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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-14, 16) in the reply filed on 06/26/2026 is acknowledged.
Claims 15, 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/26/2026.
Specification
The disclosure is objected to because of the following informalities: The sentence “as shown in Fig. 3” on paragraph 83 should be amended to read “as shown in Fig. 4”.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the dual-mode tissue ablation needle comprising a device host and the various other features, as described in each of claims 13 and 14, must be shown or the feature(s) canceled from the claim(s). The Examiner notes that the present figures fail to display the device host as a portion of the needle itself. Further, it appears from the disclosure that the device host is an external portion connected through the connector of the needle, rather than a structure of the needle itself. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-14, and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "an outside" in line 9. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this outside refers to the outside of the needle body, the insulation assembly, the water delivery assembly, the water channel, or a combination of all/some components. Furthermore, it is unclear if an outside refers to tissue or air surrounding the other end of the water channel. For examination purposes, Examiner will treat an outside as an outside of at least the insulation assembly, capable of being exposed to air and/or tissue. Claims 2-14, and 16 are also rejected because they are dependent on claim 1.
Claim 2 recites the limitation " wherein the temperature measuring device is an insulation and high pressure resistant temperature measuring device" in lines 4-5. The recitation renders the scope of the claim as indefinite because it is unclear if the “insulation” is being recited as a descriptive structural feature of the temperature measuring device or, alternatively, is describing a functional recitation that the temperature measuring device provides to the overall ablation needle. The Examiner respectfully suggests that language such as “wherein the temperature measuring device is insulated and resistant to high pressure” would be sufficient to address the current issue noted above. Claims 3-12 are also rejected because they are dependent on claim 2.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Chen (C.N. Application No. 105943159 B), and further in view of Ciro (U.S. Application No. 20170348049 A1).
Regarding independent claim 1, Chen discloses a tissue ablation needle (page 3, lines 6-7, bottom-up & Fig. 1), configured for realizing tissue ablation of a radio frequency energy (page 3, lines 1-2), comprising:
a needle body (1);
an insulation assembly (combination of insulating sleeve 2 and scale sliding block 5), slidably sleeved outside the needle body (page 4, lines 1-3 and lines 28-30 & Fig. 3); and
a water delivery assembly (combination of water pipe 80 and female Luer 800) (page 4, lines 14-15);
wherein a water channel (i.e., a hollow tube) is provided inside the insulation assembly, an end of the water channel is in communication with the water delivery assembly (via shank/needle fixing seat 6 and water pipe fixing seat 7), and an other end of the water channel is in communication with an outside (with the air/tissue) (page 2, lines 9-12, bottom up; page 4, line 24).
However, Chen does not disclose a dual-mode tissue ablation needle, configured for realizing tissue ablation of a pulsed electric field.
Ciro, in the same field of endeavor, teaches a catheter system comprising an ablation device coupled to a generator (for example, a pulse-generating device or power generator) that applies power or delivers electrical (e.g., radiofrequency (RF)) signals or pulses to the electrodes located at or near the distal end portion of the ablation catheter (pa. 0186-0187, 0387).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the pulse-generating device of Ciro to the tissue ablation needle of Chen for the purpose of providing high-voltage pulses to create microscopic pores in cell membranes while avoiding unwanted damage to untargeted neighboring cells.
Claims 2-3, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Chen and Ciro as applied to claim 1 above, and evidenced by Barry (U.S. Application No. 20190133668 A1).
Regarding claim 2, Chen discloses wherein the needle body comprises a needle tip (101) and a needle tube that are integrally connected, the water channel is arranged in the needle tube, and a temperature measuring device (801) is arranged in the water channel (page 3, lines 3-4; page 4, lines 10-13 & Fig. 2).
However, Chen does not disclose wherein the temperature measuring device is an insulation and high pressure resistant temperature measuring device.
Examiner notes that pending the 112(b) rejection cited above, the claim language will be provisionally interpreted as the temperature measuring device being insulated and resistant to high pressure.
Ciro, in the same field of endeavor, teaches electrode wires configured to connect the electrode elements to an RF generator, wherein the electrode wires are comprised of 40 gauge bifilar type T thermocouple wires. In some embodiments, the thermocouple wires are insulated with a polymer layer such as polyimide (pa. 0214).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the polyimide layer, as taught by Ciro, to the temperature measuring device of Chen for the purpose of providing insulation from electrical energy.
However, Chen/Ciro combination do not specify that the polyimide layer contains high pressure resistant properties.
