DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. Applicant’s Amendment filed December 22, 2025 (hereinafter “12/22/25 Amendment") has been entered, and fully considered. In the 12/22/25 Amendment, claims 1-24 were amended. No claims were cancelled, or newly added. Therefore, claims 1-24 remain pending in the application.
3. The 12/22/25 Amendment has overcome the claim objections, and the rejections under §§ 112(b) & 103 previously set forth in the Non-Final Office Action mailed 10/01/25 (“10/01/25 Action”), with the exception of those that have been reiterated herein.
4. New claim objections, and new rejections under §§ 112(b) & 103 are set forth herein, necessitated by Applicant’s Amendment.
5. Applicant's arguments are addressed in detail below in the “Response to Arguments” section.
Claim Objections
6. Claims 1, 11, 13, & 24 are objected to because of the following informalities:
a. In claim 1, lines 3-5, the recitation of “produces electrical currents in at least one waveform for cutting and coagulating tissue” should instead recite --produces electrical currents in at least one waveform for cutting and in at least one waveform for coagulating tissue--.
b. In claim 11, lines 4-5, the recitation of “produces electrical currents in at least one waveform for cutting and coagulating tissue” should recite --produces electrical currents in at least one waveform for cutting and in at least one waveform for coagulating tissue--.
c. In claim 13, line 8, the recitation of “in a fist waveform” should instead recite --in a first waveform--.
d. In claim 17, lines 3-4, the recitation of “to produce the electrical current in a first waveform” should instead recite --to produce electrical current in a first waveform--.
e. In claim 18, lines 3-4, the recitation of “to produce the electrical current in a second waveform” should instead recite --to produce electrical current in a second waveform--.
f. In claim 24, lines 5-6, the recitation of “produces electrical currents in at least one waveform for cutting and coagulating tissue” should recite --produces electrical currents in at least one waveform for cutting and in at least one waveform for coagulating tissue--.
g. In claim 24, line 13, the recitation of “wherein suction tube is fixed” should instead recite --wherein the suction tube is fixed--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 2, 4, & 13-15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
9. Claim 2 recites the limitation “the same electrosurgical device” in line 4. There is insufficient antecedent basis for this recitation in the claim. Examiner suggests amending the claim to recite “wherein the suction tube is interchangeable with additional suction tubes of various sizes and configurations for use with the electrosurgical device” to obviate the rejection.
10. Claim 4 is rejected as ultimately depending from a claim (claim 2) rejected under 35 U.S.C. 112(b).
11. Claim 13 recites the limitation “the electrical current” in line 4. There is insufficient antecedent basis for this recitation in the claim.
12. Claim 13 further recites the limitation “to produce the electrical current in a fist [sic] waveform” in line 8. This recitation renders the claim indefinite, as it is not clear whether “the electrical current” recited in line 8 is intended to be the same “the electrical current” previously recited in line 4, or a separate current. Clarification is required. To obviate the rejection, Examiner suggests amending the claim to clearly differentiate between the electrical current produced to generate a force against a spring to move a sliding apparatus, and the electrical current produced to enable the electrode tip to cut tissue.
13. Claim 14 recites the limitation “the electrical current” in line 4. There is insufficient antecedent basis for this recitation in the claim.
14. Claim 14 recites the limitation “the sliding apparatus” in line 5. There is insufficient antecedent basis for this recitation in the claim.
15. Claim 14 further recites the limitation “to produce the electrical current in a second waveform” in lines 8-9. This recitation renders the claim indefinite, as it is not clear whether “the electrical current” recited in line 8 is intended to be the same “the electrical current” previously recited in line 4, or a separate current. Clarification is required. To obviate the rejection, Examiner suggests amending the claim to clearly differentiate between the electrical current produced to generate a force against a spring to move a sliding apparatus, and the electrical current produced to enable the electrode tip to coagulate tissue.
16. Claim 15 is rejected as ultimately depending from a claim (claim 14) rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 103
17. 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.
18. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
19. Claims 1-4, 7, 8, 10, 12, 16-18, 20, & 24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0335376 to Hufnagel et al. (“Hufnagel”) in view of U.S. Patent Application Publication No. 2018/0036064 to Shvetsov et al. ("Shvetsov").
