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 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Yates (US 2017/0000554) in view of Friedrichs (US 2017/0209202).
Regarding claims 1 and 9, Yates discloses an energy delivery system including an energy source for generating electrosurgical and ultrasonic drive waveforms as controlled by an energy source controller (see discussion associated with fig. 3, including [0111] and [0112]). The system further includes an instrument that uses electrosurgical and ultrasonic drive waveforms (108) that is attached by a plug to a single receptacle of the energy source (not numbered, via 146). Yates does not disclose the use of direct current and an inverter to generate electrosurgical and ultrasonic drive waveforms, controlled by the energy source controller, or different ports for the electrosurgical and ultrasonic drive waveforms. However, it is noted that Yates teaches that the electrosurgical and ultrasonic drive waveforms can be generated by units inside a console (114, 116 within 102), by units outside the console (114, 116 outside of 102) by an integrated energy source ([0102]) or even within the instrument itself ([0106]). Further, Yates provides no details about how this particular combination of electrosurgical and ultrasonic drive waveform generation would work. These two elements together establish that a person of ordinary skill in the art would be very familiar with how the appropriate circuitry for generating electrosurgical and ultrasonic drive waveforms would be made and used. In fact, using DC current and an inverter for generating electrosurgical and ultrasonic drive waveforms is common in the art. Friedrichs, for example, discloses such a configuration and also teaches the energy source controller for controlling the inverter and power supply (see discussion associated with figure 3). Further, Friedrichs discloses that some ports are configured to transmit the electrosurgical waveform and other ports are configured to transmit ultrasonic drive waveform (234, 236, 230, 232, fig. 3). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Yates to include any structure commonly known for delivering electrosurgical and ultrasonic drive waveforms, including DC power supply and an inverter as taught by Friedrichs, and further to including any structure commonly known for allowing electrosurgical and ultrasonic drive waveforms to be delivered from the receptable of Yates, including distinct ports also as taught by Friedrichs, and further to include the appropriate elements in the energy source controller to allow control of the inverter and power supply as also taught by Yates, that would produce the predictable result of system that can deliver electrosurgical and ultrasonic drive waveforms to an instrument. Yates as modified does not disclose a plurality of energy sources, a plurality of receptacles and a plurality of instruments. However, it has been held that duplication of parts is an obvious modification (MPEP 2144.04(VI)(B)) and there is no evidence that increasing the number of energy sources, receptacles and instruments 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 system of Yates to include multiples of any elements including energy sources, receptacles and instruments that would produce the predictable result of a system that can be used to treat tissue using electrosurgical and ultrasonic drive waveforms.
Claims 2-4 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yates and Friedrichs, further in view of Allen (US 2017/0312004).
Regarding claims 2-4 and 10-12, the system of Yates as modified does not disclose a main controller for identification of attached devices and control of the energy source to output waveforms on the basis of that identification. However, controlling various operational parameters of a medical system based on the identification of instruments attached to a console is common in the art. Allen, for example, discloses a system usable with many different instruments using many different receptacles (fig. 1) and teaches that a main controller can identify the attached device and control supply of energy in a desired manner ([0044)]. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Yates to include a main controller for controlling the energy source based on the identification of the attached device such as taught by Allen, that would produce the predictable result of allowing the system to delivery energy to tissue in safe and effective manner. It is noted that since Yates already discloses that electrosurgical and ultrasonic drive waveforms are delivered to respective ports of a given receptacle, this modification is understood to include activating the ports based on whether the connected instrument can and should deliver the corresponding energy to tissue.
Claims 5-8 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Yates and Friedrichs, further in view of Shelton (US 2019/0290269).
Regarding claims 5-8 and 13-16, Yates as modified does not disclose the specific features of the receptacle or ports, presumably because a person of ordinary skill in the art would know how to make a functional electrical connector. Electrical connectors are ubiquitous in the art and there is no evidence that the claimed connectors are critical or produce an unexpected result. Shelton discloses an electrosurgical system and teaches that a port can include a plurality of contacts along and defining opposing longitudinal surfaces (figs. 21-23B). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)), where the fact that Yates does not disclose a receptacle configuration suggests it would be a matter for a person of ordinary skill in the art to choose from those available in the prior art. Therefore, before the application was filed, it would have been obvious to modify the ports in the receptacles of Yates to have any commonly known configuration, including ports defining longitudinal surfaces having a plurality of contacts as taught by Shelton, that would produce the predictable result of allowing electrical communication between the energy source and the instrument.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Yates and Friedrichs, further in view of Pemen (US 2018/0140824).
Regarding claims 17 and 18 the system of Yates must have a plurality of plugs to connect to the respective plurality of ports, but does not disclose any particular details of the plugs. This is presumably because a person of ordinary skill in the art would know how to make a functional plug. Pemen discloses a medical device with plug at the proximal end having two extensions (fig. 1, see also fig. 7). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)), where the fact that Yates does not disclose a plug configuration suggests it would be a matter for a person of ordinary skill in the art to choose from those available in the prior art. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Yates to include any commonly known plug configuration, including extensions from a substrate as taught by Pemen, that would produce the predictable result of allowing an instrument to be electrically connected to an energy source.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yates, Friedrichs and Pemen, further in view of Medina (US 2019/0245310).
