DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see pg. 5, filed 07 Sep 2025, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections of 09 Jun 2025 have been withdrawn in view of the amended claims.
Applicant’s arguments, pg. 6-8, filed 07 Sep 2025, with respect to the 35 U.S.C. 103 rejections have been fully considered but are not persuasive.
Regarding the independent claim 1, Applicant argues, see pg. 6-7, that “the term “soak” (used by Applicant to describe/limit its claims) are readily distinguishable from all of its definitions of relevant/verb forms of “coat,” as set forth below: Dictionary.com definitions of SOAK (verb used with object)- 1. to place or keep in liquid in order to saturate thoroughly; steep. 2. to wet thoroughly; saturate or drench. … The term cot/coating used by Kong teaches only that Kong applied its custom-made, biocompatible, near-infrared fluorescent polymeric material, about which nothing in the art is said further, and nothing teaches or even suggests soaking Kong’s marker …”. However, the Examiner respectfully disagrees. As evidenced by Cambridge Dictionary, the term “saturate”, which Applicant relied on to define the term “soak”, means “to cover in or fill with liquid” (see attached screenshot of Cambridge Dictionary). Therefore, the claimed term of soaking, under a broadest reasonable interpretation as evidenced by Applicant as well as Cambridge Dictionary definition of saturate, includes covering in or filling with a liquid, or in this case, a fluorescent dye. Hence, such broadest reasonable interpretation includes Kong’s method of coating a fiducial with a fluorescent polymeric material, or covering the fiducial with the fluorescent polymeric material. See the 35 U.S.C. 103 rejections below. Additionally, the Examiner presents the 35 U.S.C. 102 rejections in view of previously presented prior art Kaji below when the claimed soaking is given a broadest reasonable interpretation as filling with liquid, or in this case, a fluorescent dye. See the 35 U.S.C. 102 rejections below.
Regarding the dependent claims, Applicant argues, see pg. 7-8, that neither Panescu nor Blair cure the shortcomings of Baker in view of Kong. However, the Examiner respectfully disagrees at least for the reasons explained above for the independent claim 1.
Status of Claims
Claims 1-20 are currently under examination. Claims 16-20 have been newly added since the Non-Final Office Action of 09 Jun 2025.
Claim Objections
Claims 1 and 17-19 are objected to because of the following informalities:
“comprising steps of:” should read “comprising step of:” since only the step of soaking is positively recited (claim 1);
“fiducial marker wherein a state of being impregnated includes” should read “fiducial marker, wherein a state of being impregnated includes” (claim 1);
“such that the dye is impregnated within the at least a part of the fiducial marker” should read “such that the dye is impregnated within the part of the fiducial marker” (claim 1);
“where the fiducial marker” should read “wherein the fiducial marker” (claims 17-19).
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the new limitations “wherein a state of being impregnated includes one or both of the dye occupying an otherwise void space within outer boundaries of the fiducial marker and the dye being captured between surface portions of the fiducial marker” recited in claim 1; “being impregnated includes the dye being captured between surface portions of the synthetic fibers” recited in claim 12; “the state of being impregnated includes the dye being captured between helices of the coil and/or in a central cavity of the coil” recited in claim 14; and “the state of being impregnated includes the dye being captured between helices of the coil and/or in a central cavity of the coil” recited in claim 16 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Specifically, the original drawings do not adequately show the new limitations. Fig. 2A of the instant application even shows a void space in the center of fiducial marker, contradicting “the dye occupying an otherwise void space within outer boundaries of the fiducial marker” or “the dye being captured in a central cavity of the coil” recited in claims 1, 14, and 16, respectively:
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Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Applicant is further reminded that “Photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications”. See 37 CFR 1.84(b)(1).
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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 1-20 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.
Claim 1 recites the new limitation “wherein a state of being impregnated includes one or both of the dye occupying an otherwise void space within outer boundaries of the fiducial marker and the dye being captured between surface portions of the fiducial marker”. A review of the original specification of the instant application does not disclose the new limitation. Even Fig. 2A of the instant application shows a void space in the center of fiducial marker, or “within outer boundaries of the fiducial marker”, contradicting the new limitation reciting “the dye occupying an otherwise void space within outer boundaries of the fiducial marker”. Thus, the new limitation in claim 1 introduces new matter. Claims 2-20 inherit the deficiency by the nature of their dependency on claim 1.
Claim 12 recites the new limitation “being impregnated includes the dye being captured between surface portions of the synthetic fibers”. A review of the original specification of the instant application does not disclose the new limitation. Thus, the new limitation in claim 12 introduces new matter.