Barry, in the same field of endeavor, teaches a catheter (200) comprising a polyimide, wherein the polyimide is flexible, has good pushability characteristics, and is able to withstand high temperature and pressures (pa. 0065).
Thus, the polyimide layer used in the Ciro reference inherently has the insulation and the resistance to high pressures features described in the claim language.
Regarding claim 3, Chen/Ciro/Barry combination discloses further comprising a handle (4);
wherein the insulation assembly comprises a sliding mechanism (5) and an insulation sleeve (2), the sliding mechanism is slidably arranged in the handle, and an end of the needle body penetrates through the handle and the sliding mechanism (Chen, page 4 lines 1-3 and lines 28-30 & Fig. 3); and
the insulation sleeve is fixedly connected to the sliding mechanism (via adjusting sleeve pipe 10) (Chen, page 2, lines 12-14, bottom-up).
Regarding claim 12, Chen/Ciro/Barry combination discloses wherein a sidewall of the needle tube is provided with a water outlet hole (102) in communication with the water channel, and the water outlet hole is located next to the needle tip (Chen, page 4, lines 16-17 & Fig. 2).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Chen, Ciro, and Barry as applied to claims 1 and 3 above, and further in view of Zhang (W.O. Application No. 2020038216 A1).
Regarding claim 4, Chen discloses wherein the handle is provided with a sliding groove (combination of waist-shaped hole 401 and sleeve pipe 10) extending along a radial direction of the needle body (see Fig. 1), and a sidewall of the sliding groove is provided with a plurality of limiting grooves (grooves 100 on adjusting sleeve pipe 10, seen on Fig. 6) (page 3, lines 5-6, bottom-up; page 4, lines 1-3 & Fig. 3);
the sliding mechanism comprises: a base (10), a button (5); and
the base is slidably arranged in the sliding groove, the button is connected with the base and the button is able to move on the base along the radial direction of the needle body (page 4, lines 1-3 & Fig. 6).
However, Chen/Ciro/Barry combination do not disclose a clamp pin, the button being connected with the base through a spring, and the clamp pin is fixed to the button.
Zhang, in the same field of endeavor, teaches an ablation needle (10) comprising an ablation handle (12) including a driving assembly (120) and a connecting member (121) rotatably connected to the driving assembly (page 5, lines 1-4 of paragraph 5 & Fig. 9). The driving assembly includes a sliding member (122, analogous to the base of Chen) and an adjusting member (123, analogous to the button of Chen) connected to the sliding member 122 along the axial direction (page 5, lines 1-2 of paragraph 6). An elastic member (125) is further provided between the adjusting member and the sliding member, wherein the elastic member is a spring (page 6, lines 1-5 of paragraph 3 & Fig. 11). The adjusting member is further provided with at least one protrusion/clamp pin (1231). In a natural state, the elastic member pushes the protrusion/clamp pin and snaps it into a locking position (1226) to realize the positioning of the adjusting member and the sliding member (page 6, lines 3-5 of paragraph 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the structural arrangement of the clamp pin being fixed to the button and the button being connected with the base through a spring, as taught by Zhang, to the sliding mechanism of Chen since both sliding mechanisms are known variants in the art and they would both would yield the same predictable results of sliding/moving a needle body based on the manipulation of controls located on the handle of the ablation needle.
Regarding claim 5, Chen/Ciro/Zhang combination discloses wherein the sliding mechanism further comprises a scale indicator (303) fixed on the base (Chen, page 2, lines 17-18, bottom-up).
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chen, Ciro, and Barry as applied to claims 1 and 3 above, and further in view of Cao (E.P. Application No. 2954865 A1).
Regarding claim 6, Chen discloses wherein the ablation needle further comprises a needle seat (6) fixedly connected to the handle (page 4, lines 3-5), the needle body is penetrated through the handle and is in communication with the needle seat (see Fig. 4), and the water delivery assembly is fixedly connected to the needle seat (via step 601) (page 4, line 23); and
an energy transmission wire (802) is pressed and fixed on an outer wall surface of the needle seat, and the energy transmission wire is configured for receiving a pulse current or a radio frequency energy (page 2, last paragraph).
However, Chen/Ciro/Barry combination do not teach a metal pressure tube is sleeved outside the needle seat.
