DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/20/2026 has been entered.
As indicated by the amendment submitted with the request for continued examination: claims 1, 4, 14, 18, 19-23 and 26-27 have been amended. Claims 1-2, 4-17, 19-23 and 25-28 are presently pending in the application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6-7 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of copending Application No. 18/835,302 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because all steps and elements in the application claims are covered by the copending application claim. Except for a minor difference in terminology, it is clear that all steps and elements of claims 6-7 and 10 are found in claim 28 of the copending application. The difference between the claims of the application and the claim of the copending application lies in the fact that the copending application claim includes more steps and is, thus, more specific. Thus, the method of claim 28 of the copending application is in effect a “species” of the “generic” method of claims 1, 6-7 and 10 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1, 6-7 and 10 are anticipated by claim 28 of the copending application, they are not patentably distinct from the copending application claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 17 and 9-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of copending Application No. 18/835,302 in view of Zupkofska et al (US 2016/0178519 A1). Except for a minor difference in terminology, it is clear that all steps and elements of claims 17 and 19-23 are found in claim 28 of the copending application, except for VGT-309 being administered between 2 hours and 4 days prior to the navigating. Zupkofska teaches an analogous method for visualizing cancerous tissue wherein a marking agent is administered to a patient (par. [0087]). Zupkofska teaches that once the marker has been delivered to the patient, the marker may be allowed to permeate into the nodule (par. [0087]). Zupkofska also teaches that in some instances, a time period in the range of 20-30 minutes, in the range of several hours, in the range of a day, in the range of several days, or more may be necessary to allow the marker to permeate into the nodule (par. [0087]). Zupkofska further teaches that the time period may be selected to not only allow the marker to permeate into the nodule, but also allow the non-absorbed marker to clear from the healthy tissue. It would have been obvious to one having ordinary skill in the art to wait between 2 hours and 96 hours (several days or more), as taught by Zupkofska, prior to navigating, in order to not only allow the marker to permeate into the nodule, but also allow the non-absorbed marker to clear from the healthy tissue thereby allowing clear viewing of the cancerous tissue, as taught by Zupkofska
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4, 6-10 and 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kularatne et al. (US 2021/0353151 A1) in view of Suurs et al. (“Fluorescent image-guided surgery in breast cancer by intravenous application of a quenched fluorescence activity-based probe for cysteine cathepsins in a syngeneic mouse model”, EJNMMI Research, (2020) 10:1 11) in view of Whitley et al. (“A mouse-human phase 1 co-clinical trial of a protease-activated fluorescent probe for imaging cancer”, Science Translational Medicine, (2016), 8:320).
Regarding claim 1, Kularatne disclose a method comprising: navigating an instrument (bronchoscope; par. [0005], [0011], [0061] and [0063]), via a minimally invasive route (par. [0005], [0011] and [0063]), into a human patient to whom a molecular imaging agent has been administered (par. [0011] and [0013]), to position the instrument in an area of a tissue abnormality (par. [0005], [0011] and [0063]); and visualizing, via the instrument, tissue in the area under near-infrared (NIR) light (par. [0049] and [0066]), wherein the molecular imaging agent, as administered, causes abnormal tissue in the area to fluoresce under the NIR light and enable the fluorescing abnormal tissue to be localized within the area (par. [0049] and [0066]), wherein the molecular imaging agent comprises a pharmaceutically acceptable salt (par. [0013]).
