DETAILED ACTION
Applicant’s arguments, filed on 03/18/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 03/18/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 3-17, 19, and 21 are the current claims hereby under examination.
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 .
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 1, 3-17, 19, and 21 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.
Regarding claim 1, the claim recites the limitation “another one” in line 11. It is unclear what is being referred to as “another one”. It is unclear if this limitation is meant to refer to the first interface and the second interface, or a different component, as the term another one is very vague. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to either the first interface or the second interface. Claims 2-17, 19, and 21 are also rejected due to their dependence on claim 1.
Regarding claim 13, the claim recites the limitation “another one” in line 6. It is unclear what is being referred to as “another one”. It is unclear if this limitation is meant to refer to the first interface and the second interface, or a different component, as the term another one is very vague. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to either the first interface or the second interface. Claims 14-15 are also rejected due to their dependence on claim 13.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-13, 16-17, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wardle (US 20050187489) in view of Guo (CN 209808523) and Larson (US 20190388073). Citations to CN 209808523 will refer to the English Machine Translation that accompanies this Office Action.
Regarding independent claim 1, Wardle teaches an electrosurgical biopsy needle (Abstract: “Devices, methods and systems for obtaining biopsy tissue samples are provided”), comprising:
a puncture assembly comprising a puncture tube having a front end and a rear end (Fig. 2B, Shaft 14, distal portion 18).
Wardle discloses a tissue collection chamber, however the tissue collection chamber is not in the form of a sampling groove in a tube wall of the puncture tube.
Guo discloses a biopsy device. Specifically, Guo teaches a tube wall of the puncture tube is provided with a sampling groove ([0004]: “The outer blade has a sampling groove along the radial direction near its front end. After puncturing into the epidermis, the soft tissue is drawn into the sampling groove under negative pressure”). Wardle and Guo are analogous arts as they are both related to biopsy devices for taking samples using radiofrequency cutters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sampling groove from Guo into the device from Wardle as it would be a simple substitution of structures used to hold the sample, as well as having the sample stored closer to where it was cut from, reducing the distance it needs to travel to be collected.
The Wardle/Guo combination teaches a cutting assembly comprising a cutting member (Wardle, Loop cutter 72; [0040]: “Loop cutter 72 may be any cutting element, such as a sharp blade; however, loop cutter 72 is preferably a RF cutter, such as a loop of conducting wire operably connected to a RF power source 38”);
wherein the cutting member is capable of moving back and forth along an axis of the puncture tube (Wardle, [0043]: “The path taken by cutting loop 72 is determined by the guides of the shaft 14 and of tube 44, such as channel 106 and rail 96, which constrain the motion of tube 44 and of cutting loop 72 along a tissue cutting pathway defined by channel 106, the shaft guide shown in FIG. 2B”);
wherein the cutting assembly has a first electrode (Wardle, [0056]: “Tube electrode wire 102, which supplies cutting loop 72 with RF power, is insulated by the non-conductive material of rail 96 surrounding it”), and the puncture assembly has a second electrode (Wardle, [0056]: “Shaft electrode wires 114 leading to distal cutter 20 are also shown”; [0054]: “RF connector 34 operably connected to shaft RF wire 114 to provide an electrical connection effective to supply RF power to distal cutter 20”. The distal cutter 20 is part of the puncture tube (shaft 14), which includes the shaft electrode wires, forming a second electrode.), the cutting assembly further comprises a first interface and a second interface electrically connected to the first electrode and the second electrode, respectively (Wardle, [0034]: “RF cable 36 leads to RF power source 38. Radiofrequency cutters may be monopolar or bipolar; a monopolar cutting surface is connected to one conductor leading to a source of radiofrequency energy, and requires a separate ground or indifferent electrode to be placed in contact with a patient's body in order to cut a patient's body tissue”; [0040]: “loop cutter 72 is preferably a RF cutter, such as a loop of conducting wire operably connected to a RF power source 38”; [0034]: “RF connector 34 provides RF energy to cutting element 20”. The RF cable 36 and the RF connector 34 are the first and second interfaces.), any one of the first interface and the second interface is configured to be directly or indirectly connected to a high-frequency output terminal of a host, and another one is configured to be directly or indirectly connected to a high-frequency input terminal of the host (Wardle, [0025]: “FIG. 5E is a side, cross-sectional view of the proximal tip of an elongated shaft embodying features of the invention showing a vacuum connection and vacuum port and a radiofrequency electrode connection”; [0030]: “A cutting surface may be any surface configured to cut tissue, e.g., by having a sharp edge, by having a thin cross-section, by being hard, by conducting radiofrequency energy, or by any combination of these or other properties”; Claim 44: “a source of radiofrequency energy operably connected to said tissue extraction device”. The radiofrequency power source is the high-frequency terminal and includes both the input terminal and output terminal, and the interfaces are connected to the radiofrequency power source, therefore they are connected to the input terminal and the output terminal.),
