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 Objections
Claim 21 objected to because of the following informalities: claim 21 should recite an “active electrode end.” Appropriate correction is required.
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, 3, 5, 10-12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ellman (US 2014/0276770) in view of Haemmerich (US 2006/0064084) and Palanker (US 2008/0027428).
Regarding claims 1, 3, 5 and 10-12, Ellman discloses an electrosurgical system with a handpiece (16, fig. 1) having a mounting channel (located in the distal end of the handpiece but not specifically numbered, figs. 3-4) in communication with an electrical contact in the form of a tubular member (38 connected to generator by 52, fig. 5). The system further includes an electrode arrangement with a mounting shaft (32 and the insulated portion of 28, fig. 2) in communication with an active electrode end (the uninsulated portion of 28), where the electrode is configured to be attached to the handpiece by interaction between the mounting shaft and mounting channel ([0032]). Ellman further discloses the mounting shaft is malleable ([0029]) and that the handpiece is selectively coupled by contacts to a console generator by an electrical cable (15, fig. 16-20). Ellman does not disclose the electrode end includes an edge that includes a visual indicator of treatment depth. However, visual indicators of treatment depth are common in the art and there is no evidence that using such indicators would produce an unexpected result (within the meaning of MPEP 716.02(a)). Haemmerich, for example, discloses an electrode with depth markings along an edge (fig. 5) and teaches this allows a user to know/control insertion depth ([0061]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Ellman to include depth indicators on an edge of the electrode such as taught by Haemmerich that would produce the predictable result of allowing a user to know and control the depth that the electrode has been inserted into tissue. The system of Ellman does not disclose the particular configuration of the electrode end. However, Ellman does teach that many different electrode configurations are contemplated (e.g. fig. 12) for use in a cut mode ([0027]) and there is no evidence that the claimed configuration produces an unexpected result. Palanker discloses an electrode for cutting and teaches that several configurations are contemplated including a concave shape ([0023]) with insulation on the surfaces other than the edge ([0021]). 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 any commonly known configuration of electrode end useful for cutting, including an insulated concave shape with insulation exposed at a cutting edge as taught by Palanker, in addition to those electrode ends already disclosed by Ellman, that would produce the predictable results of allowing a user to cut tissue in a desired manner.
Regarding claim 21, the device of Ellman when modified as discussed above performs the method steps during normal use. Note that the claim does not recite the bottom convex surface is used to apply energy to tissue, only that the bottom surface contacts tissue and is moved across tissue. This would happen in a tissue region constrained enough to contact both the cutting edge and the and the convex portion, a scenario which justifies the use of insulation of claim 3 in the first place (i.e. to prevent applying energy to any tissue other than the tissue it is desired to cut with the peripheral edge).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ellman, Haemmerich and Palanker, further in view of Yossepowitch (US 2004/0064139).
Regarding claim 4, the system of Ellman does not disclose an electrode in the shape of an oval. However, ovals, and shapes in general, are commonly known in the art where there is no evidence that the change of shape produces an unexpected result (where it has been held that a change of shape is an obvious modification, MPEP 2144.04(IV)(B)). Yossepowitch discloses a cutting electrode and teaches that an electrode may be provided in an oval shape, among other shapes ([0025], fig. 9A). therefore, before the application was filed, it would have bene obvious to one of ordinary skill in the art to further modify the system of Ellman to include an electrode of any commonly known shape, including an oval as taught by Yossepowitch, that would produce the predictable result of allowing a user to interact with tissue in a desired manner.
Claims 1, 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 3,532,095) in view of Archambault (US 2010/0049229) and Garito (US 2009/0069802).
