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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/10/2025 has been entered.
Information Disclosure Statement
Applicant is again reminded of their ongoing duty to disclose all information known to be material to patentability to the Office. The inventors and applicant, Beekley Corporation, have a significant amount of undisclosed publication history that predate the effective filing date of the claimed invention including blog posts (e.g., blog.beekley.com), educational resources such as videos, presentations, webinars, marketing materials, brochures, catalogs, clinical testimony, clinical guidance, and white papers (e.g., beekley.com), and commercial offers for sale.
Response to Arguments
Claim Objections
Applicant’s arguments, see Remarks at 8 and Amended Claim Set, filed 10/10/2025, with respect to the objections to claims 18 and 22 have been fully considered and are persuasive. The objection to claims 18 and 22 have been withdrawn.
112(b) Rejections
Applicant’s arguments, see Remarks at 8 and Amended Claim Set, filed 10/10/2025, with respect to the rejections of claims 1-26 as reciting the terms “substantially” and “sufficient” have been fully considered and are persuasive. The rejection of claims 1-26 under 35 U.S.C. 112(b) for reciting the terms “substantially” and “sufficient” have been withdrawn.
Applicant’s arguments, see Remarks at 8 and Amended Claim Set, filed 10/10/2025, with respect to the rejection of claim 18 as reciting “the third means is located between the first and second means that is translucent, radiolucent or invisible on the image of the marker… simulation” have been fully considered and are persuasive. The rejection of claims 1-26 under 35 U.S.C. 112(b) for reciting “the third means is located between the first and second means that is translucent, radiolucent or invisible on the image of the marker… simulation” has been withdrawn.
Applicant’s arguments, see Remarks at 8-9 and Amended Claim Set, filed 10/10/2025, with respect to the rejections of claims 1-26 as reciting the term “at least about 1 millimeter” have been fully considered but they are not persuasive. The Applicant admits that “a PHOSITA would understand from the plan language of the claims that any thickness that is the recited thickness or greater would be within the scope of the claims.” However, a PHOSITA in view of the specification and drawings would be appraised that in Applicant’s specification paragraph [0030] the applicant has set forth an upper limit of “about 4 millimeters” and provides no disclosure of embodiments above 4 millimeters. Thus, the Applicant appears to admit that the claim reads literally on embodiments outside the disclosed range. As the disclosure provides no disclosure of embodiments above 4 millimeters a PHOSITA in view of the specification and drawings would be unable to ascertain the scope of the cited term and claim limitations. See MPEP 2173.05(c). See also Final Rejection dated 2/5/2025 (“FR”) at 6-11.
For example, it is unclear that every marker spacing of above 4 millimeters would meet the limitations of “to 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” as recited in claim 1, lines 16-19. There is no disclosure of what degree or an objective standard for determining a degree of thickness/distance that achieves either function as recited. No objective standard for measuring the degree of distance is claimed, disclosed, or known to a PHOSITA. Additionally, applicant provides neither an objective standard in the art that is recognized for measuring the degree intended nor a submission of a declaration showing examples that meet the claim limitation and examples that do not. Furthermore, as per MPEP 716.01(c) "[t]he arguments of counsel cannot take the place of evidence in the record." In re Schulze, 346 F. 2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)."
102/103 Rejections
I. Independent claim 1 stands rejected as being anticipated by Park, or, in the alternative, as being unpatentable over Park in further view of Zero Slice, or, in the alternative as being unpatentable over Park in further view of Zero Slice in further view of Traboulsi. Independent claim 1 is directed to “[a]n imaging marker” and is, therefore, an apparatus and/or article claim. Applicant’s arguments are directed to functional language recited within the apparatus and/or article claim that are examined according to MPEP 2114.
MPEP 2114 II Manner of Operating the Device Does Not Differentiate Apparatus Claim from the Prior Art provides:
"apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Here, as detailed in FR at 38-42, Park discloses all the structural limitations of the claim. The limitation “configured for use in connection with… radiation treatment planning and/or simulation software” describes what the imaging marker does (i.e., that the imaging marker is used by software), not what the imaging marker is. The “imager” recited in claim 1, line 3 is not part of the claimed imaging marker. Further, the “radiation treatment planning and/or simulation software” in claim 1, line 4 is not part of the claimed imaging marker. Applicant admits that the radiation treatment planning and/or simulation software is not part of the claimed imaging marker. Remarks at 11.
In so far as the limitation imparts any structure to the claim, applicant’s specification paragraphs [0020] and [0030] disclose that the structural elements of the imaging marker that provide for use of the imaging marker with the software is that the radiopaque marker is spaced at a distance of at least 1 mm away from the skin by the radiolucent spacer. These structural elements are recited in independent claim 1 and are disclosed by Park as detailed in FR at 38-42, see also FR at 12-16.
Thus, as Park discloses all the structural elements of the imaging marker as claimed, Park anticipates the invention recited in claim 1 regardless of any recitation with respect to the manner in which the claimed imaging marker is intended to be employed.
Applicant argues that the Office found that the functional language of claim 1, lines 3-6 does not require the accomplishment of a specified objective. Remarks at 10. The Office made no such finding. FR at 12-13 set forth that
applicant’s citation to Aspex Eyewear (Remarks, P.3) is unfounded. In Aspex the Court found that the limitation “arms and magnetic members ‘adapted to extend across respective side portions’ of a primary frame” was structural in that the claim required that the arms and magnetic members had to accomplish the specified objective of extending across respective side portions. See Id. at 1350. Here, even accepting the proposition that the limitation “configured for use in connection with… radiation treatment planning and/or simulation software” provides a specified objective, as addressed above, Park discloses all the structural elements of the imaging marker necessary to achieve the specified objective.
