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
Overview
In brief, Applicant’s independent claims 1, 18, and 21 recite at least a deformable marker supported upon a radiolucent, adhesive-backed foam spacer, the foam spacer comprising a flexible, elastic/stretchy, and compressible foam and having a thickness of between 1 mm and 4 mm, and the function/method of spacing the marker from the skin such that the marker is distinct from the skin and prevents dose perturbation (e.g., Fig. 1)
In brief, Applicant admits (U.S. PGPub. No. 2022/0160455 [0003]-[0008]) that the prior art encompasses at least a deformable marker supported upon a radiolucent, adhesive-backed spacer. Comparing between the Applicant admitted prior art and the independent claims appears to indicate that the alleged inventive concept is 1) the selected spacer material: a flexible, elastic/stretchy, and compressible foam, 2) a spacer thickness of between 1 mm and 4 mm, and 3) the function/method of spacing the marker from the skin such that the marker is distinct from the skin and prevents dose perturbation.
In brief, the references of record teach at least the following features:
Park teaches at least a deformable marker supported upon a radiolucent, adhesive-backed foam spacer, the foam spacer comprising a flexible and compressible foam and having a thickness of between 0.5 mm and 15mm that spaces the marker from the skin providing the function/method of spacing the marker from the skin such that the marker is distinct from the skin and prevents dose perturbation (e.g., Fig. 5B).
Jones teaches at least a deformable electrode supported upon a radiolucent, adhesive-backed foam spacer, the foam spacer comprising a flexible and elastic/stretchy foam and having a thickness of between 1.27 mm and 2mm (e.g., Fig. 1).
Zero Slice teaches at least a deformable marker supported upon a radiolucent, adhesive-backed spacer, and the function/method of spacing the marker from the skin such that the marker is distinct from the skin and prevents dose perturbation (e.g., Fig. 4-5).
Traboulsi teaches at least a deformable marker supported upon a radiolucent, adhesive-backed foam spacer, the foam spacer comprising a flexible and compressible foam and having a thickness of between 0.397 mm and 3.175 mm that spaces the marker from the skin providing the function/method of spacing the marker from the skin such that the marker is distinct from the skin and prevents dose perturbation (e.g., Fig. 9).
Beekley ’19 teaches a deformable marker supported upon a radiolucent, adhesive-backed spacer, the spacer a flexible, elastic/stretchy, and compressible material (e.g., Fig. 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis”).
Russell teaches a deformable marker supported upon a plurality of radiolucent, adhesive-backed pads (e.g., Fig. 1).
Jessop teaches a marker supported upon a radiolucent, adhesive-backed pad (e.g., Fig.1).
Claim Objections
Applicant’s arguments, see Remarks and Amendments to the Claims, filed 6/15/26, with respect to the objection to claim 26 have been fully considered and are persuasive. The objection to claim 26 has been withdrawn.
112(a) Rejections
Applicant’s arguments, see Remarks and Amendments to the Claims, filed 6/15/26, with respect to the rejections of claims 1-4 and 6-26 under 35 U.S.C. 112(a) have been fully considered and are persuasive. The rejection of claims 1-4 and 6-26 has been withdrawn.
With regard to claim 5, Applicant's arguments filed 6/15/26 have been fully considered but they are not persuasive. Claim 5 was rejected under 35 U.S.C. 112(a) as reciting an open-ended numerical range and reading literally on embodiments outside the disclosed range. The newly amended claim 5, lines 3-4 recites “said uniform thickness is at least about 1-1/5 millimeters, at least about 1-2/5 millimeters, or at least about 1-3/5 millimeters.” “[S]aid uniform thickness” appears to refer back to “a uniform thickness between the first and second surfaces within the range of about 1 millimeter to about 4 millimeters” as recited in claim 1, lines 21-22. While claim 1, lines 21-22 recites an upper bound, it is unclear whether claim 5, lines 3-4 are subject to the same upper bound. Therefore, claim 5 appears to recite an open-ended numerical range that reads literally on embodiments outside the disclosed range.
112(b) Rejections
Applicant’s arguments, see Remarks and Amendments to the Claims, filed 6/15/26, with respect to the rejections of claims 1-4 and 6-26 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 1-4 and 6-26 has been withdrawn.
With regard to claim 5, Applicant's arguments filed 6/15/26 have been fully considered but they are not persuasive. Claim 5 was rejected under 35 U.S.C. 112(b) as reciting an open-ended numerical range wherein a PHOSITA in view of the specification and drawings would be unable to ascertain the scope of the cited term and claim limitation. The newly amended claim 5, lines 3-4 recites “said uniform thickness is at least about 1-1/5 millimeters, at least about 1-2/5 millimeters, or at least about 1-3/5 millimeters.” “[S]aid uniform thickness” appears to refer back to “a uniform thickness between the first and second surfaces within the range of about 1 millimeter to about 4 millimeters” as recited in claim 1, lines 21-22. While claim 1, lines 21-22 recites an upper bound, it is unclear whether claim 5, lines 3-4 are subject to the same upper bound. Therefore, claim 5 appears to recite an open-ended numerical range wherein a PHOSITA in view of the specification and drawings would be unable to ascertain the scope of the cited term and claim limitation
102/103 Rejections
Applicant's arguments filed 6/15/26 have been fully considered but they are not persuasive.
Regarding the Park reference, Applicant first argues that
Accordingly, Park, in effect, teaches away from the claimed invention by preventing the upper surface of the foam structure 506 from flexing, stretching, or conforming to the contour of the skin. Remarks at 17.
In response to Applicant’s argument that Park teaches away from the claimed invention because the top surface of the foam deformable structure would be unable to be flexible, stretchable, and/or conforming due to the attachment of a rigid marker to the top surface, Applicant improperly excludes the teachings of the embodiment of Park paragraphs [0056]-[0060] and Figs. 6A-6B. Remarks at 16-18.
Paragraph [0059] states that
device 601 may not comprise a rigid structure. In particular, in one example base structure 602 may bend in one or more directions. For example, base structure 602 may substantially conform to one or more areas of curvature of the human body onto which it is a fixed.
Paragraph [0059] explictly teaches that, contrary to Applicant’s contention, the marker/device and the base structure is not rigid and can bend and/or conform to the curvature of the body.
Paragraph [0056] states that
Accordingly, device 601 may be similar in one or more aspects described herein to one or more of device 100, 200, 300, 400, and/or 500.
Paragraph [0056] explictly teaches that any of the aspects of device 500 (described in paragraphs [0052]-[0055] and Figs. 5A-5B) can be combined with those of device 601 (described in paragraphs [0056]-[0060] and Figs. 6A-6B).
Further, as admitted by the Applicant, paragraphs [0052]-[0055] disclose that one of the aspects of device 500 is a foam deformable structure which is provided below the base structure along the top surface of the deformable structure. Therefore, contrary to Applicant’s contention, Park explictly teaches both a foam deformable structure with a top surface supporting and attached to a deformable marker. Therefore, Applicant’s argument is not persuasive.
In addition, Applicant provides no evidence to establish a teaching away by Park.
"A reference may be said to teach away when a person of ordinary skill, upon reading the reference ... would be led in a direction divergent from the path that was taken by the applicant." In re Haruna, 249 F .3d 1327, 1335 (Fed. Cir. 2001) (quoting Tee Air, Inc. v. Denso Mfg. Mich. Inc., 192 F.3d 1353, 1360 (Fed. Cir. 1999)); see In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (holding that, to teach away, the prior art must "criticize, discredit, or otherwise discourage the solution claimed").
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.")
First, there is no suggestion in Park that the base structure is required to be rigid. In fact, as discussed above, Park explictly states that the base structure is not required to be rigid. Second, there is no suggestion in Park that the foam deformable structure’s top surface is required to be attached to a rigid base structure. In fact, as discussed above, Park explictly contemplates using any of the aspects of the device 500 including the foam deformable structure as part of device 601, wherein the foam deformable structure’s top surface would be attached to a non-rigid, bendable, conforming base structure. As there are no teachings in Park that criticizes, discredits, or otherwise discourages the solution claimed, i.e., a flexible, elastic/stretchy, conformable top surface of a foam spacer, Applicant’s argument is not persuasive.
Second, regarding the Park reference, Applicant next argues that
Further, Park teaches away from spacing the underside of the marker a substantially uniform distance away from the contoured surface of the skin, as further recited in the amended independent claims. Rather, as clearly set forth in FIG. 5B reproduced above, Park teaches spacing the underside of the marker a non-uniform distance away from the contoured surface of the skin in order to maintain the planar shape of the radiopaque scale 504 of concentric circles thereon. Remarks at 17.
In response to Applicant’s argument that Park teaches away from the claimed invention because the spacing of the underside of the mark is non-uniform to maintain the planar shape of the radiopaque scale, Applicant improperly excludes the teachings of the embodiment of Park paragraphs [0056]-[0060] and Figs. 6A-6B. Remarks at 16-18. As discussed above, paragraph [0059] explictly teaches that, contrary to Applicant’s contention, the marker/device and the base structure is not rigid and can bend and/or conform to the curvature of the body. And, as discussed above, paragraph [0056] explictly teaches that any of the aspects of device 500 (described in paragraphs [0052]-[0055] and Figs. 5A-5B) can be combined with those of device 601 (described in paragraphs [0056]-[0060] and Figs. 6A-6B). And, as discussed above, as admitted by the Applicant, paragraphs [0052]-[0055] disclose that one of the aspects of device 500 is a foam deformable structure which is provided below the base structure along the top surface of the deformable structure. Therefore, contrary to Applicant’s contention, Park explicitly discloses a deformable foam spacer (deformable structure) with a surface supporting and attached to a deformable marker (base structure). Thus, Park teaches that both the spacer (deformable structure) and the marker supported thereon (base structure) are non-rigid and conform to the curvilinear contour of the surface of the skin. These teachings combined with Park’s teaching that the deformable foam spacer (deformable structure) has a single/uniform thickness of between 0.5 mm and 15 mm teach the alleged claim features (the foam spacer spacing the marker from the skin by the foam spacer’s thickness of about 1 millimeter to about 4 millimeters while allowing the foam spacer and the marker to conform to the contour of the surface of the skin). Therefore, Applicant’s argument is not persuasive.
In addition, Applicant provides no evidence to establish a teaching away by Park.
Again, there is no suggestion in Park that the base structure is required to be rigid. In fact, as discussed above, Park explictly states that the base structure is not require to be rigid. Second, there is no suggestion in Park that the foam deformable structure’s top surface is required to be attached to a rigid base structure. In fact, as discussed above, Park explictly contemplates using any of the aspects of the device 500 including the foam deformable structure as part of device 601, wherein the foam deformable structure’s top surface would be attached to a non-rigid, bendable, conforming base structure. Thus, Park teaches that both the marker (base structure) and the spacer (deformable structure) as non-rigid and confirming to the curvilinear contoured of the surface of the skin, Park teaches the alleged claim features. As there are no teachings in Park that criticize, discredit, or otherwise discourage the solution claimed, i.e, Park teaches the spacing is substantially uniform as the marker and the spacer both conform to the contour of the skin, Applicant’s argument is not persuasive.
Applicant’s arguments allegedly to “Jessop” appear to be irrelevant and moot as Applicant appears to have mistakenly argued as to the teachings of Jessop et al. (U.S. Patent No. 6,269,148) instead of Jessop et al. (U.S. Pub. No. 2004/0116802) which was cited in the rejections under 35 U.S.C. 103 in the Non-Final Rejection mailed 1/15/2026. Remarks at 19.