20. Regarding claim 1, Hufnagel teaches an electrosurgical device with integrated smoke evacuation and suction, the electrosurgical device comprising:
an assembled unit [instrument (400) - ¶[0053]; FIGS. 8A-8C] connected to an external generator [electrosurgical generator - ¶’s [0012], [0013]; see also electrosurgical generator (140) - FIG. 1] …; and
an electrode tip [electrode (435) - ¶[0053]; FIGS. 8A-8C] disposed within the assembled unit [within instrument (400) - ¶[0053]; FIGS. 8A-8C], which is supported and configured for translation such that the electrode tip [(435)] is configured to transition from a retracted position to an extended position, relative to the assembled unit [relative to the housing (415) of instrument (400) - see ¶[0053] (“…an electrode 435 coaxially disposed within the first and second cannulas 420, 425 and selectively extendable from a distal end of the housing 415”), & ¶’s [0058]-[0060]];
wherein the assembled unit [(400)] comprises a housing unit [housing (415) - ¶[0053]; FIGS. 8A-8C] comprising a channel [interior or inner surface of housing (415) that receives first cannula (420) - ¶’s [0053], [0056]; FIGS. 8A-8C] for a smoke evacuation suction tube [first cannula (420) & second cannula (425) - see ¶’s [0053]-[0056] and [0061] (“In addition, electrode 435 may be replaceable to enable electrodes of differing lengths and profiles to be utilized, and first cannula 420 and/or second cannula 425 may be replaceable to enable use of aspiration tubes of differing lengths and/or diameter, having one or more pre-aspiration ports, having an elastomeric or rigid aspiration tip, and so forth”)] with a suction tip [the distal end of second cannula (425) - ¶’s [0053]-[0057]];
wherein the suction tube [(420)/(425)] is fixed and locked into place [¶’s [0056]-[0057] with a connection to an external vacuum source [to vacuum source - ¶[0054]; see also vacuum (150) - FIG. 1], the suction tube [(420)/(425)] is insertable and interchangeable with respect to the channel of the housing unit [(415)] [see ¶[0061] (“In addition… first cannula 420 and/or second cannula 425 may be replaceable to enable use of aspiration tubes of differing lengths and/or diameter, having one or more pre-aspiration ports, having an elastomeric or rigid aspiration tip, and so forth”)] …
A. Cutting & Coagulation Functionality & Buttons
While Hufnagel teaches the use of electrosurgical energy [¶’s [0010], [0054]], along with a push-button [electrosurgical actuator (430) - ¶[0054]; FIGS. 8A-8C] for controlling electrosurgical energy, as well as the ability to vary a property of the delivered electrosurgical energy [¶[0054]], Hufnagel does not teach the following emphasized claim limitations:
an assembled unit connected to an external generator that produces electrical currents in at least one waveform for cutting and coagulating tissue, which electrical currents are activated via two respective buttons.
However, the use of an electrosurgical device for cutting and coagulation, activated via respective buttons, was well known in the art, before the effective filing date of the claimed invention.
As one example, Shvetsov, in a similar field of endeavor, teaches an electrosurgical device (10) comprising, inter alia, a vacuum tube (16) [suction tube] and electrode (11), each capable of extending from the device housing [see ¶’s [0022], [0025] (“Vacuum tube 16 is capable of telescopically extending from and retracting into the cavity. However, even when fully retracted, a portion of vacuum tube 16 will be protruding from body 22 and can be laterally gripped by a user. Electrode 11 may also telescopically extend from second member 24. The vacuum tube 16 and electrode 11 may extend together or separately”); FIG. 1].
Shvetsov further teaches that the device includes a coagulate button (19) and a cut button (18) for effectuating coagulating and cutting of tissue, respectively [see ¶[0036] (“When the user is ready to initiate electrosurgery, either button 18, for cutting, or button 19, for coagulating, will be depressed by the user's index finger. Pressing button 18 will cause current to pass from electrical line 25 to internal contact 27 and out electrode 11 to a patient's body with enough current to typically cause cutting of tissue”); and ¶[0038]; FIG. 1].