The Office found, in arguendo, that even accepting the proposition that the functional language of claim 1 provides a specified objective, the specified objective is achieved by structure such that “the radiopaque marker is spaced at a distance of at least 1 mm away from the skin by the radiolucent spacer” Id. at 12. Again, these structural elements are recited in independent claim 1 and are disclosed by Park as detailed in Id. at 38-42, see also Id. at 12-16, see also Id. at 42 (citing the Remarks filed 5/14/2024 at 8-9 wherein Applicant admitted that the thickness of at least about 1 millimeter of the spacer inherently substantially 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).
Applicant further argues that the specified objective is:
[t]he marker must have a structure that, when used in connection with an imager and radiation treatment planning and/or simulation software; the marker is opaque or visible on an image of the marker taken by the imager in connection with the radiation treatment planning and/or simulation. Remarks at 10.
In arguendo, even accepting the proposition that the functional language of claim 1 provides the Applicant’s alleged specified objective, the specified objective is achieved by structure such that “the marker is opaque or visible on an image of the marker taken by the imager in connection with the radiation treatment planning and/or simulation.” Applicant’s abstract and specification paragraphs [0005], [0006], [0009], [0010], [0015], [0016], [0017], [0018], [0029], [0030], [0031], and [0035] disclose that the structural elements of the imaging marker that provide opacity/visibility is that the marker comprises a radiopaque material. For example, Applicant’s specification paragraph [0015] discloses that
[i]n some embodiments of the present invention, the marker is made of a thermoplastic including a filler of sufficient density to make the marker substantially radiopaque at a level of radiation used in connection with a radiation treatment planning and/or simulation.
Applicant’s specification does not provide examples of “a filler of sufficient density” or “a level of radiation used in connection with a radiation treatment planning and/or simulation.” Therefore, a PHOSITA would not be appraised in view of Applicant’s disclosure of any specific structures that satisfy the specified objective other than that the marker is radiopaque and, thereby, appears on radiographic images, wherein the radiographic images can be used in connection with radiation treatment planning and/or simulation software. Applicant’s disclosure is devoid of any examples of markers having insufficient or sufficient densities and is devoid of any examples of levels of radiation used in connection with a radiation treatment planning and/or simulation software, let alone any examples of markers having insufficient or sufficient densities at any level of radiation.
Ergo, even accepting the proposition that the functional language of claim 1 provides the Applicant’s alleged specified objective, the specified objective is achieved by any marker that is radiopaque. In effect, the broadest reasonable interpretation (BRI) of the asserted claim language in independent claim 1 encompasses any marker that comprises radiopaque material such that the marker appears in images when imaged using any radiographic imager, wherein the images can be and/or are capable of being used in connection with radiation treatment planning and/or simulation software. These structural elements are recited in independent claim 1 and are disclosed by Park as detailed in FR at 39-40.
Applicant further argues that
[t]here is no evidence that the Park procedure and radiation treatment planning / simulation use or require the same radiation dosing or that the composition and/or radiopacity of Park is the same as the composition/radiopacity of Applicant's claimed marker that is configured for use in connection with an imager and radiation treatment planning and/or simulation software and is opaque or visible on an image taken in connection with radiation treatment planning and/or simulation. Respectfully, the Office Action makes the unwarranted assumption that all imaging procedures are the same and, consequently, that Park and the claimed marker are the same or substantially identical. That is, the mere appearance of Park on a radiographic image is not sufficient to conclude that Park meets Applicant's claim limitations. Remarks at 11.
Applicant misapplies the law by requiring Park to teach not only that the marker is radiopaque and appears on a radiological image taken by a radiological imager, but also teach that the radiological image is taken in connection with radiation treatment and/or simulation. The anticipation analysis does not require a finding “that all imaging procedures are the same and, consequently, that Park and the claimed marker are the same or substantially identical” as asserted by the Applicant. The anticipation analysis also does not require a finding “that the Park procedure and radiation treatment planning / simulation use or require the same radiation dosing or that the composition and/or radiopacity of Park is the same as the composition/radiopacity of Applicant's claimed marker that is configured for use in connection with an imager and radiation treatment planning and/or simulation software and is opaque or visible on an image taken in connection with radiation treatment planning and/or simulation.” As addressed above, the BRI of the asserted claim language in independent claim 1 encompasses any marker that comprises radiopaque material such that the marker appears in images when imaged using any radiographic imager, wherein the images can be and/or are capable of being used in connection with radiation treatment planning and/or simulation software.
To anticipate the alleged claim features, Park need only teach a single embodiment of a marker that comprises radiopaque material such that the marker appears in images when imaged using any radiographic imager, wherein the images can be and/or are capable of being used in connection with radiation treatment planning and/or simulation software. The Office had set forth a basis in fact and/or technical reasoning to reasonably support the determination that the marker of Park comprises one or more radiopaque elements and appears on a generated radiological image captured by a radiological image imaging system, wherein the images can be and/or are capable of being used in connection with radiation treatment planning and/or simulation software in FR at 38-42, see also FR at 45-46.
The Office has pointed to evidence in Applicant’s admissions and Applicant’s specification to support that the property of the marker having one or more radiopaque elements that appear on a generated radiological image captured by a radiological image imaging system wherein the images can be and/or are capable of being used in connection with radiation treatment planning and/or simulation software as disclosed by Park defines a prior art device that is identical or substantially identical in structure to that claimed in the asserted claim features in claim 1. Thus, the burden is upon the applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed invention. The applicant has not provided any evidence or arguments to satisfy the applicant’s burden of proof. Therefore, Applicant’s arguments are not persuasive.
