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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22 Jun 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03 Mar 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Response to Arguments
Applicant’s arguments, see pg. 5, filed 22 Jun 2026, with respect to the claim objections have been fully considered and are persuasive. The claim objections of 29 Jan 2026 have been withdrawn in view of the amended claims.
Applicant’s arguments, see pg. 5-6, filed 22 Jun 2026, with respect to the drawing objections have been fully considered and are persuasive in part.
The drawing objections of 29 Jan 2026 directed to now removed limitations (see item 6 in the Final Office Action of 29 Jan 2026) have been withdrawn in view of the amended claims.
However, the drawing objection directed to the photographs (see item 7 in the Final Office Action of 29 Jan 2026) is hereby maintained as Applicant did not submit a petition nor new drawings that are not photographs. See the drawing objection being maintained below.
Applicant’s arguments, see pg. 6, filed 22 Jun 2026, with respect to the 35 U.S.C. 112(a) rejections have been fully considered and are persuasive in part.
The 35 U.S.C. 112(a) rejections to claims 1 and 12 of 29 Jan 2026 have been withdrawn in view of the amended claims.
However, the 35 U.S.C. 112(a) rejections to claims 14 and 16 are hereby being maintained as claims 14 and 16 still recites the new matter “the dye being captured in a central cavity of the coil”. See the 35 U.S.C. 112(a) rejections to claims 14 and 16 below.
Applicant’s arguments, see pg. 6-7, filed 22 Jun 2026, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive in part.
The 35 U.S.C. 112(b) rejections to claims 13-14 and 16 of 29 Jan 2026 have been withdrawn in view of the amended claims.
Regarding claim 1, Applicant argues, see pg. 7, that the inconsistency between the preamble of the claim and the body of the claim “is standard claim drafting where the preamble provides context and states the purpose of the method”. However, the Examiner respectfully disagrees. Claim 1 is directed to a method. The only explicit step of “soaking at least a part of a fiducial marker, which includes spaced synthetic fibers, in a fluorescent dye …” is inconsistent with the intended purpose of “marking a lesion or nodule within a lung of a mammal for subsequent surgical resection”. It is unclear whether the preamble should be construed as a statement of effect that may or may not be desired or appreciated, or a statement of the intentional purpose for which the method of “marking a lesion or nodule within a lung of a mammal” must be performed. See MPEP 2111.02. See the 35 U.S.C. 112(b) rejection to claim 1 below.
Regarding claims 18-19, Applicant argues, see pg. 7, that “indocyanine green is a species of the genus “fluorescent dye”. The claims simply specify which fluorescent dye is used, and a person of ordinary skill in the art would understand this relationship”. However, the Examiner respectfully disagrees. Claims 18 and 19 each merely recites “the fiducial marker” rather than, for example, soaked or dye-impregnated fiducial marker, to distinguish from the fiducial marker that is being soaked (see claim 1 to which claims 18 and 19 each depends) that the antecedent for “the fiducial marker” and consequently indocyanine green recited in each claim are unclear. See the 35 U.S.C. 112(b) rejections to claims 18-19 below.
Regarding claim 20, Applicant argues, see pg. 7, that “Claim 20, as amended, now recites “a lesion or nodule” with the proposer article”. However, the Examiner respectfully disagrees. The amended recitation “a lesion or nodule” in claim 20 is confusing as claim 1, to which claim 20 depends, also recites “a lesion or nodule” in the preamble. It is unclear whether “a lesion or nodule” in claim 20 is the same or different from “a lesion or nodule” recited in the preamble of claim 1. See the 35 U.S.C. 112(b) rejection to claim 20 below.
Applicant’s arguments, see pg. 8-9, filed 22 Jun 2026, with respect to the 35 U.S.C. 102 and 103 rejections have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner notes that Applicant continues to argue, see pg. 9, that “The Examiner’s equation of “coating” with “soaking” is improper, as argued in prior responses. Coating applies material to an exterior surface, whereas soaking immerses the marker in liquid to achieve saturation and binding to structures like synthetic fibers”. However, the Examiner again respectfully disagrees. “Soaking”, or immersing the marker in a liquid to achieve saturation and binding to, for example, an exterior surface of the marker certainly includes “coating” or applying the liquid to the surface of the marker. Further, Kong discloses its fiducial marker having a helix shape and the fluorescent dye occupying between the threads, or helices, 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). Thus, Kong at least discloses “soaking” fluorescent dye on the exterior surface of its marker, including between helices of the marker. See the 35 U.S.C. 103 rejection to claim 1 in view of Schroeder and Kong below.