Claim 14 recites the new limitation “the state of being impregnated includes the dye being captured between helices of the coil and/or in a central cavity of the coil”. A review of the original specification of the instant application does not disclose the new limitation. Fig. 2A of the instant application even shows a void space in the center of fiducial marker, contradicting the new limitation reciting “the dye being captured in a central cavity of the coil”. Thus, the new limitation in claim 14 introduces new matter.
Claim 16 recites the new limitation “the state of being impregnated includes the dye being captured between helices of the coil and/or in a central cavity of the coil”. A review of the original specification of the instant application does not disclose the new limitation. Fig. 2A of the instant application even shows a void space in the center of fiducial marker, contradicting the new limitation reciting “the dye being captured in a central cavity of the coil”. Thus, the new limitation in claim 16 introduces new matter.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “A method of marking a lesion or nodule within a lung of a mammal for subsequent surgical resection comprising steps of: soaking at least a part of a fiducial marker in a fluorescent dye such that …” While the preamble recites “marking a lesion or nodule within a lung of a mammal for subsequent surgical reception”, the only positively recited function of this method claim is “soaking at least a part of a fiducial marker in a fluorescent dye such that the dye is impregnated within at least a part of the fiducial marker”. Applicant is reminded that the limitation “wherein, following placement of the dye-impregnated fiducial marker onto or inside the lesion or nodule, the dye-impregnated fiducial marker is identifiable using an imaging technique” in the claim recites the intended use of the dye-impregnated fiducial marker. Therefore, the preamble of the claim is inconsistent with the only recited function of soaking at least a part of a fiducial marker in a fluorescent dye, and consequently the metes and bounds of the claim are unclear. Claims 2-20 inherit the deficiency by the nature of their dependency on claim 1. For purposes of the examination, claim 1 is being given a broadest reasonable interpretation as “A method comprising soaking at least a part of a fiducial marker in a fluorescent dye such that …”
Claim 1 also recites the limitation “wherein, following placement of the dye-impregnated fiducial marker onto or inside the lesion or nodule, the dye-impregnated fiducial marker is identifiable using an imaging technique”. While the limitation recites the intended use of the dye-impregnated fiducial marker being identifiable using an imaging technique, it is unclear whether “following placement of the dye-impregnated fiducial marker onto or inside the lesion or nodule” is a required function of the method of claim 1. Claims 2-20 inherit the deficiency by the nature of their dependency on claim 1, and claims 2-3 and 8 specifically recites “wherein the dye-impregnated fiducial marker is placed onto or inside the lesion or nudle”. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “placing the dye-impregnated fiducial marker onto or inside a lesion or nodule, wherein the dye-impregnated fiducial marker is identifiable using an imaging technique”, thus positively reciting the step of placing the dye-impregnated fiducial marker in the method of claim 1 and the limitation serving as the antecedent basis for “wherein the dye-impregnated fiducial marker onto or inside the lesion or nodule” in claims 2-3 and 8.
Claim 13 recites the limitation “wherein the fiducial marker includes platinum in its construction material”. It is unclear to what “its” is referring. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the fiducial marker includes platinum”.
Claim 14 recites the limitation “the state of being impregnated includes the dye being captured between helices of the coil and/or in a central cavity of the coil”. It is unclear whether “a central cavity of the coil” recited in the limitation is the same or different from “an otherwise void space” recited in claim 1, to which claim 14 depends. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “the state of being impregnated includes the dye being captured between helices of the coil and/or in the void space of the coil”.
Claim 16 recites the limitation “the state of being impregnated includes the dye being captured between helices of the coil and/or in a central cavity of the coil”. It is unclear whether “a central cavity of the coil” recited in the limitation is the same or different from “an otherwise void space” recited in claim 1, to which claim 16 depends. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “the state of being impregnated includes the dye being captured between helices of the coil and/or in the void space of the coil”.
Claim 18 recites the limitation “where the fiducial marker includes synthetic fibers to which indocyanine green dye will adhere”. It is unclear whether “indocyanine green dye” recited in the limitation is the same or different from “a fluorescent dye” recited in claim 1, to which claim 18 depends. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “where the fiducial marker includes synthetic fibers to which the fluorescent dye will adhere”.
Claim 19 recites the limitation “where the fiducial marker is made with platinum and further includes synthetic fibers to which indocyanine green dye will adhere”. It is unclear whether “indocyanine green dye” recited in the limitation is the same or different from “a fluorescent dye” recited in claim 1, to which claim 19 depends. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “where the fiducial marker is made with platinum and further includes synthetic fibers to which the fluorescent dye will adhere”.
Claim 20 recites the limitation “a subsequent step of performing a surgical resection of the lung, including using visualization of the dye-impregnated fiducial marker to locate lesion or nodule”. First, it is unclear whether “a surgical resection” recited in the limitation is the same or different from “subsequent surgical resection” recited in the preamble of claim 1, to which claim 20 depends. Second, it is unclear whether “lesion or nodule” recited in the limitation is the same or different from “a lesion or nodule” recited in the preamble of claim 1. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “a subsequent step of performing the surgical resection of the lung, including using visualization of the dye-impregnated fiducial marker to locate the lesion or nodule”.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-5, 7, 10, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaji et al. (US PG Pub No. 2005/0182318) – hereinafter referred to as Kaji.