Furthermore, there is no indication in Park that the generated radiological image that includes the imaged radiopaque marker as disclosed in Park cannot be and/or is incapable of being used in connection with radiation treatment planning and/or simulation software.
Moreover, Applicant provides no evidence that the generated radiological image that includes the imaged radiopaque marker as disclosed in Park cannot be and/or is incapable of being used in connection with radiation treatment planning and/or simulation software. Applicant provides no evidence that the “radiation dosing” used in Park is different from/is incompatible with that used for treatment planning/simulation in the art, let alone in the alleged functional limitations recited in claim 1. Applicant provides no evidence that the “the composition/radiopacity” of the marker in Park is different from that used for treatment planning/simulation in the art, let alone in the alleged functional limitations recited in claim 1. As per MPEP 716.01(c) "[t]he arguments of counsel cannot take the place of evidence in the record." In re Schulze, 346 F. 2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)."
Further, Applicant provides no evidence from Applicant’s originally filed disclosure (and as discussed above cannot do so as there is no corresponding disclosure) of “the composition/radiopacity of Applicant's claimed marker that is configured for use in connection with an imager and radiation treatment planning and/or simulation software and is opaque or visible on an image taken in connection with radiation treatment planning and/or simulation,” let alone that the composition/radiopacity of the one or more radiopaque elements disclosed in Park or that the generated radiological image that includes the imaged radiopaque marker as disclosed in Park cannot be and/or is incapable of being used in connection with radiation treatment planning and/or simulation software. Again, as per MPEP 716.01(c) "[t]he arguments of counsel cannot take the place of evidence in the record." In re Schulze, 346 F. 2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)."
Therefore, Applicant’s arguments are not persuasive.
Additionally, MPEP 2112.01 I. Product and Apparatus Claims — When the Structure Recited in the Reference is Substantially Identical to That of the Claims, Claimed Properties or Functions are Presumed to be Inherent provides:
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).
See also In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971) (Claim 1 was directed to a parachute canopy having concentric circumferential panels radially separated from each other by radially extending tie lines. The panels were separated "such that the critical velocity of each successively larger panel will be less than the critical velocity of the previous panel, whereby said parachute will sequentially open and thus gradually decelerate." The court found that the claim was anticipated by Menget. Menget taught a parachute having three circumferential panels separated by tie lines. The court upheld the rejection finding that applicant had failed to show that Menget did not possess the functional characteristics of the claims.); Northam Warren Corp. v. D. F. Newfield Co., 7 F.Supp. 773, 22 USPQ 313 (E.D.N.Y. 1934) (A patent to a pencil for cleaning fingernails was held invalid because a pencil of the same structure for writing was found in the prior art.).
MPEP 2144 I. Inherency and Functional Limitations in Apparatus Claims provides:
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40, 100 USPQ2d 1433, 1440 (Fed. Cir. 2011). The burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971) ("where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on").
MPEP 2112 IV. Examiner Must Provide Rationale or Evidence to Show Inherency provides that:
The fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic. In re Rijckaert, 9 F.3d 1531, 1534, 28 USPQ2d 1955, 1957 (Fed. Cir. 1993) (reversed rejection because inherency was based on what would result due to optimization of conditions, not what was necessarily present in the prior art); In re Oelrich, 666 F.2d 578, 581-82, 212 USPQ 323, 326 (CCPA 1981). Also, "[a]n invitation to investigate is not an inherent disclosure" where a prior art reference "discloses no more than a broad genus of potential applications of its discoveries." Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367, 71 USPQ2d 1081, 1091 (Fed. Cir. 2004) (explaining that "[a] prior art reference that discloses a genus still does not inherently disclose all species within that broad category" but must be examined to see if a disclosure of the claimed species has been made or whether the prior art reference merely invites further experimentation to find the species)
"In relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990) (emphasis in original). In PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186, 112 USPQ2d 1945 (Fed. Cir. 2014), the Federal Circuit remanded a decision to the district court because the record did not present sufficient evidence to prove inherency in the context of obviousness. The district court concluded the pharmacokinetic parameters of a claim are inherent properties of the obvious formulation. The Federal Circuit stated that while "inherency may support a missing claim limitation in an obviousness analysis", "the use of inherency, a doctrine originally rooted in anticipation, must be carefully circumscribed in the context of obviousness." Id. at 1194-95, 112 USPQ2d at 1952. "[I]n order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis – the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art." Id. at 1195-96, 112 USPQ2d at 1952. But see, Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements." (emphasis in original). The court found that pharmacokinetic limitations of the asserted claims were inherently met by combining prior art references because the limitations were necessarily present in the prior art combination. Id. See also Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329-32, 2020 USPQ2d 6227 (Fed. Cir. 2020).
MPEP 2112 V. Once A Reference Teaching Product Appearing to be Substantially Identical is Made the Basis of a Rejection, and The Examiner Presents Evidence or Reasoning to Show Inherency, The Burden of Production Shifts to the Applicant provides that:
"[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255).
The Office had set forth a basis in fact and/or technical reasoning to reasonably support the determination that the property of the spacer and the imaging marker comprising the spacer wherein the deformable structure of Park has a thickness of between 0.5-15mm thick and covers the underside of the marker inherently possess the functions claimed in claim 1 as addressed above. The examiner pointed to evidence in Applicant’s admissions and Applicant’s specification to support that the property of the spacer’s thickness and placement covering the underside of the marker as disclosed by Park defines a prior art device that is identical or substantially identical in structure to that claimed in claim 1. Thus, the burden is upon the applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed invention. The applicant has not provided any evidence or arguments to satisfy the applicant’s burden of proof. Therefore, applicant’s arguments are not persuasive.