As detailed in infra rejections:
Claims 1-3, 5, 11, and 16 are rejected over the combination of Park in further view of Jones, or, in the alternative, Park in further view of Jones in further view of Zero Slice, or, in the alternative, Park in further view of Jones in further view of Traboulsi;
Claim 4 is rejected over the combination of Park in further view of Jones in further view of Jessop, or, in the alternative, Park in further view of Jones in further view of Zero Slice in further view of Jessop, or, in the alternative, Park in further view of Jones in further view of Traboulsi in further view of Jessop;
Claims 7-9 are rejected over the combination of Park in further view of Jones in further view of Beekley ‘19, or, in the alternative, Park in further view of Jones in further view of Zero Slice in further view of Beekley ‘19, or, in the alternative, Park in further view of Jones in further view of Traboulsi in further view of Beekley ‘19;
Claim 10 is rejected over the combination of Park in further view of Jones in view of Zero Slice, or, in the alternative, Park in further view of Jones in further view of Zero Slice in further view of Traboulsi;
Claim 12 is rejected over the combination of Park in further view of Jones in further view of Jessop, or, in the alternative, Park in further view of Jones in further view of Zero Slice in further view of Jessop, or, in the alternative, Park in further view of Jones in further view of Traboulsi in further view of Jessop;
Claims 13-15 are rejected over the combination of Park in further view of Jones in further view of Russell, or, in the alternative, Park in further view of Jones in further view of Zero Slice in further view of Russell, or, in the alternative, Park in further view of Jones in further view of Traboulsi in further view of Russel;
Claim 17 is rejected over the combination of Park in further view of Jones in further view of Traboulsi, or, in the alternative, Park in further view of Jones in further view of Zero Slice in further view of Traboulsi;
Claims 18-20 are rejected over the combination of Park in further view of Jones, or, in the alternative, Park in further view of Jones in further view of Zero Slice, or, in the alternative, Park in further view of Jones in further view of Traboulsi;
Claims 21-22, 24, and 26 are rejected over the combination of Park in further view of Jones, or, in the alternative, Park in further view of Jones in further view of Zero Slice, or, in the alternative, Park in further view of Jones in further view of Traboulsi;
Claim 23 is rejected over the combination of Park in further view of Jones in further view of Accuracy, or, in the alternative, Park in further view of Jones in further view of Zero Slice in further view of Accuracy, or, in the alternative, Park in further view of Jones in further view of Traboulsi in further view of Accuracy; and
Claim 25 is rejected over the combination of Park in further view of Jones in further view of Jessop, or, in the alternative, Park in further view of Jones in further view of Zero Slice in further view of Jessop, or, in the alternative, Park in further view of Jones in further view of Traboulsi in further view of Jessop.
Specification
The substitute specification filed 6/15/26 has been entered.
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 18, lines 2, 5, 10, 13, 14, and 15 and claim 19, lines 1-2;
“second means” in claim 18, lines 2, 8, and 10 and claim 19, line 2; and
“third means” in claim 18, lines 2, 10 and claim 19, lines 2-3.
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 [0016]. Thus, “first means” is interpreted as covering “a substantially radiopaque marker” and equivalents thereof; “second means” is interpreted as covering “adhesive” as equivalents thereof, and “third means” is interpreted as covering “a substantially radiolucent 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.
Claim 5 is 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 limitations “of at least about 1-1/5 millimeters, at least about 1-2/5 millimeters, or at least about 1-3/5 millimeters” in claim 5, lines 3-4 does not impose any upper limit on the distance the spacer spaces the marker from the skin. The open-ended numerical range claimed does not have an upper limit, while turning to the applicant’s specification (U.S. Pub. No. 2022/0160455), in paragraph [0030] applicant appears to set out an upper limit of “about 4 millimeters” but does not recite such in the claims. Further, “said uniform thickness” appears to refer back to “a uniform thickness between the first and second surfaces within the range of about 1 millimeter to about 4 millimeters” as recited in claim 1, lines 21-22. While claim 1, lines 21-22 recites an upper bound, it is unclear whether claim 5, lines 3-4 are subject to the same upper bound. Therefore, a PHOSITA in view of the specification and drawings would not consider thickness of the spacer greater than 4 millimeters 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 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.
Claim 5 is 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 limitations “of at least about 1-1/5 millimeters, at least about 1-2/5 millimeters, or at least about 1-3/5 millimeters” in claim 5, lines 3-4 does not impose any upper limit on the distance the spacer spaces the marker from the skin. 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. 2022/0160455), in paragraph [0030] applicant appears to set out an upper limit of “about 4 millimeters” but does not recite such in the claims. Further, “said uniform thickness” appears to refer back to “a uniform thickness between the first and second surfaces within the range of about 1 millimeter to about 4 millimeters” as recited in claim 1, lines 21-22. While claim 1, lines 21-22 recites an upper bound, it is unclear whether claim 5, lines 3-4 are subject to the same upper bound.
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 1-3, 5, 11, and 16 are rejected under 35 U.S.C. 103 as being obvious over Park (U.S. Pub. No. 2018/0098820), hereinafter “Park,” in further view of Jones (U.S. Pub. No. 2012/0253162), hereinafter “Jones,” or, in the alternative, as being obvious over Park in further view of Jones in further view of Beekley (“CT Treatment Planning: Finding the Zero Slice” 2016), hereinafter “Zero Slice,” or, in the alternative, Park in further view of Jones in further view of Zero Slice in further view of Traboulsi (U.S. Pub. No. 2010/0276056), hereinafter “Traboulsi.”
Regarding claim 1, Park discloses an imaging marker (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]) for use in connection with an imager and radiation treatment planning and/or simulation software (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]; note that the limitation “configured for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “an imager” is not part of the claimed “imaging marker”), wherein the imaging marker is adhesively attachable and conformable to a contoured surface of the skin of a person (deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]; adhesive layer is configured to temporarily and removably bonded to the skin, [0051], see also [0053], Fig. 5B) undergoing a radiation treatment planning and/or simulation (during radiation imaging, [0056]-[0057]; note that the limitation “undergoing the radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed imaging marker adhesive and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.) and is configured to prevent the radiation treatment planning and/or simulation software from including the marker as part of the underlying person or contoured surface of the skin, or indicating that the person will absorb more radiation at the location of the marker than the person otherwise would absorb at that location during the radiation treatment (deformable structure may be between 0.5-15mm thick, [0054]; 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 spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “the software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature), the imaging marker comprising:
a marker (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]), an adhesive (adhesive layer is configured to temporarily and removably bond to the skin, [0051], see also [0053], Fig. 5B) and a spacer (deformable structure spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]);
wherein the imaging marker is configured for use in connection with the imager (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]; note that the limitation “configured for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “an imager” is not part of the claimed “imaging marker”) and radiation treatment planning and/or simulation software (deformable structure may be between 0.5-15mm thick, [0054]; 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 spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature);
the marker is opaque or visible on an image of the marker taken by the imager (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]; note that the limitation “configured for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.) for use in connection with the radiation treatment planning and/or simulation (deformable structure may be between 0.5-15mm thick, [0054]; 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 spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature), wherein the marker defines an underside (radiopaque marker element defines a back surface, Figs. 4A-4B, 5A-5B, Fig. 6A-6B); and
the spacer is formed of a flexible and compressible foam material (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e, is flexible and conformable, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]) that is translucent, radiolucent or invisible on the image of the marker taken by the imager (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, 11A11D, 15A-15B, 16; see also [0056]; note that the limitation “the image of the marker taken by the imager” 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”) in connection with the radiation treatment planning and/or simulation (deformable structure may be between 0.5-15mm thick, [0054]; 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 spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature), wherein the spacer is located between the adhesive and the marker (deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]), the spacer defines a first surface supporting the marker thereon (deformable structure has a top surface that faces the base structure of the radiopaque marker element, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), a second surface located on an opposite side of the spacer relative to the first surface and including the adhesive thereon (deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface on the opposite side of the spacer that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), and a uniform thickness between the first and second surfaces within the range of about 1 millimeter to about 4 millimeters (deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure may be between 0.5-15mm thick, i.e., a uniform thickness, [0054]), the adhesive is configured to releasably attach the imaging marker to the contoured surface 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]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]; adhesive layer is configured to temporarily and removably bonded to the skin, [0051], see also [0053], Fig. 5B), the foam spacer, including the first and second surfaces thereof, is configured to at least one of flex or compress and conform to the contoured surface of the skin (deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), and space the underside of the marker a substantially uniform distance away from the contoured surface of the skin within the range of about 1 millimeter to about 4 millimeters (deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure may be between 0.5-15mm thick, i.e., a uniform thickness, [0054]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), and prevent the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker than the person otherwise would absorb at that location during the radiation treatment (deformable structure may be between 0.5-15mm thick, [0054]; 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 spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “the software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature).
However, while Park discloses an adhesive-backed, flexible, and compressible foam spacer, Park does not appear to explictly disclose the spacer is formed of an elastic/stretchy foam material.
However, in the same field of endeavor of adhesive-backed support pads and solving substantially the same problem of providing a stretchable adhesive-backed support pad, Jones teaches the spacer is formed of a flexible and elastic foam material (foam backing pad has a bottom surface upon which a pressure sensitive adhesive is included and is configured to elastically stretch, [0032]-[0033]; electrode and backing pad are configured to adhere and flexibly conform to skin contours, [0009], [0031]-[0033]; also see electrode and backing pad being radiolucent during an imaging procedure, [0005], [0009]); and
the foam spacer, including the first and second surfaces thereof, is configured to at least one of flex or stretch and conform to the contoured surface of the skin (top surface and bottom surface of the foam backing pad are configured to flex and elastically stretch to thereby deform with deformation of the electrode to adhere and flexibly conform to skin contours, [0009], [0031]-[0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Jones’ known technique of an adhesive-backed, flexible, elastic, stretchable foam layer for adhering to and conforming to the contoured surface of the subject’s skin to Park’s known imaging marker with an adhesive-backed, flexible, conformable foam adhesive layer to achieve the predictable result that providing an elastically stretchable foam layer allows for the layer to remain attached and conform to the contours of the subject’s body during initial attachment and during body positioning changes when the subject is in motion. See, e.g., Jones, [0031]-[0032].
Additionally, or, in the alternative, while Park in further view of Jones teaches the imaging marker is configured for use in connection with a radiation imager as detailed above, Park in further view of Jones does not appear to explictly teach the imaging is in connection with radiation treatment planning and/or simulation software.
