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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/20/2026 has been entered.
Response to Amendment
The amendment filed on 04/20/2026 has been entered. Claims 33, 38 and 39 have been amended. Claims 50-62 have been cancelled. New Claims 63-69 have been added. Claims 33-49 and 63-69 remain pending.
Response to Arguments
On Pages 6-7 of Remarks, Applicant argues that reference Panescu does not disclose the limitation of the liquid metal forming an electrically continuous metallic body, which Panescu’s conductive fluid does not satisfy, and Panescu discloses a solid component as electrode, but does not teach “electrically coupling an RF energy source directly to the liquid metal such that the liquid metal forms the active RF electrode”. Further, Applicant argues that modification of Panescu by reference Sun would alter Panescu’s operating principle, specifically, abandoning Panescu’s irrigated solid-tip architecture. Examiner respectfully disagrees. First, structurally, the claimed liquid metal is delivered via a fluid channel 112 through a shaft 110, as shown in Figs. 1 and 2. Similarly, in Panescu, conductive fluid can be delivered via infusion lumen and then irrigation ports 235, which is within shaft 229, as shown in Fig. 4. Also note that, under broadest reasonable interpretation, the disclosed conductive fluids by Panescu, with examples of saline and aluminum sulfate, correspond to the claimed liquid metal. Therefore, the claimed structure and Panescu’s structure are essentially the same. Second, functionally, Panescu discloses “conducting the delivered ablation energy (e.g., RF or microwave) to more tissue than the surface of the electrode contacts, thus, in effect, increasing the effective electrode size (i.e. creating a virtual electrode)” (Panescu, Para 0055). Fig. 4 of Panescu shows an electrically continuous conductive body 216 formed by the injected conductive fluid, which generates an extended region of ablation 244. What Panescu achieves functionally agrees with the Application.
Claim Objections
Claims 33, 67 and 69 are objected to because of the following informalities:
Claim 33, Lines 4-5, “said bronchial airway” should be changed to “a bronchial airway”.
Claim 67, Line 2, “a recess manner” should be changed to “a recessed manner”.
Claim 69, Line 1, “claim 63, the liquid” should be changed to “claim 63, wherein the liquid”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 33-49 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 33, Line 3 recites “having a liquid metal”. It is unclear whether the recited liquid metal is part of the claim or not. For present purposes of examination, Examiner interprets the recited phrase as “providing a liquid metal”.
Claims 34-49 are also rejected under 35 U.S.C. 112(b) because they inherit the indefiniteness of the claim(s) they respectively depend upon.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 33-43, 48-49, 63-66 and 68 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Panescu et al (US 20190343581 A1; hereafter Panescu).
With regard to Claim 33, Panescu discloses a method of treating a lung tumor in a patient (Panescu, Para 0008; “This disclosure is related to methods, devices, and systems for transbronchial ablation of a lung tumor.”), comprising:
having a liquid metal (Panescu, Para 0060; “Perfused hypertonic saline could be doped with nonionic iodinated contrast agent to render it visible on computed tomography (CT). Other conductive irrigation fluids could be imagined such as aluminum sulfate.” The disclosed liquids all contain metal);
instilling a volume of the liquid metal within said bronchial airway (Panescu, Para 0060; “during a preclinical study ablation experiment 5 ml/min of hypertonic saline was infused. Over the course of a 2 minute RF delivery, 10 ml of hypertonic saline was infused.”) such that the liquid metal forms an electrically continuous metallic body (Panescu, Fig. 4 shows that the injected conductive fluid 216 form a body in selected airway 151); and
electrically coupling an RF energy source to the liquid metal such that the liquid metal forms the active RF electrode for ablating the lung tumor (Panescu, Para 0075; “While the targeted lung portion is … infused with conductive liquid RF ablation energy may be delivered from an energy delivery console to the distal electrode 234.”).