Further, the Office has pointed to evidence in Applicant’s admissions and Applicant’s specification to support that the property of the marker having one or more radiopaque elements that appear on a generated radiological image captured by a radiological image imaging system wherein the images can be and/or are capable of being used in connection with radiation treatment planning and/or simulation software as disclosed by Park defines a prior art device that is identical or substantially identical in structure to that claimed in the asserted claim features in claim 1. Thus, the burden is upon the applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed invention. The applicant has not provided any evidence or arguments to satisfy the Applicant’s burden of proof. Therefore, Applicant’s arguments are not persuasive.
II. Independent claim 18 stands rejected as being anticipated by Park, or, in the alternative, as being unpatentable over Park in further view of Zero Slice, or, in the alternative, as being unpatentable over Park in further view of Zero Slice in further view of Traboulsi. Applicant does not present particular arguments for claim 18, but rather argues “for the same or similar reasons as discussed above with respect to claim 1.” Remarks at 12. Therefore, Applicant’s arguments are not persuasive as set forth above regarding claim 1.
III. Independent claim 21 stands rejected as being unpatentable over Park in further view of Zero Slice, or, in the alternative, as being unpatentable over Park in further view of Zero Slice in further view of Trabousli.
Applicant argues that
because Park does not disclose imaging in connection with the radiation treatment planning and/or simulation, Park does not and cannot disclose the claimed steps of spacing a marker away from the skin and preventing 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. Remarks at 12.
Applicant’s argument is fundamentally flawed as it relies on the incorrect underlying premise that Park alone was relied upon to “disclose imaging in connection with the radiation treatment planning and/or simulation.” Applicant again argues that because Park does not disclose radiation treatment planning and/or simulation software, the Office cannot rely on Park to teach the limitations of claim 21, lines 12-17. First, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Park alone is not relied upon to teach the asserted claim features of the marker being used in connection with radiation treatment and/or simulation. The combination of Park in further view of Zero Slice or, in the alternative, Park in further view of Zero Slice in further view of Trabousli is relied upon to teach the asserted claim limitations. See also FR at 17-20.
Second, as stated in the FR at 65-66, addressed in the FR at 17-20, and discussed above in addressing applicant’s arguments as to claim 1 above, the limitations of claim 21, lines 12-17 according to
applicant’s specification paragraphs [0020] and [0030] is provided by spacing the radiopaque marker at a distance of at least 1 mm away from the skin by the radiolucent spacer. Park alone was not relied upon to teach each and every alleged feature of claim 21, lines 12-17 as recited, but rather selected features thereof. The spacing of the radiopaque marker at a distance of at least 1 mm away from the skin by the radiolucent spacer provides the method steps as set forth in FR at 65-66 (citations omitted):
imaging with the imager the marker portion of the imaging marker and the person such that the marker portion is opaque or visible and the spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager; and
during the imaging step, spacing with the spacer substantially the entirety of the underside of the marker portion a sufficient distance of at least about 1 millimeter away from the skin and thereby substantially 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.
As stated in FR at 66
thereby substantially 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 substantially 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).
In summary, that Park discloses spacing the marker by a spacer thickness of between 0.5-15mm from the part of the person or skin provides the result of substantially 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. That Park alone does not disclose “imaging in connection with the radiation treatment planning and/or simulation” does not preclude Park from disclosing the spacing of the marker of at least about 1mm that provides the claimed result. Therefore, applicant’s argument is not persuasive.
Moreover, the Applicant’s arguments are misleading and mischaracterize the rejection by isolating the teachings of Park from what the teachings of the combination of Park in further view of Zero Slice, or, in the alternative, Park in further view of Zero Slice in further view of Trabousli would suggest to one having ordinary skill in the art. The argument presented by the Applicant attacking Park’s disclosure in isolation are precisely the arguments that the courts were concerned with in holding that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The reasoning and teachings set forth in FR at 65-66 regarding the teachings of Park cannot be read and attacked in isolation from the reasoning and teachings of Zero Slice and Trabousli set forth in FR at 66-68. The Office found that a PHOSITA in view of the combination of Park in further view of Zero Slice, or, in the alternative, Park in further view of Zero Slice in further view of Trabousli that spacing the marker away from the patient or skin by at least 1mm achieves the results claimed in claim 21, lines 12-17. It is inappropriate for Applicant to isolate the teachings of Park from the combination of references. Therefore, applicant’s argument is not persuasive.
Applicant further argues that “it is the mask that spaces the marker away from the skin, not by a spacer as claim 21.” Remarks, P.12-13. Applicant misleads and mischaracterizes the teachings of Zero Slice relied upon in the rejection.
First, Zero Slice was not relied upon to teach “spacing with the spacer.” As stated in FR at 67-68
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 substantially the entirety of the underside of the marker portion a sufficient distance away from the skin and thereby substantially 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 sufficient 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 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).
Therefore, contrary to Applicant’s contention, Zero Slice was relied upon to teach spacing of the marker away from the skin to achieve the result claimed in claim 21, lines 12-17, not that the spacing of the marker away from the skin was provided by the spacer. Therefore, applicant’s argument is not persuasive.
Additionally, as stated in FR at 21
the teachings of the 2nd and 3rd images of P.2 of Zero Slice which as detailed in the Non-Final Rejection of 6/27/24 show spacing of the marker by the backing layer and mask away from the skin such that the skin is distinct from the marker in the CT image. The 2nd image shows that the markers are spaced by the mask and backing layer away from the skin in preparation for imaging during radiation treatment planning/simulation. The 3rd image shows that the spacing of the markers by the mask and backing layer away from the skin provides an image taken during radiation treatment planning/simulation wherein the markers (white dots) are spaced away and distinct from the skin line (light gray). The gap/space between the white dots of the marker and the light gray of the skin line is significant.