However, in the same field of endeavor of imaging markers, Zero Slice teaches an imaging marker for use in connection with an imager and radiation treatment planning and/or simulation software (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation software, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image), wherein the imaging marker is attachable to a surface of the skin of a person undergoing a radiation treatment planning and/or simulation (CT-SPOT crosshair has a backing layer that is placed on the patient’s skin that spaces the marker away from the surface of the skin and does not appear in the CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 6-7, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image; during CT set-up and imaging CT-Spot crosshair is applied to the patient’s skin, P.1, ¶6-8; see also placement of CT-Spot crosshair on patient to be imaged, Figs. 1-2, P.2, 2nd and 3rd images) and is configured to prevent the radiation treatment planning and/or simulation software from including the marker as part of the underlying person or surface of the skin, or indicating that the person will absorb more radiation at the location of the marker than the person otherwise would absorb at that location during the radiation treatment (CT-Spot Crosshair is spaced a distance away from the skin by the backing layer and the mask in a 3pt set-up as in P.2, 2nd and 3rd images thereby preventing the radiation treatment planning and/or simulation software from including the marker as part of the person or skin, or indicating that the patient will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, particularly note that in P.2 3rd image each of the CT-SPOT crosshairs is spaced away at a distance from the surface of the skin and is therefore distinct from the surface of the skin);
wherein the imaging marker is configured for using in connection with the imager and radiation treatment planning and/or simulation software (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation software, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image);
the marker is opaque or visible on an image of the marker taken by the imager for use in connection with the radiation treatment planning and/or simulation (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image);
the spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager for use in connection with the radiation treatment planning and/or simulation (CT-SPOT crosshair has a backing layer that is placed on the patient’s skin and does not appear in the CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 6-7, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image); the spacer is configured to space the underside of the marker a distance away from the surface of the skin, and prevent the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the first means than the person otherwise would absorb at that location during the radiation treatment (CT-Spot Crosshair is spaced a distance away from the skin by the backing layer and the mask in a 3pt set-up as in P.2, 2nd and 3rd images thereby preventing the radiation treatment planning and/or simulation software from including the marker as part of the person or skin, or indicating that the patient will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, particularly note that in P.2 3rd image each of the CT-SPOT crosshairs is spaced away at a distance from the surface of the skin and is therefore distinct from the surface of 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 Zero Slice’s known technique of a cross-shaped radiopaque imaging marker and use of radiopaque imaging markers during radiation planning and/or simulation and for 3 point setups to Park’s known apparatus of a radiopaque imaging marker to achieve the predictable result of improving the ease of identification of the zero slice or central axis of the treatment field. See, e.g., Zero Slice, P.1, ¶¶1, 3, 8, and 10. See also MPEP 2141 III. (C).
Additionally, or, in the alternative, even if Park in further view of Jones in further view of Zero Slice does not teach the imaging marker comprising the foam spacer is configured to prevent indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, in the same field of endeavor of radiation planning and in solving the same problem of providing a comfortable patient contact surface during irradiation, Traboulsi teaches the imaging marker comprising the foam spacer is configured to prevent indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment (thermoplastic foam spacer having a thickness of about 1/64-1/8 in, i.e., 0.397-3.175 mm, has minimal effect on the surface dose of radiation, [0036], [0038]; see also thermoplastic foam spacer being used to mark treatment planning reference points and during radiation therapy and imaging including crosshairs, field borders, leveling lines, and shielding marks, [0006], [0010], [0017], [0019], [0035], [0047], Fig. 9).
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 Park’s known apparatus using a foam deformable structure 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).
Regarding claim 2, Park discloses wherein the imager generates images by transmitting radiation (imager generates an image by transmitting radiation, [0056]-[0057], Figs. 6A-6B; see also [0063]-[0065]; note that the limitation “the imager generates images by transmitting radiation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “the imager” is not part of the claimed “imaging marker”),
the marker is formed by at least one radiopaque portion that is at least partially radiopaque on the iamge taken by the imager (marker has one or more radiopaque elements that are radiopaque on radiological images, [0005]; see also [0006]-[0007], and [0028]-[0029]; see also [0056]-[0057] and [0063]-[0065], and Figs. 6A-6B, 7, 11A-11D, 15A-15B, and 16; note that the limitation “image taken by the imager” is merely a purpose and/or intended use for the claimed marker 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”) in connection with the radiation treatment planning and/or simulation (deformable structure may be between 0.5-15mm thick, [0054]; 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 spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature), and
the spacer is translucent or radiolucent on the image taken by the imager (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 “image taken by the imager” is merely a purpose and/or intended use for the claimed marker 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”) in connection with the radiation treatment planning and/or simulation (deformable structure may be between 0.5-15mm thick, [0054]; 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 spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature).
Additionally, or, in the alternative, while Park discloses the imaging marker is configured for use in connection with a radiation imager and comprises a radiopaque marker and a translucent/radiolucent spacer as detailed above, Park does not appear to explictly disclose the imaging is in connection with radiation treatment planning and/or simulation.
However, in the same field of endeavor of imaging markers, Zero Slice teaches the imager generates images by transmitting radiation (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image),
the marker is formed by at least one radiopaque portion that is at least partially radiopaque on the image taken by the imager in connection with the radiation treatment planning and/or simulation (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image), and
the spacer is translucent or radiolucent on the image taken by the imager in connection with the radiation treatment planning and/or simulation (CT-SPOT crosshair has a backing layer that is placed on the patient’s skin and does not appear in the CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 6-7, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image).
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 Zero Slice’s known technique of a cross-shaped radiopaque imaging marker and use of radiopaque imaging markers during radiation planning and/or simulation and for 3 point setups to Park’s known apparatus of a radiopaque imaging marker to achieve the predictable result of improving the ease of identification of the zero slice or central axis of the treatment field. See, e.g., Zero Slice, P.1, ¶¶1, 3, 8, and 10. See also MPEP 2141 III. (C).
Regarding claim 3, Park discloses the marker is linear shaped, cross-shaped or pellet shaped (device deployment guide is a linear shaped marker, Figs. 14A-14B).
Regarding claim 5, Park discloses the spacer extends between the adhesive and the marker and said uniform thickness is at least about 1-1/5 millimeters, at least about 1-2/5 millimeters, or at least about 1-3/5 millimeters (deformable structure may be between 0.5-15mm thick, i.e., a uniform thickness, [0054]; 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]).
Regarding claim 11, Park discloses the adhesive defines an adhesive coating underlying the spacer (adhesive layer covers entirety of back surface of deformable structure, [0053], Figs. 5A-5B).
Regarding claim 16, Park discloses the foam spacer is configured to flex and compress and conform to the contoured surface of the skin (deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]).
However, while Park discloses an adhesive-backed, flexible, and compressible foam spacer, Park does not appear to explictly disclose the spacer is formed of an elastic/stretchy foam material.
However, in the same field of endeavor of adhesive-backed support pads and solving substantially the same problem of providing a stretchable adhesive-backed support pad, Jones teaches the foam spacer is configured to flex and stretch and conform to the contoured surface of the skin (top surface and bottom surface of the foam backing pad are configured to flex and elastically stretch to thereby deform with deformation of the electrode to adhere and flexibly conform to skin contours, [0009], [0031]-[0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Jones’ known technique of an adhesive-backed, flexible, elastic, stretchable foam layer for adhering to and conforming to the contoured surface of the subject’s skin to Park’s known imaging marker with an adhesive-backed, flexible, conformable foam adhesive layer to achieve the predictable result that providing an elastically stretchable foam layer allows for the layer to remain attached and conform to the contours of the subject’s body during initial attachment and during body positioning changes when the subject is in motion. See, e.g., Jones, [0031]-[0032].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Park in further view of Jones, Park in further view of Jones in further view of Zero Slice, or Park in further view of Jones in further view of Zero Slice in further view of Traboulsi as applied to claim 3 above, and further in view of Jessop et al. (U.S. Pub. No. 2004/0116802), hereinafter “Jessop.”
Regarding claim 4, Park in further view of Jones does not appear to teach the marker is pellet shaped and consists of a single pellet.
However, in the same field of endeavor of imaging markers, Jessop teaches the marker is pellet shaped and consists of a single pellet (radiopaque marking body is spherical, [0040], [0047]-[0048], Figs. 1-3).
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 technique of a spherical shaped radiopaque imaging marker to Park in further view of Jones’s known apparatus of a radiopaque imaging marker to achieve the predictable result of improving the imaging of the imaging marker when imaging is taken along different directions or planes. See, e.g., Jessop, [0047]. See also MPEP 2141 III. (C).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Park in further view of Jones, Park in further view of Jones in further view of Zero Slice, or Park in further view of Jones in further view of Zero Slice in further view of Traboulsi as applied to claim 1 above, and further in view of Beekley (“Discover TomoSpot Skin Markers for 3D Breast Tomosynthesis” September 2019), hereinafter “Beekley ‘19,” with additional evidence from Searing (U.S. Design Patent No. D879,963), hereinafter “Searing,” and Axis Imaging News (“Product Showcase: Skin Markers Geared Toward Women with Sensitive Skin” 2006), hereinafter “Axis.”
Regarding claim 7, Park discloses the marker is linear shaped and defines an elongated axis (device deployment guide is a linear shaped marker defining an elongated axis, Figs. 14A-14B), and the foam spacer defines an axially-elongated portion extending along the elongated axis (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 comprises foam, [0054]) between the linear marker and the adhesive (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]).
However, Park in further view of Jones does not appear to teach the spacer defines 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, and at least a portion of a plurality of the laterally-extending portions are axially spaced relative to each other along the elongated axis.
However, in the same field of endeavor of imaging markers, Beekley ‘19 teaches the spacer defines a plurality of laterally-extending portions (P.2, 4th image demonstrates that the Beekley TomoSpot scar marker comprises a marker line (caption to P.2, 4th image) supported by an adhesive backing material (P.2, line 8) 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, P.2, 4th Image; note that while not relied upon in this rejection and provided as additional evidence, Searing U.S. Design Patent No. D879,963 Figures 1 and 2 further demonstrates that for the Beekley TomoSpot scar marker, the backing material supports the marker line along both the axially-elongated portion and the axially-spaced, laterally-extending portions), wherein a plurality of the laterally-extending portions are located on opposite sides of the elongated axis relative to each other (P.2, 4th image demonstrates that the Beekley TomoSpot scar marker’s axially-spaced, laterally-extending portions, are located on opposite sides of the elongated axis relative to each other, P.2, 4th image), and at least a portion of a plurality of the laterally-extending portions are axially spaced relative to each other along the elongated axis (P.2, 4th image demonstrates that the Beekley TomoSpot scar marker’s laterally-extending portions are axially-spaced, P.2, 4th image).
Additionally, Beekley ’19 teaches the marker is linear shaped and defines an elongated axis (TomoSPOT Scar Marker has an imaging marker in the form of 1.0mm diameter line, P.2, caption to 4th image and 4th image), and the spacer defines an axially-elongated portion extending along the elongated axis (P.2, 4th image demonstrates that the Beekley TomoSpot scar marker comprises a marker line supported by an adhesive backing material (P.2, line 8) 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, 4th image; 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 a linear marker and a spacer having both an axially-elongated portion and axially-spaced, laterally-extending portions to Park in further view of Jones’s known linear marker and foam spacer to improve patient comfort under compression by preventing pinching of the patient’s skin. See, e.g., Beekley ‘19, P.2, line 8, caption to 4th image. See also MPEP 2141 III. (C).
Regarding claim 8, Park discloses the linear marker is flexible and conformable to the curvilinear 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]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), and the foam spacer is configured to flex with the 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]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), and conformably attach to (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e, is flexible and conformable, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), and space the underside of the marker the substantially uniform distance away from, the contoured surface of the skin (deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure may be between 0.5-15mm thick, i.e., a uniform thickness, [0054]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]).
However, while Park in further view of Jones teaches a linear marker that is flexible and conformable to the curvilinear contour of the skin, Park in further view of Jones does not appear to explictly teach the linear marker is configured to substantially follow the curvilinear contour of a scar or other anatomical feature of the skin.