Although Kularatne teaches administering a molecular imaging agent (par. [0011] and [0013]), it does not specifically disclose that it is administered intravenously and that it comprises VGT-309 or a pharmaceutically acceptable salt of VGT-309. Suurs teaches an analogous method for visualizing cancerous tissue wherein molecular imaging agent VGT-309 is administered intravenously (materials and methods; page 2). Suurs teaches that it is known to administer molecular imaging agents either topically or intravenously (introduction; page 2). Suurs also teaches that VGT-309 selectively targets cathepsins, the expression of which is frequently increased in cancerous tissue compared with normal tissue and is used with a near-infrared ICG fluorophore (introduction and materials and methods; page 2). Moreover, Suurs teaches administering VGT-309 at 1, 2, 4, 8 and 24 hours post VGT-309 injection (page 8, bottom right, additional file 1). It would have been obvious to one having ordinary skill in the art to administer VGT-309 intravenously, as taught by Suurs as a known method of administration, and to administer VGT-309 between 2 hours and 4 days prior to navigation, as VGT-309 selectively targets cathepsins and is used with a near-infrared ICG fluorophore, thereby enabling viewing cancerous tissue using the near-infrared imaging instrument of Kularatne, and improving interoperative tumor detection.
Although Kularatne discloses administering the imaging agent and allowing time for it to distribute at an intervention site (par. [0011]), and that the effective amount to be administered to a patient is based on body surface area, patient weight, and physician assessment of patient condition (par. [0081]), it does not specifically disclose wherein the molecular imaging agent is administered to the patient at a dose from [[0.1]] 0.2 mg/kg to [[0.5]] 0.64 mg/kg. Whitley teaches an analogous molecular imaging agent that is administered to the patient in doses of 0.5 mg/kg, 1 mg/kg, or 1.5 mg/kg (page 4). It would have been obvious to one having ordinary skill in the art to administer a dose in an amount 0.5 mg/kg per, as taught by Whitley, as an effective amount for imaging cancerous tissue with the molecular imaging agent, as taught by Whitley.
Regarding claim 4, Kularatne in view of Suurs in view of Whitley disclose the method of claim 1. It would have been obvious to one having ordinary skill in the art to provide a dose from [[0.16]] 0.2 mg/kg to 0.4 mg/kg, since where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Additionally, as Kularatne discloses that the effective amount to be administered to a patient is based on body surface area, patient weight, and physician assessment of patient condition (par. [0081]), a smaller patient, in height and weight, would require a smaller dosage.
Regarding claim 6, Kularatne in view of Suurs in view of Whitley disclose the method of claim 1, wherein the fluorescing abnormal tissue is in the patient’s lungs (par. [0005], [0052] and [0063]).
Regarding claim 7, Kularatne in view of Suurs in view of Whitley disclose the method of claim 6, wherein the fluorescing abnormal tissue comprises a nodule external to a bronchus (par. [0005], [0052] and [0063]).
Regarding claim 8, Kularatne in view of Suurs in view of Whitley disclose the method of claim 6, wherein: the instrument comprises a flexible bronchoscope (par. [0061]), and the navigating comprises guiding the flexible bronchoscope through the patient’s airway (par. [0005], [0061] and [0063]).
Regarding claim 9, Kularatne in view of Suurs in view of Whitley disclose the method of claim 1, further comprising diagnosing and/or treating the fluorescing abnormal tissue (par. [0078]).
Regarding claim 10, Kularatne in view of Suurs in view of Whitley disclose the method of claim 1, wherein the navigating, via a minimally invasive route, is an endoluminal procedure (par. [0005], [0056] and [0063]).
Regarding claim 12, Kularatne in view of Suurs in view of Whitley disclose the method of claim 1, wherein: the instrument comprises a biopsy needle or other biopsy tool (par. [0062]); and the diagnosing and/or treating comprises collecting one or more biopsy samples from the fluorescing abnormal tissue (par. [0062] and [0078]).
Regarding claim 13, Kularatne in view of Suurs in view of Whitley disclose the method of claim 1, wherein the diagnosing and/or treating comprises resection or destruction of the fluorescing abnormal tissue (par. [0053], [0062]-[0063], [0062] and [0078]).
Regarding claim 14, Kularatne in view of Suurs in view of Whitley disclose the method of claim 13, wherein the destruction of the fluorescing abnormal tissue comprises (i) ablation (par. [0062] and [0067]), and/or (it) local administration of a drug to the fluorescing abnormal tissue.
