DETAILED ACTION
This action is in response to amendments received on 8/19/2025. Claims 6-12 were previously rejected. Claim 6 has been amended and claims 9 and 11 have been canceled. A complete action on the merits of claims 6-8, 10 and 12 follows below.
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 .
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 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.
Claim Objections
Claim 6 is objected to because of the following informalities: “.” In line 23 should be changed to “,”. 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 6-8, 10 and 12 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 pre-AIA the applicant regards as the invention.
Claim 6 recites the limitation “the operating instrument comprises a first operating instrument, a second operating instrument and a return electrode”. It is noted that earlier in the claim a single operating instrument is introduced in addition to a single “inbuilt chip of the operating instrument”. By further limiting the operating instrument to be two instruments, it is at most unclear how a single inbuilt chip can be in both of the instruments at the same time. It is suggested to amend line 2 of the claim to introduce two operating instruments and further amend the remaining of the claim accordingly (e.g., a first inbuild chip of the first operating instrument and a second inbuilt chip of the second operating instrument,…). Clarification and appropriate correction is required.
Claim 6 recites the limitation “on one same operating instrument” in line 18 of the claim. It is at most unclear what is meant by “on one same”. Furthermore, it is unclear which operating instrument is being claimed here. Clarification and appropriate correction is required.
Claim 6 recites the limitation “when performing the cutting action” in line 19 of the claim. First, it is unclear if the claim is a product claims or a process claim. (See MPEP 2173.05(p)II) It is suggested to amend "when performing" to --is configured to perform-- in order to functionally claim the cutting action rather than positively. The claim will be interpreted in this manner. Moreover, since no cutting actions have been introduced prior to this recitation, it is unclear what cutting action is being referred to by the term “the”. Clarification and appropriate correction is required.
Claim 6 recites the limitation “the master control unit enables” in line 20. it is unclear if the claim is a product claims or a process claim. (See MPEP 2173.05(p)II) It is suggested to amend "enables" to --is configured to enable-- in order to functionally claim the enabling action rather than positively.
Claim 6 recites the limitation “a first operating end of the first operating instrument” in line 20 going to line 21. First, it is noted that a tail end of the first operating instrument has been introduced earlier in the claim. It is at most unclear if the first end is the same or different than the tail end. Furthermore, it is unclear how current is configured to flow through an “end” of the operating instrument without associating the end to any kind of electrode or conductive surface. It is also unclear if “one same operating instrument” is here being further limited to be the first operating instrument or not since the first operating instrument has been introduced as a bipolar instrument. Clarification and appropriate correction is required.
Claim 6 recites the limitation “when performing the tissue coagulation action” in line 24 of the claim. First, it is unclear if the claim is a product claims or a process claim. (See MPEP 2173.05(p)II) It is suggested to amend "when performing" to --is configured to perform-- in order to functionally claim the tissue coagulation action rather than positively. The claim will be interpreted in this manner. Moreover, since no coagulation actions have been introduced prior to this recitation, it is unclear what coagulation action is being referred to by the term “the”. Clarification and appropriate correction is required.
Claim 6 recites the limitation “the master control unit enables” in line 25. it is unclear if the claim is a product claims or a process claim. (See MPEP 2173.05(p)II) It is suggested to amend "enables" to --is configured to enable-- in order to functionally claim the enabling action rather than positively.
Claim 6 recites the limitation “a second operating end of the first operating instrument” in line 27. First, it is noted that a tail end of the first operating instrument has been introduced earlier in the claim. It is also noted that a first end of the first operating instrument has also been introduced in the claim. It is at most unclear if the second end is the same or different than the tail end and/or how many ends the first operating instrument has. Furthermore, it is unclear how current is configured to flow through a first or second “end” of the operating instrument without associating the ends to any kind of electrode or conductive surfaces. It is also unclear if “one same operating instrument” is here being further limited to be the first operating instrument or not since the first operating instrument has been introduced as a bipolar instrument. Clarification and appropriate correction is required.
