DETAILED ACTION
Claims 1, 3, 5 12, 15-18 and 20 are currently amended. A complete action on the merits of pending claims 1-20 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites “the second portion distal-most surface configured to electrosurgically treating tissue” it sounds grammatically odd. The examiner believes something like --the second portion distal-most surface configured to electrosurgically treat tissue-- would sound better.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-15 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 pre-AIA the applicant regards as the invention. It is unclear what is meant by the limitation “the electrically insulative spacer surface a distal-facing and distal-most surface of the insulative spacer”. The examiner is not sure if the limitation is only stating the insulative spacer has a distal-facing and distal-most surface, if the second portion extends toward/over/on/within/etc. a distal-facing and distal-most surface of the insulative spacer (like the two limitations before it), the insulative spacer surface is distal-facing and is the distal-most surface of the insulating spacer, or something else. Further, there is a dash “-,” before this limitation so something could have been left out of the claim or it could be part of a line out for the amendment. Additionally, this limitation has “the electrically insulative spacer” and “the insulative spacer”, is there a difference between the two? If so, this would be an antecedent basis issue. If not, consistent language should be used throughout the claims. This is also seen in claims 3, 8-11, and 15.
Claims 2-15 are also rejected under 112(b) based on dependency.
For the purposes of examination, the interpretation will be that the electrically insulative spacer has a distal-facing and distal-most surface.
Claim Rejections - 35 USC § 102
Claims 1, 2, and 4-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Germain US 20200222108.
Regarding claim 1, Germain teaches a tubular distal end that is electrically conductive (Fig. 8 meal outer sleeve 120), with a cutting window on a first circumferential side (Fig. 8 window 128); an electrically insulative spacer wrapped over a second circumferential side of the tubular distal end (Fig. 8 125); an active electrode secured to the electrically insulative spacer (Fig. 7B 140), the active electrode defining two portions, angularly offset from each other, the two portions including a first portion that extends circumferentially and axially along the tubular distal end (Fig. 7A 168s) and a second portion (Fig. 7A 170) that extends from a distal end of the first portion towards a central axis of the tubular distal end (Fig. 8 170 has a thickness and part 180 extending upward), over and along a surface of the electrically insulative spacer (Figs. 7A and 7B), the electrically insulative spacer surface a distal-facing and distal-most surface of the insulative spacer (see 112(b) above, the interpretation taken is met by Fig. 8 tip 166), the second portion having at least one flange (Fig. 7A pin 180) configured to engage a notch in the electrically insulative spacer to resist separation of the active electrode from the electrically insulative spacer (par. [0047]).
Regarding claim 2, Germain teaches wherein the second portion extends perpendicularly to the longitudinal axis (Fig. 8 180 perpendicular to 112).
Regarding claim 4, Germain teaches wherein the first portion is axially tapered, configured to finely dissect tissue at the first portion distal end (Fig. 7A notches 184 on 168).
Regarding claim 5, Germain teaches wherein the at least one flange extends proximally to directly engage a proximally extending notch in the electrically insulative spacer (Figs. 7A and 8 notches 184 making a proximal extension of 180, 180 also has a thickness so it can be seen as extending proximally from the distal surface or distally from the proximal surface).
Regarding claim 6, Germain teaches wherein the at least one flange includes bilateral flanges (Fig. 7A notches 184 on both sides of 180).
Regarding claim 7, Germain teaches wherein the second portion defines a distal facing concave surface configured to deflect external forces on the active electrode during use (Fig. 7A notches 184 on 180 the functional limitation is a result of the shape).
Regarding claim 8, Germain teaches wherein the insulative spacer extends around the tubular distal end up to a cutting edge of the cutting window (Fig. 8 125 with collar 155).
Regarding claim 9, Germain teaches wherein the insulative spacer extends over to cover a distal facing end surface of the tubular distal end, thereby defining at least a portion of a distal-most end of the tissue resecting probe (Fig. 8 166).