Regarding claim 15, Kularatne in view of Suurs in view of Whitley disclose the method of claim 1, which is done without a preoperative marking procedure (par. [0054]-[0056]).
Regarding claim 16, Kularatne in view of Suurs in view of Whitley disclose the method of claim 1, wherein the navigating the instrument comprises use of a robotic or robotically-assisted system (par. [0066]).
Claim(s) 2, 5 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kularatne in view of Suurs in view of Whitley as applied to claim 1 above, and further in view of Zupkofska et al. (US 2016/0178519 A1).
Regarding claim 2, Kularatne in view of Suurs in view of Whitley disclose the method of claim 1, but does not specifically disclose wherein the molecular imaging agent is administered to the patient between 72 hours and 96 hours prior to the navigating. Zupkofska teaches an analogous method for visualizing cancerous tissue wherein a marking agent is administered to a patient (par. [0087]). Zupkofska teaches that once the marker has been delivered to the patient, the marker may be allowed to permeate into the nodule (par. [0087]). Zupkofska also teaches that in some instances, a time period in the range of 20-30 minutes, in the range of several hours, in the range of a day, in the range of several days, or more may be necessary to allow the marker to permeate into the nodule (par. [0087]). Zupkofska further teaches that the time period may be selected to not only allow the marker to permeate into the nodule, but also allow the non-absorbed marker to clear from the healthy tissue. It would have been obvious to one having ordinary skill in the art to wait between 72 hour and 96 hours (several days or more), as taught by Zupkofska, prior to navigating, in order to not only allow the marker to permeate into the nodule, but also allow the non-absorbed marker to clear from the healthy tissue thereby allowing clear viewing of the cancerous tissue, as taught by Zupkofska.
Regarding claim 5, Kularatne in view of Suurs in view of Whitley disclose the method of claim 1, but does not specifically disclose wherein the dose is administered to the patient between 12 hours and 96 hours prior to the navigating. Zupkofska teaches an analogous method for visualizing cancerous tissue wherein a marking agent is administered to a patient (par. [0087]). Zupkofska teaches that once the marker has been delivered to the patient, the marker may be allowed to permeate into the nodule (par. [0087]). Zupkofska also teaches that in some instances, a time period in the range of 20-30 minutes, in the range of several hours, in the range of a day, in the range of several days, or more may be necessary to allow the marker to permeate into the nodule (par. [0087]). Zupkofska further teaches that the time period may be selected to not only allow the marker to permeate into the nodule, but also allow the non-absorbed marker to clear from the healthy tissue. It would have been obvious to one having ordinary skill in the art to wait between 12 hours and 96 hours (several days or more), as taught by Zupkofska, prior to navigating, in order to not only allow the marker to permeate into the nodule, but also allow the non-absorbed marker to clear from the healthy tissue thereby allowing clear viewing of the cancerous tissue, as taught by Zupkofska.
Regarding claim 11, Kularatne in view of Suurs in view of Whitley disclose the method of claim 1, but does not specifically disclose wherein the area of the tissue abnormality is identified from one or more preoperative scans. Zupkofska teaches an analogous method for visualizing cancerous tissue wherein a preoperative scan (CT scan; par. [0085]) is taken prior to the procedure and the area of the tissue abnormality is identified from the preoperative scan (step 110; par. [0087]). It would have been obvious to one having ordinary skill in the art to take a preoperative scan and confirm that the area of tissue abnormality is the same as that as in the preoperative scan, as taught by Zupkofska, thereby allowing the surgeon to confirm that the tissue was taken from the desired region, as taught by Zupkofska (par. [0087]).
Claim(s) 17, 19-23 and 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kularatne et al. (US 2021/0353151 A1) in view of Suurs et al. (“Fluorescent image-guided surgery in breast cancer by intravenous application of a quenched fluorescence activity-based probe for cysteine cathepsins in a syngeneic mouse model”, EJNMMI Research, (2020) 10:1 11) in view of Whitley et al. (“A mouse-human phase 1 co-clinical trial of a protease-activated fluorescent probe for imaging cancer”, Science Translational Medicine, (2016), 8:320) in view of Zupkofska et al. (US 2016/0178519 A1).