Given that Hufnagel already contemplates the ability to vary a property of the delivered electrosurgical energy [¶[0054]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Hufnagel such that the generator be configured to produce electrical currents in at least one waveform for cutting and coagulating tissue, which electrical currents are activated via two respective buttons, since such a modification would provide the benefit/advantage of enabling a practitioner to perform different electrosurgical operations (i.e., cutting and coagulation) on target tissue during a surgical procedure without having to switch instruments, thereby facilitating (and increasing the overall efficiency of) the surgical procedure.
B. Radial Offset
Finally, in Hufnagel, the electrode (435) is coaxially disposed and centered within the suction tube [(420)/(425)] [¶[0053]; FIGS. 8A-8C]. While Hufnagel contemplates various alternative positions for the electrode (435), first cannula (420), and second cannula (425) [see ¶[0061]], Hufnagel does not explicitly teach the following emphasized claim limitations:
… the suction tube is offset from the electrode tip in a radial direction with respect to an axis of the electrode tip.
Shvetsov further teaches that it was known in the art to position the electrode tip and vacuum tube [suction tube] relative to one another in numerous different arrangements including, e.g.:
positioning the electrode tip separate from, and above, the vacuum tube [see FIG. 1],
positioning the electrode tip separate from, and below, the vacuum tube [see FIG. 5], and
positioning the electrode tip within the vacuum tube [see FIG. 7], similar to the arrangement depicted in FIGS. 8A-8C of Hufnagel.
Additionally, when disposed within the vacuum tube, Shvetsov teaches that the electrode tip may be disposed in the center of the vacuum tube, or offset from the center [see ¶[0045] (“Turning to FIG. 8, the electrode 411 is received in a socket 440 that is supported inside the vacuum tube 416. As shown, the electrode 411 is disposed in the center of the vacuum tube 416. Other configurations with the electrode 411 inside the vacuum tube 416 but offset from the center may also be suitable for some applications”)]. In such a configuration, it is noted that the vacuum tube would be offset from the electrode tip in a radial direction with respect to an axis [e.g., a longitudinal axis] of the electrode tip [radially offset in an eccentric configuration, wherein the center point of the electrode tip is shifted away from the center point of the vacuum tube, despite the fact that they are coaxial & parallel].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Hufnagel and Shvetsov such that the suction tube and electrode tip be positioned relative to one another in any number of well-known, art-recognized configurations including, e.g., one wherein the electrode tip in Hufnagel remains within the suction tube, but the suction tube is offset from the electrode tip in a radial direction with respect to an axis of the electrode tip, as taught by Shvetsov, since such a modification merely constitutes a rearrangement (repositioning) of parts, which has been found to be an example of a common practice which the court has held normally requires only ordinary skill in the art, and is hence considered to be a routine expedient. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); & In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
In the instant case, keeping the electrode tip of Hufnagel disposed within the suction tube (420)/(425), but merely shifting its position up or down such that suction tube and electrode tip are radially offset, would not modify operation of the device, as the suction tube would still operate normally to remove surgical smoke (and other debris) from the treatment site.
21. Regarding claim 2, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Hufnagel further teaches wherein the suction tube [(420)/(425)] is interchangeable with various sizes and configurations of suction tubes within the same electrosurgical device [see ¶[0061] (“In addition, electrode 435 may be replaceable to enable electrodes of differing lengths and profiles to be utilized, and first cannula 420 and/or second cannula 425 may be replaceable to enable use of aspiration tubes of differing lengths and/or diameter, having one or more pre-aspiration ports, having an elastomeric or rigid aspiration tip, and so forth”)].
22. Regarding claim 3, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Hufnagel further teaches wherein the suction tube [(420)/(425)] comprises a cam configured to lock the suction tube within the channel of the housing unit [see ¶[0056] (“First cannula 420 includes an annular rib 421 disposed at a proximal end thereof that is configured to engage an inner surface of housing 415. In embodiments, annular rib 421 forms a vacuum seal to reduce or eliminate any vacuum leakage from first cannula 420. Additionally or alternatively, annular rib 421 is configured to engage one or more detents 427 provided on an inner surface of housing 415, which enables a user to securely retain first cannula 420 at a desired position. The one or more detents 427 may be arranged to provide one or more preset positions at which to secure first cannula 420. Additionally or alternatively, the one or more detents 427 may be arranged in a closely-spaced or ratchet-like configuration to enable substantially continuous adjustment of first cannula 420. In embodiments, annular rib 421 and/or the one or more detents 427 are configured to provide an audible click and/or tactile feedback to the user as first cannula 420 is moved into engagement at each detent position”)].