However, in the same field of endeavor of imaging markers, Beekley ‘19 teaches the linear marker is flexible and conformable 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 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) and configured to substantially follow the curvilinear contour of a scar or other anatomical feature of 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 the spacer is configured to flex with the marker (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 conformably attach to, and space the underside of the marker the distance away from, the contoured surface of the skin (Figure 3 demonstrates that the Beekley TomoSpot scar marker, including the adhesive backing material and line-shaped marker, conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; adhesive backing material is soft and stretchy and compressible, P.2, Fig. 7; backing material is adhesive for application to scars, P.2; Figure 7 “TomoSpot Scar Markers for 3D Breast Tomosynthesis” demonstrates that the Beekley TomoSpot scar marker comprises an adhesive backing material with a top surface supporting the line-shaped marker and a bottom surface having an adhesive for adhering to the skin; note that while not relied upon in this rejection and provided as additional evidence Axis, P.6 demonstrates that Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material is soft, stretchy, and compressible, and adheres to and bends and expands to the shape of the patient’s breast during compression and that sticks better during positioning and compression with the material bending and expanding within the patient’s breast during compression and is releasably attached to the skin).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Beekley ‘19’s known technique of a linear marker and a spacer having both an axially-elongated portion and axially-spaced, laterally-extending portions to Park in further view of Jones’s known linear marker and foam spacer to improve patient comfort under compression by preventing pinching of the patient’s skin. See, e.g., Beekley ‘19, P.2, line 8, caption to 4th image. See also MPEP 2141 III. (C).
Regarding claim 9, while Park in further view of Jones teaches a foam spacer as detailed above, Park in further view of Jones does not appear to teach the spacer defines a plurality of pairs of laterally-extending portions extending laterally on opposite sides of the elongated axis relative to each other, and relatively narrow-width portions located between axially-spaced pairs of laterally-extending portions.
However, in the same field of endeavor of imaging markers, Beekley ‘19 teaches the spacer defines a plurality of pairs of laterally-extending portions extending laterally on opposite sides of the elongated axis relative to each other (P.2, 4th image demonstrates that the Beekley TomoSpot scar marker comprises a marker line (caption to P.2, 4th image) supported by an adhesive backing material (P.2, line 8) 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, P.2, 4th Image; 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; P.2, 4th image demonstrates that the Beekley TomoSpot scar marker’s axially-spaced, laterally-extending portions, are located on opposite sides of the elongated axis relative to each other, P.2, 4th image), and relatively narrow-width portions located between axially-spaced pairs of laterally-extending portions (P.2, 4th image 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, P.2, 4th image, 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, P.2, 4th image; 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 a spacer having both an axially-elongated portion and axially-spaced, laterally-extending portions to Park’s known linear marker and foam spacer to improve patient comfort under compression by preventing pinching of the patient’s skin. See, e.g., Beekley ‘19, P.2, line 8, caption to 4th image. See also MPEP 2141 III. (C).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Park in further view of Jones, Park in further view of Jones in further view of Zero Slice, or Park in further view of Jones in further view of Zero Slice in further view of Traboulsi as applied to claim 1 above, and further in view of Zero Slice.
Regarding claim 10, while Park discloses the marker is defined by a linear-shaped portion defining an elongated axis (device deployment guide is a linear shaped marker defining an elongated axis, Figs. 14A-14B), and the spacer extends along the elongated axis (deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B) and is located between the linear-shaped portion and the adhesive (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]), Park in further view of Jones does not appear to teach the marker is cross-shaped, is defined by two intersecting linear-shaped portions, and each linear-shaped portions defines an elongated axis, and the spacer extends along each elongated axis.
However, in the same field of endeavor of imaging markers, Zero Slice teaches the marker is cross-shaped (CT-SPOT crosshair in the formation of an “X”, P.1, ¶3, Figure 1, P.2, 1st image and 2nd image), is defined by two intersecting linear-shaped portions (CT-SPOT crosshair in the formation of an “X” with the “X” formed by two intersecting linear-shaped portions, P.1, ¶3, Figure 1, P.2, 1st image and 2nd image), each linear-shaped portion defines an elongated axis (CT-SPOT crosshair in the formation of an “X” with each of the two intersecting linear-shaped portions defining an elongated axis, P.1, ¶3, Figure 1, P.2, 1st image and 2nd image), and the spacer extends along each elongated axis (circular marker backing of the CT-SPOT crosshair covers the entirety of both linear-shaped portions, Figure 1, P.2, 1st image and 2nd image).
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 Zero Slice’s known technique of a cross-shaped radiopaque imaging marker to Park in further view of Jones’s known apparatus of a radiopaque imaging marker to achieve the predictable result of improving the ease of identification of the zero slice or central axis of the treatment field. See, e.g., Zero Slice, P.1, ¶¶1, 3, 8, and 10. See also MPEP 2141 III. (C).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Park in further view of Jones, Park in further view of Jones in further view of Zero Slice, or Park in further view of Jones in further view of Zero Slice in further view of Traboulsi as applied to claim 1 above, and further in view of Jessop.
Regarding claim 12, while Park discloses the spacer is located between the marker and the adhesive (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]), Park in further view of Jones does not appear to teach the marker consist essentially of a single pellet.
However, in the same field of endeavor of imaging markers, Jessop teaches the marker consists essentially of a single pellet (radiopaque marking body is spherical, [0040], [0047]-[0048], Figs. 1-3).
Additionally, Jessop teaches the spacer is located between the pellet and the adhesive (attachment substrate is between the marking body and the adhesive layer, [0032], Fig. 1).
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 technique of a spherical shaped radiopaque imaging marker to Park in further view of Jones’s known apparatus of a radiopaque imaging marker to achieve the predictable result of improving the imaging of the imaging marker when imaging is taken along different directions or planes. See, e.g., Jessop, [0047]. See also MPEP 2141 III. (C).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Park in further view of Jones, Park in further view of Jones in further view of Zero Slice, or Park in further view of Jones in further view of Zero Slice in further view of Traboulsi as applied to claim 1 above, and further in view of Russell (Re. 36,461), hereinafter “Russell.”
Regarding claim 13, Park in further view of Jones does not appear to teach the imaging marker is mounted on a releasable liner, and the releasable liner is releasably attached to the adhesive.
However, in the same field of endeavor of imaging markers, Russell teaches 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).
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’s known technique of removably mounting the radiopaque imaging marker onto a backing layer using the adhesive layer to Park in further view of Jones’s known apparatus of a radiopaque, linear imaging marker with a lower adhesive layer to achieve the predictable result of allowing the backing layer to protect the adhesive layer and imaging marker prior to use including preventing self-adherence. See, e.g., Traboulsi, [0043]. See also MPEP 2141 III. (C).
Regarding claim 14, while Park discloses the marker defines an elongated axis and a continuous linear shape extending along the elongated axis (device deployment guide is a linear shaped marker defining a continuous linear shape along an elongated axis, Figs. 14A-14B), Park in further view of Jones does not appear to teach the releasable liner defines an axially-elongated shape extending along the elongated axis of the linear marker.
However, in the same field of endeavor of imaging markers, Russell teaches the marker defines an elongated axis and 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).
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’s known technique of removably mounting the radiopaque imaging marker onto a backing layer using the adhesive layer to Park in further view of Jones’s known apparatus of a radiopaque, linear imaging marker with a lower adhesive layer to achieve the predictable result of allowing the backing layer to protect the adhesive layer and imaging marker prior to use including preventing self-adherence. See, e.g., Traboulsi, [0043]. See also MPEP 2141 III. (C).
Regarding claim 15, Park in further view of Jones does not appear to teach 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.
However, in the same field of endeavor of imaging markers, Russell teaches 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).
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’s known technique of cutting the radiographic, linear imaging marker and the backing layer to desired lengths to Park in further view of Jones’s known apparatus of a radiopaque imaging marker with a lower adhesive layer to achieve the predictable result of “a product that is conveniently dispensed and produces markers which are of a desired length and shape [and] saves time in diagnostic radiology or treatment planning, and results in an effective, comfortable, sanitary, convenient radiographic marking system.” See Russell, Col. 4, lines 30-35. See also MPEP 2141 III. (C).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Park, Park in further view of Zero Slice, or Park in further view of Zero Slice in further view of Traboulsi as applied to claim 16 above, and further in view of Traboulsi.
Regarding claim 17, Park does not appear to disclose the foam is a thermoplastic or thermoset foam.
However, in the same field of endeavor of radiation planning and in solving 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]).
Additionally, note that Traboulsi teaches the spacer prevents absorption of more radiation at the location of the marker than the person otherwise would absorb at that location during the radiation treatment (thermoplastic foam spacer has minimal effect on the surface dose of radiation, [0036]).
Additionally, note that Traboulsi teaches a flexible, linear shaped spacer defining an axially-elongated portion, 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, and at least a portion of a plurality of the laterally-extending portions are axially spaced relative to each other along the elongated axis (thermoplastic foam spacer is linear in shape and defines an axially-extending portion [0034]-[0035], Figs. 1-3, 6, and 9-12; thermoplastic foam spacer bends/flexes to conform to contours, [0035], Figs. 6 and 9; thermoplastic foam spacer has a plurality of laterally-extending portions that are located on opposite sides of the elongated axis, [0034], Figs. 1 and 10; the laterally-extending portions are axially spaced relative to each other along the elongated axis, [0034], Figs. 1-3, 6, and 9-12).
Additionally, note that Traboulsi teaches that the flexible, linear shaped spacer has an adhesive layer mounted to a releasable liner layer along the elongated axis of the linear shaped spacer, [0013].
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 Park’s known foam deformable structure 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).
Claims 18-20 are rejected under 35 U.S.C. 103 as being obvious over Park in further view of Jones, or, in the alternative, as being obvious over Park in further view of Jones in further view of Zero Slice, or, in the alternative, Park in further view of Jones in further view of Zero Slice in further view of Traboulsi.