wherein the cutting member comprises a cutting member body and a cutting blade provided on a front end opening of the cutting member body (Wardle, [0040]: “The distal portion of tube 44 includes a loop cutter 72 disposed on the rim 74 of the orifice 76”; Fig. 2B. The rim and orifice are the cutting member body, and the loop cutter is the cutting blade.), the cutting member body is insulated (Wardle, [0055]: “Tube electrode wire 102, which supplies cutting loop 72 with RF power, is insulated by the non-conductive material of rail 96 surrounding it”), the cutting blade is electrically conductive and forms the first electrode (Wardle, [0040]: “loop cutter 72 is preferably a RF cutter, such as a loop of conducting wire operably connected to a RF power source 38”),, and the puncture tube is electrically conductive and forms the second electrode (Wardle, [0034]: “RF connector 34 provides RF energy to cutting element 20”; [0056]: “Shaft electrode wires 114 leading to distal cutter 20 are also shown”. The distal cutter 20 is part of the puncture tube (shaft 14), which includes the shaft electrode wires, forming a second electrode.).
However, the Wardle/Guo combination does not teach wherein the cutting blade, the puncture tube, the first interface, and the second interface form a circuit to conduct high-frequency energy, and a high-frequency electric wave is generated between the cutting blade and an edge of the sampling groove of the puncture tube.
Guo teaches wherein the cutting blade, the puncture tube, the first interface, and the second interface form a circuit to conduct high-frequency energy ([0034]: “The radiofrequency generator transmits high-frequency energy to the first electrode 110 through the first wire. The high-frequency energy is emitted by the first electrode 110 and received by the second electrode, forming a closed loop. During the transmission of high-frequency energy between the first electrode 110 and the second electrode 130, it comes into contact with the harder tissue at the site of surgery, causing the cells in the harder tissue to vibrate at high speed, thereby breaking the intercellular bonds and achieving the effect of radiofrequency cutting. In this way, the puncture sheath 150 can easily cut open the harder tissue”.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the cutting blade (the first electrode), the puncture tube (the second electrode), and the first and second interfaces (the wires connecting them to the energy source) to form a closed loop circuit from Guo into the Wardle/Guo combination as it allows the device to easily cut through harder tissue, which makes it more effective taking the required sample.
However, the Wardle/Guo combination does not teach a high-frequency electric wave is generated between the cutting blade and an edge of the sampling groove of the puncture tube.
Larson discloses a biopsy system for enhanced tissue harvesting. Specifically, Lardon teaches a high-frequency electric wave is generated to cut the tissue ([0101]: “The high frequency alternating current may be applied in a continuous waveform to cut tissue”. As stated in the rejection above, the energy flows from the cutting blade to the puncture tube (which includes the sampling groove), and therefore the continuous waveform from Larson is generated between the cutting blade and an edge of the sampling groove of the puncture tube.). Wardle, Guo, and Larson are analogous art as they are all related to biopsy devices for taking samples using radiofrequency cutters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the waveform from Larson into the Wardle/Guo combination as the combination is silent on how the current is applied, and Larson discloses a suitable way to apply the current in an analogous device.
Regarding claim 3, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 1, wherein the cutting blade is shaped as a circle or an arc extending along a periphery of the front end opening (Wardle, Fig. 2B, loop cutter 72; [0040]: “A loop cutter 72 may be a continuous loop in the shape of a closed loop, or may be discontinuous, in the shape of a partial loop such as a loop with ends that do not fully connect with one another, or be made up of more than one separate cutting elements arrayed about the rim 74 of an orifice 76 in a loop shape”).
Regarding claim 4, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 3, wherein the cutting blade is formed by bending a metal wire (Wardle, Fig. 2B; [0040]: “A loop cutter may be formed from any loop-shaped cuffing surface, such as a wire”).