Regarding claim 17, Kularatne disclose a method comprising: navigating an instrument (bronchoscope; par. [0005], [0011], [0061] and [0063]), via an endoluminal invasive route (par. [0005], [0011], [0063], and [0066]), into a patient to whom a pharmaceutically acceptable salt has been administered (par. [0011] and [0013]), to position the instrument in a target area (par. [0005], [0011] and [0063]); and visualizing, via the instrument, tissue in the area under near-infrared (NIR) light (par. [0049] and [0066]), identifying in real time the location of any abnormal or cancerous tissue within
the target area by the florescence of the abnormal or cancerous tissue caused by the pharmaceutically acceptable salt under the NIR light (par. [0063], [0066] and [0078]).
Although Kularatne teaches administering a molecular imaging agent (par. [0011] and [0013]), it does not specifically disclose that it is administered intravenously and that it comprises VGT-309 or a pharmaceutically acceptable salt of VGT-309. Suurs teaches an analogous method for visualizing cancerous tissue wherein molecular imaging agent VGT-309 is administered intravenously (materials and methods; page 2). Suurs teaches that it is known to administer molecular imaging agents either topically or intravenously (introduction; page 2). Suurs also teaches that VGT-309 selectively targets cathepsins, the expression of which is frequently increased in cancerous tissue compared with normal tissue and is used with a near-infrared ICG fluorophore (introduction and materials and methods; page 2). Moreover, Suurs teaches administering VGT-309 at 1, 2, 4, 8 and 24 hours post VGT-309 injection (page 8, bottom right, additional file 1). It would have been obvious to one having ordinary skill in the art to administer VGT-309 intravenously, as taught by Suurs as a known method of administration, and to administer VGT-309 between 2 hours and 4 days prior to navigation, as VGT-309 selectively targets cathepsins and is used with a near-infrared ICG fluorophore, thereby enabling viewing cancerous tissue using the near-infrared imaging instrument of Kularatne, and improving interoperative tumor detection.
Although Kularatne discloses administering the imaging agent and allowing time for it to distribute at an intervention site (par. [0011]), and that the effective amount to be administered to a patient is based on body surface area, patient weight, and physician assessment of patient condition (par. [0081]), it does not specifically disclose wherein the molecular imaging agent is administered to the patient at a dose from [[0.1]] 0.2 mg/kg to 0.4 mg/kg. Whitley teaches an analogous molecular imaging agent that is administered to the patient in doses of 0.5 mg/kg, 1 mg/kg, or 1.5 mg/kg (page 4). It would have been obvious to one having ordinary skill in the art to administer a dose in an amount 0.5 mg/kg per, as taught by Whitley, as an effective amount for imaging cancerous tissue with the molecular imaging agent, as taught by Whitley. Furthermore, it would have been obvious to one having ordinary skill in the art to provide a dose from 0.2 mg/kg to 0.4 mg/kg, since where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Additionally, as Kularatne discloses that the effective amount to be administered to a patient is based on body surface area, patient weight, and physician assessment of patient condition (par. [0081]), a smaller patient, in height and weight, would require a smaller dosage.
Kularatne does not specifically disclose wherein the molecular imaging agent is administered to the patient between 12 hours and 96 hours prior to the navigating. Zupkofska teaches an analogous method for visualizing cancerous tissue wherein a marking agent is administered to a patient (par. [0087]). Zupkofska teaches that once the marker has been delivered to the patient, the marker may be allowed to permeate into the nodule (par. [0087]). Zupkofska also teaches that in some instances, a time period in the range of 20-30 minutes, in the range of several hours, in the range of a day, in the range of several days, or more may be necessary to allow the marker to permeate into the nodule (par. [0087]). Zupkofska further teaches that the time period may be selected to not only allow the marker to permeate into the nodule, but also allow the non-absorbed marker to clear from the healthy tissue. It would have been obvious to one having ordinary skill in the art to wait between 12 hour and 96 hours (several days or more), as taught by Zupkofska, prior to navigating, in order to not only allow the marker to permeate into the nodule, but also allow the non-absorbed marker to clear from the healthy tissue thereby allowing clear viewing of the cancerous tissue, as taught by Zupkofska.