Status of Claims
Claims 1-20 are currently under examination. No claim has been cancelled, added, nor withdrawn since the Final Office Action of 29 Jan 2026.
Drawings
The drawings are objected to under 37 CFR 1.83(b)(1). Applicant is 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 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(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 no longer recites the original limitation “placing a dye impregnated fiducial marker impregnated with a fluorescent dye onto or inside the lesion or nodule identified for subsequent surgical resection within the lung of the mammal”. Therefore, the claimed invention is broader than the narrower scope of the written description of the instant application. See MPEP 2163.II.A.2. Furthermore, the instant application is a continuation application to parent applications 18173891 (now US Patent No. 11872093) and 18412522, and the originally presented claims of each parent application explicitly recited placing a dye-soaked fiducial coil onto or inside a target lesion or nodule within mammalian tissue (see claim 1 of 24 Feb 2023 of parent application 18173891 as well as claim 1 of 13 Jan 2024 of parent application 18412522). Exclusion of originally recited, explicit step of placing the dye impregnated fiducial marker in claim 1 of the instant continuation application fails to comply with the original claims of the parent applications for the benefit of earlier priority date. See MPEP 2163.II.3(b): “Akeva LLC v. Nike, Inc., 817 Fed. Appx. 1005, 1012-13, 2020 USPQ2d 10797 (Fed. Cir. 2020) … if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as lacking adequate written description, or in the case of a priority or benefit claim under 35 U.S.C. 119, 120, 365, or 386, the priority or benefit claim must be denied.” In particular, claim 1 recites in the preamble “marking a lesion or nodule within a lung of a mammal for subsequent surgical resection” but only explicitly recites the step of “soaking at least a part of a fiducial marker, which includes spaced synthetic fibers, in a fluorescent dye”. Thus, the step of placing the dye-impregnated fiducial marker onto or inside the lesion or nodule is essential or critical in “marking a lesion or nodule within a lung of a mammal for subsequent surgical resection” as disclosed in the original specification of the instant application. Claims 2-20 inherit the deficiency by the nature of their dependency on claim 1.
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”. A review of the original specification of the instant application does not disclose the dye being captured in a central cavity of the coil. Fig. 2A of the instant application even shows a void space in the center of fiducial marker, contradicting the 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 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 dye being captured in a central cavity of the coil. Fig. 2A of the instant application even shows a void space in the center of fiducial marker, contradicting the 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, which includes spaced synthetic fibers, in a fluorescent dye, and consequently claim is 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 nodule”. 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 18 recites the limitation “wherein the fiducial marker includes indocyanine green dye bound to at least some of the synthetic fibers”. The antecedent basis for “the fiducial marker including indocyanine green dye” is unclear. In particular, claim 1, to which claim 18 depends, merely recites the step of “soaking at least a part of a fiducial marker, which includes spaced synthetic fibers, in a fluorescent dye such that …”. By merely stating “the fiducial marker including indocyanine green dye” in claim 18, it is unclear whether “the fiducial marker” is referring to the fiducial marker that is being soaked; the soaked fiducial marker (or dye-impregnated fiducial marker”; or otherwise. Additionally, it is unclear whether “indocyanine green dye” is referring to “a fluorescent dye” recited in claim 1, or is an additional dye. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the fluorescent dye is indocyanine green dye, and the fluorescent dye is bound to at least some of the synthetic fibers”.
Claim 19 recites the limitation “wherein the fiducial marker is made with platinum and further includes indocyanine green dye bound to at least some of the synthetic fibers”. The antecedent basis for “the fiducial marker … further including indocyanine green dye” is unclear. In particular, claim 1, to which claim 19 depends, merely recites the step of “soaking at least a part of a fiducial marker, which includes spaced synthetic fibers, in a fluorescent dye such that …”. By merely stating “the fiducial marker including indocyanine green dye” in claim 19, it is unclear whether “the fiducial marker” is referring to the fiducial marker that is being soaked; the soaked fiducial marker (or dye-impregnated fiducial marker”; or otherwise. Additionally, it is unclear whether “indocyanine green dye” is referring to “a fluorescent dye” recited in claim 1, or is an additional dye. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the fiducial marker is made with platinum, wherein the fluorescent dye is indocyanine green dye, and the fluorescent dye is bound to at least some of the synthetic fibers”.
