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 § 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]), where the RF energy output by the inverter to the instrument remains “actual HF-output.” 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 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.
Allowable Subject Matter
Claims 17-20 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 of the previous Action, 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.
Response to Arguments
Applicant's arguments filed 04 May 2026 have been fully considered but, to the degree they are relevant to the pending rejections, they are not persuasive.
The main thrust of Applicant’s argument in fact cannot be persuasive because it is a piecemeal analysis of the references. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant first discusses Rupp, then discusses Pankratov, and finally discusses Bisch before concluding that because no single reference has a particular feature or set of features, the prior art cannot be combined to reject the claims. But at no point does Applicant consider the teachings of the references together, beyond the explicit structure disclosed, and what those teachings would suggest to a person of ordinary skill in the art. Even the amendment to the independent claim, while clarifying, is an indication that because Applicant considers RF energy passthrough to be missing from one of the secondary references, such an amendment should define around the rejection as a whole. But Rupp includes the use of RF energy from a single inverter to multiple sockets, and, as discussed both in the rejection and in more detail below, there is no reason that mere modularity would necessarily change that aspect of Rupp.
Relatedly, Applicant’s arguments are based on an extremely literally reading of each reference without considering the level of ordinary skill in the art. For example, the rejection notes that Pankratov does not provide specific guidance for how to implement the disclosed modularity features which include, as noted by Applicant, the use of RF energy. Because the prior art is assumed to be enabling as required by 35 U.S.C. 112(a), discussed in MPEP 2121, the examiner noted Pankratov’s disclosure thus provides support for the position that a person of ordinary skill in the art would be able to make and use Pankratov’s invention without access to the particular details of the circuits. This level of ordinary skill in the art is directly relevant to the modification proposed in the rejection, where it is well established that “a person of ordinary skill in the art is also a person of ordinary creativity, not an automaton” (as discussed in MPEP 2141(II)(C)). Applicant’s response is that because Pankratov does not disclose the circuits, Pankratov discloses nothing of value to the obviousness process. But if Applicant is correct, then Pankratov along with every prior art document that does not include circuit diagrams is unusable in an obviousness rejection regarding generator features described generally. Further, the level of ordinary skill in the art becomes a meaningless determination. Both of those positions are untenable. The level of ordinary skill in the art is critical to the determination of obviousness (MPEP 2141(II)), and the rejections are based on a level of ordinary skill in the art which itself is based at least on the fact that such a person would be able to make and use the modular system disclosed by Pankratov without circuit diagrams. The question is not whether the implementation of the invention of Pankratov is “common knowledge,” the question is whether a person of ordinary skill in the art would be able to instantiate the teachings of Pankratov into a functional system. The examiner maintains, as instructed by the MPEP (as noted above), that such a person would in fact be able to produce the system of Pankratov, which is relevant to the question of whether such a person would be able to apply the teachings of Pankratov in other contexts. This includes a modification of Rupp when also considering the teachings of Bisch.
It is noted that Pankratov is clearly analogous art to the claimed invention, both being RF generators for use treating tissue. To claim they are not analogous art on the grounds that the type of tissue being treated is different, or that a hypothetical operator has a different education level, is unreasonable and incommensurate with the manner in which the prior art contemplates RF generators for treating tissue. It is also noted that the invention is classified in A61B18/1206 “generators for passing current through the tissue to be heated” and Pankratov is classified in A61B18/14 “probes or electrodes for passing a current through the tissue to be heated,” both being subclasses indented under A61B18/12, “passing a current through the tissue to be heated.”
The arguments about Bisch are similarly unpersuasive on the grounds that the teachings contained therein have not been considered together with the teachings of the other references within the context of the level of ordinary skill in the art. As noted in the rejection, the teaching Bisch is relied upon is simply the use of a main circuit with connectors for modular circuits (discussed in more detail in the rejection). The fact that these circuits have a different functionality, by itself, is not relevant to the question of whether a person of ordinary skill in the art, considering the general teaching of how Bisch uses circuit modules and submodules, would be motivated to modify other references, including Rupp which explicitly supplies energy from a single RF inverter to a plurality of output sockets (each benefiting from modularity as discussed in the rejection).
The invention described by Applicant’s specification is sophisticated and presumably, even if only based on the subject matter of the claims indicated allowable, has features that the prior art does not teach or suggest. But the examiner maintains that the rejections of most of the pending claims, even as amended, are reasonable in view of the breadth of the claim language, the teachings of the prior art, and the high level of skill of the person of ordinary skill in the art.
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 DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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