Regarding claim 10, Germain teaches wherein the active electrode includes a neck extending proximally from the active electrode first portion (Fig. 7A 168s) configured to extend along a tunnel through the insulative spacer and thereby retain the active electrode at a second location proximally separated from the second portion (par. [0047] glued in channels of 125).
Regarding claim 11, Germain teaches a retention clip (Fig. 7A 140) extending around an external surface of insulative spacer and both electrically and mechanically coupled to the tubular distal end (Fig. 7B lead 185).
Regarding claim 12, Germain teaches wherein the tubular distal end and retention clip both define external surfaces of the tissue resecting probe (Fig. 8 170).
Regarding claim 13, Germain teaches wherein the retention clip includes a distally extending tab disposed adjacent the active electrode (Fig. 7B 170 exposed part of electrode 140), configured to balance a spacing around the active electrode, between the active electrode and return electrode (par. [0045] spacing of electrode 140), and thereby improve the electrosurgical tissue effect (pars. [0009] and [0043] farther spacing vs close spacing which allows for better cutting).
Regarding claim 14, Germain teaches wherein retention clip includes bilateral radially jogged ends (Fig. 7A 168s).
Regarding claim 15, Germain teaches further comprising an axial gap (Fig. 1 gap created between distal end of hub 104 and about where 125 is) between a proximal most end of the active electrode first portion (Fig. 7A proximal end of 168s where 185 attaches) and a spacer distal edge (Fig. 1 distal edge of 104), the proximal-most end and spacer distal edge facing each other (Fig. 1 distal end of 104 faces 125 proximal edge of 125 where proximal ends of 168s are housed faces 104), and the axial gap configured to mitigate stress transfer to the insulative spacer during bending and flexing of the active electrode (Fig. 1 where the gap does not overlap 125 so any bending where the gap is would not put any stress on 125).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Germain in view of Deutmeyer US 20200222108.
Regarding claim 3, Germain does not explicitly teach wherein the second portion defines a distal- most surface radially coextensive with the insulative spacer distal-most end, the second portion distal-most surface configured to electrosurgically treating tissue.
However, Germain teaches where the electrode 140 has an exposed portion 170 that transitions to an upward pin 180 and goes within a channel 182 to be secured to the insulator 125 (Fig. 8 and par. [0047]).
Deutmeyer, in an analogous device, teaches where the electrode can be exposed only on the bottom of the tube (Fig. 20), similar to Germain, or on the bottom and distal-most end (Fig. 23), as claimed.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the electrode configuration to be at the distal-most end, as in the second configuration of Deutmeyer. It is seen as an obvious matter of design choice to one of ordinary skill in the art since it can be chosen by the practitioner to treat certain regions of tissue relative to the cutting window. It would yield the predictable result of treating tissue with the electrode at the distal-most end of the device.
Regarding claims 16 and 20, Germain teaches a metal component (Fig. 8 120) defining a cutting window on a first circumferential side of the tubular end effector (Fig. 8 128), the metal component configured as a return electrode (par. [0046]); a ceramic spacer coupled in a fixed manner to the metal component such that the ceramic spacer forms a second circumferential side of the tubular end effector opposing the first circumferential side (Fig. 8 ceramic housing 125), and wherein a distal end of the ceramic spacer includes a groove (Fig. 8 channel holding 180); an active electrode secured to the ceramic spacer (Fig. 7B 140), the active electrode positioned opposite the cutting window, wherein the active electrode includes a circumferential treatment surface and a retention hook (Fig. 7A pin 180) extending from a distal end of the circumferential treatment surface and angularly offset therefrom, the retention hook including at least one projection (Fig. 7A notches 184) directly engaging the groove and thereby retaining the active electrode with the tubular end effector (par. [0047]).
Germain does not explicitly teach a distal-most surface of the retention hook coextensive with the groove and configured to engage and electrosurgically treat tissue.