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 a lesion or nodule”. It is unclear whether “a 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 a surgical resection of the lung, including using visualization of the dye-impregnated fiducial marker to locate the lesion or nodule”.
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, 10-12, and 14-17 are rejected under 35 U.S.C. 103 as obvious over 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 provided previously in the Final Office Action of 29 Jan 2026.) – hereinafter referred to as Schroeder – 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). doi: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, Schroeder discloses a method of marking a lesion or nodule within a lung of a mammal (Abstract - Methods: fiducial marker placement in nonoperative patients with isolated lung tumors) comprising:
placing a fiducial marker, which includes a spaced synthetic fibers (Fig. 2B: coiled spring fiducial marker with thrombogenic filament attachments that are spaced apart), onto or inside the lesion or nodule within the lung of the mammal (Fig. 2 and pg. 1140: coil spring platinum markers with dense polyester fibers attached were placed in lung lesions); 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. 1138: CyberKnife planning CT scans were performed 7 to 14 days after fiducial marker placement and reviewed by a thoracic surgeon).
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.
Schroeder 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 the dye being bound to one or both of the synthetic fibers and another of the at least a part of the fiducial marker,
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 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 the dye being bound to a part 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
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).
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 Schroeder’s method to include Kong’s method of soaking a fiducial marker with a fluorescent dye and placing the marker in a lesion. 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 Schroeder and Kong are directed to marking a lesion in a lung. In particular, Schroeder discloses platinum coil spring fiducial marker with synthetic fibers at least on the exterior of the platinum coil spring (see Fig. 2B of Schroeder), and Kong discloses coating an exterior surface, including threads, of a fiducial (see pg. 2864: Fluorescent gold fiducials of Kong). Therefore, the combination of Schroeder and Kong results in coating the exterior surface of Schroeder’s marker, including the synthetic fibers on the platinum coil spring. 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, Schroeder in view of Kong discloses all limitations of claim 1, as discussed above, and Schroeder 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 (Fig. 2A: flattened coil spring fiducial marker loaded in tip of specimen brush; pg. 1139: Fiducial Marker Placement: fiducial markers were delivered using wax tip microbiology specimen brushes (catalogue no. 130; ConMed Endoscopic Technologies, Chelmsford, Mass) (Figure 2, A) through the extended working channel sheath under fluoroscopic control).
Regarding claim 7, Schroeder in view of Kong discloses all limitations of claim 1, as discussed above, and Schroeder further discloses:
wherein the mammal is a human (Abstract - Methods: fiducial marker placement in nonoperative patients with isolated lung tumors).
Regarding claim 10, Schroeder in view of Kong discloses all limitations of claim 2, as discussed above, and the limitation “wherein a position of the dye-impregnated 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).
Regarding claim 11, Schroeder in view of Kong discloses all limitations of claim 1, as discussed above, and Schroeder further discloses:
wherein the fiducial marker is a fiducial coil (pg. 1138: Fiducial Marker Placement: platinum coil spring marker).
Regarding claim 12, Schroeder in view of Kong discloses all limitations of claim 1, as discussed above, and Schroeder further discloses:
wherein the fiducial marker is a fiducial coil that includes platinum (pg. 1138: Fiducial Marker Placement: platinum coil spring marker).
Regarding claim 14, Schroeder in view of Kong discloses all limitations of claim 1, as discussed above, and Schroeder further discloses:
wherein the fiducial marker includes a fiducial coil (pg. 1138: Fiducial Marker Placement: platinum coil spring marker).
Schroeder 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 Schroeder’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 Schroeder and Kong are directed to marking a lesion in a lung. 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, Schroeder in view of Kong discloses all limitations of claim 10, as discussed above, and Schroeder further discloses:
wherein the fiducial marker is a fiducial coil (pg. 1138: Fiducial Marker Placement: platinum coil spring marker).
Regarding claim 16, Schroeder in view of Kong discloses all limitations of claim 15, 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, Schroeder in view of Kong discloses all limitations of claim 1, as discussed above, and Schroeder further discloses:
wherein the fiducial marker is made with platinum (pg. 1138: Fiducial Marker Placement: platinum coil spring marker).