Regarding claim 5, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 3, wherein the front end opening is provided with a closed or non-closed metal sheet extending along the periphery of the front end opening, the cutting blade is formed at a front end of the metal sheet, and the metal sheet is electrically connected to the first interface (Wardle, [0064]: “the open distal end 76 of a tissue extraction tube 44 with a ramp-shaped curved guide on its distal portion 70 will emerge from the shaft aperture 26 … Such flexible curved guides may be made from previously discussed materials, or other materials, such as memory materials and spring materials. Memory materials include, for example, memory metals”; Fig. 2B; [0034]: “RF cable 36 leads to RF power source 38. Radiofrequency cutters may be monopolar or bipolar; a monopolar cutting surface is connected to one conductor leading to a source of radiofrequency energy, and requires a separate ground or indifferent electrode to be placed in contact with a patient's body in order to cut a patient's body tissue”; [0040]: “loop cutter 72 is preferably a RF cutter, such as a loop of conducting wire operably connected to a RF power source 38”).
Regarding claim 6, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 3, wherein the cutting blade is directly fixed on an end surface of the front end opening (Wardle, Fig. 2B).
Regarding claim 7, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 3, wherein the cutting blade is relatively provided on a front side of the front end opening at a certain distance (Wardle, Fig. 2B), at least one electrically conductive leg is provided between the cutting blade and the front end opening, one end of the leg is electrically connected to the cutting blade, and another end thereof is electrically connected to the first interface (Wardle, [0040]: “A cutter support 73 or plurality of cutter supports 73 may connect with a cutter 72 in order to support a cutter 72 at a position distal to the rim 74 of an orifice 76”; Fig. 5A).
Regarding claim 8, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 7, wherein the cutting blade is shaped as a circle (Wardle, Fig. 2B, loop cutter 72; [0040]: “A loop cutter 72 may be a continuous loop in the shape of a closed loop, or may be discontinuous, in the shape of a partial loop such as a loop with ends that do not fully connect with one another, or be made up of more than one separate cutting elements arrayed about the rim 74 of an orifice 76 in a loop shape”), the at least one electrically conductive leg comprises two legs, and a line connecting the two legs extends through a center of the circle (Wardle, [0040]: “A cutter support 73 or plurality of cutter supports 73 may connect with a cutter 72 in order to support a cutter 72 at a position distal to the rim 74 of an orifice 76”; Fig. 5A).
Regarding claim 9, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 7, wherein the cutting blade is shaped as an arc (Wardle, Fig. 2B, loop cutter 72; [0040]: “A loop cutter 72 may be a continuous loop in the shape of a closed loop, or may be discontinuous, in the shape of a partial loop such as a loop with ends that do not fully connect with one another, or be made up of more than one separate cutting elements arrayed about the rim 74 of an orifice 76 in a loop shape”), the at least one electrically conductive leg comprises three legs, ends of two of the three legs are connected to both ends of the arc, and one end of a remaining one of the three legs is connected to an apex of the arc (Wardle, [0040]: “A cutter support 73 or plurality of cutter supports 73 may connect with a cutter 72 in order to support a cutter 72 at a position distal to the rim 74 of an orifice 76”; Fig. 5A).
Regarding claim 10, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 1, wherein the cutting member body comprises a tube body made of metal (Wardle, [0064]: “the open distal end 76 of a tissue extraction tube 44 with a ramp-shaped curved guide on its distal portion 70 will emerge from the shaft aperture 26 … Such flexible curved guides may be made from previously discussed materials, or other materials, such as memory materials and spring materials. Memory materials include, for example, memory metals”) and an insulation layer wrapping a surface of the tube body (Wardle, [0055]: “Tube electrode wire 102, which supplies cutting loop 72 with RF power, is insulated by the non-conductive material of rail 96 surrounding it”), and the tube body is electrically connected to the cutting blade and the first interface (Wardle, Fig. 2B; [0034]: “RF cable 36 leads to RF power source 38. Radiofrequency cutters may be monopolar or bipolar; a monopolar cutting surface is connected to one conductor leading to a source of radiofrequency energy, and requires a separate ground or indifferent electrode to be placed in contact with a patient's body in order to cut a patient's body tissue”; [0040]: “loop cutter 72 is preferably a RF cutter, such as a loop of conducting wire operably connected to a RF power source 38”).