Regarding claim 1, Kaji discloses a method of marking a lesion or nodule within a lung of a mammal for subsequent surgical resection (at least Fig. 1, 16A, 20C and [0096]: identify lesion 100 such as lung 200 with the rigidscope 14 through the use of lesion identification system for surgical operation) comprising:
soaking at least a part of a fiducial marker in a fluorescent dye such that the dye is impregnated within the at least a part of the fiducial marker (Fig. 16A and [0146]: fluorescent marker 212 comprising fluorescent substance 214, which includes ICG (Indocyanine Green)),
wherein a state of being impregnated includes one or both of the dye occupying an otherwise void space within outer boundaries of the fiducial marker (Fig. 16A and [0146]: fluorescent marker 212 comprising fluorescent substance 214) and
the dye being captured between surface portions of the fiducial marker (Fig. 16A: fluorescent substance 214 within a surface portion of transparent capsule member and a surface portion of cap 218),
wherein, following placement of the dye-impregnated fiducial marker onto or inside the lesion or nodule (Fig. 20A-C and [0162]-[0163]: fluorescent markers 212 placed at a location of lesion 100 recognized (identified) for surgical operation), the dye-impregnated fiducial marker is identifiable using an imaging technique ([0163]: fluorescent markers 212 emit fluorescent lights; [0156]: use of the light with such a portion of the wavelength allows the lesion to be more easily observed with the endoscope, providing the ease of identifying the lesion).
It is noted that the term “soak” has been given a broadest reasonable interpretation to include filling in, and Kaji discloses filling in ICG into its fluorescent marker 212 (Fig. 16A and [0146]).
Regarding claim 2, Kaji discloses all limitations of claim 1, as discussed above, and Kaji further discloses:
wherein the dye-impregnated fiducial marker is placed onto or inside the lesion or nodule using an image guided endoscopic technique that uses an endoscope, a needle, or a catheter (Fig. 1, 20A-C and [0162]-[0163]: fluorescent markers 212 placed at a location of lesion 100 recognized (identified) through the rigidscope 14; Fig. 1, 3A and [0085]: endoscope 14 is a rigidscope (optical viewing tube)).
Regarding claim 4, Kaji discloses all limitations of claim 1, as discussed above, and Kaji further discloses:
wherein the dye is indocyanine green ([0146]: fluorescent marker 212 comprising fluorescent substance 214, which includes ICG (Indocyanine Green)).
Regarding claim 5, Kaji discloses all limitations of claim 2, as discussed above, and Kaji further discloses:
wherein the dye is indocyanine green ([0146]: fluorescent marker 212 comprising fluorescent substance 214, which includes ICG (Indocyanine Green)).
Regarding claim 7, Kaji discloses all limitations of claim 1, as discussed above, and Kaji further discloses:
wherein the mammal is a human (Fig. 1 and [0079]: patient P).
Regarding claim 10, Kaji discloses all limitations of claim 2, as discussed above, and Kaji further discloses:
wherein a position of the dye-impregnated fiducial marker within the lung is identifiable after placement of the fiducial marker and thereby allows the lesion or nodule to be surgically resected in a lung sparing surgery (Fig. 16A and [0146]: fluorescent marker 212 comprising sealed fluorescent substance 214, which includes ICG (Indocyanine Green); [0163]: fluorescent markers 212 emit fluorescent lights; [0156]: use of the light with such a portion of the wavelength allows the lesion to be more easily observed with the endoscope, providing the ease of identifying the lesion).
Regarding claim 20, Kaji discloses all limitations of claim 2, as discussed above, and Kaji further discloses:
performing a surgical resection of the lung, including using visualization of the dye-impregnated fiducial marker to locate lesion or nodule (Fig 7A-B, 8; [0100]-[0104]: lesion 100 of lung and light source clips 12 are surgically incised in a lump after locating the light source clips 12, which include the lesion 100, using a CCD element 58 of the rigidscope 14).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 7, 10-11, and 14-17 are rejected under 35 U.S.C. 103 as obvious over Baker et al. (Baker et al. Endovascular Coils as Lung Tumor Fiducial Markers for Real-Time Tumor Tracking in Stereotactic Body Radiotherapy: Comparison of Complication Rates with Transthoracic Fiducial Marker Placement. J Vasc Interv Radiol, 2019; 30:1901-1907. https://doi.org/10.1016/j.jvir.2019.04.025. A copy provided previously in the Non-Final Office Action of 09 Jun 2025.) - hereinafter referred to as Baker - in view of Kong et al. (Kong et al. Robust augmented reality registration method for localization of solid organs’ tumors using CT-derived virtual biomechanical model and fluorescent fiducials. Surg Endosc 31, 2863–2871 (2017). https://doi.org/10.1007/s00464-016-5297-8. A copy provided previously in the Non-Final Office Action of 09 Jun 2025.) - hereinafter referred to as Kong.