Therefore, the 2nd and 3rd images of P.2 of Zero Slice show that the spacing of the marker away from the skin is by both the backing layer and mask, the backing layer being the spacer and the marker being disposed on the side of the marking layer that is opposite from the skin. The spacer or the mask alone was not relied upon to teach the spacing to achieve the result claimed in claim 21, lines 12-17. The spacing away from the skin was relied upon to teach the spacing to achieve the result claimed in claim 21, lines 12-17, not that the spacer alone provided such spacing. Therefore, applicant’s argument is not persuasive.
Applicant further present arguments regarding Fig. 2 of Zero Slice in response to the explanation of the teachings Fig. 2 in FR at 23-24. Remarks at 13. The explanation of Fig. 2 in the FR was solely provided to respond to applicant’s mischaracterization of the teachings of Fig.2 in the Remarks filed 12/24/2025, and not relied upon to teach the alleged claim features. Thus, again, whether Zero Slice, Figure 2 alone teaches that the marker is spaced such that it images distinct from the skin line is irrelevant. Therefore, applicant’s arguments regarding Fig.2 are irrelevant and applicant’s arguments are not persuasive.
Applicant further argues that
Traboulsi shows a crosshair marker attached to the outside of the mask (see arrow in annotated Fig. 9 below) and, as in Zero Slice, the backing upon which the marker is attached is neither attached to the skin to the surface of the skin nor spaces the marker per claim 21. The Office Action appears to be conflating the foam cushioning 16 that is applied to the sharp edges of the mask and the backing upon which the crosshair marker is attached (which is square-shaped in FIG. 9). See Paragraphs [0002], [0004], [0008], [0019]. While Traboulsi discloses exemplary thicknesses of the foam cushioning, it teaches nothing regarding the thickness of the marker backing, or that such would space the underside of the marker as recited in claim 21. Remarks at 14.
Applicant’s argument relies on mischaracterization and misdirection, crafting a strawman by limiting the scope of Traboulsi’s teachings to a single, narrow embodiment extracted by the applicant from the broader teachings of Traboulsi. Contrary to Applicant’s preference, the teachings of Traboulsi are not limited to “a crosshair marker attached to the outside of the mask… the backing upon which the marker is attached is neither attached to the skin to the surface of the skin nor spaces the marker.” Rather, the teachings of Traboulsi is broader in scope.
The teachings of Trabousli paragraphs [0036], [0038], [0006], [0010], [0017], [0019], [0035], [0047], Fig. 9, and [0037] were cited in the FR at 68. Traboulsi paragraph [0036] teaches that the resilient layer/tape provides a minimal effect on the surface dose of radiation at the skin surface when the resilient layer/tape is used as a spacer spacing between the skin surface and a thermoplastic object disposed on the side opposite to the skin surface. Traboulsi paragraph [0038] teaches that the resilient layer/tape has a thickness of about 1/64-1/8 in, i.e., 0.397-3.175 mm and the resilient layer/tape is used as a spacer spacing between the skin surface and a thermoplastic object disposed on the side opposite to the skin surface. Traboulsi paragraph [0006] teaches that the resilient layer/tape are marked and used to mark treatment planning reference points. Traboulsi paragraph [0010] teaches that the resilient layer/tape is marked, the resilient layer/tape is used as a spacer spacing between the skin surface and a thermoplastic object disposed on the side opposite to the skin surface, and the resilient layer/tape has a thickness of about 1/64-1/16 in, i.e., 0.397-1.588 mm. Traboulsi paragraph [0017] teaches an exposed surface of the resilient layer/tape is marked in connection with radiation therapy treatment. Traboulsi paragraph [0019] teaches an exposed surface of the resilient layer/tape is marked for crosshairs, field borders, leveling lines, shielding marks while remaining affixed for the duration of an entire radiation therapy treatment period and that the resilient layer/tape is used as a spacer spacing between the skin surface and a thermoplastic object disposed on the side opposite to the skin surface. Traboulsi paragraph [0035] teaches a top surface of the resilient layer/tape is marked for treatment planning marks, the resilient layer/tape is made of foam, and the resilient layer/tape is used as a spacer spacing between the skin surface and a thermoplastic object disposed on the side opposite to the skin surface. Traboulsi paragraph [0047] teaches the resilient layer/tape can include additional layers for marking. Traboulsi Fig. 9 teaches the resilient layer/tape can be placed along the edges of a thermoplastic object as a spacer spacing between the skin surface and a thermoplastic object disposed on the side opposite to the skin surface and the resilient layer/tape can be marked on an exposed surface. Traboulsi paragraph [0037] teaches the resilient layer/tape is made of patient friendly material that enhances comfort and is safe for use with patients and will not irritate when in the resilient layer/tape is in contact with or touches the skin such as foam.
In summary, Trabousli teaches at least that the resilient layer/tape has a thickness of about 1/64-1/8 in, i.e., 0.397-3.175 mm, the resilient layer/tape provides a minimal effect on the surface dose of radiation at the skin surface when the resilient layer/tape is adhered to the skin and used as a spacer spacing between the skin surface and a thermoplastic object disposed on the side opposite to the skin surface, and an exposed surface of the resilient layer/tape is marked for crosshairs, field borders, leveling lines, shielding marks, and treatment planning reference points including while remaining affixed for the duration of an entire radiation therapy treatment period. Therefore, contrary to Applicant’s preference, the teachings of Traboulsi are not limited to “a crosshair marker attached to the outside of the mask… the backing upon which the marker is attached is neither attached to the skin to the surface of the skin nor spaces the marker.” Therefore, as applicant’s contention is contrary to the teachings of Traboulsi, applicant’s arguments are not persuasive.