23. Regarding claim 4, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Hufnagel further teaches wherein the suction tube [(420)/(425)] is configured to connect to different suction tip [(425)] sizes and configurations [e.g., ¶[0061] (“In addition, electrode 435 may be replaceable to enable electrodes of differing lengths and profiles to be utilized, and first cannula 420 and/or second cannula 425 may be replaceable to enable use of aspiration tubes of differing lengths and/or diameter, having one or more pre-aspiration ports, having an elastomeric or rigid aspiration tip, and so forth”].
24. Regarding claim 7, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Hufnagel further teaches wherein the electrode tip [(435)] is insertable and removable within a sliding apparatus of the housing unit [¶’s [0058]-[0060]; FIGS. 8A-8C; see also ¶[0044] - electrode support (138) and slide control (134), and FIG. 2].
25. Regarding claim 8, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Hufnagel further teaches wherein the sliding apparatus and the electrode tip [(435)] are configured to translate in a longitudinal direction, between the retracted and extended positions [¶’s [0053], ]0058]-[0061]; FIGS. 8A-8C].
26. Regarding claim 10, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Hufnagel further teaches wherein in the retracted position, the electrode tip [(435)] remains drawn back relative to the suction tip [(425)] [e.g., ¶’s [0034], [0048], [0055], [0061]; FIG. 8B.
27. Regarding claim 12, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
As amended above (in the rejection of claim 1) to include the cutting and coagulating functionality, Hufnagel further teaches, wherein in the extended position, the electrode tip [(435)] deploys longitudinally past the suction tip [(425)] to perform a cut or coagulate function [e.g., FIG. 8C].
28. Regarding claim 16, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Hufnagel further teaches wherein a sliding apparatus is configured to be mechanically locked in the extended position by activating a lock button [broadly, slide control/detent interaction, e.g., ¶[0044]].
29. Regarding claim 17, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Hufnagel was modified above (in the rejection of claim 1) to include the cut button and cut waveforms of Shvetsov. As such, as modified, Hufnagel/Shvetsov further teaches wherein in the locked, extended position, a cut button is configured to be depressed to produce the electrical current in a first waveform, activating the electrode tip and enabling it to cut tissue [Shvetsov, e.g., ¶[0036]].
30. Regarding claim 18, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 17 for the reasons set forth in detail (above) in the Office Action.
Hufnagel was modified above (in the rejection of claim 1) to include the coagulate button and coagulate waveforms of Shvetsov. As such, as modified, Hufnagel/Shvetsov further teaches, wherein in the locked, extended position, a coagulate button is configured to be depressed to produce the electrical current in a second waveform, activating the electrode tip and enabling it to coagulate tissue [Shvetsov, e.g., ¶’s [0036], [0038]].
31. Regarding claim 20, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Hufnagel further teaches wherein in the locked, extended position, the sliding apparatus is configured to be mechanically unlocked, and move from the extended position to the retracted position [via the slide control/detent interaction, e.g., ¶[0044]].