Regarding claim 19, Kularatne in view of Suurs in view of Whitley in view of Zupkofska disclose the method of claim 17, wherein the VGT-309 or the pharmaceutically acceptable salt of VGT-309 is administered to the patient between 12 hours and 36 hours prior to the navigating (Zupkofska: par. [0087]).
Regarding claim 20, Kularatne in view of Suurs in view of Whitley in view of Zupkofska disclose the method of claim 17, wherein the VGT-309 or the pharmaceutically acceptable salt of VGT-309 is administered to the patient between 72 hours and 96 hours prior to the navigating (Zupkofska: par. [0087]).
Regarding claim 21, Kularatne in view of Suurs in view of Whitley in view of Zupkofska disclose the method of claim 17, wherein the VGT-309 or the pharmaceutically acceptable salt of VGT-309 is administered to the patient at a dose from 0.3 mg/kg to 0.4 mg/kg as it would have been obvious to one having ordinary skill in the art to provide a dose from 0.3 mg/kg to 0.4 mg/kg, since where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Additionally, as Kularatne discloses that the effective amount to be administered to a patient is based on body surface area, patient weight, and physician assessment of patient condition (par. [0081]), a smaller patient, in height and weight, would require a smaller dosage.
Regarding claim 22, Kularatne in view of Suurs in view of Whitley in view of Zupkofska disclose the method of claim 17, wherein the VGT-309 or the pharmaceutically acceptable salt of VGT-309 is administered to the patient between 48 hours and 96 hours prior to the navigating (Zupkofska: par. [0087]).
Regarding claim 23, Kularatne in view of Suurs in view of Whitley in view of Zupkofska disclose the method of claim 17, wherein the VGT-309 is administered to the patient between 48 hours and 96 hours prior to the navigating (Zupkofska: par. [0087]). It would have been obvious to one having ordinary skill in the art to provide a dose from [[0.16]] 0.2 mg/kg to 0.4 mg/kg, since where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Additionally, as Kularatne discloses that the effective amount to be administered to a patient is based on body surface area, patient weight, and physician assessment of patient condition (par. [0081]), a smaller patient, in height and weight, would require a smaller dosage.
Regarding claim 25, Kularatne in view of Suurs in view of Whitley in view of Zupkofska disclose the method of claim 17, wherein the navigating the instrument comprises use of a robotic or robotically-assisted system (par. [0066]).
Regarding claim 26, Kularatne disclose a method comprising: navigating an instrument (bronchoscope; par. [0005], [0011], [0061] and [0063]), via an endoluminal invasive route (par. [0005], [0011], [0063], and [0066]), into a patient to whom a pharmaceutically acceptable salt has been administered (par. [0011] and [0013]), to position the instrument in a target area (par. [0005], [0011] and [0063]); visualizing, via the instrument, tissue in the area under near-infrared (NIR) light (par. [0049] and [0066]), identifying in real time the location of any abnormal or cancerous tissue within
the target area by the florescence of the abnormal or cancerous tissue caused by the pharmaceutically acceptable salt under the NIR light (par. [0063], [0066] and [0078]).