Cao, in the same field of endeavor, teaches a manufacturing method of a cable-type radio frequency ablation tube (pa. 0137 & Figs. 27a-e), wherein one of the steps includes a copper wire (301) wound around an exposed section of a nickel-titanium alloy support (conductive section 303), and then a platinum ring/metal pressure tube (304) is sleeved on the wound copper wire to be fixed (pa. 0139). This manufacturing process ensures that wires in the tube body are orderly arranged, and are insulated from each other, thereby avoiding uneven arrangement of wires during assembling, and also avoiding mutual interference of the wires (pa. 0141).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the metal pressure tube of Cao to sleeve the outside of the needle seat of Chen for the purpose of further fixing the energy transmission wire to the outer wall surface of the needle seat, as well as avoiding interference of multiple wires.
Regarding claim 7, Chen/Ciro/Barry/Cao combination discloses wherein the water delivery assembly comprises a water tube seat (7), a water delivery tube (80) and a Ruhr joint (800) (Chen, page 4, lines 4-5, lines 14-15, and line 23);
the water tube seat is sealingly adhered to the needle seat (Chen, page 4, lines 8-9), an end of the water delivery tube is fixed to the water tube seat, and the Ruhr joint is fixed to an other end of the water delivery tube (Chen, see Figs. 1 and 4).
Examiner notes that the term "Ruhr" is a regional variation of the word "Luer," which refers to a standardized, leak-proof connector system widely used in medical and laboratory devices.
Regarding claim 8, Chen/Ciro/Barry/Cao combination discloses wherein a step hole (cavity inside the needle seat) is arranged in the needle seat, the needle body is fixed to an end of the step hole with a small inner diameter, and the water tube seat is fixed to an end of the step hole with a large inner diameter (Chen, see Fig. 4).
Regarding claims 9-10, Chen/Barry/Cao discloses the invention substantially as claimed in claims 1 and 7 discussed above.
However, they do not disclose wherein the insulation assembly further comprises an insulation layer covering the temperature measuring device, wherein the insulation layer is made of at least one of a polyimide and an epoxy.
Ciro, in the same field of endeavor, teaches electrode wires configured to connect the electrode elements to an RF generator, wherein the electrode wires are comprised of 40 gauge bifilar type T thermocouple wires. In some embodiments, the thermocouple wires are insulated with multiple layers of polymers selected from a group including, but not limited to, Teflon, PTFE, polyimide, PET polyester, nylon polyurethane, Butvar, PVDF, PFA, polyethylene, TFE copolymers, etc.) (pa. 0214).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the layer of polymer, as taught by Ciro, to the temperature measuring device of Chen for the purpose of providing insulation from electrical energy.
Claims 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Chen, Ciro, and Barry as applied to claims 1-2 above, and further in view of Yang (C.N. Application No. 112472147 A).
Regarding claim 11, Chen/Ciro/Barry combination discloses the invention substantially as claimed in claims 1-2 discussed above.
However, they do not disclose wherein an annular groove is arranged at a joint of the needle tip and the needle tube.
Yang, in the same field of endeavor, teaches a needle biopsy needle comprising an inner needle core (2), wherein an outer surface of the inner needle core comprises a plurality of trapezoidal or V-shaped grooves (page 5, lines 4-10 & Figs. 2-3) to aid in penetrating and biopsy the tissue (page 9, last paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the plurality of grooves, taught by Yang, at a joint of the needle tip and the needle tube of Chen for the purpose of aiding in penetrating and biopsy tissue.
Regarding claim 16, Chen/Ciro/Barry/Yang combination discloses wherein a sidewall of the needle tube is provided with a water outlet hole (102) in communication with the water channel, and the water outlet hole is located next to the needle tip (Chen, page 4, lines 16-17 & Fig. 2).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Chen and Ciro as applied to claim 1 above, and further in view of Burgess (U.S. Application No. 20150164331 A1).
Regarding claim 13, Chen/Ciro combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose a device host, the device host comprising a temperature measuring master board and a temperature measuring sub-board inserted into the temperature measuring master board, and the temperature measuring master board being electrically connected with the temperature measuring sub-board.
Burgess, in the same field of endeavor, teaches an integrated architecture system/measuring master board (10) comprising a CPU component (70) and an electronic subsystem/measuring sub-board that generates data in some remote location and converts the data to digital form. A digitizer converts the data to digital form, and this digital data is transmitted across a network/host and received on the opposite end of the network/host with another subsystem that performs other tasks (archival, analysis, display) on the data (pa. 0014-0015). The network/host includes any system of at least two individual members (e.g. system and host computer) that are interconnected by a communications channel in order to transmit information (pa. 0017).