32. Regarding claim 24, Hufnagel teaches a method of providing smoke evacuation [e.g., ¶’s [0005], [0047], [0048]] as well as suction [e.g., ¶’s [0005], [0037]] during an electrosurgical procedure, the method comprising:
providing an electrosurgical device with integrated smoke evacuation and suction, the electrosurgical device comprising:
an assembled unit [instrument (400) - ¶[0053]; FIGS. 8A-8C] connected to an external generator [electrosurgical generator - ¶’s [0012], [0013]; see also electrosurgical generator (140) - FIG. 1]…;
an electrode tip [electrode (435) - ¶[0053]; FIGS. 8A-8C] disposed within the assembled unit [within instrument (400) - ¶[0053]; FIGS. 8A-8C], which is supported and configured for translation such that the electrode tip [(435)] is configured to transition from a retracted position to an extended position, relative to the assembled unit [relative to the housing (415) of instrument (400) - see ¶[0053] (“…an electrode 435 coaxially disposed within the first and second cannulas 420, 425 and selectively extendable from a distal end of the housing 415”), & ¶’s [0058]-[0060]]; and
the assembled unit [(400)] comprises a housing unit [housing (415) - ¶[0053]; FIGS. 8A-8C] comprising a channel [interior or inner surface of housing (415) that receives first cannula (420) - ¶’s [0053], [0056]; FIGS. 8A-8C] for a smoke evacuation suction tube [comprising first cannula (420) & second cannula (425) - see ¶’s [0053]-[0056] and [0061] (“In addition, electrode 435 may be replaceable to enable electrodes of differing lengths and profiles to be utilized, and first cannula 420 and/or second cannula 425 may be replaceable to enable use of aspiration tubes of differing lengths and/or diameter, having one or more pre-aspiration ports, having an elastomeric or rigid aspiration tip, and so forth”)] with a suction tip [the distal end of second cannula (425) - ¶’s [0053]-[0057]], wherein suction tube [(420)/(425)] is fixed and locked into place [¶’s [0056]-[0057]] with a connection to an external vacuum source [to vacuum source - ¶[0054]; see also vacuum (150) - FIG. 1], the suction tube [(420)/(425)] is insertable and interchangeable with respect to the channel of the housing unit [(415)] [see ¶[0061] (“In addition… first cannula 420 and/or second cannula 425 may be replaceable to enable use of aspiration tubes of differing lengths and/or diameter, having one or more pre-aspiration ports, having an elastomeric or rigid aspiration tip, and so forth”)]…, and
using the electrosurgical device to evacuate, through suction from the external vacuum source, smoke through the suction tube of the electrosurgical device [Hufnagel, e.g., ¶’s [0005], [0047], [0048]].
A. Cutting & Coagulation Functionality & Buttons
While Hufnagel teaches the use of electrosurgical energy [¶’s [0010], [0054]], along with a push-button [electrosurgical actuator (430) - ¶[0054]; FIGS. 8A-8C] for controlling electrosurgical energy, as well as the ability to vary a property of the delivered electrosurgical energy [¶[0054]], Hufnagel does not teach the following emphasized claim limitations:
an assembled unit connected to an external generator that produces electrical currents in at least one waveform for cutting and coagulating tissue, which electrical currents are activated via two respective buttons.
However, the use of an electrosurgical device for cutting and coagulation, activated via respective buttons, was well known in the art, before the effective filing date of the claimed invention.
As one example, Shvetsov, in a similar field of endeavor, teaches an electrosurgical device (10) comprising, inter alia, a vacuum tube (16) [suction tube] and electrode (11), each capable of extending from the device housing [see ¶’s [0022], [0025] (“Vacuum tube 16 is capable of telescopically extending from and retracting into the cavity. However, even when fully retracted, a portion of vacuum tube 16 will be protruding from body 22 and can be laterally gripped by a user. Electrode 11 may also telescopically extend from second member 24. The vacuum tube 16 and electrode 11 may extend together or separately”); FIG. 1].
Shvetsov further teaches that the device includes a coagulate button (19) and a cut button (18) for effectuating coagulating and cutting of tissue, respectively [see ¶[0036] (“When the user is ready to initiate electrosurgery, either button 18, for cutting, or button 19, for coagulating, will be depressed by the user's index finger. Pressing button 18 will cause current to pass from electrical line 25 to internal contact 27 and out electrode 11 to a patient's body with enough current to typically cause cutting of tissue”); and ¶[0038]; FIG. 1].
Given that Hufnagel already contemplates the ability to vary a property of the delivered electrosurgical energy [¶[0054]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Hufnagel such that the generator be configured to produce electrical currents in at least one waveform for cutting and coagulating tissue, which electrical currents are activated via two respective buttons, since such a modification would provide the benefit/advantage of enabling a practitioner to perform different electrosurgical operations (i.e., cutting and coagulation) on target tissue during a surgical procedure without having to switch instruments, thereby facilitating (and increasing the overall efficiency of) the surgical procedure.
B. Offset
Finally, in Hufnagel, the electrode (435) is coaxially disposed and centered within the first and second cannulas [(420), (425)] [¶[0053]; FIGS. 8A-8C]. While Hufnagel contemplates various alternative positions for the electrode (435), first cannula (420), and second cannula (425) [see ¶[0061]], Hufnagel does not explicitly teach the following emphasized claim limitations:
… the suction tube is offset from the electrode tip in a radial direction with respect to an axis of the electrode tip.