Moreover, it is unclear how the cutting or coagulation modes are selected since the claim does not associate a switch to either of the modes. It is noted that the claim recites the limitation “the high-frequency power module (3) has three energy output modes corresponding to three output modes of the surgical operating system: a monopolar output mode, a bipolar output mode and a monopolar-bipolar hybrid output mode on one same operating instrument” and thus when “monopolar-bipolar hybrid output mode” is selected how it distinguishes between the cutting mode and coagulation mode.
Finally, claim 6 recites the limitation “complete the tissue coagulation action in the monopolar-bipolar hybrid mode on the first operating instrument”. It is unclear what is meant by completing the tissue coagulation action in the monopolar-bipolar hybrid mode “on the first operating instrument” as it appears the coagulation action will be completed on the target tissue and not on the operating instrument. Clarification and appropriate correction is required.
Claim 7 recites the limitation “wherein the switch matrix (4) comprises a first switch tube (41), a second switch tube (42), a third switch tube (43) and a fourth switch tube (44); the central control unit (2) is configured to send a switch drive signal to the first switch tube (41), the second switch tube (42), the third switch tube (43) and the fourth switch tube (44) according to the received selected instruction, to control the connection and disconnection of the first switch tube (41), the second switch tube (42), the third switch tube (43) and the fourth switch tube (44)”. First, it is noted that claim 6 on which claim 7 depends on introduces the limitation of “a first output socket (21) of the switch matrix (4) is connected to a tail end of the first operating instrument, a second output socket (22) of the switch matrix (4) is connected to a tail end of the second operating instrument and a tail end of the return electrode (5) respectively”. It is therefore unclear how the output sockets are related to the switch tubes and what components each of the switch tubes are connected to. It is unclear how “the connection and disconnection” of each of the tubes play a role in the operation of the system of claim 6. Moreover, it is noted that “a switch drive signal” has been introduced in claim 6. It is unclear if the two are the same or different.
Similar to claim 7, claim 8 recites the limitation “the switch matrix (4) further comprises a sixth switch tube and a seventh switch tube; the central control unit (2) is configured to send a switch drive signal to the sixth switch tube and the seventh switch tube according to the received selected instruction, to control the connection and disconnection of the sixth switch tube and the seventh switch tube”. It is unclear what each of these tubes are connected to and how the connect or disconnection of them plays a role in the operation of the system of claim 6. It is also noted that both claims 6 and 7 introduce “a switch drive signal”. It is unclear if they are all the same or different.
Claim 10 depends on canceled claim 9. It is unclear if this claim was also meant to be canceled or its dependency changed. Please note that if its dependency is changed to claim 6, claim 6 already introduces a bipolar instrument (associated with the first operating instrument” having a tail end connected to the switch matrix. Also as noted above, it is unclear if the first operating element being a bipolar instrument has electrodes or conductive regions thereon. By amending claim 6 to correct the issue, claim 10 will also need to be amended to address all of the issues accordingly to be in an acceptable dependent form.
Claim 12 depends on canceled claim 11. It is unclear if this claim was also meant to be canceled or its dependency changed. Please note that if its dependency is changed to claim 6, claim 6 already introduces a bipolar instrument (associated with “the first operating instrument”) having a tail end connected to the switch matrix. Also as noted above, it is unclear if the first operating element being a bipolar instrument has electrodes or conductive regions thereon. By amending claim 6 to correct the issues (e.g., introducing conductive regions), claim 12 will also need to be amended to address all of the issues accordingly to be in an acceptable dependent form. Please also note that claims 10 and 12 are duplicates of one another.
Claim Rejections - 35 USC § 102
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 6-8, 10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cosman (US Pub. No. 2015/0320481).