Regarding claim 1, Baker discloses a method of marking a lesion or nodule within a lung of a mammal (Abstract: fiducial marker placement in patients with early-stage lung cancer for stereotactic body radiotherapy) comprising:
placing a fiducial marker onto or inside the lesion or nodule within the lung of the mammal (pg. 1902: Endovascular Coil Placement: Platinum embolization microcoils placed into pulmonary artery using a catheter and under fluoroscopic guidance; pg. 1903: Transthoracic Fiducial Placement: percutaneous placement of platinum markers into the lung under fluoroscopic or CT guidance using a needle); and
following the placement of the fiducial coil onto or inside the target lesion or the nodule, identifying the fiducial coil marking the targeted lesion or the nodule using an imaging technique (pg. 1904: Complication Scoring: treatment planning CT scans were obtained approximately 4-7 days after the procedure of fiducial marker placement).
It is noted that the recitations “for a (or the) subsequent surgical resection” in claim 1 have been given a limited patentable weight since they recite intended use of the claimed method of placing the dye-impregnated fiducial marker. Applicant may consider explicitly reciting in the method claim 1 the function of performing a subsequent surgical resection based on the placement of the dye-impregnated fiducial marker for a consideration of patentable weight.
Baker does not disclose:
soaking at least a part of the fiducial marker in a fluorescent dye such that the dye is impregnated within the part of the fiducial marker,
wherein a state of being impregnated includes one or both of the dye occupying an otherwise void space within outer boundaries of the fiducial marker and the dye being captured between surface portions of the fiducial marker; and
following the placement of the dye-impregnated fiducial marker onto or inside the lesion or nodule, identifying the dye-soaked fiducial coil marking the targeted lesion or the nodule using an imaging technique.
Kong, however, in the same field of placing a marker teaches:
soaking at least a part of a fiducial marker in a fluorescent dye such that the dye is impregnated within the at least a part of the fiducial marker (pg. 2864: Fluorescent gold fiducials: fiducials were coated with a custom-made, bio-compatible, near-infrared fluorescent polymeric material (Fig. 1)),
wherein a state of being impregnated includes one or both of the dye occupying an otherwise void space within outer boundaries of the fiducial marker (pg. 2864: Fluorescent gold fiducials: fiducial having a helix shape and coated with the fluorescent polymeric material (Fig. 1), thus dye occupying between threads, or helices, of the fiducial) and the dye being captured between surface portions of the fiducial marker (pg. 2864: Fluorescent gold fiducials: fiducial having a helix shape and coated with the fluorescent polymeric material (Fig. 1), thus dye captured between the helices of the fiducial); and
following the placement of the dye-impregnated fiducial marker onto or inside the lesion, identifying the dye-soaked fiducial coil marking a lesion using an imaging technique (pg. 2866-2867: In vivo experiments and Fig. 5: fiducials were successfully placed on the surface of the kidney and clearly identified by near-infrared fluorescence camera system).
It is noted that the term “soak” recited in the claim has been given a broadest reasonable interpretation as saturating, as Applicant even acknowledged (see Response to Arguments above), and coating is well known in the art to be a type of saturating, as evidenced by Cambridge Dictionary (see Response to Arguments above and the attached screenshot of Cambridge Dictionary). Further, the term “dye-impregnated” has been given a broadest reasonable interpretation as dye-retaining.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker’s method to include Kong’s method of placing a fluorescent dye impregnated fiducial marker. One of ordinary skill in the art would have combined the elements as claimed (i.e., soaking the fiducial marker with a fluorescent dye, then imaging the dye-impregnated fiducial marker placed in a lesion, as disclosed by Kong), and the combination would result in a reasonable expectation of success since both Baker and Kong are directed to placing a marker onto a lesion. The motivation for the combination would have been to allow the fiducial marker be visible under a plurality of imaging modalities, including near-infrared fluorescent imaging (pg. 2866-2867: In vivo experiments of Kong).
Regarding claim 2, Baker in view of Kong discloses all limitations of claim 1, as discussed above, and Baker further discloses:
placing the fiducial marker onto or inside the lesion or nodule using an image guided endoscopic technique that uses an endoscope, a needle, or a catheter (pg. 1902: Endovascular Coil Placement: Platinum embolization microcoils placed into pulmonary artery using a catheter and under fluoroscopic guidance), or using an image guided percutaneous technique that uses a needle or a catheter (pg. 1903: Transthoracic Fiducial Placement: percutaneous placement of platinum markers into the lung under fluoroscopic or CT guidance using a needle).