Shvetsov further teaches that it was known in the art to position the electrode tip and vacuum tube [suction tube] relative to one another in numerous different arrangements including, e.g.:
positioning the electrode tip separate from, and above, the vacuum tube [see FIG. 1],
positioning the electrode tip separate from, and below, the vacuum tube [see FIG. 5], and
positioning the electrode tip within the vacuum tube [see FIG. 7], similar to the arrangement depicted in FIGS. 8A-8C of Hufnagel.
Additionally, when disposed within the vacuum tube, Shvetsov teaches that the electrode tip may be disposed in the center of the vacuum tube, or offset from the center [see ¶[0045] (“Turning to FIG. 8, the electrode 411 is received in a socket 440 that is supported inside the vacuum tube 416. As shown, the electrode 411 is disposed in the center of the vacuum tube 416. Other configurations with the electrode 411 inside the vacuum tube 416 but offset from the center may also be suitable for some applications”)]. In such a configuration, it is noted that the vacuum tube would be offset from the electrode tip in a radial direction with respect to an axis [e.g., a longitudinal axis] of the electrode tip [radially offset in an eccentric configuration, wherein the center point of the electrode tip is shifted away from the center point of the vacuum tube, despite the fact that they are coaxial & parallel].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Hufnagel and Shvetsov such that the suction tube and electrode tip be positioned relative to one another in any number of well-known, art-recognized configurations including, e.g., one wherein the electrode tip in Hufnagel remains within the suction tube, but the suction tube is offset from the electrode tip in a radial direction with respect to an axis of the electrode tip, as taught by Shvetsov, since such a modification merely constitutes a rearrangement (repositioning) of parts, which has been found to be an example of a common practice which the court has held normally requires only ordinary skill in the art, and is hence considered to be a routine expedient. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); & In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
In the instant case, keeping the electrode tip of Hufnagel disposed within the suction tube (420)/(425), but merely shifting its position up or down such that suction tube and electrode tip are radially offset, would not modify operation of the device, as the suction tube would still operate normally to remove surgical smoke (and other debris) from the treatment site.
33. Claims 5 & 6 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hufnagel and Shvetsov, as applied to claim 1 above, and further in view of U.S. Patent No. 5,830,214 to Flom et al. ("Flom").
34. Regarding claim 5, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Hufnagel and Shvetsov does not, however, teach:
wherein the suction tube comprises a valve configured to modulate a suction force by an operator covering the valve, either partially or fully, thereby controlling a vacuum level within the suction tube.
Flom, in a similar field of endeavor, teaches an electrosurgical device and method for cauterizing tissue and evacuating fluid from the surgical site [Abstract]. More particularly, Flom teaches an electrosurgical device (2) coupled to a source of electrical energy such as a radio frequency generator (40) [col. 6, ll. 9-12], as well as a vacuum (50) source by a suction line (52) [col. 6, ll. 26-28; FIG. 4].
Flom teaches that device handle (26) may comprise a sliding vent [broadly, a valve (in that it is used to modulate air flow) that can be manipulated by a finger covering part of the vent when it is manipulated/actuated] in communication with lumen (14) of shaft (4) to allow for selectable diversion of the vacuum outside of the lumen [see col. 6, ll. 43-52 (“For example, a sliding vent on handle 26 in communication with lumen 14 would allow selectable diversion of the vacuum outside of lumen 14 to vary the strength of vacuum exerted through lumen 14. An electronic, slidable or rotatable valve on handle 26, suction line 52, or vacuum source 50 may also be used”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Hufnagel and Shvetsov such that the suction tube comprises a valve configured to modulate a suction force by an operator covering the valve, either partially or fully, thereby controlling a vacuum level within the suction tube, since such a modification would provide the benefit/advantage of providing a practitioner with the ability to directly control and conveniently vary the strength of the vacuum as needed during a procedure based on the operating conditions, so as to ensure that visibility remains relatively unobstructed, thereby facilitating the overall procedure for the practitioner [Flom, col. 6, ll. 42-47].