With regard to Claim 34, Panescu discloses the method of Claim 33, and further discloses aspirating said liquid metal out of said bronchial airway (Panescu, Para 0054; “… optionally removing fluid remaining in the lung portion through the catheter …”) (Panescu, Para 0080; “… if the electrode is irrigated by injecting fluid through ports 235 the fluid may be retracted by applying suction to the guidewire lumen 236 …”).
With regard to Claim 35, Panescu discloses the method of Claim 33, and further discloses wherein said bronchial airway is segmental bronchi (Panescu, Para 0039; “The present disclosure is directed generally to devices and methods … through the patient's airway. … The term airway refers to any of the anatomical lumens of the respiratory system through which air passes including the trachea, bronchi, and bronchioles”).
With regard to Claim 36, Panescu discloses the method of Claim 33, and further discloses wherein said bronchial airway is subsegmental bronchi (Panescu, Para 0039; “The present disclosure is directed generally to devices and methods … through the patient's airway. … The term airway refers to any of the anatomical lumens of the respiratory system through which air passes including the trachea, bronchi, and bronchioles”).
With regard to Claim 37, Panescu discloses the method of Claim 33, and further discloses wherein said bronchial airway is bronchioles and terminal bronchioles (Panescu, Para 0039; “The present disclosure is directed generally to devices and methods … through the patient's airway. … The term airway refers to any of the anatomical lumens of the respiratory system through which air passes including the trachea, bronchi, and bronchioles”).
With regard to Claim 38, Panescu discloses the method of Claim 33, and further discloses wherein the step of instilling comprises instilling said liquid metal into multiple branches of said bronchial airway such that the liquid metal forms a branching metallic network (Panescu, Fig. 4 shows that injected conductive fluid fills multiple branches of the airway).
With regard to Claim 39, Panescu discloses the method of Claim 33, and further discloses wherein alveoli and lung parenchyma are not filled with said liquid metal (Panescu, Para 0098; “The one or both balloons occlude the natural airway form a portion of the airway in which the HTS solution is injected and suppress flow of the liquid outside of that portion of the airway.”; Para 0039; “The term airway refers to any of the anatomical lumens of the respiratory system through which air passes including the trachea, bronchi, and bronchioles.” Here the term airway does not include alveoli and lung parenchyma).
With regard to Claim 40, Panescu discloses the method of Claim 33, and further discloses comprising:
inserting an ablation catheter into said bronchial airway (Panescu, Para 0042; “… an extended working channel is advanced through the airway into the lung and along the pathway to the point of interest.”); and
advancing said ablation catheter to said bronchial airway (Panescu, Para 0042; “A catheter may be advanced though the extended working channel to the targeted region of the lung.”).
With regard to Claim 41, Panescu discloses the method of Claim 40, and further discloses comprising:
having a flexible bronchoscope that comprises an instrument channel (Panescu, Para 0043; “An extended working channel may be positioned within a patient, optionally through a bronchoscope or as part of a bronchoscope”; Para 0109; “… a flexible bronchoscope 221 …”);
inserting said ablation catheter through said instrument channel of said bronchoscope (Panescu, Para 0054; “placing the occlusion-ablation catheter through the bronchoscope working channel;”);
advancing said bronchoscope to said bronchial airway (Panescu, Para 0042; “an extended working channel is advanced through the airway into the lung and along the pathway to the point of interest.”. Para 0043; “An extended working channel may be … part of a bronchoscope.…”);
advancing said ablation catheter out of said instrument channel of said bronchoscope and into said bronchial airway (Panescu, Para 0042; “A catheter may be advanced though the extended working channel to the targeted region of the lung.”).
With regard to Claim 42, Panescu discloses the method of Claim 41, and further discloses comprising aspirating said liquid metal out of said bronchial airway by suction through said bronchoscope (Panescu, Para 0054; “… optionally removing fluid remaining in the lung portion through the catheter …”) (Panescu, Para 0080; “… if the electrode is irrigated by injecting fluid through ports 235 the fluid may be retracted by applying suction to the guidewire lumen 236 …”).
