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.
Election/Restriction
This application contains claims directed to the following patentably distinct species: Species I, fig. 16A and 16D; Species II, fig. 16B; Species III, fig. 16E and Species IV, fig. 16F. The species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 1, 7, 8, 10 and 11 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Michael Bascobert on 21 January 2026 a provisional election was made without traverse to prosecute the invention of Species I, claims 1-4, 7, 8, 10 and 11. Affirmation of this election must be made by applicant in replying to this Office action. Claims 5, 6 and 9 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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 1-4, 7, 8, 10 and 11 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 claims 1-4, 7, 8, 10 and 11, claim 1 recites that the active electrode has a reservoir in communication with a fluid connector, but then states that the fluid connector is for passing gel from the fluid connector to “a electrode reservoir.” Aside from the fact that the claim should read “an electrode reservoir,” It is not clear how many reservoirs the electrode has. Claims 2-4, 7, 8, 10 and 11 depend from claim 1 and are therefore also indefinite.
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 Ellman (US 2014/0276770) in view of Lax (US 5,458,596).
Regarding claim 1, Ellman discloses what an electrosurgical system including a handpiece (10, fig. 1) with a mounting channel (38) having an electrical contact (via 52, fig. 5) engageable with an electrode arrangement (fig. 2) having a mounting shaft (32) in communication with an active electrode end having a contact surface (28) for delivery RF energy transmitted through the various conductive elements between the electrode end and a generator (fig. 5). Ellman does not disclose any of the elements related to gel delivery. However, using various fluids to enhance an ablation procedure is common in the art. Lax, for example, discloses an electrosurgical system (figs. 9 and 44) that includes an electrode (18) with a contact surface having apertures (42) connected to a reservoir (the interior of the electrode, fig. 9) connected through a handle (12), which can understood to include a fluid connector, to an external reservoir (54) so that a pump (60) can provide either a fluid or gel (col. 4 lines 33-38). Lax discloses this gel improves the electrical path between the electrode and tissue (col. 8 lines 19-24). Therefore, before the application was filed, it would have been obvious to modify the electrosurgical system of Ellman to include the gel delivery structures of Lax, including the external gel reservoir, pump, fluid connector, electrode reservoir and electrode apertures, as taught by Lax, that would produce the predictable result of allowing a user to improve the electrical path between the electrode and tissue by delivering gel from the external reservoir to tissue adjacent the electrode. It is noted that this modification is understood to result in the fluid connector being located in the mounting channel because that is where a fluid connector must be located if it is to functionally connect the electrode reservoir to the external reservoir.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ellman and Lax, further in view of Batchelor (US 2019/0262092).
Regarding claim 2, the system of Ellman as modified does not disclose the shape of the apertures, presumably because a person of ordinary skill in the art would be able to choose an appropriate aperture shape. In fact, various aperture shapes are common in the art and there is no evidence the particular shape produces an unexpected result (within the meaning of MPEP 716.02(a)). Batchelor, for example, discloses an electrosurgical system with fluid apertures and teaches these apertures can be various shapes include spherical (or more appropriately, circular, [0030]). 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 Ellman to include apertures with any commonly known shapes, including spherical as taught by Batchelor, that would produce the predictable result of allowing gel to be delivered out of the electrode.
Claims 3, 4, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ellman, Lax and Batchelor, further in view of Yossepowitch (US 2004/0064139) and Beeckler (US 2019/0105698).
Regarding claims 3 and 4, the system of Ellman as modified does not disclose the size of the apertures increases toward and outer area of an oval with a concave side and a convex side. However, electrodes with that shape are so commonly known they are often called referred to as having a “spoon” shape, such as taught by Yossepowitch which also discloses an electrode in an electrosurgical system could have several other shapes (fig. 9A, [0061]). The fact that Ellman also discloses the electrodes can have a wide range of shapes (fig. 12) further suggests that a person of ordinary skill in the art would understand there are many electrode shapes possible. Regarding the change of shape of the apertures, this is also a common feature of electrosurgical devices that use a flowable conductive material. Beeckler discloses that apertures can be the same size or different sizes by virtue of changing the aperture size as a function of radial distance from a central point ([0030]). Beeckler does not disclose whether the aperture size increases or decreases as the radius changes, but it can only be one or the other which suggests that a person of ordinary skill in the art would be able to choose an appropriate aperture size which could be either scenario. 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 Ellman to include a spoon shaped electrode such as taught by Yossepowitch having any commonly known arrangement of aperture size relative to radial distance from a center point, including increasing or decreasing as taught by Beeckler, that would produce the predictable result of allowing a gel to be delivered to tissue.
Regarding claims 10 and 11, the system of Ellman as modified in the manner discussed above with respect to claims 3 and 4 does not disclose which side of the electrode arrangement has the apertures, although it must be at least one or the other. Further, there is no evidence that where the apertures are located produces an unexpected result (within the meaning of MPEP 716.02(a)) and the fact that Applicant has claimed two mutually exclusive species of aperture locations suggests the opposite, that putting apertures on either side of the electrode only does what a person of ordinary skill in the art would expect. Lax further discloses that the apertures can be located on one side of the electrode arrangement (fig. 9), where it has been held that the reversal of parts is an obvious modification (MPEP 2144.04(VI)(A)) which in this case is understood to encompass reversing the side of the electrode used as the contact surface and thus which side has the apertures. Therefore, before the application was filed, it would have been obvious to further modify the system of Ellman to have the apertures on one side of the electrode arrangement such as taught by Lex, including either the convex side or the concave side, that would produce the predictable result of allowing a user to treat tissue with that side of the electrode.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ellman and Lax, further in view of Gutbrod (US 2017/0273732).
Regarding claim 7, the system of Ellman does not disclose the use of a volume sensor for controlling the amount of gel delivered to the contact surface. However, having established that use of a gel is beneficial, it follows both that some amount of gel is necessary for the benefit and that a person of ordinary skill in the art would be motivated to ensure that the correct amount of gel is used. Gutbrod discloses an electrosurgical system and teaches that both RF energy and fluid flow can be controlled based on a determination of the volume of fluid present around the electrode (110, fig 1, [0055], [0068], [0073]). Therefore, before the application was filed, it would have been obvious to further modify the system of Ellman to include a volume sensor on the contact surface as taught by Gutbrod to allow a controller to control the flow of gel (by the pump) through the electrode to ensure a desired amount of gel is present during tissue treatment.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ellman and Lax, further in view of Shelton (US 2019/0059980).
Regarding claim 8, the system of Ellman does not disclose an impedance sensor for determining impedance of RF energy for controlling the pump. However, this is common practice in devices which use a conductive fluid to facilitate tissue ablation. Shelton, for example, discloses an electrosurgical system and teaches that impedance of RF energy (which is “total” in some sense of the word) is used to actuate the pump to ensure a desired flow of fluid ([0116]-[0117], see also [0128] and [0149] for other embodiments of using impedance to control fluid flow as an indication of the level of ordinary skill in the 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 Ellman to include impedance-based control elements controlling the delivery of an electrically conductive substance such as taught by Shelton that would produce the predictable result of ensuring that the desired amount of the substance is used.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding another system that uses impedance to control fluid delivery, see paragraph [0029] of US 2002/0058933 to Christopherson. Regarding a device that specifically controls gel flow based on measured volume (as indicated by pressure), see paragraph [0026] of US 2012/0157985 to Ballou.
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