Regarding claim 7, Baker in view of Kong discloses all limitations of claim 1, as discussed above, and Baker further discloses:
wherein the mammal is a human (pg. 1902: Endovascular Coil Placement: Platinum embolization microcoils placed in patients).
Regarding claim 10, Baker in view of Kong discloses all limitations of claim 2, as discussed above, and the limitation “wherein a position of the dye-impreganted fiducial marker within the lung is identifiable up to and including nine days after placement of the fiducial marker and thereby allows the lesion or nodule to be surgically resected in a lung sparing surgery” recited in claim 10 recites intended use of the placed dye-impregnated fiducial marker within the lung. Kong’s dye-impregnated fiducial marker is placed in a lesion for a subsequent surgery (see pg. 2867-2870: Discussion). Applicant may consider explicitly reciting in the claim the function of performing a lung sparing surgery following identifying a position of the dye-impregnated fiducial marker within the lung for a consideration of patentable weight.
Regarding claim 11, Baker in view of Kong discloses all limitations of claim 1, as discussed above, and Baker further discloses:
wherein the fiducial marker is a fiducial coil (pg. 1902: Endovascular Coil Placement: Platinum embolization microcoils placed into pulmonary artery using a catheter and under fluoroscopic guidance).
Regarding claim 14, Baker in view of Kong discloses all limitations of claim 1, as discussed above, and Baker further discloses:
wherein the fiducial marker includes a fiducial coil (pg. 1902: Endovascular Coil Placement: Platinum embolization microcoils placed into pulmonary artery using a catheter and under fluoroscopic guidance; pg. 1903: Transthoracic Fiducial Placement: percutaneous placement of platinum markers into the lung under fluoroscopic or CT guidance using a needle).
Baker does not disclose:
the state of being impregnated includes the dye being captured between helices of the coil and/or in a central cavity of the coil.
Kong, however, in the same field of placing a marker teaches (also see claim 1 above):
wherein the state of being impregnated includes the dye being captured between helices of the coil and/or in a central cavity of the coil (pg. 2864: Fluorescent gold fiducials: fiducial having a helix shape and coated with the fluorescent polymeric material (Fig. 1), thus dye occupying between threads, or helices, of the fiducial).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker’s method to include Kong’s method of soaking a fiducial marker in a fluorescent dye such that the dye is impregnated within a part of the fiducial marker. One of ordinary skill in the art would have combined the elements as claimed (i.e., soaking the fiducial marker with a fluorescent dye, as disclosed by Kong), and the combination would result in a reasonable expectation of success since both Baker and Kong are directed to placing a marker onto a lesion. The motivation for the combination would have been to allow the fiducial marker be visible under a plurality of imaging modalities, including near-infrared fluorescent imaging (pg. 2866-2867: In vivo experiments of Kong).
Regarding claim 15, Baker in view of Kong discloses all limitations of claim 10, as discussed above, and Baker further discloses:
wherein the fiducial marker is a fiducial coil (pg. 1902: Endovascular Coil Placement: Platinum embolization microcoils placed into pulmonary artery using a catheter and under fluoroscopic guidance).
Regarding claim 16, Baker in view of Kong discloses all limitations of claim 5, as discussed above, and Kong further teaches (also see claim 1 above):
wherein the state of being impregnated includes the dye being captured between helices of the coil and/or in a central cavity of the coil (pg. 2864: Fluorescent gold fiducials: fiducial having a helix shape and coated with the fluorescent polymeric material (Fig. 1), thus dye occupying between threads, or helices, of the fiducial).
Regarding claim 17, Baker in view of Kong discloses all limitations of claim 1, as discussed above, and Baker further discloses:
wherein the fiducial marker is made with platinum (pg. 1903-1904: Transthoracic Fiducial Placement: platinum markers manufactured from platinum thread placed into the lung).
Claims 3, 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Baker in view of Kong, as applied to claims 1 and 7 respectively above, and further in view of Panescu et al. (US PG Pub No. 2023/0355300, priority date of 28 Sep 2020) – hereinafter referred to as Panescu.
Regarding claim 3, Baker in view of Kong disclose all limitations of claim 1, as discussed above, and Baker does not disclose:
wherein the dye-impregnated fiducial marker is placed onto or inside the lesion or nodule using a robotic assisted navigation bronchoscopy (RANB) procedure.
