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 . 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.
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 2, 4, 14, 15, 19 and 20 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.
Regarding claim 2, it is not clear exactly what structure is required by the language “universal connector” since there are clearly countless connectors that would not functionally connect to the disclosed connector.
Regarding claim 2, the language “in particular” renders the claim indefinite because it is not clear if the limitation that follows is required or not.
Regarding claim 4, it is not clear exactly what structure is required by the language “universal socket” since there are clearly countless instruments that would not functionally connect to the disclosed socket.
Regarding claim 4, it is not clear what the relationship is between “a plurality of connection ports” and “at least one connection port” in claim 1.
Regarding claim 14, the word “optional” renders the claim indefinite because it is not clear if the limitation that follows is required or not.
Regarding claim 15, the phrase “is/are” is at best grammatically inappropriate and at worst renders the claim indefinite because it is not clear how many extension lines there are.
Regarding claim 19, there is no antecedent basis for “the extension board.”
Regarding claim 20, the claim borders on incoherent. First, there is no antecedent basis for “the interface.” Second, it is unclear why there is a comma after “interface comprises.” Third, what the interface comprises is not structure but a method step, making it unclear what structure is actually required by the claim. Fourth, what “actuated” means in this context is unclear. Fifth, there is no antecedent basis for either “the at least one connection port of the extension” or “the extension.”
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 1-10 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Rupp (US 2018/0042659), Pankratov (US 2009/0043293) and Bisch (US 5,997,528).
Regarding claims 1-5, 9 and 10, Rupp discloses what can be considered a generic electrosurgical generator (figs. 2-4) comprising an inverter (228, [0030]) generating HF energy for RF and ultrasonic instruments through various electrode lines (whatever electrical conductors carry electricity to the instruments, e.g. 228a in fig. 3), where those lines and associated circuitry can be considered a “high-voltage connection.” Rupp does not disclose that the high-voltage connection comprises a distribution unit having connection ports, all of which together define a base module. However, making electrosurgical generator components modular is very common in the art. Pankratov, for example, discloses a medical system with electrosurgical components and teaches that modular components allow replacement and upgrade without having to replace the entire system, in addition to simple customizability ([0026]). Further, the fact that Pankratov does not disclose any of the particular circuitry that would allow this modularity is evidence that the level of ordinary skill in the art is high enough to encompass such modifications. Bisch discloses another electrosurgical generator (fig. 1) that includes a base module circuit board with “universal” hybrid connection ports (127) for connecting to, and powering, various submodules (13) and a distribution unit having energy distribution lines and data communication wiring (various elements associated with base unit 7 in fig. 2, note in particular “power and comm bus”). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the high-voltage connection of Rupp to have modular components such as taught by Pankratov including by using the base module configuration of Bisch that would produce the predictable result of allowing HF energy from the inverter to be delivered through the various components to the instruments to allow the instruments to be used to treat tissue in a desired manner. This modification is understood to allow any of the outputs of Rupp to be modular sockets including at least monopolar, bipolar and ultrasound such as discussed by Rupp ([0020]). Further, the modification is understood the use of a HF bus (which is also a “bar”) since that is the output energy used by Rupp.
Regarding claims 6-8, the electrosurgical generator of Rupp as modified discloses ultrasonic lines, as discussed above, but does not disclose at least three electrode lines. However, duplication of parts has been held to be an obvious modification (MPEP 2144.04(VI)(B)), where instruments having various combinations of one or more active and neutral electrodes are common in the art. Therefore, it would have been obvious to provide any number of active electrode lines and any number of return electrode lines that would produce the predictable result of allowing the use of an instrument with those numbers of electrodes. It is noted that the ultrasonic frequency being on the same or another conductor are the only two possible options.
Regarding claims 14 and 15, the electrosurgical generator of Rupp does not specifically disclose an additional base module, or that the modules are connected. However, duplication of parts has been held to be an obvious modification (MPEP 2144.04(VI)(B)), and the modules are either connected or not connected where it has further been held that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to further modify the generator of Rupp to have any number of base modules, including two, connected or not, that would produce the predictable result of allowing a user to use the generator to power instruments to treat tissue in a desired manner. It is noted that in the absence of other details any connecting elements between the respective lines (HF, data, etc.) of the modules can be considered an “interface.”
Regarding claim 16, the electrosurgical generator of Rupp as modified does not that one of the base modules has more conductors for more electrodes. However, duplication of parts has been held to be an obvious modification (MPEP 2144.04(VI)(B)), where instruments having various combinations of one or more active and neutral electrodes are common in the art. Therefore, it would have been obvious to provide any number of active electrode lines and any number of return electrode lines to any of the base modules, including one either module having more than the other(s), that would produce the predictable result of allowing the use of an instrument with those numbers of electrodes.
Claims 11-13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rupp, Pankratov and Bisch, further in view of Denen (US 5,400,267).
Regarding claims 11-13, the electrosurgical generator of Rupp does not disclose any form of compatibility checking. However, ensuring that that the parts of an electrosurgical generator do not destroy themselves or harm patients is self-evidently beneficial. The prior art commonly uses compatibility checks to prevent incompatible components for use together such as taught by Denen (col. 2 lines 41-45). Further, relays are a common electrical component and where there is no evidence that where the relay is located (on a module, on a submodule, on a handle, on the housing, etc.) produces an unexpected result (within the meaning of MPEP 716.02(a)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the electrosurgical generator of Rupp to include any commonly known circuitry including one or more relays that would allow the system to prevent the use of incompatible components such as taught by Denen, including submodules, that would produce the predictable result of not damaging the generator or hurting a patient through supplying power to incompatible components.
Regarding claim 20, the electrosurgical generator of Rupp does not disclose operating the sub module based on the type of sub module attached. This is common in the art such as taught by Denen (col. 2 lines 20-27). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the generator of Rupp to include automatically controlling the operational parameters of the instrument automatically based on the type of instrument attached, such as taught by Denen, that would produce the predictable result of allowing a user to use the instrument in a safe and effective manner.
Allowable Subject Matter
Claims 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims (pending a correction of the issues under 35 U.S.C. 112(b) as discussed above).
The following is a statement of reasons for the indication of allowable subject matter: While modular systems are known, such as cited above and in the Conclusion below, there are none which have distinct base modules connected by switches on an interface between the modules for allowing different combinations of conductors between the modules to be connected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding other modular electrosurgical generators, see figure 3 of US 2017/0312004 to Allen, figure 3A of US 2022/0192727 to Canady. Figure 4 of US 2015/0282861 to Anderson and figure 1 of US 5,837,001 to Mackey. Regarding the general teaching that relays controlled by switching signals are known in the art, see paragraph [0077] of US 2020/0078083 to Sprinkle.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794