With regard to Claim 43, Panescu discloses the method of Claim 40, and further discloses comprising visualizing said ablation catheter by x-ray fluoroscopy while advancing said ablation catheter to said bronchial airway (Panescu, Para 0020; “… Once in position, fluoroscopy may be used to visualize the ablation catheter as it is further maneuvered towards the nodule or point of interest.”).
With regard to Claim 48, Panescu and Sun disclose the method of Claim 33. Panescu further discloses wherein said conductive fluid is instilled only into bronchial airways having a diameter of less than 5 mm (Panescu, Para 0081; “The obturator 431 or 481 may be a balloon (e.g., compliant balloon) sized to occlude the airway or a range of airway diameters (e.g., diameters in a range of 3 mm to 10 mm).”. Fig. 6 shows that the airway diameter can be controlled by using 2 obturators (431 and 481)).
With regard to Claim 49, Panescu and Sun disclose the method of Claim 33. Panescu further discloses wherein said conductive fluid is instilled only into bronchial airways having a length of less than 6 cm (Panescu, Para 0081; “The distance between the distal obturator and the proximal obturator is prefixed in this embodiment. For example, the distance between the balloons may be in a range of 20 mm to 40 mm.”) (Panescu, Para 0090; “… the adjustable distance between the proximal obturator and the distal obturator allows a more specific segment of an airway to be isolated …”).
With regard to Claim 63, Panescu discloses a radiofrequency (RF) ablation catheter (Panescu, Abstract; “An ablation catheter configured to ablate tissue … to deliver radiofrequency (RF) electrical current to the tissue …”) for treating a lung tumor (Panescu, Para 0008; “This disclosure is related to methods, devices, and systems for transbronchial ablation of a lung tumor.”), the ablation catheter comprising:
a flexible shaft (Panescu, Para 0067; “The shaft 229 … The shaft may be a flexible shaft capable of turning …”) comprising an inner shaft (second shaft 230) and an outer shaft (Panescu, Para 0078; “The first shaft 229 comprises a lumen 233 through which a second shaft 230 … may be telescopically advanced”; the disclosed first shaft 229 corresponds to the claimed outer shaft, and second shaft 230 corresponds to the claimed inner shaft) extending between a proximal end and a distal end (Panescu, Para 0067; “an elongated shaft 229 having a proximal region intended to remain outside the patient's body and a distal region 215 intended to be delivered through a working channel to a target region of a lung proximal to a targeted lung tumor.”);
a fluid channel (infusion lumen) formed within the inner shaft (Panescu, Para 0089; “The infusion lumen runs from the irrigation ports (e.g., 535) through the second shaft 230 …”) configured to instill a volume of liquid metal (Panescu, Para 0060; “Perfused hypertonic saline could be doped with nonionic iodinated contrast agent to render it visible on computed tomography (CT). Other conductive irrigation fluids could be imagined such as aluminum sulfate.” The disclosed liquids all contain metal) into a bronchial airway (as shown in Fig. 6B, the infused fluid via ports 535 enters the airway 151) such that the liquid metal forms an electrically continuous metallic body within the bronchial airway (Panescu, Para 0074; “the previously aerated space may be infused with an electrically conductive fluid such as hypertonic. Use of hypertonic saline may enhance RF delivery based on the virtual electrode effect”. The disclosed conductive fluid forms an electrically conductive body 216 in Figs. 4 and 6);
an inflatable balloon mounted on the outer shaft (Panescu, Para 0068; “an inflatable balloon or obturator 231”; as shown in Fig. 3, balloon 231 is mounted on the outer side of shaft 229); and
an RF connector (Panescu, Para 0042; “… RF electrodes are used to deliver ablation energy”; Para 0071; “… a distal electrode 234 positioned on the distal region 215 of the device 220”) configured for electrically coupling an RF energy source to the liquid metal (Panescu, Para 0075; “While the targeted lung portion is … infused with conductive liquid RF ablation energy may be delivered from an energy delivery console to the distal electrode 234.”) such that the liquid metal forms the active RF electrode for ablating the lung tumor (Panescu, Para 0074; “Use of hypertonic saline may enhance RF delivery based on the virtual electrode effect”).