Regarding Claim 6, as best understood in view of the 112 rejections above, Cosman teaches a surgical operating system (Figs. 2, 7 and 9-10), comprising:
a master control unit (Figs. 2, 7 and 9-10), a control panel (1) and an operating instrument (either of 251-254 in Fig. 2, 761-766 in Fig. 7, 961-962 in Fig. 9 and 1061-1063 in Fig. 10), wherein the master control unit comprises a central control unit (2) (controller 840 in Fig. 8), a high-frequency power module (3) (850 in Fig. 8) and a switch matrix (4) (860 in Fig. 8), the high-frequency power module (3) is connected to the central control unit (2) and the switch matrix (4) respectively, the central control unit (2) is configured to receive a selected instruction output by the control panel (1) and read mode information of an inbuilt chip of the operating instrument or a footswitch instruction, and the central control unit (2) is configured to output a switch drive signal to the switch matrix (4) to control the switch matrix (4) to switch on and drive the operating instrument (Fig. 8 and automatic control (by an inbuilt chip) [0198]-[0202]);
the operating instrument comprises a first operating instrument, a second operating instrument (251-252 together, 253-254 together in Fig. 2 or operating any two of 861-866 as the first operating instrument and any other one as the second operating element in Fig. 8) and a return electrode (5) (221-224 in Fig. 2 or 835-836 in Fig. 8);
a first output socket (21) (SGE-2 in Fig. 8) of the switch matrix (4) 380 is connected to a tail end of the first operating instrument 862 (Fig. 8), a second output socket (22) (SEG-1 in Fig. 8) of the switch matrix (4) 860 is connected to a tail end of the second operating instrument 861 (Fig. 8) and a tail end of the return electrode (5) 835 respectively, wherein the first operating instrument is a bipolar instrument (7), and the second operating instrument is an electrode structure (6) (either of SRE1-6 and SGE1-6 are coupled to the tail of one of the instruments 861-866, where the controller is configured to switch them on and off to produce monopolar or bipolar configurations, see [0201]);
wherein the high-frequency power module (3) has three energy output modes corresponding to three output modes of the surgical operating system: a monopolar output mode, a bipolar output mode and a monopolar-bipolar hybrid output mode on one same operating instrument (“RF generator system includes connections for multiple electrodes and multiple ground pads, and radiofrequency ablation can be effected at multiple electrodes at the same time; in this example, the generator provides user controls for activating and deactivating each electrode, changing the settings for each electrode individually or collectively, and selecting the electrical potentials and patterns of switching electrical potentials to each other electrodes to effect radiofrequency ablation configurations including monopolar, bipolar, dual, multipolar, clustered, and sequences thereof; in some embodiments of this example, the system can include a controller that distributes current from the electrodes among the ground pads by sequentially connecting and disconnecting different subsets of the ground pads to source of the electrode current” [0042], also see [0056] and [0189] and Fig. 2),
in the monopolar-bipolar hybrid mode, when performing the cutting action (tissue ablation), the master control unit enables, through a first set of control signals, the current to flow through a first operating end of the first operating instrument and then through human tissues to reach a return electrode to form a first current loop and complete the cutting action in the monopolar-bipolar hybrid mode on the first operating instrument (“tissue ablation” [0191] and [0196]-[0201]).
in the monopolar-bipolar hybrid mode, when performing the tissue coagulation action, the master control unit enables, through a second set of control signals, the current to flow through the first operating end of the first operating instrument and then through the tissue to be cut off to reach a second operating end of the first operating instrument to form a second current loop and complete the tissue coagulation action in the monopolar-bipolar hybrid mode on the first operating instrument (“the generator 700 can be configured for surgical coagulation” [0191]).
Regarding Claim 7, Cosman teaches wherein the switch matrix (4) 860 comprises a first switch tube (41), a second switch tube (42), a third switch tube (43) and a fourth switch tube (44) (multiple tubes shown in Fig. 8); the central control unit (2) 840 is configured to send a switch drive signal to the first switch tube (41), the second switch tube (42), the third switch tube (43) and the fourth switch tube (44) according to the received selected instruction, to control the connection and disconnection of the first switch tube (41), the second switch tube (42), the third switch tube (43) and the fourth switch tube (44) ([0198]-[0201]).
