell ’06.”
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 at a level of radiation used 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 at the level of radiation used 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 at the level of radiation used 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 at the level of radiation used 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 at the level of radiation used 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 does not appear to teach the marker is formed by at least one radiopaque portion that is at least partially radiopaque, partially radiolucent at a level of radiation used by the imager in connection with the imaging procedure.
However, in the same field of endeavor of radiography markers, Russell ’06 teaches the marker is formed by at least one radiopaque portion that is at least partially radiopaque, partially radiolucent at a level of radiation used 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 ‘06’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’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 ’06, Abstract. See also MPEP 2141 III. (C).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Russell in further view of Beekley ‘19 (with additional evidence from Searing) in further view of Park as applied to claim 1 above, further in view of Traboulsi (U.S. Pub. No. 2010/0276056), hereinafter “Traboulsi.”
Regarding claim 11, while Russell in further view of Beekley ‘19 in further view of Park teaches a foam spacer as detailed above, Russell in further view of Beekley ’19 in further view of Park 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 in further view of Beekley ’19 in further view of Park’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 in further view of Beekley ‘19 (with additional evidence from Searing) in further view of Park 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 in further view of Beekley ’19 in further view of Park 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 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 in further view of Beekley ‘19 (with additional evidence from Searing) in further view of Park 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 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 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 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).
Claim 14 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).
Regarding claim 14, Russell 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 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.), comprising:
first means for releasably attaching the imaging marker to a surface of the skin of a person undergoing the imaging procedure (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; ; 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 an 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 is located on an underside of the third means on an opposite side of the third means relative to the second means (top, non-adhesive side of adhesive pad is attached to marker wire and bottom, adhesive side contacts the tape, Col. 2, line 66 – Col. 3, line 16), and the third means is for contacting the surface of the skin of the person undergoing the imaging procedure, is for adhesive attachment to the skin by the first means, and is for preventing said forces exerted on the third means from detaching the third means and second means supported thereon 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 spacer 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 said forces exerted on the third means from detaching the third means and second means supported thereon 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.),).
However, while Russell 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 does not appear to explictly disclose the surface of the skin defines a curvilinear contour and a scar or other anatomical feature also defining a curvilinear contour; the second means forming a line-shaped image thereof in the image; and the third means 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 contours 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, and the third means is for substantially conforming to the surface of the skin.
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);
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); and
third means 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), wherein the first means is located on an underside of the third means on an opposite side of the third means relative to the second means (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), and the third means is for contacting and substantially conforming to the surface of the skin of the person undergoing the imaging procedure, is for adhesive attachment to the skin by the first means, and is for preventing said forces exerted on the third means form detaching the third means and second means supported thereon 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 said forces exerted on the third means form detaching the third means and second means supported thereon 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).
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).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Russell in further view of Beekley ’19 (with additional evidence from Searing) in further view of Park.
Regarding claim 15, Russell 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, while Russell discloses 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), Russell 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 the axially-elongated portion 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 (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 axially-elongated portion 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’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 ‘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 located between the first means, adhesive, and second means, marker (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, radiolucent or invisible on the image of the device 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”), for flexing with deformation of the second means, marker (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]; 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.), for substantially conforming to the contour of 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]; 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 for preventing forces exerted thereon in flexing with deformation of the second means, marker and flexibly conforming to and following the contours from detaching the first means, adhesive, from the skin (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]; 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, i.e., the conforming, flexible spacer and the adhesive on the spacer prevents forces exerted on the spacer from detaching the spacer from the skin during imaging; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, [0059]; 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, adhesive, is located on an underside of the third means, foam spacer, on an opposite side of the third means, foam spacer, relative to the second means, marker (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]), and the third means, foam spacer, is for contacting and substantially conforming to the surface of the skin of the person undergoing the imaging procedure (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]; adhesive layer is configured to temporarily and removably bond to the skin, [0051], see also [0053], Fig. 5B), is for adhesive attachment to the skin by the first means, adhesive (adhesive layer is configured to temporarily and removably bond to the skin, [0051], see also [0053], Fig. 5B), and is for preventing said forces exerted on the third means, foam spacer, from detaching the third means, foam spacer, and second means, marker supported thereon from the skin (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]; 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, i.e., the conforming, flexible spacer and the adhesive on the spacer prevents forces exerted on the spacer from detaching the spacer and marker from the skin during imaging; note that the limitation “for preventing said forces exerted on the third means form detaching the third means and second means supported thereon 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 layer and the foam deformable structure applied to the skin, MPEP 2111.02 II.).
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].
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Russell in further view of Beekley ‘19 in further view of Park as applied to claim 1 above, further in view of Isaacson.
Regarding claim 16, while Russell 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 in further view of Beekley 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 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 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Russell in further view of Beekley ’19 (with additional evidence from Axis) in further view of Park in further view of Jessop.