Regarding claim 18, Park discloses an imaging marker (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]) for use in connection with an imager and radiation treatment planning and/or simulation software (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]; note that the limitation “configured for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “an imager” is not part of the claimed “imaging marker”), wherein the imaging marker is adhesively attachable and conformable to a contoured surface of the skin of a person (deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]; adhesive layer is configured to temporarily and removably bonded to the skin, [0051], see also [0053], Fig. 5B) undergoing a radiation treatment planning and/or simulation (during radiation imaging, [0056]-[0057]; note that the limitation “undergoing the radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed imaging marker adhesive and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.) and is configured to prevent the radiation treatment planning and/or simulation software from including the marker as part of the underlying person or contoured surface of the skin, or indicating that the person will absorb more radiation at the location of the marker than the person otherwise would absorb at that location during the radiation treatment (deformable structure may be between 0.5-15mm thick, [0054]; 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 spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “the software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature), the imaging marker comprising:
first means (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]), second means (adhesive layer is configured to temporarily and removably bond to the skin, [0051], see also [0053], Fig. 5B) and third means (deformable structure spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]);
wherein the imaging marker is configured for use in connection with the imager (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]; note that the limitation “configured for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “an imager” is not part of the claimed “imaging marker”) and radiation treatment planning and/or simulation software (deformable structure may be between 0.5-15mm thick, [0054]; 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 spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature);
the first means is opaque or visible on an image of the marker taken by the imager (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]; note that the limitation “configured for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker 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”) in connection with the radiation treatment planning and/or simulation (deformable structure may be between 0.5-15mm thick, [0054]; 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 spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature) for forming an image thereof (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]; note that the limitation “for forming an image thereof” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.) during the radiation treatment planning and/or simulation (during radiation imaging, [0056]-[0057]; note that the limitation “during the radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed radiopaque imaging marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.);
second means is for releasably attaching the imaging marker to the contoured surface of the skin of the person (deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]; adhesive layer is configured to temporarily and removably bonded to the skin, [0051], see also [0053], Fig. 5B) undergoing the radiation treatment planning and/or simulation (during radiation imaging, [0056]-[0057]; note that the limitation “undergoing the radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed imaging marker adhesive and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.); and
the third means is defined by a flexible and compressible 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]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e, is flexible and conformable, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]) located between the first and the second means (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]), is translucent, radiolucent or invisible on the image of the marker taken by the imager (deformable structure spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; deformable structure is not radiopaque and does not appear in generated radiological image, Figs. 6A-6B, 7, 11A11D, 15A-15B, 16; see also [0056]; note that the limitation “the image of the marker taken by the imager” 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”) in connection with the radiation treatment planning and/or simulation (deformable structure may be between 0.5-15mm thick, [0054]; 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 spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature), defines a first surface and a second surface located on an opposite side of the first means relative to the first surface (deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface on the opposite side of the spacer that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), the first means is supported on and attached to the first surface (deformable structure has a top surface that supports and is attached to the radiopaque marker element, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), the second means is located on the second surface (deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface on the opposite side of the spacer that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), and the third means, including the first and second surfaces thereof, is conformable to the contoured surface of the skin (deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), the third means defines a uniform thickness within the range of about 1 millimeter to about 4 millimeters (deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure may be between 0.5-15mm thick, i.e., a uniform thickness, [0054]), and the third means, including the first and second surfaces thereof, is for at least one of flexing or compressing and conforming to the contoured surface of the skin (deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), and for spacing the underside of the first means a substantially uniform distance within the range of about 1 millimeter to about 4 millimeters away from the contoured surface of the skin (deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure may be between 0.5-15mm thick, i.e., a uniform thickness, [0054]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), for preventing the software from including the first means as part of the person or skin, or indicating that the person will absorb more radiation at the location of the first means than the person otherwise would absorb at that location during the radiation treatment (deformable structure may be between 0.5-15mm thick, [0054]; 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 spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “the software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature).
However, while Park discloses an adhesive-backed, flexible, and compressible foam spacer, Park does not appear to explictly disclose the third means is defined by an elastic/stretchy foam.
However, in the same field of endeavor of adhesive-backed support pads and solving substantially the same problem of providing a stretchable adhesive-backed support pad, Jones teaches the third means is defined by a flexible and elastic foam located between the first means and second means (foam backing pad has a top surface attached to a flexible electrode and a bottom surface upon which a pressure sensitive adhesive is included and is configured to elastically stretch, [0032]-[0033]; electrode and backing pad are configured to adhere and flexibly conform to skin contours, [0009], [0031]-[0033]); and
the third means, including the first and second surfaces thereof, is for at least one of flexing or stretching and conforming to the contoured surface of the skin (top surface and bottom surface of the foam backing pad are configured to flex and elastically stretch to thereby deform with deformation of the electrode to adhere and flexibly conform to skin contours, [0009], [0031]-[0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Jones’ known technique of an adhesive-backed, flexible, elastic, stretchable foam layer for adhering to and conforming to the contoured surface of the subject’s skin to Park’s known imaging marker with an adhesive-backed, flexible, conformable foam adhesive layer to achieve the predictable result that providing an elastically stretchable foam layer allows for the layer to remain attached and conform to the contours of the subject’s body during initial attachment and during body positioning changes when the subject is in motion. See, e.g., Jones, [0031]-[0032].
Additionally, or, in the alternative, while Park in further view of Jones teaches the imaging marker is configured for use in connection with a radiation imager as detailed above, Park in further view of Jones does not appear to explictly teach the imaging is in connection with radiation treatment planning and/or simulation software.
However, in the same field of endeavor of imaging markers, Zero Slice teaches an imaging marker for use in connection with an imager and radiation treatment planning and/or simulation software (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation software, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image), wherein the imaging marker is attachable to a surface of the skin of a person undergoing a radiation treatment planning and/or simulation (CT-SPOT crosshair has a backing layer that is placed on the patient’s skin that spaces the marker away from the surface of the skin and does not appear in the CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 6-7, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image; during CT set-up and imaging CT-Spot crosshair is applied to the patient’s skin, P.1, ¶6-8; see also placement of CT-Spot crosshair on patient to be imaged, Figs. 1-2, P.2, 2nd and 3rd images) and is configured to prevent the radiation treatment planning and/or simulation software from including the marker as part of the underlying person or surface of the skin, or indicating that the person will absorb more radiation at the location of the marker than the person otherwise would absorb at that location during the radiation treatment (CT-Spot Crosshair is spaced a distance away from the skin by the backing layer and the mask in a 3pt set-up as in P.2, 2nd and 3rd images thereby preventing the radiation treatment planning and/or simulation software from including the marker as part of the person or skin, or indicating that the patient will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, particularly note that in P.2 3rd image each of the CT-SPOT crosshairs is spaced away at a distance from the surface of the skin and is therefore distinct from the surface of the skin);
wherein the imaging marker is configured for using in connection with the imager and radiation treatment planning and/or simulation software (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation software, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image);
the first means is opaque or visible on an image of the marker taken by the imager for use in connection with a radiation treatment planning and/or simulation for forming an image thereof during the radiation treatment planning and/or simulation (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image);
the third means, is located between the first and the second means, is translucent, radiolucent or invisible on the image of the marker taken by the imager for use in connection with the radiation treatment planning and/or simulation (CT-SPOT crosshair has a backing layer that is placed on the patient’s skin and does not appear in the CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 6-7, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image), the third means for spacing the underside of the first means a distance away from the surface of the skin, for preventing the software from including the first means as part of the person or skin, or indicating that the person will absorb more radiation at the location of the first means than the person otherwise would absorb at that location during the radiation treatment (CT-Spot Crosshair is spaced a distance away from the skin by the backing layer and the mask in a 3pt set-up as in P.2, 2nd and 3rd images thereby preventing the radiation treatment planning and/or simulation software from including the marker as part of the person or skin, or indicating that the patient will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, particularly note that in P.2 3rd image each of the CT-SPOT crosshairs is spaced away at a distance from the surface of the skin and is therefore distinct from the surface of 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 Zero Slice’s known technique of a cross-shaped radiopaque imaging marker and use of radiopaque imaging markers during radiation planning and/or simulation and for 3 point setups to Park’s known apparatus of a radiopaque imaging marker to achieve the predictable result of improving the ease of identification of the zero slice or central axis of the treatment field. See, e.g., Zero Slice, P.1, ¶¶1, 3, 8, and 10. See also MPEP 2141 III. (C).
Additionally, or, in the alternative, even if Park in further view of Jones in further view of Zero Slice does not teach the imaging marker comprising the foam spacer is configured to prevent indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, in the same field of endeavor of radiation planning and in solving the same problem of providing a comfortable patient contact surface during irradiation, Traboulsi teaches the imaging marker comprising the third means is for preventing the software from including the first means as part of the person or skin, or indicating that the person will absorb more radiation at the location of the first means than the person otherwise would absorb at that location during the radiation treatment (thermoplastic foam spacer having a thickness of about 1/64-1/8 in, i.e., 0.397-3.175 mm, has minimal effect on the surface dose of radiation, [0036], [0038]; see also thermoplastic foam spacer being used to mark treatment planning reference points and during radiation therapy and imaging including crosshairs, field borders, leveling lines, and shielding marks, [0006], [0010], [0017], [0019], [0035], [0047], Fig. 9).
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 Park’s known apparatus using a foam deformable structure 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).
Regarding claim 19, Park discloses the first means is at least partially radiopaque marker (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]), the second means is an adhesive (adhesive layer, Fig. 4B, 5A-5B; see also [0051]), and the third means is a translucent or radiolucent foam spacer (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, 11A11D, 15A-15B, 16; see also [0056]; deformable structure comprises foam, [0054]).
Regarding claim 20, Park discloses the marker is linear shaped or cross shaped, or consists of a single, spherical-shaped pellet (device deployment guide is a linear shaped marker, Figs. 14A-14B).
Claims 21-22, 24, and 26 are rejected under 35 U.S.C. 103 as being obvious over Park in further view of Jones in further view of Zero Slice, or, in the alternative, Park in further view of Jones in further view of Zero Slice in further view of Traboulsi.
Regarding claim 21, Park discloses a method (method, Abstract, [0005]-[0007]) comprising:
releasably attaching to a contoured surface of the skin of a person an adhesive portion of an imaging 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]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]; adhesive layer is configured to temporarily and removably bonded to the skin, [0051], see also [0053], Fig. 5B), wherein the imaging marker includes a marker portion that is opaque or visible on an image of the marker taken by an imager (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]), and a spacer formed of a flexible and compressible foam material located between the adhesive and the marker portion (deformable structure comprises foam, [0054]; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e, is flexible and conformable, [0059]; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]) that is translucent, radiolucent or invisible on the image of the marker taken by the imager(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]), wherein the foam spacer defines a first surface supporting the marker portion thereon (deformable structure has a top surface that faces the base structure of the radiopaque marker element, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), a second surface located on an opposite side of the foam spacer relative to the first surface and including the adhesive thereon (deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface on the opposite side of the spacer that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), and a uniform thickness between the first and second surfaces within the range of about 1 millimeter to about 4 millimeters (deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure may be between 0.5-15mm thick, i.e., a uniform thickness, [0054]), and during the releasable attaching step, the foam spacer, including the first and second surfaces thereof, at least one of flexes or compresses and conforms to the contoured surface of the skin (deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]), and spaces the underside of the marker a substantially uniform distance within the range of about 1 millimeter to about 4 millimeters away from the contoured surf ace of the skin (deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure may be between 0.5-15mm thick, i.e., a uniform thickness, [0054]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]);
imaging with the imager the marker portion of the imaging marker and the person (radiopaque imaging marker appearing on a generated radiological image of the person with the imaging marker attached to the skin captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]; see also, undergoing radiation imaging, [0056]-[0057]; see also imaging system and imaging using imaging system, [0063]-[0066]) such that the marker portion is opaque or visible (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]) and the spacer is translucent, radiolucent or invisible (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) on the image of the marker taken by the imager (radiopaque imaging marker appearing on a generated radiological image of the person with the imaging marker attached to the skin captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]; see also, undergoing radiation imaging, [0056]-[0057]; see also imaging system and imaging using imaging system, [0063]-[0066]); and
during the imaging step (during radiation imaging, [0056]-[0057]), spacing with the spacer the underside of the marker portion a substantially uniform distance within the range of about 1 millimeter to about 4 millimeters away from the contoured surface of the skin (deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]; deformable structure has a top surface that faces the base structure of the radiopaque marker element and a bottom surface that faces the adhesive layer for attachment to the skin, Figs. 5A-5B, see also [0051] and [0053]; deformable structure may be between 0.5-15mm thick, i.e., a uniform thickness, [0054]; deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, i.e., deformable structure is flexible and compressible, [0054]-[0055], Fig. 5B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, i.e., base structure and marker are flexible and deformable, [0059] ; see also the device comprising the flexible and conformable base structure includes the aspects of the device comprising the flexible and compressible deformable structure, i.e., the embodiments are combined, [0056]) and thereby preventing software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment (applicant admits in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature).
However, while Park discloses an adhesive-backed, flexible, and compressible foam spacer, Park does not appear to explictly disclose the spacer is formed of an elastic/stretchy foam material.