Regarding claim 11, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 1, wherein the cutting member body is made of an insulation material, at least one connecting wire is provided in a tube wall of the cutting member body (Wardle, [0055]: “Tube electrode wire 102, which supplies cutting loop 72 with RF power, is insulated by the non-conductive material of rail 96 surrounding it”), one end of the connecting wire is electrically connected to the cutting blade (Wardle, Fig. 2B; [0040]: “A loop cutter may be formed from any loop-shaped cuffing surface, such as a wire”), and another end thereof is electrically connected to the first interface (Wardle, Fig. 2B; [0034]: “RF cable 36 leads to RF power source 38. Radiofrequency cutters may be monopolar or bipolar; a monopolar cutting surface is connected to one conductor leading to a source of radiofrequency energy, and requires a separate ground or indifferent electrode to be placed in contact with a patient's body in order to cut a patient's body tissue”; [0040]: “loop cutter 72 is preferably a RF cutter, such as a loop of conducting wire operably connected to a RF power source 38”).
Regarding claim 12, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 1, wherein the puncture assembly further comprises a tubular housing (Wardle, Shaft 14; [0030]: “Shaft 14 may have any cross-sectional shape, including round, square, hexagonal, or other shape”), the rear end of the puncture tube is inserted and fixed in a front end of the housing, a rear end of the cutting member extends out of the puncture tube and extends into the housing (Wardle, Fig. 2B), a pushing rod is fixed and sleeved on the cutting member extending into the housing (Wardle, [0045]: “As shown in FIG. 3A, vacuum tube support 66 and proximal brace 62 have moved distally to the full extent of their effective longitudinal travel distance on support beam 64, pushing tube 44 to its full travel within shaft 14”), a first gear is threadedly mated to the pushing rod (Wardle, [0048]: “Tissue extraction tube 44 is preferably somewhat longer than shaft 14, so that tube 44 may be inserted within shaft bore 110 with tube distal portion 70 fully extended into cutting bowl 22 and still allow proximal end 43 of tube 44, with its vacuum connection 50, to extend proximally beyond the vacuum connection 30 and thumbwheel 32 at shaft proximal portion 31”; Fig. 4), and further comprises a stop-rotation mechanism configured to limit the cutting member from rotating relative to the puncture tube (Wardle, [0048]: “FIG. 4 also illustrates optional radial indents 94 on RF connector 34 which may be used to help to hold shaft 14 in a desired radial orientation after rotation of the shaft 14, as by turning thumbwheel 32. Pins, detents, or other devices may be used to engage indents 94 effective to secure the position of shaft 14”).
Regarding claim 13, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 1, wherein the cutting member comprises the cutting member body (Wardle, Loop cutter 72; [0040]: “Loop cutter 72 may be any cutting element, such as a sharp blade; however, loop cutter 72 is preferably a RF cutter, such as a loop of conducting wire operably connected to a RF power source 38”), an electrode sleeve ring is provided on the cutting member body, the first electrode is connected to the first interface through the electrode sleeve ring (Wardle, [0052]: “External RF connector 46, which includes a conductive ring around the diameter of tube 44, is operably connected to RF connection wire 102 as shown”), any one of the first interface and the second interface is further configured to be directly or indirectly connected to the high-frequency output terminal of the host, and another one is further configured to be directly or indirectly connected to the high-frequency input terminal of the host (Wardle, [0025]: “FIG. 5E is a side, cross-sectional view of the proximal tip of an elongated shaft embodying features of the invention showing a vacuum connection and vacuum port and a radiofrequency electrode connection”; [0030]: “A cutting surface may be any surface configured to cut tissue, e.g., by having a sharp edge, by having a thin cross-section, by being hard, by conducting radiofrequency energy, or by any combination of these or other properties”; Claim 44: “a source of radiofrequency energy operably connected to said tissue extraction device”. The radiofrequency power source is the high-frequency terminal and includes both the input terminal and output terminal, and the interfaces are connected to the radiofrequency power source, therefore they are connected to the input terminal and the output terminal.).
Regarding claim 16, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 1, wherein the cutting member is capable of rotating relative to the puncture tube (Wardle, [0034]: “Thumbwheel 32, also disposed on shaft proximal portion 31, enables an operator to manually rotate shaft 14 around longitudinal axis 80 to orient aperture 26 so that it opens in a variety of radial directions 82 towards body tissue surrounding shaft 14”).
Regarding claim 17, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 1, wherein the puncture assembly further comprises a tubular housing (Wardle, Shaft 14; [0030]: “Shaft 14 may have any cross-sectional shape, including round, square, hexagonal, or other shape”), the rear end of the puncture tube is inserted and fixed in a front end of the housing, a rear end of the cutting member extends out of the puncture tube and extends into the housing (Wardle, Fig. 2B), and the first interface and the second interface are provided on the housing (Wardle, Fig. 2A).
Regarding claim 19, the Wardle/Guo/Larson combination teaches an electrosurgical biopsy needle kit, comprising: the electrosurgical biopsy needle according to claim 1.