With regard to Claim 64, Panescu discloses the RF ablation catheter according to Claim 63, and further discloses wherein a portion of said flexible shaft that is distal to said inflatable balloon is defined as a distal segment of said flexible shaft (As shown in the cited Fig. 4 of Panescu, one segment of the disclosed shaft 229 is on the distal side of balloon 231).
Fig. 4 of Panescu
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With regard to Claim 65, Panescu discloses the RF ablation catheter according to Claim 64, and further discloses wherein said RF connector (electrode 234 in the cited Fig. 4 of Panescu) is located at said distal segment (as shown in the cited Fig. 4, electrode 234 is located at the distal side of the balloon 231) and is configured for connecting RF energy to said liquid metal thereby heating said bronchial airway (Panescu, Para 0076; “as shown in Fig. 4 the extent of an ablation 244 …”. In the cited Fig. 4, the extent of an ablation 244 covers the airway 151, so intrinsically heats the airway).
With regard to Claim 66, Panescu discloses the RF ablation catheter according to Claim 64, and further discloses wherein said distal segment forms a conduit inside said distal segment (Panescu, Fig. 3: as shown in the cited figure, the space highlighted by dotted line corresponds to the claimed conduit) in such a way said conduit conveys said liquid metal from said fluid channel (The space highlighted by dotted line in the cited Fig. 3 is directly connected to the ports 235, through which conductive fluid is released, so should function to convey conductive fluid from infusion lumen).
Partial Fig. 3 of Panescu
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With regard to Claim 68, Panescu discloses the RF ablation catheter according to Claim 64, and further discloses wherein said RF connector is positioned at a proximal end of said distal segment, adjacent to said inflatable balloon (Panescu, Para 0071; “An optional proximal electrode 237 is positioned on the shaft 229 distal to the obturator 231 (e.g., a distance 239 in a range of 5 to 40 mm, about 20 mm) and proximal to the distal electrode 234”. Also shown in the cited Fig. 4 above, the disclosed proximal electrode 237 is at a proximal end of the distal segment, and is adjacent to the disclosed balloon 231).
Claim Rejections - 35 USC § 103
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.
Claims 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over Panescu in view of Swanson (US 20030216722 A1; hereafter Swanson).
With regard to Claim 44, Panescu discloses the method of Claim 40, but does not disclose comprising visualizing said conductive fluid by x-ray fluoroscopy while instilling said conductive fluid into said bronchial airway.
Swanson in an analogous field of endeavor discloses comprising visualizing said conductive fluid by x-ray fluoroscopy while instilling said conductive fluid into said bronchial airway (Swanson, Para 0042; “…a biocompatible dye 7 (shown in FIGS. 3(a) and 3(b)) can be added to the conductive fluid 6 to provide a means for tracking the location of the injection pattern.”) (Swanson, Para 0042; “In situations where fluoroscopy is available, it may be desirable to document the pattern of the applied lesion using radiographic images.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Panescu, as suggested by Swanson, in order to visualize the instilling of the conductive fluid using x-ray fluoroscopy. One of ordinary skill in the art would have been motivated to make the modification for the benefit of ensuring the target region to be properly filled with conductive fluid (Swanson, Para 0042; “If the physician performing the ablation procedure notices a gap in the injection pattern, the gap can be filled in with additional injections. The dye 7 can also be used to determine if the injectate volume is properly distributed in the tissue.”).
With regard to Claim 45, Panescu discloses the method of Claim 33, but does not disclose wherein the volume of said conductive fluid instilled is less than 1.0 ml.