Panescu, however, in the same field of placing a marker teaches:
placing a fiducial marker onto or inside a lesion or nodule ([0320]: fiducial marker or guidewire left in place where the biopsy is taken using a biopsy catheter advanced through a working channel of robotically manipulated sheath) using a robotic assisted navigation bronchoscopy (RANB) procedure ([0280]-[0281]: robotically delivered working channels such as the Ion endoluminal system by Intuitive Surgical).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method by Baker to include Panescu’s method of using a robotic assisted navigation bronchoscopy to place a marker within a lung. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., using a robot to deliver a marker to the lung, as disclosed by Panescu), and the combination would have yielded a reasonable expectation of success, since both Baker and Panescu are directed to delivering a fiducial marker to a lung. The motivation for the combination would have been since “Robotically delivered working channels such as the Ion™ endoluminal system by Intuitive Surgical or the Monarch™ platform by Auris Health have advantages over traditional manually operated bronchoscopy such as very precise delivery and positioning of the working channel's tip”, as taught by Panescu ([0279]-[0280]), and improve positioning of the fiducial marker within the lung.
Regarding claim 8, Baker in view of Kong disclose all limitations of claim 7, as discussed above, and Baker does not disclose:
wherein the dye-impregnated fiducial marker is placed onto or inside the lesion or nodule using a robotic assisted navigation bronchoscopy (RANB) procedure.
Panescu, however, in the same field of placing a marker teaches:
placing a fiducial marker onto or inside a lesion or nodule ([0320]: fiducial marker or guidewire left in place where the biopsy is taken using a biopsy catheter advanced through a working channel of robotically manipulated sheath) using a robotic assisted navigation bronchoscopy (RANB) procedure ([0280]-[0281]: robotically delivered working channels such as the Ion endoluminal system by Intuitive Surgical).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method by Baker to include Panescu’s method of using a robotic assisted navigation bronchoscopy to place a marker within a lung. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., using a robot to deliver a marker to the lung, as disclosed by Panescu), and the combination would have yielded a reasonable expectation of success, since both Baker and Panescu are directed to delivering a fiducial marker to a lung. The motivation for the combination would have been since “Robotically delivered working channels such as the Ion™ endoluminal system by Intuitive Surgical or the Monarch™ platform by Auris Health have advantages over traditional manually operated bronchoscopy such as very precise delivery and positioning of the working channel's tip”, as taught by Panescu ([0279]-[0280]), and improve positioning of the fiducial marker within the lung.
Regarding claim 13, Baker in view of Kong and Panescu discloses all limitations of claim 3, as discussed above, and Baker further discloses:
wherein the fiducial marker includes platinum (pg. 1903-1904: Transthoracic Fiducial Placement: platinum markers manufactured from platinum thread placed into the lung).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Blair in view of Kong, as applied to claims 1-2, above respectively, and further in view of Blair et al. (US PG Pub No. 2021/0153972, priority date of 27 Nov 2019) – hereinafter referred to as Blair.
Regarding claim 4, Baker in view of Kong discloses all limitations of claim 1, as discussed above, and Baker does not disclose:
wherein the dye is indocyanine green.
Blair, however, in the same field of marking a lesion teaches:
placing a dye-impregnated fiducial marker with a fluorescent dye (Fig. 6A, [0144]: gel body 604 comprising fluorescent dye 503 and radiopaque wire/band 610 wrapped around the outer surface of the gel body 604; [0100]: radiopaque wire/band takes the form of open coil, closed coil, etc.),
wherein the fluorescent dye is indocyanine green ([0118]: fluorescent dye 503 includes ICG (indocyanine green)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker’s method to include Blair’s method of using an indocyanine green dye impregnated fiducial marker. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., using specifically an indocyanine green as the fluorescent dye), and the combination would have yielded a reasonable expectation of success, since both Baker and Blair are directed to delivering a fiducial marker to a tissue of interest. The motivation for the combination would have been since indocyanine green dye has “the maximum absorption at 780 nm and a relatively low quantum yield for fluorescence” ([0118] of Blair) and improve detection of the marker under fluorescent imaging.
Regarding claim 5, Baker in view of Kong discloses all limitations of claim 2, as discussed above, and Baker does not disclose:
wherein the dye is indocyanine green.
Blair, however, in the same field of marking a lesion teaches:
placing a dye-impregnated fiducial marker with a fluorescent dye (Fig. 6A, [0144]: gel body 604 comprising fluorescent dye 503 and radiopaque wire/band 610 wrapped around the outer surface of the gel body 604; [0100]: radiopaque wire/band takes the form of open coil, closed coil, etc.),
wherein the fluorescent dye is indocyanine green ([0118]: fluorescent dye 503 includes ICG (indocyanine green)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker’s method to include Blair’s method of using an indocyanine green dye impregnated fiducial marker. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., using specifically an indocyanine green as the fluorescent dye), and the combination would have yielded a reasonable expectation of success, since both Baker and Blair are directed to delivering a fiducial marker to a tissue of interest. The motivation for the combination would have been since indocyanine green dye has “the maximum absorption at 780 nm and a relatively low quantum yield for fluorescence” ([0118] of Blair) and improve detection of the marker under fluorescent imaging.