However, Germain teaches where the electrode 140 has an exposed portion 170 that transitions to an upward pin 180 and goes within a channel 182 to be secured to the insulator 125 (Fig. 8 and par. [0047]).
Deutmeyer, in an analogous device, teaches where the electrode can be exposed only on the bottom of the tube (Fig. 20), similar to Germain, or on the bottom and distal-most end (Fig. 23), as claimed.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the electrode configuration to be at the distal-most end, as in the second configuration of Deutmeyer. It is seen as an obvious matter of design choice to one of ordinary skill in the art since it can be chosen by the practitioner to treat certain regions of tissue relative to the cutting window. It would yield the predictable result of treating tissue with the electrode at the distal-most end of the device.
Regarding claim 17, the combination of Germain and Deutmeyer teaches wherein the retention hook distal-most surface defines a distal-most surface of the tissue resecting probe (Germain Fig. 7A 180 and Deutmeyer Fig. 23 309).
Regarding claim 18, Germain teaches wherein the retention hook includes a first projection that extends towards a longitudinal axis of the tissue resecting probe (Fig. 8 180 going toward axis 112) and a flange projection extending from the first projection (Fig. 7A notches 184), and wherein the insulative spacer has a cavity (Fig.8 and par. [0047] bore 182 with glue therein) having a first width portion (Figs. 7A and 8 space taken up with the glue of the bore by 180) and a second with portion (Figs. 7A and 8 space taken up by 184 attached to 180), larger than the first width portion, the first width portion for receiving the first projection therein and the second with portion for housing the flange projection therein (Figs. 7A and 8 and par. [0047] since 184 on is 180 the width of the two is larger than the width of just the space 180 takes up in the areas where 184 is not on 180. Thus, the second cavity holding 184 and 180 is larger than the first cavity holding 180 without 184).
Regarding claim 19, Germain teaches wherein the flange projection extends along the longitudinal axis (Fig. 7A notches 184 going left and right of 180).
Response to Arguments
Applicant's arguments filed 1/27/26 have been fully considered but they are not persuasive. Regarding claim 1 please see the 112(b) rejection above and the interpretation taken by the examiner. The independent claims claim slightly different features but if the interpretation is supposed to be similar to the hook of the electrode being at the distal most end, like in claims 16 and 20, see the rejection of claims 3, 16, and 20.
Regarding claim 5, the applicant argues that 180 of Germain is inserted in to a channel and is silent regarding a proximally extending notch. The applicant states that 180 is received within a linear channel. The examiner agrees and notes that the channel shown has a width not only a height which makes it extend proximally. The applicant states that the relies on adhesive to fill the gaps; however, par. [0047] states that it “can” have an adhesive not that it must and that a different portion can be welded for security. Further, even if Germain must have the adhesive, there is nothing in the claims to preclude the adhesive from being part of the pin or the adhesive from being part of the insulating spacer.
Regarding claim 15, the applicant argues that Germain does not read on the limitations since the back end of electrode 170 appear to be in contact with 125. However, 170 is the second portion of while the claim requires the first portion of the electrode. The examiner uses 168s in Fig. 7A for the first portion of the electrode not 170. Additionally, the claim states a spacer distal edge. It would appear that this does not require 125 of Germain since that part is used for an electrically insulative spacer. The claim does not state that a spacer distal edge is an edge of the electrically insulative spacer.
Regarding claim 18, the applicant states that Germain does not have a cavity with a first and second width where the second with is larger than the first. The examiner disagrees with this assertion. As seen in Germain Fig. 7A the protrusions 184 are on flange 180. The cavities can be where 180 and 184 sits within an adhesive as stated in par. [0047]. As seen in Figs. 7A and 8, the part of 180 where the notches 184 sit is wider than the area of 180 where notches 184 do not sit. Thus, the width of the space that 184 attached to 180 is in is wider than the space 180 takes up without 184 within bore 182.
The arguments to claims 3, 16, and 20 have been considered but do not apply to the new combination of references used in the rejection above.
Conclusion
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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/R.T.C./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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