35. Regarding claim 6, the combination of Hufnagel, Shvetsov, & Flom teaches all of the limitations of claim 5 for the reasons set forth in detail (above) in the Office Action.
The combination of Hufnagel & Shvetsov was modified above (in the rejection of claim 5) to include the vent of Flom. Flom further teaches wherein the housing unit comprises a window that provides access to the valve of the suction tube for suction force modulation [broadly, the opening/cut-out in handle (26) in which the sliding vent is placed].
36. Claims 9 & 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hufnagel and Shvetsov, and further in view of U.S. Patent Application Publication No. 2016/0135868 to Joseph et al. (“Joseph”).
37. Regarding claim 9, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
The combination of Hufnagel and Shvetsov does not, however, teach:
wherein the housing unit comprises a solenoid subassembly, configured to move the sliding apparatus and the electrode tip between the retracted and extended positions.
Joseph, in a similar field of endeavor, teaches a surgical instrument comprising a housing [FIGS. 3-4], a sleeve (210) extending distally therefrom, and an energizable member (220) having an electrically conductive tip (224) that extends through sleeve (210), and distally therefrom [¶[0046]; FIGS. 3-4].
With reference to FIGS. 3-4, Joseph teaches the use of a solenoid subassembly [broadly comprising, inter alia, electromagnet (82), actuator (84) coupled to energizable member (220), and biasing member (spring) (88) - see ¶’s [0051], [0052]] to axially translate energizable member [(220/224)] between a storage (or proximal) position [FIGS. 2B, 3] and a deployed (or distal position) [FIGS. 2D, 4] [see ¶’s [0051]-[0054]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Hufnagel and Shvetsov such that the housing unit comprises a solenoid subassembly, configured to move the sliding apparatus and the electrode tip between the retracted and extended positions, since such a particular known electrode actuation technique was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Joseph, and one of ordinary skill in the art would have been capable of applying this known actuation technique to the known device (of Hufnagel/Shvetsov), and the results [extending and retracting the sliding apparatus/electrode tip of Hufnagel/Shvetsov] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
38. Regarding claim 13, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Hufnagel was modified above (in the rejection of claim 1) to include the cutting and coagulating waveforms, activated via respective buttons, of Shvetsov.
The combination of Hufnagel and Shvetsov does not, however, teach the following emphasized claim limitations concerning the effectuation of a sliding apparatus to extend the electrode tip (for cutting):
the housing unit comprises contains a cut button that when depressed produces the electrical current to generate a force against a spring to move a sliding apparatus and the electrode tip to the extended position; and
when the sliding apparatus moves to the extended position, an electrical contact is made to produce the electrical current in a fist [first] specific waveform, activating the electrode tip and enabling it to cut tissue.
Joseph, in a similar field of endeavor, teaches a surgical instrument comprising a housing [FIGS. 3-4], a sleeve (210) extending distally therefrom, and an energizable member (220) having an electrically conductive tip (224) that extends through sleeve (210), and distally therefrom [¶[0046]; FIGS. 3-4].
With reference to FIGS. 3-4, Joseph teaches the use of a solenoid subassembly [broadly comprising, inter alia, electromagnet (82), actuator (84) coupled to energizable member (220), and biasing member (spring) (88) - see ¶’s [0051], [0052]] to axially translate energizable member [(220/224)] between a storage (or proximal) position [FIGS. 2B, 3] and a deployed (or distal position) [FIGS. 2D, 4] [see ¶’s [0051]-[0054]].
Jospeh further teaches the use of an activation switch to generate current to activate the deployment assembly (80), as well as distal and proximal switches that respectively activate/deactivate a circuit to provide energy, so that as the actuator (84) moves distally to extend the energizable member, the energy delivery circuit is activated (switch “On”) enabling the delivery of energy to energizable member (220), while proximal movement (retraction) deactivates the energy delivery circuit (switch “Off”) [see ¶’s [0053] & [0056]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Hufnagel and Shvetsov to implement the solenoid subassembly of Joseph for effectuating movement of the electrode tip, such that the cut button of Hufnagel/Shvetsov, when depressed, produces the electrical current to generate a force against a spring to move a sliding apparatus and the electrode tip to the extended position, and when the sliding apparatus moves to the extended position, an electrical contact is made to produce the electrical current in a fist [first] specific waveform, activating the electrode tip and enabling it to cut tissue, since such a particular known electrode actuation & activation technique was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Joseph, and one of ordinary skill in the art would have been capable of applying this known electrode actuation & activation technique to the known device (of Hufnagel/Shvetsov), and the results [extending and retracting the sliding apparatus/electrode tip of Hufnagel/Shvetsov, and activating the cutting waveform] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
39. Regarding claim 14, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Hufnagel was modified above (in the rejection of claim 1) to include the cutting and coagulating waveforms, activated via respective buttons, of Shvetsov.