Applicant further argues that “Nor does Traboulsi teach or suggest using the foam cushioning as a backing for a marker.” Remarks at 14. As detailed above, Traboulsi teaches the resilient layer/tape is of a foam material and an exposed surface of the resilient layer/tape is marked for crosshairs, field borders, leveling lines, shielding marks, and treatment planning reference points including while remaining affixed for the duration of an entire radiation therapy treatment period. Therefore, as applicant’s contention is contrary to the teachings of Traboulsi, applicant’s arguments are not persuasive.
Applicant further argues that “Nothing in the prior art suggests that prior art markers are uncomfortable or that comfort could be improved by using the foam material.” Remarks at 14. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) (emphasis added). In this case, as stated in the FR at 68
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 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).
Therefore, as provided in the rejection of record, Traboulsi provides a teaching, suggestion, or motivation to do so in the reference itself, that comfort is improved. Applicant appears to attempt to discount this teaching, suggestion, or motivation by asserting that “the marker in Traboulsi is attached to the outside of the mask, not the skin, and thus can cause no discomfort to the patient.” As addressed above, the teachings of Traboulsi are not limited to attachment of the resilient layer/tape to the outside of the mask. Traboulsi teaches at least that the resilient layer/tape provides a minimal effect on the surface dose of radiation at the skin surface when the resilient layer/tape is adhered to the skin and used as a spacer spacing between the skin surface and a thermoplastic object disposed on the side opposite to the skin surface, the resilient layer/tape is formed of foam, and an exposed surface of the resilient layer/tape is marked for crosshairs, field borders, leveling lines, shielding marks, and treatment planning reference points including while remaining affixed for the duration of an entire radiation therapy treatment period. Therefore, contrary to Applicant’s contention, Traboulsi teaches that the foam resilient layer/tape bearing the marker on an exposed surface can be placed in contact with the skin. Thus, applicant’s arguments are not persuasive.
Applicant responds to the FR at 25 by contending that the Applicant intended to “point[] out that Trabousli does not state or suggest that radiopaque markers can be applied to the foam, but merely that the foam can be marked, i.e., written on.” First, as stated in the FR at 25
“[t]hat the markers of Traboulsi do not appear to be disclosed in Traboulsi individually to be radiopaque does not alone disqualify the teachings of Traboulsi. Again, it is the combination of Park, Zero Slice, and Trabousli that is relied upon to teach the asserted imaging marker placed upon a foam spacer. Furthermore, applicant has not provided any arguments or evidence to challenge the motivation to combine the teachings of Traboulsi with those of Park in further view of Zero Slice provided on P.38 of the Non-Final Action of 6/27/24. Thus, applicant’s arguments are unpersuasive.
Again, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). That Traboulsi does not alone teach that the markers including crosshairs, field borders, leveling lines, shielding marks, and treatment planning reference points are radiopaque markers does not disqualify the teachings of Traboulsi. Thus, applicant’s arguments are not persuasive.
Furthermore, applicant has not provided any arguments or evidence to challenge the motivation to combine the teachings of Traboulsi with those of Park in further view of Zero Slice provided on P.38 of the Non-Final Action of 6/27/24 or the FR at 68. In addition, applicant’s contention that the marking in Traboulsi is limited to being written on is unfounded. As discussed above, at least Traboulsi paragraph [0047] teaches the resilient layer/tape can include additional layers that provide or provide for markings. Thus, contrary to applicant’s contention the teachings of Traboulsi are not limited to written markers.
Thus, applicant’s arguments are not persuasive.
Double Patenting
Applicant provides no arguments to the provisional rejection of claims 1-19 under non-statutory double patenting over co-pending U.S. patent application number 17/456,516.
Claim Objections
Claim 26 is objected to because of the following informalities:
Applicant has amended claim 26 to recite “further comprising substantially
Appropriate correction is required.
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.
Claims 1-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation “of at least about 1 millimeter” in claim 1, line 12 encompasses any thickness “of at least about 1 millimeter” without imposing any upper limit on the thickness of the spacer. The open-ended numerical range claimed does not have an upper limit, while turning to the applicant’s specification (U.S. Pub. No. 2022/0160455), in paragraph [0030] applicant appears to set out an upper limit of “about 4 millimeters” but does not recite such in the claims. Therefore, a PHOSITA in view of the specification and drawings would not consider thickness of the spacer greater than 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 limitation “a distance of at least about 1 millimeter away from the skin” in claim 1, line 16 encompasses any distance “of at least about 1 millimeter away from the skin.” This term 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. 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 limitation “a level of radiation used by the imager” in claim 2, line 3 and “the level of radiation used by the imager” in claim 2, line 5 encompasses any level of radiation without imposing any upper limit on the level of radiation. The open-ended numerical range claimed does not have an upper limit and no level of radiation is disclosed in the applicant’s originally filed specification, drawings, or claims. Therefore, a PHOSITA in view of the specification and drawings would not consider any level of radiation to be inherently supported by the discussion in the original disclosure as the claim reads literally on undisclosed embodiments. See MPEP 2163.05 III.