Regarding Claim 8, Cosman teaches wherein the switch matrix (4) 860 further comprises a sixth switch tube and a seventh switch tube (more than 7 tubes shown in Fig. 8); the central control unit (2) 840 is configured to send a switch drive signal to the sixth switch tube and the seventh switch tube according to the received selected instruction, to control the connection and disconnection of the sixth switch tube and the seventh switch tube ([0198]-[0201]).
Regarding Claims 10 and 12, Cosman teaches wherein the bipolar instrument (7) comprises a first conductive region (73), a second conductive region (74), a handle assembly (75) (the distal section of each of the instruments configured to be held by a user is here interpreted to be a handle) and a bipolar instrument operating end (Fig. 2 for example shows a bipolar configuration between 251-252 as depicted 294A); the first conductive region (73) is connected to a first output end of the first output socket (21), the second conductive region (74) is connected to a second output end of the first output socket (21), and the handle assembly (75) is connected to the bipolar instrument operating end, wherein the bipolar instrument operating end comprises a first operating end (71) and a second operating end (72), and the electrode structure (6) comprises a third operating end (see Figs. 2, [0141]-[0145], also see [0198] and [0201]).
Response to Arguments
Applicant's arguments filed 8/19/2025 have been fully considered but they are not persuasive.
Applicant’s arguments on the grounds that “Cosman does not disclose any structure or control logic for achieving monopolar and bipolar hybrid output on a single operating instrument, nor does it involve any mechanism for switching output paths based on different output control signals. The Cosman refers to the concepts of monopolar, bipolar, and multipolar, which correspond to configurations involving a single electrode, two electrodes, or multiple electrodes. In present patent, the terms monopolar, bipolar, and monopolar-bipolar hybrid refer to the structural design principles by which a single electrode operates” are not found persuasive.
First, as best understood in view of the 112 rejections above, a system is being claimed that comprises multiple instruments/electrodes coupled to a switching unit and an output generator configured to operate in monopolar, bipolar and a monopolar-bipolar hybrid mode. As applicant points out in the arguments “Cosman refers to the concepts of monopolar, bipolar, and multipolar, which correspond to configurations involving a single electrode, two electrodes, or multiple electrodes” which are all coupled to a switching unit and a HF generator and therefore, configured to be switched to operate in the claimed functional manner.
Second, in response to applicant's argument that the references fail to show certain features of the invention “According to the technical solution of the present application, the same operating instrument can operate in a monopolar-bipolar hybrid output mode. In this hybrid mode, the same instrument can perform cutting in monopolar mode and hemostasis in bipolar mode, overcoming the respective limitations of conventional monopolar and bipolar outputs, while integrating their respective advantages. Under the monopolar-bipolar hybrid output mode: a bipolar instrument can perform cutting using a monopolar mode, enabling one end of the bipolar instrument to achieve a higher energy density; with the cutting force of the bipolar instrument, cutting can be achieved at low power, significantly reducing surgical trauma to the patient. Moreover, coagulation under the hybrid mode still essentially uses bipolar coagulation, which, compared to monopolar coagulation, concentrates power within a certain depth at the coagulation site, resulting in a thicker coagulation layer and better hemostatic effect at the bleeding point”, it is noted that the features upon which applicant relies (i.e., “In present patent, the terms monopolar, bipolar, and monopolar-bipolar hybrid refer to the structural design principles by which a single electrode operates” … “the same instrument can perform cutting in monopolar mode and hemostasis in bipolar mode”) are not recited in the rejected claim(s). At most applicant is claiming “a first operating instrument, a second operating instrument and a return electrode (5); a first output socket (21) of the switch matrix (4) is connected to a tail end of the first operating instrument, a second output socket (22) of the switch matrix (4) is connected to a tail end of the second operating instrument and a tail end of the return electrode (5) respectively, wherein the first operating instrument is a bipolar instrument (7), and the second operating instrument is an electrode structure”. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794