Regarding claims 19 and 20, the device of Yates as modified does not disclose that the extensions include two surfaces each with contacts, where the substrate is a printed circuit board and the contacts are traces. However, PCBs are ubiquitous in the art and there is no evidence that using a common technology produces an unexpected result. Medina discloses a medical device that uses a port/plug configuration that includes electrical contacts on both sides of a substrate ([0089], fig. 9B) and teaches that PCBs and traces are well known for use as plugs and contacts, respectively ([0083], [0054]). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)), where the fact that neither Yates nor Pemen discloses the exact contact configuration on the plug suggests it would be a matter for a person of ordinary skill in the art to choose from those available in the prior art. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Yates to include any commonly known plug configuration, including the use of PCBs with conductive traces on two surfaces, such as taught by Medina, that would produce the predictable result of allowing an instrument to be connected to an energy source.
Response to Arguments
Applicant's arguments filed 28 October 2025 have been fully considered but they are not persuasive. Applicant’s first argument is that neither reference in the combination teaches each energy source has the three elements listed. This argument is not persuasive. Most critically, it relies upon limitations that the claims do not require. The terms “generator” and “energy source” can be used synonymously and other than stating that some nebulous element which is a “generator” that “comprises” some elements there is no claimed structural relationship between the “generator” and “energy sources,” such as, for example, the energy sources being housed within the confines of a console or cabinet. Further, because of the nature of electrical connectivity that forms the basis for circuitry, even a single inverter/power supply can be part of both an RF and ultrasound “energy source” since the claim does not define the “generator” to require multiples of components (e.g. first inverter, second inverter). Finally, while not specifically argued, it is noted that the claim language that “each” receptacle is coupled to the plurality of energy sources is understood, by the omission of a second occurrence of “each,” to not be required to connect to each of the plurality of energy sources. Thus, simply duplicating the functioning RF/ultrasound circuitry of Yates as modified by Friedrichs reads on the claim because the result is a plurality of RF/ultrasound “energy sources” that together comprise a “generator.” Relatedly, this argument does not address the rejection as it is written including all the rationales advanced for the obviousness of various modifications, specifically the simple duplication of extant, functional components.
Applicant’s second argument is about receptacles and ports. The arguments both read into the claim language limitations that are not there and are a piecemeal analysis of the references. First, the terms “receptacle” and “port” can be used synonymously and Applicant has not described any particular structural relationship between them other than that an arbitrary one “includes” a plurality of the other. Yates explicitly shows a single receptacle/port, both schematically in figure 3 as noted in the remarks, and actually in figure 1. Further, Yates discloses that all the instruments, including the instrument that uses both RF and ultrasonic energy (108) is connected to that single receptacle/port. The only elements missing are the specific details of that single receptacle/port, presumably because a person of ordinary skill in the electrosurgical generator art would understand how plugs work. Friedrichs shows that in a device that uses both RF and ultrasonic energy, two receptacle/ports can be used to provide the device with those energies. Therefore, it is maintained that it would be obvious to provide the receptacle/port of Yates with the two receptacles/ports of Friedrichs, even if there are other obvious configurations of the ubiquitous electrical connector. Second, 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). To argue that because neither reference has one port with two ports or one receptacle with two receptacles or one receptacle with two ports or one port with two receptacles is to ignore what the references together would suggest to a person of ordinary skill in the art, a person, it is noted, who is “a person of ordinary creativity, not an automaton” (as discussed in MPEP 2141(II)(C)).
It is noted that a rejection could have been written based on the interpretation of elements 114 and 116 in figure 3 of Yates as “energy sources” even with the single inverter from Friedrichs being part of both “energy sources,” for the reasons noted above. But since the core issue is the breadth of the claim language, specifically the lack of details regarding “generator,” “energy source,” “receptacle” and “port,” it was deemed a lateral move from the rejection as it appears above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the use of distinct inverters for “energy sources,” see paragraph [0037] of Allen (US 2017/0312004). Regarding a generator with a plurality of modules each with a power source and inverter, see figure 3 of US 2019/0126037 to Sarnago Andia. Regarding the general teaching that a DC source can be converted to AC using one or more inverters within the system itself, but also that the DC sources may be provided with one or more inverters, to further establish that the level of ordinary skill in the art encompasses such elementary components as DC power and DC/AC conversion, see paragraph [0426] of US 2019/0201025 to Shelton. Regarding the well-known fact that both RF and ultrasound “energy sources” may employ AC/DC and then DC/AC conversion, such that simply putting those two “sources” in the same “generator” would be the simplest way to make an RF/ultrasound “generator” see figure 2A of US 2015/0088117 to Gilbert (for RF) and paragraph [0031] of US 2016/0374711 to Van Tol.
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 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.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794