However, the Wardle/Guo combination does not teach the electrosurgical biopsy needle kit comprising a handle, the handle comprising a housing and a circuit board provided in the housing, the handle further comprises a third interface and a fourth interface mated with the first interface and the second interface, respectively, the third interface and the fourth interface are electrically connected to the circuit board, the electrosurgical biopsy needle is connected to the housing, and the first interface and the second interface are electrically connected to the third interface and the fourth interface, respectively.
Larson teaches a handle ([0134]: “A handle to the encasement may be added”), the handle comprising a housing and a circuit board provided in the housing ([0139]: “The second portion of the electrical circuit may be connected to the battery (130), which may be situated inside the encasement (118) or handle”), the handle further comprises a third interface and a fourth interface mated with the first interface and the second interface, respectively, the third interface and the fourth interface are electrically connected to the circuit board ([0139]: “the needle or expanded cutting element (104) may be in contact with the conductive needle tip (103), completing one aspect of the circuit from inside the needle. The second portion of the electrical circuit may be connected to the battery (130), which may be situated inside the encasement (118) or handle”; [0020]: “the electrodes may comprise conductive strips, ribbons, or wires disposed axially along the surface of the outer sheath, the needle surface, or embedded and fixed within the needle”. The wire connections form the connections between the electrodes and the circuit board, therefore the wire connections are the third interface and the fourth interface.), the electrosurgical biopsy needle is connected to the housing ([0134]: “FIG. 20C is a non-limiting embodiment of an encasement (118) adjacent to the vacuum collection chamber (115) housing the attached syringe/vacuum source, and needle rotating mechanism … A handle to the encasement may be added”), and the first interface and the second interface are electrically connected to the third interface and the fourth interface, respectively ([0139]: “the needle or expanded cutting element (104) may be in contact with the conductive needle tip (103), completing one aspect of the circuit from inside the needle. The second portion of the electrical circuit may be connected to the battery (130), which may be situated inside the encasement (1 18) or handle”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the handle and the structures within the handle as it allows for the user to hold and control the device, which allows for the user to have more control over the procedure.
Regarding claim 21, the Wardle/Guo/Larson combination teaches a vacuum-assisted breast biopsy system (Wardle, [0011]: “Vacuum may be applied to a proximal portion of the tissue extraction tube to aspirate tissue specimens through the inner lumen of the tube”), comprising: the electrosurgical biopsy needle kit according to claim 19 (see the above rejection of claim 19); and a host comprising a high-frequency transmitting module configured to generate high frequency, the high-frequency transmitting module has a high-frequency output terminal and the high-frequency input terminal, the high-frequency output terminal and the high-frequency input terminal are connected to the circuit board through a cable and thus indirectly connected to the first interface and the second interface, or the high-frequency output terminal and the high-frequency input terminal are directly connected to the first interface and the second interface through the cable (Wardle, [0025]: “FIG. 5E is a side, cross-sectional view of the proximal tip of an elongated shaft embodying features of the invention showing a vacuum connection and vacuum port and a radiofrequency electrode connection”; [0030]: “A cutting surface may be any surface configured to cut tissue, e.g., by having a sharp edge, by having a thin cross-section, by being hard, by conducting radiofrequency energy, or by any combination of these or other properties”; Claim 44: “a source of radiofrequency energy operably connected to said tissue extraction device”; Larson, [0139]: “The second portion of the electrical circuit may be connected to the battery (130), which may be situated inside the encasement (118) or handle”; [0139]: “the needle or expanded cutting element (104) may be in contact with the conductive needle tip (103), completing one aspect of the circuit from inside the needle. The second portion of the electrical circuit may be connected to the battery (130), which may be situated inside the encasement (118) or handle”; [0020]: “the electrodes may comprise conductive strips, ribbons, or wires disposed axially along the surface of the outer sheath, the needle surface, or embedded and fixed within the needle”. The radiofrequency power source from Wardle is the high-frequency terminal and includes both the input terminal and output terminal, and the interfaces are connected to the radiofrequency power source, therefore they are connected to the input terminal and the output terminal, and the wires (cable) from Larson form the connection to the electrical circuit (the circuit board) ).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over the Wardle/Guo/Larson combination as applied to claim 13 above, and further in view of Wardle.