The 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. 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 limitation “a distance of at least about 1 millimeter away from the skin” in claim 18, line 13 encompasses any distance “of at least about 1 millimeter away from the skin.” This term 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. 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 limitation “a distance of at least about 1 millimeter away from the skin” in claim 21, line 13 encompasses any distance “of at least about 1 millimeter away from the skin.” This term 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. 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 limitation “transmitting radiation through the imaging marker at a level” in claim 22, lines 1-2 encompasses any level of radiation without imposing any upper limit on the level of radiation. The open-ended numerical range claimed does not have an upper limit and no level of radiation is disclosed in the applicant’s originally filed specification, drawings, or claims. Therefore, a PHOSITA in view of the specification and drawings would not consider any level of radiation to be inherently supported by the discussion in the original disclosure as the claim reads literally on undisclosed embodiments. See MPEP 2163.05 III.
Claims 3-17, 19-20, and 23-26 are rejected as being dependent upon the above rejected claims.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The limitation “of at least about 1 millimeter” in claim 1, line 12 encompasses any thickness “of at least about 1 millimeter” without imposing any upper limit on the thickness of the spacer. The open-ended numerical range claimed does not have an upper limit and therefore, a PHOSITA in view of the specification and drawings would be unable to ascertain the scope of the cited term and claim limitation. See MPEP 2173.05(c). It is noted that turning to the applicant’s specification (U.S. Pub. No. 2022/0160455), in paragraph [0030] applicant appears to set out an upper limit of “about 4 millimeters” but does not recite such in the claims.
The limitation “a distance of at least about 1 millimeter away from the skin” in claim 1, line 16 encompasses any distance “of at least about 1 millimeter away from the skin.” This term 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.
The limitation “a level of radiation used by the imager” in claim 2, line 3 and “the level of radiation used by the imager” in claim 2, line 5 encompasses any level of radiation without imposing any upper limit on the level of radiation. 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). No level of radiation is disclosed in the applicant’s originally filed specification, drawings, or claims.
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.
The limitation “a distance of at least about 1 millimeter away from the skin” in claim 18, line 13 encompasses any distance “of at least about 1 millimeter away from the skin.” This term 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.
The limitation “a distance of at least about 1 millimeter away from the skin” in claim 21, line 13 encompasses any distance “of at least about 1 millimeter away from the skin.” This term 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.
The limitation “transmitting radiation through the imaging marker at a level of radiation” in claim 22, lines 1-2 encompasses any level of radiation without imposing any upper limit on the level of radiation. 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). No level of radiation is disclosed in the applicant’s originally filed specification, drawings, or claims.
Claims 3-17, 19-20, and 22-26 are rejected as being dependent upon the above rejected claims.
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, 5-6, 10-11, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park (U.S. Pub. No. 2018/0098820), hereinafter “Park,” or, in the alternative, under 35 U.S.C. 103 as being obvious over Park 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 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]), 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 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]; 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.) in connection with a 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 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 a 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 thickness between the adhesive and the underside of the marker of at least about 1 millimeter (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), the adhesive is configured to releasably attach the imaging marker to a surface of a person’s skin (adhesive layer is configured to temporarily and removably bond 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.) at an interface of the imaging marker and 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]), and the spacer spaces the underside of the marker a distance of at least about 1 millimeter away from 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) to 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).
Additionally, or, in the alternative, while Park discloses the imaging marker is configured for use in connection with a radiation imager as detailed above, Park 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 the imaging marker is configured 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);
the marker 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 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 defines a thickness between the skin and the underside of the marker, and is configured to attach the imaging marker to a surface of a person’s skin undergoing the radiation treatment planning and/or simulation at an interface of the imaging marker and the skin (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 the spacer spaces the underside of the marker a distance away from the skin to 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 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’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, Park in further view of Zero Slice, or Park in further view of Zero Slice in further view of Traboulsi discloses/teaches an imaging marker as defined in claim 1 (see rejection of claim 1 above).
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 at a level of radiation used 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 “used 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 at the level of radiation used 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 “used 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 at a level of radiation used 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 at the level of radiation used 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 defines a thickness between the adhesive and the underside of the marker of 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, [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 6, Park discloses the thickness between the adhesive and the underside of the marker is uniform (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).
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 spacer is formed of a foam (deformable structure comprises foam, [0054]).
Claim 4 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 Jessop et al. (U.S. Pub. No. 2004/0116802), hereinafter “Jessop.”
Regarding claim 4, Park does not appear to disclose 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’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, Park in further view of Zero Slice, or Park 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.”
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 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) 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 does not appear to disclose 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 spacer having both an axially-elongated portion and axially-spaced, laterally-extending portions to Park’s known linear marker and 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, while Park discloses the linear marker is flexible (device deployment guide is a linear shaped marker defining an elongated axis, Figs. 14A-14B; base structure and marker are not rigid and may bend and conform the curvature of the human body onto which it is fixed, [0059]) and the spacer is configured to flex to thereby allow the spacer to flex with the marker (deformable structure is not rigid and may bend, conform, deform, and compress to the undulations of an uneven surface of the skin, [0054]-[0055], Fig. 5B), Park does not appear to disclose the spacer is configured to flex at least between the axially-spaced, laterally-extending portions.
However, in the same field of endeavor of imaging markers, Beekley ‘19 teaches the linear marker is flexible, and the spacer is configured to flex at least between the axially-spaced, laterally-extending portions to thereby allow the spacer to flex with the marker (Figure 3 demonstrates that the Beekley TomoSpot scar marker conforms to the shape of the surgical scar on the skin of a patient’s breast for breast tomosynthesis imaging, Fig. 3; adhesive backing material is soft and stretchy and compressible, P.2, line 8, P.2, caption to 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).
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 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, Park does not appear to disclose 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 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, Park in further view of Zero Slice, or Park 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 does not appear to disclose 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’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, Park in further view of Zero Slice, or Park 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 does not appear to disclose 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’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, 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 Russell (Re. 36,461), hereinafter “Russell.”