Although Kularatne teaches administering a molecular imaging agent (par. [0011] and [0013]), it does not specifically disclose that it is administered intravenously and that it comprises VGT-309 or a pharmaceutically acceptable salt thereof of VGT-309. Suurs teaches an analogous method for visualizing cancerous tissue wherein molecular imaging agent VGT-309 is administered intravenously (materials and methods; page 2). Suurs teaches that it is known to administer molecular imaging agents either topically or intravenously (introduction; page 2). Suurs also teaches that VGT-309 selectively targets cathepsins, the expression of which is frequently increased in cancerous tissue compared with normal tissue and is used with a near-infrared ICG fluorophore (introduction and materials and methods; page 2). Moreover, Suurs teaches administering VGT-309 at 1, 2, 4, 8 and 24 hours post VGT-309 injection (page 8, bottom right, additional file 1). It would have been obvious to one having ordinary skill in the art to administer VGT-309 intravenously, as taught by Suurs as a known method of administration, and to administer VGT-309 between 2 hours and 4 days prior to navigation, as VGT-309 selectively targets cathepsins and is used with a near-infrared ICG fluorophore, thereby enabling viewing cancerous tissue using the near-infrared imaging instrument of Kularatne, and improving interoperative tumor detection.
Although Kularatne discloses administering the imaging agent and allowing time for it to distribute at an intervention site (par. [0011]), and that the effective amount to be administered to a patient is based on body surface area, patient weight, and physician assessment of patient condition (par. [0081]), it does not specifically disclose wherein the molecular imaging agent is administered to the patient at a dose from [[0.1]] 0.2 mg/kg to [[0.5]] 0.64 mg/kg. Whitley teaches an analogous molecular imaging agent that is administered to the patient in doses of 0.5 mg/kg, 1 mg/kg, or 1.5 mg/kg (page 4). It would have been obvious to one having ordinary skill in the art to administer a dose in an amount 0.5 mg/kg per, as taught by Whitley, as an effective amount for imaging cancerous tissue with the molecular imaging agent, as taught by Whitley.
Modified Kularatne teaches administration of VGT-309 to the patient between 1 hour and 24 hours (see Suurs: page 8, bottom right, additional file 1), it does not specifically disclose wherein the molecular imaging agent is administered to the patient between 25 hours and 96 hours prior to the navigating. Zupkofska teaches an analogous method for visualizing cancerous tissue wherein a marking agent is administered to a patient (par. [0087]). Zupkofska teaches that once the marker has been delivered to the patient, the marker may be allowed to permeate into the nodule (par. [0087]). Zupkofska also teaches that in some instances, a time period in the range of 20-30 minutes, in the range of several hours, in the range of a day, in the range of several days, or more may be necessary to allow the marker to permeate into the nodule (par. [0087]). Zupkofska further teaches that the time period may be selected to not only allow the marker to permeate into the nodule, but also allow the non-absorbed marker to clear from the healthy tissue. It would have been obvious to one having ordinary skill in the art to wait between 25 hours and 96 hours (several days or more), as taught by Zupkofska, prior to navigating, in order to not only allow the marker to permeate into the nodule, but also allow the non-absorbed marker to clear from the healthy tissue thereby allowing clear viewing of the cancerous tissue, as taught by Zupkofska. Thus, the combination of the teaches disclose administering the VGT-309 between 2 hours and 96 hours.
Regarding claim 27, Kularatne in view of Suurs in view of Whitley in view of Zupkofska disclose the method of claim 26, wherein the VGT-309 or the pharmaceutically acceptable salt of VGT-309 is administered to the patient between 12 hours and 96 hours prior to the navigating (Zupkofska: par. [0087]).
Regarding claim 28, Kularatne in view of Suurs in view of Whitley in view of Zupkofska disclose the method of claim 26, wherein the instrument comprises a flexible bronchoscope (par. [0061] and [0066]), the navigating comprises guiding the flexible bronchoscope through the patient’s airway (par. [0066]), and the fluorescing abnormal tissue is in the patient’s lungs (par. [0066]-[0067] and [0075]).
Response to Arguments
The affidavit under 37 CFR 1.132 filed 02/20/2026 is sufficient to overcome the rejection of the claims based upon the prior art reference Kim applied under 35 U.S.C. 103. Applicant’s arguments, see pages 9-14 of the Remarks, filed 02/20/2026, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Whitley, as applied above.
Conclusion
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
09/23/26