Regarding claims 1, 6 and 7, Miller discloses an electrosurgical system with a handpiece (11, fig. 1) having a mounting channel (12, 14 and 15, fig. 5) in communication with an electrical contact (46). The system further includes an electrode arrangement with a mounting shaft (34, fig. 5) in communication with an active electrode end (33), where the electrode is configured to be attached to the handpiece by interaction between the mounting shaft and mounting channel (fig 5). Ellman further discloses the mounting shaft is has an insulating sleeve (36) which is also received within the mounting channel (fig. 5). Miller does not disclose the electrode end includes an edge that includes a visual indicator of treatment depth although it is noted that Miller teaches that electrodes in these types of systems can have different shapes and can be used for cutting (col. 1 lines 16-25). However, visual indicators of treatment depth are common in the art and there is no evidence that using such indicators would produce an unexpected result (within the meaning of MPEP 716.02(a)). Archambault, for example, discloses a cutting element with depth markings along an edge (fig. 1A) and teaches this allows a user to know/control insertion depth (abstract). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Miller to include depth indicators on the edge of the cutting element such as taught by Archambault that would produce the predictable result of allowing a user to know and control the depth that the cutting element has been inserted into tissue. The term “heat-shrinked” is a product-by-process limitation (MPEP 2113). Since the system of Miller as modified includes the product recited in claim 7, the claim is unpatentable. The system of Miller as discussed above does not disclose the active electrode end is configured to be concave shaped, defining an outer convex surface, with the edge portion around the periphery of the active electrode end. However, Miller expressly discloses that “It should be noted that the tip of the electrode may be any desired shape as required for the particular surgical situation at hand” (col. 2 lines 56-58) where concave/convex electrodes are common in the art including, even though the claims do not require it, uninsulated concave/convex electrodes. Garito, for example, discloses an active electrode end (130, fig. 3) with a convex/concave shape ([0030]) having a peripheral edge that is entirely useful for treating tissue ([0031]). 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 Miller to include any commonly known configuration of electrode end useful for cutting, including an exposed concave shape with a cutting edge as taught by Garito, that would produce the predictable results of allowing a user to cut tissue in a desired manner.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ellman, Haemmerich and Palanker, further in view of Miller (US 2018/0256139), hereinafter Miller2.
Regarding claim 8, the embodiment of Ellman as discussed above does not disclose the mounting shaft includes a pair of grooves that cooperate with a locking element disposed on an end of the handpiece to lock the electrode arrangement within the handpiece. However, using a wide range of elements to lock to parts of a medical system together is very common in the art and there is no evidence that using a pair of grooves produces an unexpected result. Miller2 discloses a medical device and teaches that detents (245, fig. 8) and locking elements (300) are used to connect to parts of a medical device ([0046]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Ellman to including elements for locking the mounting shaft to the handpiece, including the locking elements of Miller2, that would produce the predictable result of preventing the system from coming apart during use.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ellman and Haemmerich and Palanker, further in view of Ellman (US 6,994,707), hereinafter Ellman2.
Regarding claim 13, Ellman does not disclose the use of a smart plug. However, “smart plugs” as defined in the claim are very common in the art and there is no evidence that using such a plug produces an unexpected result. The fact that Applicant incorporates one of their own references from almost 20 years ago as support for this feature in the specification ([0057]) is evidence of the opposite, that this element produces a predictable result. Ellman2, the reference in question, discloses a system very similar to Ellman that includes smart plug (see discussion associated with figure 4). 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 “smart plug” such as taught by Ellman2 to produce the predictable result of a system that function in a desired manner with respect to the electrical output used to treat tissue.
Response to Arguments
Applicant's arguments filed 26 February 2026 have been fully considered but they are not persuasive. Applicant reads limitations into the claim that are not there. Claim 1, and previous claim 2, do not require “both (i) a curved electrode surface and (ii) a peripheral edge portion that are exposed and usable during a procedure” as stated in the Remarks. The claim language simply states that there is an “active electrode end,” which is broader language than “electrode” in the first place, and then states that this “active electrode end” has a convex surface with an edge portion around the periphery. The claim does not recite what conductive surfaces are exposed, or the absence of a coating, or that the entire electrode is configured to communicate energy to tissue, or any other language that would require the features outlined in the Remarks. Use of the transitional phrase “comprising” allows other elements beside those claimed (MPEP 2111.03), where in this case more specifically it is very common in the art to refer to an electrode as such even when the electrode has insulation (although, again, “active electrode end” can include more than conductive elements). Further, Palanker was used to reject previous claim 2 because of claim 3, which expressly states that the convex surface is insulated in a manner that would prevent tissue treatment with the convex side as discussed in Applicant’s paragraph [0035]. Reading pending claim 1 as Applicant attempts to do would result in a rejection under 35 U.S.C. 112(b) and (d) since claim 3 would both be indefinite and fail to further limit claim 1, due to the claims reciting mutually exclusive limitations (i.e. the convex surface cannot be exposed to treat tissue and insulated to avoid treating tissue at the same time). Claims are given their broadest reasonable interpretation and, in this case, “reasonable” includes “non-contradictory.” Regarding claim 21 in particular, as the note provided in the rejection above states, the claim does not require using the bottom convex surface to apply energy to tissue. Finally, while claim language that excludes energy-blocking insulation from the concave/convex “active electrode end” would define around Palanker, the subject matter of claim 3 was the more difficult element to find. Concave/convex shaped electrodes with the entire surface available for treating tissue are fairly common in the art such as shown by Yossepowitch, cited in the previous Action, and Garito, cited above. If other examples would be helpful, see for example, figure 1 of US 5,261,905 to Doresey and paragraph [0041] of US 2005/0222567 to Ouchi.
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.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794