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Baker in view of Kong and Panescu, as applied to claims 3 and 8, above respectively, and further in view of Blair.
Regarding claim 6, Baker in view of Kong and Panescu discloses all limitations of claim 3, as discussed above, and Baker does not disclose:
wherein the dye is indocyanine green.
Blair, however, in the same field of marking a lesion teaches:
placing a dye-impregnated fiducial marker with a fluorescent dye (Fig. 6A, [0144]: gel body 604 comprising fluorescent dye 503 and radiopaque wire/band 610 wrapped around the outer surface of the gel body 604; [0100]: radiopaque wire/band takes the form of open coil, closed coil, etc.),
wherein the fluorescent dye is indocyanine green ([0118]: fluorescent dye 503 includes ICG (indocyanine green)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker’s method to include Blair’s method of using an indocyanine green dye impregnated fiducial marker. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., using specifically an indocyanine green as the fluorescent dye), and the combination would have yielded a reasonable expectation of success, since both Baker and Blair are directed to delivering a fiducial marker to a tissue of interest. The motivation for the combination would have been since indocyanine green dye has “the maximum absorption at 780 nm and a relatively low quantum yield for fluorescence” ([0118] of Blair) and improve detection of the marker under fluorescent imaging.
Regarding claim 9, Baker in view of Kong and Panescu discloses all limitations of claim 8, as discussed above, and Baker does not disclose:
wherein the dye is indocyanine green.
Blair, however, in the same field of marking a lesion teaches:
placing a dye-impregnated fiducial marker with a fluorescent dye (Fig. 6A, [0144]: gel body 604 comprising fluorescent dye 503 and radiopaque wire/band 610 wrapped around the outer surface of the gel body 604; [0100]: radiopaque wire/band takes the form of open coil, closed coil, etc.),
wherein the fluorescent dye is indocyanine green ([0118]: fluorescent dye 503 includes ICG (indocyanine green)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker’s method to include Blair’s method of using an indocyanine green dye impregnated fiducial marker. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., using specifically an indocyanine green as the fluorescent dye), and the combination would have yielded a reasonable expectation of success, since both Baker and Blair are directed to delivering a fiducial marker to a tissue of interest. The motivation for the combination would have been since indocyanine green dye has “the maximum absorption at 780 nm and a relatively low quantum yield for fluorescence” ([0118] of Blair) and improve detection of the marker under fluorescent imaging.
Claims 12 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Baker in view of Kong, as applied to claim 1 above, and further in view of Schroeder et al. (Schroeder et al. Coil spring fiducial markers placed safely using navigation bronchoscopy in inoperable patients allows accurate delivery of CyberKnife stereotactic radiosurgery. The Journal of Thoracic and Cardiovascular Surgery. (2010). 140(5):1137-1142. doi: 10.1016/j.jtcvs.2010.07.085. A copy attached to this Office action.) – hereinafter referred to as Schroeder.
Regarding claim 12, Baker in view of Kong discloses all limitations of claim 1, as discussed above, and Baker does not disclose:
wherein the fiducial marker includes spaced synthetic fibers, and being impregnated includes the dye being captured between surface portions of the synthetic fibers.
Schroeder, however, in the same field of a coil teaches:
wherein the fiducial marker includes spaced synthetic fibers (Fig. 2B: coiled spring fiducial marker with thrombogenic filament attachments that are spaced apart).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker’s method to include Schroeder’s coil with spaced fibers. One of ordinary skill in the art would have substituted Baker’s coil with Schroeder’s coil, since both Baker and Schroeder are directed to a coil for delivery to a tissue of interest. The motivation for the substitution would have been “polyester fibers attached to the metal coil promote thrombosis and seating into the adjacent tissue”, as taught by Schroeder (pg. 1140).
Also, as noted above in claim 1, Kong in the same field of placing a marker teaches:
soaking at least a part of a fiducial marker in a fluorescent dye such that the dye is impregnated within the at least a part of the fiducial marker (pg. 2864: Fluorescent gold fiducials: fiducials were coated with a custom-made, bio-compatible, near-infrared fluorescent polymeric material (Fig. 1)),
wherein a state of being impregnated includes one or both of the dye occupying an otherwise void space within outer boundaries of the fiducial marker (pg. 2864: Fluorescent gold fiducials: fiducial having a helix shape and coated with the fluorescent polymeric material (Fig. 1), thus dye occupying between threads, or helices, of the fiducial) and the dye being captured between surface portions of the fiducial marker (pg. 2864: Fluorescent gold fiducials: fiducial having a helix shape and coated with the fluorescent polymeric material (Fig. 1), thus dye captured between the helices of the fiducial).