Claims 3, 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder 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, Schroeder in view of Kong disclose all limitations of claim 1, as discussed above, and Schroeder 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 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 Schroeder’s method 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 Schroeder and Panescu are directed to marking 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, Schroeder in view of Kong disclose all limitations of claim 7, as discussed above, and Schroeder 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 Schroeder’s method 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 Schroeder and Panescu are directed to marking 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, Schroeder in view of Kong and Panescu discloses all limitations of claim 3, as discussed above, and Schroeder further discloses:
wherein the fiducial marker includes platinum (pg. 1138: Fiducial Marker Placement: platinum coil spring marker).
Claims 4-5 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder 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, Schroeder in view of Kong discloses all limitations of claim 1, as discussed above, and Schroeder in view of Kong does not disclose:
wherein the dye is indocyanine green.
Blair, however, in the same field of marker teaches:
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 Schroeder’s method to include Blair’s indocyanine green dye. 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 Schroeder and Blair are directed to marking 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, Schroeder in view of Kong discloses all limitations of claim 2, as discussed above, and Schroeder does not disclose:
wherein the dye is indocyanine green.
Blair, however, in the same field of marker teaches:
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 Schroeder’s method to include Blair’s indocyanine green dye. 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 Schroeder and Blair are directed to marking 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 18, Schroeder in view of Kong discloses all limitations of claim 1, as discussed above, and Schroeder in view of Kong discloses (also see claim 1 above):
wherein the fiducial marker includes fluorescent dye bound to at least some of the synthetic fibers.
In particular, Schroeder discloses platinum coil spring fiducial marker with synthetic fibers at least on the exterior of the platinum coil spring (see Fig. 2B of Schroeder), and Kong discloses coating an exterior surface, including threads, of a fiducial (see pg. 2864: Fluorescent gold fiducials of Kong). Therefore, the combination of Schroeder and Kong (see claim 1 above) results in coating the exterior surface of Schroeder’s marker, including the synthetic fibers on the platinum coil spring, or “the dye-impregnated fiducial marker including fluorescent dye bound to at least some of the synthetic fibers”.
Schroeder in view of Kong does not disclose:
wherein the fluorescent dye is indocyanine green dye.
Blair, however, in the same field of marker teaches:
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 the method of Schroeder in view of Kong to include Blair’s indocyanine green dye. 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 Schroeder, Kong, and Blair are directed to marking 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 19, Schroeder in view of Kong discloses all limitations of claim 1, as discussed above, and Schroeder in view of Kong discloses (also see claim 1 above):
wherein the fiducial marker is made with platinum and includes fluorescent dye bound to at least some of the synthetic fibers.
In particular, Schroeder discloses platinum coil spring fiducial marker with synthetic fibers at least on the exterior of the platinum coil spring (see Fig. 2B of Schroeder), and Kong discloses coating an exterior surface, including threads, of a fiducial (see pg. 2864: Fluorescent gold fiducials of Kong). Therefore, the combination of Schroeder and Kong (see claim 1 above) results in coating the exterior surface of Schroeder’s marker, including the synthetic fibers on the platinum coil spring, or “the dye-impregnated fiducial marker including fluorescent dye bound to at least some of the synthetic fibers”.
Schroeder in view of Kong does not disclose:
wherein the fluorescent dye is indocyanine green dye.
Blair, however, in the same field of marker teaches:
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 the method of Schroeder in view of Kong to include Blair’s indocyanine green dye. 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 Schroeder, Kong, and Blair are directed to marking 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 Schroeder in view of Kong and Panescu, as applied to claims 3 and 8, above respectively, and further in view of Blair.
Regarding claim 6, Schroeder in view of Kong and Panescu discloses all limitations of claim 3, as discussed above, and Schroeder does not disclose:
wherein the dye is indocyanine green.
Blair, however, in the same field of marker teaches:
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 Schroeder’s method to include Blair’s indocyanine green dye. 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 Schroeder 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, Schroeder in view of Kong and Panescu discloses all limitations of claim 8, as discussed above, and Schroeder does not disclose:
wherein the dye is indocyanine green.
Blair, however, in the same field of marking a lesion teaches:
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 Schroeder’s method to include Blair’s indocyanine green dye. 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 Schroeder and Blair are directed to marking 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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Schroeder 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, Schroeder in view of Kong discloses all limitations of claim 2, as discussed above, and Schroeder 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 marker 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 Schroeder’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 Schroeder 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
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/Y.C./Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
6/30/26
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