Examiner notes while the measuring master board and the measuring sub-boards of Burgess are not explicit about being temperature measuring master board and temperature measuring sub-boards, they are still capable to receiving, transmitting, and analyzing electrical data gathered from a catheter (pa. 0016). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the host, the temperature measuring master board, and the temperature measuring sub-board of Burgess into the tissue ablation needle of Chen for the purpose of processing and analyzing data (Burgess, pa. 0015).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Chen, Ciro, and Burgess as applied to claims 1 and 13 above, and further in view of Cheng (U.S. Patent No. 6142992 A).
Regarding claim 14, Chen/Ciro combination discloses the invention substantially as claimed in claims 1 and 13 discussed above.
However, they do not disclose wherein the temperature measuring sub-board comprises a temperature measuring front end, a microcontroller unit, an isolated power supply unit, and an isolated communication unit, and the temperature measuring master board comprises a power supply circuit, an optical fiber transceiver, and a temperature measuring sub-board interface, wherein the temperature measuring front end comprises a digital temperature measuring chip circuit and the microcontroller unit is electrically connected with the digital temperature measuring chip circuit, and the optical fiber transceiver communicates with the isolated communication unit through an asynchronous transceiver communication.
Burgess, in the same field of endeavor, teaches the measuring sub-board comprising the CPU/microcontroller unit components which further comprises one or more commonly available input/output (I/O) devices and interfaces, such as a keyboard, mouse, touchpad, and printer, wherein the I/O devices and interfaces also provide a communications interface to various external devices (pa. 0032). The CPU/microcontroller unit components are connected with the sample probe by way of wires, cables, optical fibers, wireless communications, and the like. Communication between any proximal and distal ends of any part of the device, system, or apparatus (i.e., measuring front end) may be by any communication devices, such as wires, optics, wireless, RF, and the like (pa. 0014). A digitizer/measuring chip circuit converts the data to digital form, and this digital data is transmitted across a network and received on the opposite end of a network/host with another subsystem that performs other tasks (archival, analysis, display) on the data (pa. 0014-0015). The CPU components include power supplies and display monitors (pa. 0019).
Examiner is interpreting the Burgess reference to teach the optical fiber transceiver communicates with the isolated communication unit through an asynchronous transceiver communication, given that it is described how an alternative embodiment includes a sample clock generator which effectively synchronizes the data received by the digitizer (pa. 0034); therefore, the main embodiment described above does not include such sample clock generator and effectively the method of sending data between two devices does not include a shared clock signal.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the temperature measuring front end, the microcontroller unit, the power supply unit, the isolated communication unit, and the optical fiber transceiver, the temperature measuring chip circuit, and the temperature measuring sub-board interface taught by Burgess to the tissue ablation needle of Chen for the purpose of transmitting, processing, and analyzing data (Burgess, pa. 0015).
However, Chen/Ciro/Burgess combination do not disclose the temperature measuring front end comprises a pulse protection circuit, a filter circuit, and the isolated power supply unit is an isolated power supply circuit, and the power supply circuit is configured for supplying power to the isolated power supply unit.
Cheng, in the same field of endeavor, teaches a high frequency power supply for applying electrical energy to a target site. The power supply includes a spark prevention device/pulse protection circuit for eliminating or reducing sudden pulses in current when an instrument powered by the power supply contacts a low impedance source, wherein the spark prevention mechanism includes a current sensor coupled to an output electrode, a signal conditioner, a voltage comparator, a logic device, and a power output forming a feedback loop system (Col. 4, lines 36-41 and lines 57-61). Furthermore, signals from sensors are passed through a plurality of rectifying diodes and capacitors (i.e., filter circuit) which filters and conditions the analog signals from the current sensor (Col. 18, lines 34-37). Lastly, in one configuration, individual electrode terminals in an electrode array are electrically insulated from all other electrode terminals in the array within a probe and are connected to a power source which is isolated from each of the other electrode terminals in the array or to circuitry which limits or interrupts current flow to the electrode terminal when low resistivity material (e.g., blood, electrically conductive saline irrigant or electrically conductive gel) causes a lower impedance path between a return electrode and the individual electrode terminal. The isolated power sources for each individual electrode terminal may be separate power supply circuits having internal impedance characteristics which limit power to the associated electrode terminal when a low impedance return path is encountered (Col. 12, lines 30-43).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the pulse protection circuit, the filter circuit, and the isolated power circuit taught by Cheng to the tissue ablation needle of Chen for the purpose of protecting against sudden voltage spikes, providing efficient noise reduction and smoothing voltage fluctuations, and to limit power when a low impedance return path is encountered, respectively.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kester (US 20200352639 A1) teaches apparatus and associated methods related to controlling electrical power of an electrotherapeutic signal that is provided to a biological tissue.
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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