However, in the same field of endeavor of adhesive-backed support pads and solving substantially the same problem of providing a stretchable adhesive-backed support pad, Jones teaches a spacer formed of a flexible and elastic foam material located between the adhesive and the marker portion (foam backing pad has a top surface attached to a flexible electrode and a bottom surface upon which a pressure sensitive adhesive is included and is configured to elastically stretch, [0032]-[0033]; electrode and backing pad are configured to adhere and flexibly conform to skin contours, [0009], [0031]-[0033]; also see electrode and backing pad being radiolucent during an imaging procedure, [0005], [0009]);
during the attaching step, the foam spacer, including the first and second surfaces thereof, at least one of flexes or stretches and conforms to the contoured surface of the skin (foam backing pad has a top surface attached to a flexible electrode and a bottom surface upon which a pressure sensitive adhesive is included and is configured to elastically stretch, [0032]-[0033]; electrode and backing pad are configured to adhere and flexibly conform to skin contours, [0009], [0031]-[0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Jones’ known technique of an adhesive-backed, flexible, elastic, stretchable foam layer for adhering to and conforming to the contoured surface of the subject’s skin to Park’s known process using an imaging marker with an adhesive-backed, flexible, conformable foam adhesive layer to achieve the predictable result that providing an elastically stretchable foam layer allows for the layer to remain attached and conform to the contours of the subject’s body during initial attachment and during body positioning changes when the subject is in motion. See, e.g., Jones, [0031]-[0032].
However, while Park in further view of Jones teaches radiological imaging of a patient and marker using an imager as detailed above, Park in further view of Jones does not appear to explictly teach the imaging is in connection with radiation treatment planning and/or simulation software.
However, in the same field of endeavor of imaging markers, Zero Slice teaches the imaging marker includes a marker portion that is opaque or visible on an image of the marker taken by an imager in connection with a radiation treatment planning and/or simulation (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image), and a spacer that is translucent, radiolucent or invisible on the image of the marker taken by the imager for use in connection with the radiation treatment planning and/or simulation (CT-SPOT crosshair has a backing layer that is placed on the patient’s skin and does not appear in the CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 6-7, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image);
imaging with the imager the marker portion of the imaging marker and the person in connection with the radiation treatment planning and/or simulation (CT-SPOT crosshair marker is visible on CT images of the patient taken for treatment planning and/or simulation, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image) such that the marker portion is opaque or visible (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image) and the spacer is translucent, radiolucent or invisible (CT-SPOT crosshair has a backing layer that is placed on the patient’s skin and does not appear in the CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 6-7, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image) on the image of the marker taken by the imager (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image); and
during the imaging step (during CT set-up and imaging CT-Spot crosshair is applied to the patient’s skin, P.1, ¶6-8; see also placement of CT-Spot crosshair on patient to be imaged, Figs. 1-2, P.2, 2nd and 3rd images), spacing the underside of the marker portion a distance away from the surface of the skin and thereby preventing software used in connection with the radiation treatment planning and/or simulation from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment (CT-Spot Crosshair is spaced a distance away from the skin by the backing layer and the mask in a 3pt set-up as in P.2, 2nd and 3rd images thereby preventing the radiation treatment planning and/or simulation software from including the marker as part of the person or skin, or indicating that the patient will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, particularly note that in P.2 3rd image each of the CT-SPOT crosshairs is spaced away at a distance from the surface of the skin and is therefore distinct from the surface of 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 Zero Slice’s known technique of a cross-shaped radiopaque imaging marker and use of radiopaque imaging markers during radiation planning and/or simulation and for 3 point setups to Park in further view of Jones’s known process of using a radiopaque imaging marker to achieve the predictable result of improving the ease of identification of the zero slice or central axis of the treatment field. See, e.g., Zero Slice, P.1, ¶¶1, 3, 8, and 10. See also MPEP 2141 III. (C).
Additionally, or in the alternative, even if Park in further view of Zero Slice does not teach the spacer prevents indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, in the same field of endeavor of radiation planning and in solving the same problem of providing a comfortable patient contact surface during irradiation, Traboulsi teaches the spacer prevents indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment (thermoplastic foam spacer having a thickness of about 1/64-1/8 in, i.e., 0.397-3.175 mm, has minimal effect on the surface dose of radiation, [0036], [0038]; see also thermoplastic foam spacer being used to mark treatment planning reference points and during radiation therapy and imaging including crosshairs, field borders, leveling lines, and shielding marks, [0006], [0010], [0017], [0019], [0035], [0047], Fig. 9).
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 Park in further view of Jones in further view of Zero Slice’s known method of using a foam deformable structure 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).
Regarding claim 22, Park discloses the imaging includes transmitting radiation through the imaging marker (radiopaque imaging marker appearing on a generated radiological image of the person with the imaging marker attached to the skin captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]; see also, undergoing radiation imaging, [0056]-[0057]; see also imaging system and imaging using imaging system, [0063]-[0066]) and the marker portion is at least partially radiopaque to the transmitted radiation (radiopaque imaging marker appearing on a generated radiological image captured by a radiological image imaging system, [0005]; see also [0006]-[0007], and [0028]-[0029]) and the spacer is translucent or radiolucent to the transmitted radiation (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).
Regarding claim 24, Park in further view of Jones does not appear to teach the marker portion is cross shaped, and further comprising marking with the imaging marker a central axis or zero slice on a tumor field.
However, in the same field of endeavor of imaging markers, Zero Slice teaches the marker portion is cross shaped (CT-SPOT crosshair in the formation of an “X”, P.1, ¶3, Figure 1, P.2, 1st image and 2nd image), and further comprising marking with the imaging marker a central axis or zero slice on a tumor field (marking the zero slice or central axis on a tumor field, P.1, ¶¶1, 3, 8, and 10).
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 Zero Slice’s known technique of a cross-shaped radiopaque imaging marker to Park in further view of Jones’s known apparatus of a radiopaque imaging marker to achieve the predictable result of improving the ease of identification of the zero slice or central axis of the treatment field. See, e.g., Zero Slice, P.1, ¶¶1, 3, 8, and 10. See also MPEP 2141 III. (C).
Regarding claim 26, Park discloses preventing dose perturbation at the interface of the imaging marker and the surface of the skin (deformable structure may be between 0.5-15mm thick, [0054]; deformable structure covers the underside of the marker, [0052]-[0055], Figs. 5A-5B; see also [0048], [0050], [0052]-[0053], and Figs. 1-3B; applicant admits in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, i.e., dose perturbation, as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that Park discloses spacing the imaging marker with a deformable structure of between 0.5-15mm thick inherently teaches this claim feature).
Additionally, or, in the alternative, even if Park does not disclose preventing dose perturbation at the interface of the imaging marker and the surface of the skin, Zero Slice teaches preventing dose perturbation at the interface of the imaging marker and the surface of the skin (CT-Spot Crosshair is spaced a distance away from the skin by the backing layer and the mask in a 3pt set-up as in P.2, 2nd and 3rd images thereby preventing the software from including the marker as part of the person or skin, or indicating that the patient will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, i.e., preventing dose perturbation, particularly note that in P.2 3rd image each of the CT-SPOT crosshair is spaced away at a distance from the surface of the skin and is therefore distinct from the surface of 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 Zero Slice’s known technique of a cross-shaped radiopaque imaging marker and use of radiopaque imaging markers during radiation planning and/or simulation and for 3 point setups to Park in further view of Jones’s known process of using a radiopaque imaging marker to achieve the predictable result of improving the ease of identification of the zero slice or central axis of the treatment field. See, e.g., Zero Slice, P.1, ¶¶1, 3, 8, and 10. See also MPEP 2141 III. (C).
Additionally, or in the alternative, even if Park in further view of Zero Slice does not teach preventing dose perturbation at the interface of the imaging marker and the surface of the skin, in the same field of endeavor of radiation planning and in solving the same problem of providing a comfortable patient contact surface during irradiation, Traboulsi teaches preventing dose perturbation at the interface of the imaging marker and the surface of the skin (thermoplastic foam spacer having a thickness of about 1/64-1/8 in, i.e., 0.397-3.175 mm, has minimal effect on the surface dose of radiation, [0036], [0038]; see also thermoplastic foam spacer being used to mark treatment planning reference points and during radiation therapy and imaging including crosshairs, field borders, leveling lines, and shielding marks, [0006], [0010], [0017], [0019], [0035], [0047], Fig. 9).
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 Park in further view of Jones’s known method of using a foam deformable structure 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 23 is rejected under 35 U.S.C. 103 as being unpatentable over Park in further view of Jones in further view of Zero Slice, or, in the alternative Park in further view of Jones in further view of Zero Slice in further view of Traboulsi as applied to claim 21 above, and further in view of Beekley (“CT Treatment Planning: Accuracy in treatment planning affects the efficacy of the treatment” 2016), hereinafter “Accuracy.”
Regarding claim 23, Park discloses the marker portion is linear shaped (device deployment guide is a linear shaped marker, Figs. 14A-14B).
However, Park in further view of Jones does not appear to teach marking with the imaging marker a field border, tangent, scar, match line, outer canthus, node, sarcoma and/or treatment area.
However, in the same field of endeavor of imaging markers, Zero Slice teaches marking with the imaging marker a field border, tangent, scar, match line, outer canthus, node, sarcoma and/or treatment area (mark field borders and scars, P.2, ¶1).
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 Zero Slice’s known technique of using a radiopaque imaging marker during radiation planning and/or simulation and for marking field borders and scars to Park in further view of Jones’s known process of using a radiopaque imaging marker to achieve the predictable result of improving the communication of features of the patient via the bright imaging of the visualized marker during simulation. See, e.g., Zero Slice, P.2, ¶¶1. See also MPEP 2141 III. (C).
Additionally, or in the alternative, even Park in further view of Jones in further view of Zero Slice, or, in the alternative, Park in further view of Jones in further view of Zero Slice in further view of Traboulsi do not teach that a linear shaped marker portion is used to mark a field border, tangent, scar, match line, outer canthus, node, sarcoma and/or treatment area, Accuracy teaches the marker is linear shaped (CT-SPOT and S-Spot are linear markers, P.2, lines 1-3, P.2, 1st-5th images), and further comprising marking with the imaging marker a field border, tangent, scar, match line, outer canthus, node, sarcoma and/or a treatment area (CT-Spot and S-spot linear markers can be used to mark field borders, tangents, scars, sarcomas, and treatment areas, P.2, line 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 Accuracy’s known technique of marking field borders, tangents, scars, sarcomas, and treatment areas with a linear marker to Park in further view of Jones in further view of Zero Slice’s known process of using a linear marker to achieve the predictable result of improve the accuracy of CT treatment planning calculations. See, e.g., P.2, lines 2-3. See also MPEP 2141 III. (C).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Park in further view of Jones in further view of Zero Slice, or, in the alternative Park in further view of Jones in further view of Zero Slice in further view of Traboulsi as applied to claim 21 above, and further in view of Jessop.
Regarding claim 25, Park in further view of Jones does not appear to teach the marker portion is a single pellet, and further comprising marking with the imaging marker an isocenter, a point in a multiple point set up, and underlying structure, or an area of concern.
However, in the same field of endeavor of imaging markers, Zero Slice teaches marking with the imaging marker an isocenter, a point in a multiple point set up, an underlying structure, or an area of concern (mark isocenters, 3-point setups, underlying structures such as skin lesions, scars, ports, and drains, and areas of concern such as points of pain, P.2, ¶1).