Regarding claim 13, Park 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’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 does not appear to disclose 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’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 does not appear to disclose 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’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. 102(a)(1) as being anticipated by Park, or, in the alternative under 35 U.S.C. 103 as being obvious over Park in further view of Zero Slice, or, in the alternative, Park 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]), 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 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]; 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 software” 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 a 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 a surface of the skin of a person (adhesive layer is configured to temporarily and removably bond 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 located between the first and the second means, 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) for spacing the underside of the first means a distance of at least about 1 millimeter away from 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; deformable structure spaces the radiopaque marker element from the skin, Fig. 5B; see also [0053]-[0055]) 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).
Additionally, or, in the alternative, while Park discloses the imaging marker is configured for use in connection with a radiation imager as detailed above, Park 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 the imaging marker is configured 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);
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)
attaching the imaging marker to a surface of the skin of a person undergoing 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; 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
the third means, is located between the first and the second means, 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) for spacing the underside of the first means a distance away from 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 Zero Slice does not teach the third means 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 third means 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’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 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]).
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 unpatentable over Park, in further view of Zero Slice, or, in the alternative, in further view of Traboulsi.
Regarding claim 21, Park discloses a method (method, Abstract, [0005]-[0007]) comprising:
releasably attaching to a surface of the skin of a person an adhesive portion of an imaging marker (adhesive layer is configured to temporarily and removably bond to the skin, [0051], see also [0053], Fig. 5B; see also placement of imaging marker on skin, Abstract, [0005]-[0007]), 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 located between the adhesive and the marker portion (deformable structure is located between the radiopaque marker element and the adhesive layer for attachment to the skin, Figs. 5A-5B; see also [0051] and [0053]) 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]);
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 distance of at least about 1 millimeter away from 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) 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 radiological imaging of a patient and marker using an imager as detailed above, Park does not appear to disclose the imaging and software is in connection with radiation treatment planning and/or simulation.
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 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’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’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 at a level (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]) at which 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 does not appear to disclose 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’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’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’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 Zero Slice, or, in the alternative Park 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 does not appear to disclose 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’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 Zero Slice, or, in the alternative, Park 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’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 Zero Slice, or, in the alternative Park 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 does not appear to disclose 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’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 Zero Slice, or, in the alternative, Park 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’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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/456,516 in further view of Zero Slice, or, in the alternative the copending application in further view of Zero Slice in further view of Traboulsi.
Claim 1 of the present application being exemplary, claim 5 (incorporating claims 1 and 4) of the copending application (claim set filed 12/15/2025) teaches an imaging marker (claim 1, line 1), comprising:
a marker (claim 1, line 3), an adhesive (claim 1, line 6) and a spacer (claim 1, line 6);
wherein the imaging marker is configured for use in connection with an imager (claim 1, line 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 (foam spacer of about ½ mm to about 1 mm thick, claim 5, lines 1-3; spacer covers the underside of the marker, claim 1, lines 10-11; 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 copending 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 (claim 1, lines 3-4) in connection with a radiation treatment planning and/or simulation (foam spacer of about ½ mm to about 1 mm thick, claim 5, lines 1-3; spacer covers the underside of the marker, claim 1, lines 10-11; 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 copending 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 (claim 1, lines 4-5);
the spacer is translucent, radiolucent or invisible on the image of the marker taken by the imager (claim 1, lines 6-8) in connection with the radiation treatment planning and/or simulation (foam spacer of about ½ mm to about 1 mm thick, claim 5, lines 1-3; spacer covers the underside of the marker, claim 1, lines 10-11; 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 copending 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 (claim 1, lines 6-9), the spacer defines a thickness between the adhesive and the underside of the marker of at least about 1 millimeter (claim 5, lines 1-3), the adhesive is configured to releasably attach the imaging marker to a surface of a person’s skin (claim 1, lines 11-13) undergoing the radiation treatment planning and/or simulation at an interface of the imaging marker and the skin (radiopaque marker and radiolucent spacer adhered to the skin are imaged by an imager in connection with an imaging procedure at an interface of the imaging marker and the skin, claim 1, lines 3-5, 8-9, 10-14; foam spacer of about ½ mm to about 1 mm thick, claim 5, lines 1-3; spacer covers the underside of the marker, claim 1, lines 10-11; 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 copending 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 spacer spaces the underside of the marker a distance of at least about 1 millimeter away from the skin (claim 5, lines 1-3) to 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 (foam spacer of about ½ mm to about 1 mm thick, claim 5, lines 1-3; spacer covers the underside of the marker, claim 1, lines 10-11; 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 copending 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 copending application claim 5 discloses the imaging marker is configured for use in connection with a radiation imager as detailed above, the copending 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 the imaging marker is configured 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);
the marker 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 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 defines a thickness between the skin and the underside of the marker, and is configured to attach the imaging marker to a surface of a person’s skin undergoing the radiation treatment planning and/or simulation at an interface of the imaging marker and the skin (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 the spacer spaces the underside of the marker a distance away from the skin to 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 copending 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 copending 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 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 the copending 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).
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.
Axis Imaging News (“Product Showcase: Skin Markers Geared Toward Women with Sensitive Skin” 2006) discloses Beekley Soft ‘n’ Stretchy SPOT scar markers comprise a radiopaque marker supported by an underlying adhesive backing material that is soft, stretchy, and compressible, adheres to and bends and expands to the shape of the patient’s breast during compression, and is translucent/radiolucent/invisible on an image taken by a mammography imager.
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/J.M./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798