Regarding claim 14, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 13, wherein a rear end of the cutting member body has an electrically conductive area electrically connected to the first electrode (Wardle, [0064]: “the open distal end 76 of a tissue extraction tube 44 with a ramp-shaped curved guide on its distal portion 70 will emerge from the shaft aperture 26 … Such flexible curved guides may be made from previously discussed materials, or other materials, such as memory materials and spring materials. Memory materials include, for example, memory metals”), the electrically conductive area extends through a central hole of the electrode sleeve ring and is capable of moving back and forth and rotating relative to an axis of the electrode sleeve ring (Wardle, Fig. 2A, [0052]: “External RF connector 46, which includes a conductive ring around the diameter of tube 44, is operably connected to RF connection wire 102 as shown”).
With respect to the electrode sleeve ring being provided with at least one elastic contact assembly, the elastic contact assembly comprising an elastic contact provided in the central hole of the electrode sleeve ring, a head of the elastic contact being in slidably fit with an outer wall of the electrically conductive area, and the elastic contact being directly or indirectly connected to the first interface, Wardle does teach flexible guides for the cutting member assembly including elastic contacts (springs) to hold the tube in the correct location ([0064]: “Such flexible curved guides may be made from previously discussed materials, or other materials, such as memory materials and spring materials. Memory materials include, for example, memory metals such as nickel titanium alloys, and spring materials include plastic spring materials and metal spring material, such as, for example, spring steel”; [0037]: “Springs 68 and 69 are configured to apply forces so that when removal of forward pressure, the tissue extraction tube 44 and proximal brace 62 automatically retract. Spring 69 is preferably stronger than spring 68 in order to insure that the connection with vacuum source 56 is maintained while cutting”). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include this securement connection from one location of Wardle into another location in the Wardle/Guo/Larson combination, as it allows the device to hold the cutting member assembly in the correct location, ensuring it does not move and interfere with the sample collection.
Regarding claim 15, the Wardle/Guo/Larson combination teaches the electrosurgical biopsy needle according to claim 14, wherein the electrode sleeve ring further comprises a connector provided on an outer peripheral surface of the electrode sleeve ring, the connector is connected to the first interface, and the elastic contact is electrically connected to the connector (Wardle, [0052]: “External RF connector 46, which includes a conductive ring around the diameter of tube 44, is operably connected to RF connection wire 102 as shown, allowing tube 44 to rotate while maintaining effective electrical contact with RF power source 38”).
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant has amended the claims to overcome the previous 112(b) rejections; however, the amendments have introduced new 112(b) rejections.
Applicant's arguments filed 03/18/2026 have been fully considered but they are not persuasive. Applicant argues that Wardle does not teach the puncture tube forming a second electrode. However, as explained in the 103 rejection above, the puncture tube includes the distal cutter 20, which forms an electrode, and therefore the puncture tube does form the second electrode (Wardle, [0056]: “Shaft electrode wires 114 leading to distal cutter 20 are also shown”; [0054]: “RF connector 34 operably connected to shaft RF wire 114 to provide an electrical connection effective to supply RF power to distal cutter 20”. The distal cutter 20 is part of the puncture tube (shaft 14), which includes the shaft electrode wires, forming a second electrode.).
Applicant also argues that the cited references do not teach the cutting blade, the puncture tube, the first interface, and the second interface forming a circuit to conduct high-frequency energy. However, as explained in the 103 rejection above, Guo does teach this limitation ([0034]: “The radiofrequency generator transmits high-frequency energy to the first electrode 110 through the first wire. The high-frequency energy is emitted by the first electrode 110 and received by the second electrode, forming a closed loop. During the transmission of high-frequency energy between the first electrode 110 and the second electrode 130, it comes into contact with the harder tissue at the site of surgery, causing the cells in the harder tissue to vibrate at high speed, thereby breaking the intercellular bonds and achieving the effect of radiofrequency cutting. In this way, the puncture sheath 150 can easily cut open the harder tissue”).
Applicant also argues that the limitation of “a high-frequency electric wave is generated between the cutting blade and an edge of the sampling groove of the puncture tube” is not taught by WO 2018/161067 (the PCT publication that corresponds to Larson used in this Office Action). However, as explained in the 103 rejection above, Larson does teach this limitation ([0101]: “The high frequency alternating current may be applied in a continuous waveform to cut tissue”. As stated in the rejection above, the energy flows from the cutting blade to the puncture tube (which includes the sampling groove), and therefore the continuous waveform from Larson is generated between the cutting blade and an edge of the sampling groove of the puncture tube.).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN K MCCORMACK whose telephone number is (703)756-1886. The examiner can normally be reached Mon-Fri 7:30-5.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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