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 Zero Slice’s known technique of a cross-shaped radiopaque imaging marker and use of radiopaque imaging markers during radiation planning and/or simulation and for 3 point setups to Park in further view of Jones’s known process of using a radiopaque imaging marker to achieve the predictable result of improving the ease of identification of the zero slice or central axis of the treatment field. See, e.g., Zero Slice, P.1, ¶¶1, 3, 8, and 10. See also MPEP 2141 III. (C).
However, Park in further view of Jones in further view of Zero Slice, or, in the alternative, Park in further view of Jones in further view of Zero Slice in further view of Traboulsi does not appear to teach the marker portion is a single pellet.
However, in the same field of endeavor of imaging markers, Jessop teaches the marker portion is a single pellet (radiopaque marking body is spherical, [0040], [0047]-[0048], Figs. 1-3).
Additionally, Jessop teaches marking with the imaging marker an isocenter, a point in a multiple point set up, and underlying structure, or an area of concern (mark underlying structures, [0041], [0044], [0045]; see also [0006]).
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 technique of a spherical shaped radiopaque imaging marker to Park in further view of Jones in further view of Zero Slice’s known process of using a radiopaque imaging marker to achieve the predictable result of improving the imaging of the imaging marker when imaging is taken along different directions or planes. See, e.g., Jessop, [0047]. See also MPEP 2141 III. (C).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of co-pending Application No. 17/456,516 in view of Zero Slice, or, in the alternative the co-pending application in view of Zero Slice in further view of Traboulsi.
Regarding claim 1, claim 5, filed 6/26/26, discloses an imaging marker for use in connection with an imager (1:1; note that the limitation “configured for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “an imager” is not part of the claimed “imaging marker”) and radiation treatment planning and/or simulation software (1:14-25; 5:1-3; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature), wherein the imaging marker is adhesively attachable and conformable to a contoured surface of the skin of a person undergoing a radiation treatment planning and/or simulation (1:2-3; note that the limitation “undergoing a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature) and is configured to prevent the radiation treatment planning and/or simulation software from including the marker as part of the underlying person or contoured surface of the skin or indicating that the person will absorb more radiation at the location of the marker than the person otherwise would absorb at that location during the radiation treatment (1:14-25; 5:1-3; note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature), the imaging marker comprising:
a marker (1:7), an adhesive (1:11) and a spacer (1:11);
wherein the imaging marker is configured for use in connection with the imager (1:1; note that the limitation “configured for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “an imager” is not part of the claimed “imaging marker”) and radiation treatment planning and/or simulation software (1:14-25; 5:1-3; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature);
the marker is opaque or visible on an image of the marker taken by the imager for use in connection with the radiation treatment planning and/or simulation (1:7-8; note that the limitation “configured for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “an imager” is not part of the claimed “imaging marker”; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature), wherein the marker defines an underside (1:9); and
the spacer is formed of a flexible, elastic and compressible foam material (1:11-12) that is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the radiation treatment planning and/or simulation (1:11-13; note that “an imager” is not part of the claimed “imaging marker”; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature), wherein the spacer is located between the adhesive and the marker (1:14-25), the spacer defines a first surface supporting the marker thereon (1:16), a second surface located on an opposite side of the spacer relative to the first surface and including the adhesive thereon (1:14-17), and a uniform thickness between the first and second surfaces within the range of about 1 millimeter to about 4 millimeters (5:1-3), the adhesive is configure to releasably attach the imaging marker to the contoured surface of the skin (1:19-20), the foam spacer, including the first and second surfaces thereof, is configured to at least one of flex, stretch or compress and conform to the contoured surface of the skin (1:30-36), and space the underside of the marker a substantially uniform distance away from the contoured surface of the skin within the range of about 1 millimeter to about 4 millimeters (5:1-3), and prevent the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker than the person otherwise would absorb at that location during the radiation treatment (1:14-25; 5:1-3; note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature).
Again, the limitations comprising a purpose and/or intended use of the imaging marker and its components for use in connection with an imager and radiation treatment and/or stimulation software do not result in a structural difference.
Additionally, or, in the alternative, while the co-pending application claim 5 discloses the imaging marker is configured for use in connection with a radiation imager as detailed above, the co-pending application claim 5 does not appear to explictly disclose the imaging is in connection with radiation treatment planning and/or simulation software.
However, in the same field of endeavor of imaging markers, Zero Slice teaches an imaging marker for use in connection with an imager and radiation treatment planning and/or simulation software (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation software, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image), wherein the imaging marker is attachable to a surface of the skin of a person undergoing a radiation treatment planning and/or simulation (CT-SPOT crosshair has a backing layer that is placed on the patient’s skin that spaces the marker away from the surface of the skin and does not appear in the CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 6-7, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image; during CT set-up and imaging CT-Spot crosshair is applied to the patient’s skin, P.1, ¶6-8; see also placement of CT-Spot crosshair on patient to be imaged, Figs. 1-2, P.2, 2nd and 3rd images) and is configured to prevent the radiation treatment planning and/or simulation software from including the marker as part of the underlying person or surface of the skin, or indicating that the person will absorb more radiation at the location of the marker than the person otherwise would absorb at that location during the radiation treatment (CT-Spot Crosshair is spaced a distance away from the skin by the backing layer and the mask in a 3pt set-up as in P.2, 2nd and 3rd images thereby preventing the radiation treatment planning and/or simulation software from including the marker as part of the person or skin, or indicating that the patient will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, particularly note that in P.2 3rd image each of the CT-SPOT crosshairs is spaced away at a distance from the surface of the skin and is therefore distinct from the surface of the skin);
wherein the imaging marker is configured for using in connection with the imager and radiation treatment planning and/or simulation software (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation software, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image);
the marker is opaque or visible on an image of the marker taken by the imager for use in connection with the radiation treatment planning and/or simulation (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image);
the spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager for use in connection with the radiation treatment planning and/or simulation (CT-SPOT crosshair has a backing layer that is placed on the patient’s skin and does not appear in the CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 6-7, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image); the spacer is configured to space the underside of the marker a distance away from the surface of the skin, and prevent the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the first means than the person otherwise would absorb at that location during the radiation treatment (CT-Spot Crosshair is spaced a distance away from the skin by the backing layer and the mask in a 3pt set-up as in P.2, 2nd and 3rd images thereby preventing the radiation treatment planning and/or simulation software from including the marker as part of the person or skin, or indicating that the patient will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, particularly note that in P.2 3rd image each of the CT-SPOT crosshairs is spaced away at a distance from the surface of the skin and is therefore distinct from the surface of 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 Zero Slice’s known technique of a cross-shaped radiopaque imaging marker and use of radiopaque imaging markers during radiation planning and/or simulation and for 3 point setups to co-pending application claim 5’s known apparatus of a radiopaque imaging marker to achieve the predictable result of improving the ease of identification of the zero slice or central axis of the treatment field. See, e.g., Zero Slice, P.1, ¶¶1, 3, 8, and 10. See also MPEP 2141 III. (C).
Additionally, or in the alternative, even if the co-pending application claim 5 in further view of Zero Slice does not teach the spacer prevents indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, in the same field of endeavor of radiation planning and in solving the same problem of providing a comfortable patient contact surface during irradiation, Traboulsi teaches the imaging marker comprising the foam spacer is configured to prevent indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment (thermoplastic foam spacer having a thickness of about 1/64-1/8 in, i.e., 0.397-3.175 mm, has minimal effect on the surface dose of radiation, [0036], [0038]; see also thermoplastic foam spacer being used to mark treatment planning reference points and during radiation therapy and imaging including crosshairs, field borders, leveling lines, and shielding marks, [0006], [0010], [0017], [0019], [0035], [0047], Fig. 9).
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 the co-pending application claim 5’s known apparatus using a foam spacer 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 18 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of co-pending Application No. 17/456,516 in view of Zero Slice, or, in the alternative the co-pending application in view of Zero Slice in further view of Traboulsi.
Regarding claim 18, claim 5, filed 6/26/26, discloses an imaging marker for use in connection with an imager (1:1; note that the limitation “configured for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “an imager” is not part of the claimed “imaging marker”) and radiation treatment planning and/or simulation software (1:14-25; 5:1-3; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature), wherein the imaging marker is releasably attachable and conformable to a contoured surface of the skin of a person undergoing a radiation treatment planning and/or simulation (1:2-3; note that the limitation “undergoing a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature) and is configured to prevent the radiation treatment planning and/or simulation software from including the marker as part of the underlying person or contoured surface of the skin, or indicating that the person will absorb more radiation at the location of the marker than the person otherwise would absorb at that location during the radiation treatment (1:14-25; 5:1-3; note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature), the imaging marker comprising:
first means (1:7), second means (1:11) and third means (1:11);
wherein the imaging marker is configured for use in connection with the imager (1:1; note that the limitation “configured for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “an imager” is not part of the claimed “imaging marker”) and radiation treatment planning and/or simulation software (1:14-25; 5:1-3; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature);
the first means is opaque or visible on an image of the marker taken by the imager for use in connection with the radiation treatment planning and/or simulation for forming an image thereof during the radiation treatment planning and/or simulation (1:7-8; note that the limitation “configured for use in connection with an imager” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “an imager” is not part of the claimed “imaging marker”; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature; also note that the limitation “for forming an image thereof during the radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.);
second means is for releasably attaching the imaging marker to the contoured surface of the skin of the person undergoing the radiation treatment planning and/or simulation (1:19-20; note that the limitation “undergoing a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature); and
the third means is defined by a flexible, elastic and compressible foam located between the first and the second means (1:11-12, 14-21), is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the radiation treatment planning and/or simulation (1:11-13; note that “an imager” is not part of the claimed “imaging marker”; note that the limitation “in connection with a radiation treatment planning and/or simulation” is merely a purpose and/or intended use for the claimed marker and does not result in a structural difference, MPEP 2111.02 II. and 2114 II., MPEP 2114 II.; see also MPEP 2114 I. and 2112.01 I.; also note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature), defines a first surface and a second surface located on an opposite side of the first means relative to the first surface (1:14-17), the first means is supported on and attached to the first surface (1:16), the second means is located on the second surface (1:16-17), and the third means, including the first and second surfaces thereof, is conformable to the contoured surface of the skin (1:19-23), the third means defines a uniform thickness within the range of about 1 millimeter to about 4 millimeters (5:1-3), and the third means, including the first and second surfaces thereof, is for at least one of flexing, stretching or compressing and conforming to the contoured surface of the skin (1:30-36), and for spacing the underside of the first means a substantially uniform distance within the range of about 1 millimeter to about 4 millimeters away from the contoured surface of the skin (5:1-3), for preventing the software from including the first means as part of the person or skin, or indicating that the person will absorb more radiation at the location of the first means than the person otherwise would absorb at that location during the radiation treatment (1:14-25; 5:1-3; note that “radiation treatment planning and/or simulation software” is not part of the claimed “imaging marker”; applicant admitted in the Remarks filed 05/14/2024, P.8-9 that the thickness of at least about 1 millimeter of the spacer inherently prevents the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment as recited. Moreover, applicant’s specification (U.S. Pub. No. 2022/0160455) paragraph [0020] and [0030] establish that the recited claim features and advantage thereof is inherent to a thickness of a spacer thickness of at least about 1 millimeter. Therefore, that the co-pending application discloses spacing the imaging marker with a spacer of about ½ mm to about 1 mm thick inherently teaches this claim feature).