Regarding claim 17, Russell 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 adhesive is located on an opposite side of the spacer relative to the line-shaped marker portion (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 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 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 causing the spacer and the line-shaped marker 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 preventing the spacer from detaching from 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 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 does not appear to explictly disclose the surface of the skin defines a curvilinear contour and a scar or other anatomical feature also defining a curvilinear contour, the 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 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 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; 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 spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the imaging procedure; and during the releasably attaching and imaging of steps (ii) and (iii), the spacer withstanding forces exerted thereon during the flexible conforming to and following of the curvilinear counters within the spacer, and thereby preventing the 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 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-back 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), wherein the adhesive is located on an opposite side of the foam spacer relative to the line-shaped marker portion (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), 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);
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; 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), and in connection with such attaching, substantially conforming the spacer 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 (Figure 3 demonstrates that the line-shaped Beekley TomoSPOT scar 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; 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);
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, 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 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
during the releasably attaching and imaging of steps (ii) and (iii), the spacer withstanding forces exerted thereon during the flexible conforming to and following of the curvilinear counters within the spacer, and thereby preventing the spacer from detaching from the skin during the releasably attaching and imaging of steps (ii) and (iii) (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; 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, adheres to and bends and expands to the shape of the patient’s breast during compression, is translucent/radiolucent/invisible on an image taken by a mammography imager, and 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’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 adhesive-backed spacer is an adhesive pad that is made of paper or plastic and Beekley ‘19 teaches that the adhesive pad material is translucent/radiolucent/invisible in radiography images as detailed above, Russell in further view of Beekley ‘19 does not appear to explictly disclose the adhesive pad comprises a foam material that 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 to the contour of the skin, and causing the foam spacer and the marker portion to substantially follow the contour of the skin; 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 in connection with the imaging procedure; and during the releasably attaching and imaging of steps (ii) and (iii), the foam spacer withstanding forces exerted thereon during the flexible conforming to and following of the contours within the foam spacer, 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 radiopaque markers, Park teaches the adhesive pad is an adhesive-back foam spacer comprising a foam material (deformable structure comprises foam, [0054]), wherein the adhesive is located on an opposite side of the foam spacer relative to the line-shaped marker portion (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]), and 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]);
adhesively attaching the foam spacer to the surface of the skin (adhesive layer is configured to temporarily and removably bond to the skin, [0051], see also [0053], Fig. 5B) with the foam spacer in contact with and substantially conforming 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]; adhesive layer is configured to temporarily and removably bond to the skin, [0051], see also [0053], Fig. 5B), and in connection with such attaching, substantially conforming the foam spacer to the contour of the skin, and causing the foam spacer and the marker portion to substantially follow the contour of 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]; adhesive layer is configured to temporarily and removably bond to the skin, [0051], see also [0053], Fig. 5B);
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 in connection with the imaging procedure (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
during the releasably attaching and imaging of steps (ii) and (iii), the foam spacer withstanding forces exerted thereon during the flexible conforming to and following of the contours within the foam spacer, 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 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]; 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, i.e., the conforming, flexible spacer and the adhesive on the spacer prevents forces exerted on the spacer from detaching the spacer from the skin 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 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 employing 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 in further view of Beekley ’19 in further view of Park teaches a flexible and conforming foam spacer comprising a foam material, Russell in further view of Beekley ’19 in further view of Park does not appear to explictly teach the foam material absorbing forces exerted thereon.
However, in the same field of endeavor of radiography markers, Jessop teaches an adhesive-backed foam spacer comprising a foam material (foam adhesive pad, Col. 2, line 54 – Col. 3, line 13; see also Col. 3, line 51 – Col. 4, line 24; foam adhesive pad is releasably attached to the skin, Col. 2, line 54 – Col. 3, line 13, Col. 3, lines 30-50) and the foam spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the imaging procedure (foam adhesive pad is “a radiolucent layer through which imaging radiation passes without casting a discernable shadow on an image plate where a radiographic image is created,” Col. 2, line 54 – Col. 3, line 13; see also Col. 3, line 51 – Col. 4, line 24); and
during the releasably attaching and imaging of steps (ii) and (iii), the foam material absorbing forces exerted thereon, and thereby preventing the imaging marker from detaching from the skin during the releasably attaching and imaging of steps (ii) and (iii) (foam adhesive pad resists compression, i.e., absorbing forces exerted on the imaging marker, and foam can be selected for desired stiffness or compliance, Col. 3, line 51 – Col. 4, line 24; foam adhesive pad is releasably attached to the skin, Col. 2, line 54 – Col. 3, line 13, Col. 3, lines 30-50; marker system is imaged by radiographic imager, Col. 2, line 54 – Col. 3, line 13).
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 in further view of Beekley ‘19 in further view of Park’s known foam 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).
Regarding claim 19, while Russell 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 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’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).
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 Jessop as applied to claim 17 above, and further in view of Russell ’06.
Regarding claim 18, Russell discloses the imaging includes transmitting radiation through the imaging marker at a level at which the marker portion is radiopaque to the transmitted radiation (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 as detailed above, Russell does not appear to explictly disclose the spacer is substantially radiolucent to the transmitted radiation.
However, in the same field of radiography markers, Beekley ’19 teaches the spacer is substantially radiolucent to the transmitted radiation (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).
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).
Further, in the same field of endeavor of radiography markers, Jessop teaches the adhesive pad is a foam spacer (foam adhesive pad, Col. 2, line 54 – Col. 3, line 13; see also Col. 3, line 51 – Col. 4, line 24) that is substantially radiolucent at the level of radiation used by the imager in connection with the imaging procedure (foam adhesive pad is “a radiolucent layer through which imaging radiation passes without casting a discernable shadow on an image plate where a radiographic image is created,” Col. 2, line 54 – Col. 3, line 13; see also Col. 3, line 51 – Col. 4, line 24).
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 in further view of Beekley 19’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).
However, while Russell discloses a linear radiopaque imaging marker as detailed above, Russell in further view of Beekley ’19 in further view of Park in further view of Jessop does not appear to teach the imaging includes transmitting radiation through the imaging marker at a level at which the marker portion is partially radiopaque, partially radiolucent to the transmitted radiation
However, in the same field of endeavor of radiography markers, Russell ’06 teaches the imaging includes transmitting radiation through the imaging marker at a level at which the marker portion is partially radiopaque, partially radiolucent to the transmitted radiation (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 ‘06’s known marker densities and thicknesses to Russell in further view of Beekley ‘19 in further view of Park in further view of Jessop’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., 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, Fidicial 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.M./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798