Swanson in an analogous field of endeavor discloses wherein the volume of said conductive fluid instilled is less than 1.0 ml (Swanson; Para 0037; “… the total volume injected can be quite small, less than a milliliter …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Panescu, as suggested by Swanson, in order to instill the conductive fluid of a volume of less than 1 ml. One of ordinary skill in the art would have been motivated to make the modification for the benefit of limiting the applied conductive fluid to a safe amount (Swanson; Para 0037; “With such small volumes of injectate required, KCl in a concentration of 2 mEq/ml could safely be used as the conductive fluid 6 instead of 10 percent saline.”).
Claims 46-47 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Panescu, in view of Sun et al (Minimally invasive therapy & allied technologies. 27(4); 233-241; 2018; hereafter Sun).
With regard to Claim 46, Panescu discloses the method of Claim 33, but do not disclose wherein said liquid metal comprises gallium.
Sun in the same field of endeavor discloses wherein said liquid metal comprises gallium (Sun, Preparation of materials; “room temperature liquid metal EGaIn24.5 alloy with a melting point of 15.5 ⁰C, composed of Ga and In with purity of 99.99% …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Panescu, as suggested by Sun, in order to use liquid metal comprising gallium. One of ordinary skill in the art would have been motivated to make the modification for the benefit of good biocompatibility to living tissues of such liquid metal (Sun, Discussion, Para 3; “Liquid metal composed of gallium and indium or gallium alone has been proven to possess good biocompatibility to living tissues”).
With regard to Claim 47, Panescu discloses the method of Claim 33, but does not disclose wherein said liquid metal is E-GaIn.
Sun in the same field of endeavor discloses wherein said liquid metal is E-GaIn (Sun, Preparation of materials; “room temperature liquid metal EGaIn24.5 alloy with a melting point of 15.5 ⁰C, composed of Ga and In with purity of 99.99% …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Panescu, as suggested by Sun, in order to use E-GaIn as the liquid metal. One of ordinary skill in the art would have been motivated to make the modification for the benefit of good biocompatibility to living tissues of such liquid metal (Sun, Discussion, Para 3; “Liquid metal composed of gallium and indium or gallium alone has been proven to possess good biocompatibility to living tissues”).
With regard to Claim 69, Panescu discloses the RF ablation catheter according to Claim 63, but does not disclose wherein the liquid metal comprises gallium.
Sun in the same field of endeavor discloses wherein the liquid metal comprises gallium (Sun, Preparation of materials; “room temperature liquid metal EGaIn24.5 alloy with a melting point of 15.5 ⁰C, composed of Ga and In with purity of 99.99% …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Panescu, as suggested by Sun, in order to use liquid metal comprising gallium. One of ordinary skill in the art would have been motivated to make the modification for the benefit of the good biocompatibility to living tissues of such liquid metal (Sun, Discussion, Para 3; “Liquid metal composed of gallium and indium or gallium alone has been proven to possess good biocompatibility to living tissues”).
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Panescu, in view of Pomeranz (US 6032077 A; hereafter Pomeranz).
With regard to Claim 67, Panescu discloses the RF ablation catheter according to Claim 66, but does not explicitly and clearly disclose wherein said RF connector is located within said conduit in a recess manner.
Pomeranz in the same field of endeavor discloses wherein said RF connector is located within said conduit in a recess manner (Pomeranz, Column 17, Lines 30-32; “The catheter 400 includes an elongated tubular shaft 402 having central fluid lumen 404 located therein.”; Lines 45-46; “The tip 420 further includes a foam 432 covering which surrounds the metal electrode 422.”. As shown in the cited Fig. 19, fluid is delivered from the disclosed central fluid lumen 404, into the space inside the tip 420 or the form covering 432 (corresponding to the claimed conduit). Inside the space, electrode 422 is located in a recessed manner). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Panescu, as suggested by Pomeranz, in order to position an electrode in a recessed manner along path of infused fluid. One of ordinary skill in the art would have been motivated to make the modification for the benefit of achieving efficient ablation by efficiently delivering conductive fluid to tissue without interrupting fluid’s flow.
Fig. 19 of Pomeranz
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI ZHANG whose telephone number is (571)272-7172. The examiner can normally be reached Monday-Friday 8am-5pm E.T..
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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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