Again, the limitations comprising a purpose and/or intended use of the imaging marker and its components for use in connection with an imager and radiation treatment and/or stimulation software do not result in a structural difference.
Additionally, or, in the alternative, while the co-pending application claim 5 discloses the imaging marker is configured for use in connection with a radiation imager as detailed above, the co-pending application claim 5 does not appear to explictly disclose the imaging is in connection with radiation treatment planning and/or simulation software.
However, in the same field of endeavor of imaging markers, Zero Slice teaches an imaging marker for use in connection with an imager and radiation treatment planning and/or simulation software (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation software, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image), wherein the imaging marker is attachable to a surface of the skin of a person undergoing a radiation treatment planning and/or simulation (CT-SPOT crosshair has a backing layer that is placed on the patient’s skin that spaces the marker away from the surface of the skin and does not appear in the CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 6-7, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image; during CT set-up and imaging CT-Spot crosshair is applied to the patient’s skin, P.1, ¶6-8; see also placement of CT-Spot crosshair on patient to be imaged, Figs. 1-2, P.2, 2nd and 3rd images) and is configured to prevent the radiation treatment planning and/or simulation software from including the marker as part of the underlying person or surface of the skin, or indicating that the person will absorb more radiation at the location of the marker than the person otherwise would absorb at that location during the radiation treatment (CT-Spot Crosshair is spaced a distance away from the skin by the backing layer and the mask in a 3pt set-up as in P.2, 2nd and 3rd images thereby preventing the radiation treatment planning and/or simulation software from including the marker as part of the person or skin, or indicating that the patient will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, particularly note that in P.2 3rd image each of the CT-SPOT crosshairs is spaced away at a distance from the surface of the skin and is therefore distinct from the surface of the skin);
wherein the imaging marker is configured for using in connection with the imager and radiation treatment planning and/or simulation software (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation software, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image);
the first means is opaque or visible on an image of the marker taken by the imager for use in connection with a radiation treatment planning and/or simulation for forming an image thereof during the radiation treatment planning and/or simulation (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image);
the third means, is located between the first and the second means, is translucent, radiolucent or invisible on the image of the marker taken by the imager for use in connection with the radiation treatment planning and/or simulation (CT-SPOT crosshair has a backing layer that is placed on the patient’s skin and does not appear in the CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 6-7, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image), the third means for spacing the underside of the first means a distance away from the surface of the skin, for preventing the software from including the first means as part of the person or skin, or indicating that the person will absorb more radiation at the location of the first means than the person otherwise would absorb at that location during the radiation treatment (CT-Spot Crosshair is spaced a distance away from the skin by the backing layer and the mask in a 3pt set-up as in P.2, 2nd and 3rd images thereby preventing the radiation treatment planning and/or simulation software from including the marker as part of the person or skin, or indicating that the patient will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, particularly note that in P.2 3rd image each of the CT-SPOT crosshairs is spaced away at a distance from the surface of the skin and is therefore distinct from the surface of 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 Zero Slice’s known technique of a cross-shaped radiopaque imaging marker and use of radiopaque imaging markers during radiation planning and/or simulation and for 3 point setups to co-pending application claim 5’s known apparatus of a radiopaque imaging marker to achieve the predictable result of improving the ease of identification of the zero slice or central axis of the treatment field. See, e.g., Zero Slice, P.1, ¶¶1, 3, 8, and 10. See also MPEP 2141 III. (C).
Additionally, or in the alternative, even if the co-pending application claim 5 in further view of Zero Slice does not teach the spacer prevents indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, in the same field of endeavor of radiation planning and in solving the same problem of providing a comfortable patient contact surface during irradiation, Traboulsi teaches the imaging marker comprising the third means is for preventing the software from including the first means as part of the person or skin, or indicating that the person will absorb more radiation at the location of the first means than the person otherwise would absorb at that location during the radiation treatment (thermoplastic foam spacer having a thickness of about 1/64-1/8 in, i.e., 0.397-3.175 mm, has minimal effect on the surface dose of radiation, [0036], [0038]; see also thermoplastic foam spacer being used to mark treatment planning reference points and during radiation therapy and imaging including crosshairs, field borders, leveling lines, and shielding marks, [0006], [0010], [0017], [0019], [0035], [0047], Fig. 9).
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 the co-pending application claim 5’s known apparatus using a foam spacer 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 21 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of co-pending Application No. 17/456,516 in view of Zero Slice, or, in the alternative the co-pending application in view of Zero Slice in further view of Traboulsi.
Regarding claim 21, claim 5, filed 6/26/26, discloses a method (1:1) comprising:
releasably attaching to a contoured surface of the skin of a person an adhesive portion of an imaging marker (1:2-4, 19-20, 33-36), wherein the imaging marker includes a marker portion that is opaque or visible on an image of the marker taken by an imager for use in connection with a radiation treatment planning and/or simulation (1:7-10), and a spacer formed of a flexible, elastic and compressible foam material (1:11-12) located between the adhesive and the marker portion (1:13-20) that is translucent, radiolucent or invisible on the image of the marker taken by the imager in connection with the radiation treatment planning and/or simulation (1:12-14), wherein the foam spacer defines a first surface supporting the marker portion thereon (1:16), a second surface located on an opposite side of the foam spacer relative to the first surface and including the adhesive thereon (1:14-16), and a uniform thickness between the first and second surfaces within the range of about 1 millimeter to about 4 millimeters (5:1-3), and during the releasable attaching step, the foam spacer, including the first and second surfaces thereof, at least one of flexes, stretches or compresses and conforms to the contoured surface of the skin (1:30-36), and spaces the underside of the marker a substantially uniform distance within the range of about 1 millimeter to about 4 millimeters away from the contoured surface of the skin (5:1-3);
imaging with the imager the marker portion of the imaging marker and the person in connection with the radiation treatment planning and/or simulation (1:1-3, 7-8) such that the marker portion is opaque or visible (1:7-8) and the spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager (1:11-13); and
during the imaging step, spacing with the spacer the underside of the marker portion a substantially uniform distance within the range of about 1 millimeter to about 4 millimeters away from the contoured surface of the skin (1:14-25; 5:1-3) and thereby preventing software used in connection with the radiation treatment planning and/or simulation from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment (1:14-25; 5:1-3).
Additionally, or, in the alternative, while the co-pending application claim 5 discloses the imaging marker is configured for use in connection with a radiation imager as detailed above, the co-pending application claim 5 does not appear to explictly disclose the imaging is in connection with radiation treatment planning and/or simulation software.
However, in the same field of endeavor of imaging markers, Zero Slice teaches an imaging marker for use in connection with an imager and radiation treatment planning and/or simulation software (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation software, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image), wherein the imaging marker is attachable to a surface of the skin of a person undergoing a radiation treatment planning and/or simulation (CT-SPOT crosshair has a backing layer that is placed on the patient’s skin that spaces the marker away from the surface of the skin and does not appear in the CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 6-7, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image; during CT set-up and imaging CT-Spot crosshair is applied to the patient’s skin, P.1, ¶6-8; see also placement of CT-Spot crosshair on patient to be imaged, Figs. 1-2, P.2, 2nd and 3rd images) and is configured to prevent the radiation treatment planning and/or simulation software from including the marker as part of the underlying person or surface of the skin, or indicating that the person will absorb more radiation at the location of the marker than the person otherwise would absorb at that location during the radiation treatment (CT-Spot Crosshair is spaced a distance away from the skin by the backing layer and the mask in a 3pt set-up as in P.2, 2nd and 3rd images thereby preventing the radiation treatment planning and/or simulation software from including the marker as part of the person or skin, or indicating that the patient will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, particularly note that in P.2 3rd image each of the CT-SPOT crosshairs is spaced away at a distance from the surface of the skin and is therefore distinct from the surface of the skin);
wherein the imaging marker is configured for using in connection with the imager and radiation treatment planning and/or simulation software (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation software, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image);
the marker is opaque or visible on an image of the marker taken by the imager for use in connection with the radiation treatment planning and/or simulation (CT-SPOT crosshair marker is visible on CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 8-10, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image);
the spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager for use in connection with the radiation treatment planning and/or simulation (CT-SPOT crosshair has a backing layer that is placed on the patient’s skin and does not appear in the CT images taken for treatment planning and/or simulation, P.1, ¶¶1-3, 6-7, Figs. 1-2, P.2, ¶1, P.2, 1st-3rd image); the spacer is configured to space the underside of the marker a distance away from the surface of the skin, and prevent the software from including the marker as part of the person or skin, or indicating that the person will absorb more radiation at the location of the first means than the person otherwise would absorb at that location during the radiation treatment (CT-Spot Crosshair is spaced a distance away from the skin by the backing layer and the mask in a 3pt set-up as in P.2, 2nd and 3rd images thereby preventing the radiation treatment planning and/or simulation software from including the marker as part of the person or skin, or indicating that the patient will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, particularly note that in P.2 3rd image each of the CT-SPOT crosshairs is spaced away at a distance from the surface of the skin and is therefore distinct from the surface of 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 Zero Slice’s known technique of a cross-shaped radiopaque imaging marker and use of radiopaque imaging markers during radiation planning and/or simulation and for 3 point setups to co-pending application claim 5’s known process of using a radiopaque imaging marker to achieve the predictable result of improving the ease of identification of the zero slice or central axis of the treatment field. See, e.g., Zero Slice, P.1, ¶¶1, 3, 8, and 10. See also MPEP 2141 III. (C).
Additionally, or in the alternative, even if the co-pending application claim 5 in further view of Zero Slice does not teach the spacer prevents indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment, in the same field of endeavor of radiation planning and in solving the same problem of providing a comfortable patient contact surface during irradiation, Traboulsi teaches the imaging marker comprising the foam spacer is configured to prevent indicating that the person will absorb more radiation at the location of the marker portion than the person otherwise would absorb at that location during radiation treatment (thermoplastic foam spacer having a thickness of about 1/64-1/8 in, i.e., 0.397-3.175 mm, has minimal effect on the surface dose of radiation, [0036], [0038]; see also thermoplastic foam spacer being used to mark treatment planning reference points and during radiation therapy and imaging including crosshairs, field borders, leveling lines, and shielding marks, [0006], [0010], [0017], [0019], [0035], [0047], Fig. 9).
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 the co-pending application claim 5’s known process of using a foam spacer 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).
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Joseph et al. (U.S. Pub. No. 7,602,883) discloses a radiopaque imaging marker with a radiopaque marker portion, a radiolucent spacer, a radiolucent adhesive backing layer, and a releasable liner for releasable attachment to the skin of a patient during radiological imaging.
Jessop (U.S. Patent No. 6,269,148) discloses a radiopaque imaging marker with a radiopaque marker portion, a radiolucent spacer, a radiolucent adhesive backing layer, and a releasable liner for releasable attachment to the skin of a patient during radiological imaging.
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. 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.
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.
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.
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.
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.
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.
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 for use 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 the underside of the marker (adhesive substrate covers the underside of the formable wire-like marking body structure, [0043], Fig. 5C; attachment substrate has a thickness that separates 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 the underside of the marker away from the skin (adhesive substrate covers the underside of the formable wire-like marking body structure, [0043], Fig. 5C; attachment substrate has a thickness that 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 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 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 sufficiently 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 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]).
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. 5,383,233) 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.
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. 2018/0098820) 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.
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 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 sufficiently 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 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 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Johnathan Maynard whose telephone number is (571)272-7977. The examiner can normally be reached 10 AM - 6 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 571-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.M./Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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