As noted above in claim 1, the term “soak” recited in the claim has been given a broadest reasonable interpretation as saturating, as Applicant even acknowledged (see Response to Arguments above), and coating is well known in the art to be a type of saturating, as evidenced by Cambridge Dictionary (see Response to Arguments above and the attached screenshot of Cambridge Dictionary). Further, the term “dye-impregnated” has been given a broadest reasonable interpretation as dye-retaining.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify method of Baker in view of Schroeder to include Kong’s method of coating a marker with a fluorescent dye for the marker to be impregnated with the dye. One of ordinary skill in the art would have combined the elements as claimed (i.e., coating the marker with a fluorescent dye, as disclosed by Kong), and the combination would result in a reasonable expectation of success, including the result of the dye being captured between surface portions of the synthetic fibers of the marker of Baker in view of Schroeder, since Baker, Schroeder, and Kong are all directed to placing a marker onto a lesion. The motivation for the combination would have been to allow the fiducial marker be visible under a plurality of imaging modalities, including near-infrared fluorescent imaging (pg. 2866-2867: In vivo experiments of Kong) while the marker “promote(s) thrombosis and seating into the adjacent tissue”, as taught by Schroeder (pg. 1140).
Regarding claim 18, Baker in view of Kong discloses all limitations of claim 1, as discussed above, and Baker does not disclose:
where the fiducial marker includes synthetic fibers to which indocyanine green dye will adhere.
Schroder, however, in the same field of marking a lesion within a lung teaches:
a fiducial marker including synthetic fibers (Fig. 2B: coiled spring fiducial marker with thrombogenic filament attachments; pg. 1140: dense polyester
fibers attached to the metal coil).
It is noted that the limitation “to which indocyanine green dye will adhere” recites the intended use of the claimed synthetic fibers and is thus given a limited patentable weight.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker’s method to include Schroeder’s coil with synthetic fibers. One of ordinary skill in the art would have substituted Baker’s coil with Schroeder’s coil with synthetic fibers, since both Baker and Schroeder are directed to marking a lesion within a lung using a coil. The motivation for the substitution would have been “polyester fibers attached to the metal coil promote thrombosis and seating into the adjacent tissue”, as taught by Schroeder (pg. 1140).
Regarding claim 19, Baker in view of Kong discloses all limitations of claim 1, as discussed above, and Baker does not disclose:
where the fiducial marker is made with platinum and further includes synthetic fibers to which indocyanine green dye will adhere.
Schroeder, however, in the same field of marking a lesion within a lung teaches:
a fiducial marker including synthetic fibers (Fig. 2B: coiled spring fiducial marker with thrombogenic filament attachments; pg. 1140: dense polyester
fibers attached to the metal coil).
It is noted that the limitation “to which indocyanine green dye will adhere” recites the intended use of the claimed synthetic fibers and is thus given a limited patentable weight.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker’s method to include Schroeder’s coil with synthetic fibers. One of ordinary skill in the art would have substituted Baker’s coil with Schroeder’s coil with synthetic fibers, since both Baker and Schroeder are directed to marking a lesion within a lung using a coil. The motivation for the substitution would have been “polyester fibers attached to the metal coil promote thrombosis and seating into the adjacent tissue”, as taught by Schroeder (pg. 1140).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Baker in view of Kong, as applied to claim 2 above, and further in view of Velasquez et al. (Velasquez et al. Placement of markers to assist minimally invasive resection of peripheral lung lesion. Ann Trans Med. 2019; 7(15). doi: 10.21037/atm.2019.03.50. A copy attached to this Office action.) – hereinafter referred to as Velasquez.
Regarding claim 20, Baker in view of Kong discloses all limitations of claim 2, as discussed above, and Baker does not disclose:
performing a surgical resection of the lung, including using visualization of the dye-impregnated fiducial marker to locate lesion or nodule.
Velasquez, however, in the same field of marking a lesion within a lung teaches:
performing a surgical resection of the lung, including using visualization of the fiducial marker to locate lesion or nodule (pg. 2: Percutaneous fiducials and microcoils placement: resect the tumor and coil together, microcoils identified by fluoroscopy for nodule excision).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baker’s method to include Velasquez’s method of performing a surgical resection based on a visualization of the fiducial marker. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., performing a surgical resection of the lung following the placement of the fiducial marker, as disclosed by Velasquez), and the combination would have yielded a reasonable expectation of success, since both Baker and Velasquez are directed to marking a lesion within a lung using a coil. The motivation for the combination would have been to perform “Minimally invasive thoracic surgery (MITS) (which) is the preferred approach for surgical resection of PLLs (peripheral lung lesions)”, as taught by Velasquez (pg. 2: Introduction).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
01/27/2026