The combination of Hufnagel and Shvetsov does not, however, teach the following emphasized claim limitations concerning the effectuation of a sliding apparatus to extend the electrode tip (for coagulation):
the housing unit comprises a coagulate button that when depressed produces the electrical current to generate a force against a spring of a solenoid assembly to move the sliding apparatus and the electrode tip to the extended position; and
when the sliding apparatus moves to the extended position, an electrical contact is made to produce the electrical current in a second waveform, activating the electrode tip and enabling it to coagulate tissue.
Joseph, in a similar field of endeavor, teaches a surgical instrument comprising a housing [FIGS. 3-4], a sleeve (210) extending distally therefrom, and an energizable member (220) having an electrically conductive tip (224) that extends through sleeve (210), and distally therefrom [¶[0046]; FIGS. 3-4].
With reference to FIGS. 3-4, Joseph teaches the use of a solenoid subassembly [broadly comprising, inter alia, electromagnet (82), actuator (84) coupled to energizable member (220), and biasing member (spring) (88) - see ¶’s [0051], [0052]] to axially translate energizable member [(220/224)] between a storage (or proximal) position [FIGS. 2B, 3] and a deployed (or distal position) [FIGS. 2D, 4] [see ¶’s [0051]-[0054]].
Jospeh further teaches the use of an activation switch to generate current to activate the deployment assembly (80), as well as distal and proximal switches that respectively activate/deactivate a circuit to provide energy, so that as the actuator (84) moves distally to extend the energizable member, the energy delivery circuit is activated (switch “On”) enabling the delivery of energy to energizable member (220), while proximal movement (retraction) deactivates the energy delivery circuit (switch “Off”) [see ¶’s [0053] & [0056]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Hufnagel and Shvetsov to implement the solenoid subassembly of Joseph for effectuating movement of the electrode tip, such that the cut button of Hufnagel/Shvetsov, when depressed, produces the electrical current to generate a force against a spring to move a sliding apparatus and the electrode tip to the extended position, and when the sliding apparatus moves to the extended position, an electrical contact is made to produce the electrical current in a second waveform, activating the electrode tip and enabling it to coagulate tissue, since such a particular known electrode actuation & activation technique was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Joseph, and one of ordinary skill in the art would have been capable of applying this known electrode actuation & activation technique to the known device (of Hufnagel/Shvetsov), and the results [extending and retracting the sliding apparatus/electrode tip of Hufnagel/Shvetsov, and activating the coagulating waveform] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
40. Regarding claim 15, the combination of Hufnagel, Shvetsov, & Joseph teaches all of the limitations of claim 14 for the reasons set forth in detail (above) in the Office Action.
The combination of Hufnagel and Shvetsov was modified above (in the rejection of claim 14) to include the solenoid subassembly of Joseph for effectuating movement of the electrode tip. As such, the combination of Hufnagel, Shvetsov, & Joseph further teaches that when pressure on the coagulate button is released, the spring of the solenoid subassembly exerts a force to move the sliding apparatus and the electrode tip into the retracted position, and when the sliding apparatus moves to the retracted position, electrical contact is lost and the electrode tip is deactivated [again, proximal movement (retraction) deactivates the energy delivery circuit (switch “Off”) [see Joseph, ¶’s [0053] & [0056]].
41. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hufnagel and Shvetsov, as applied to claim 18 above, and further in view of U.S. Patent Application Publication No. 2009/0062791 to Lee et al. (“Lee”).
42. Regarding claim 19, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 18 for the reasons set forth in detail (above) in the Office Action.
The combination of Hufnagel and Shvetsov does not, however, teach:
wherein in the locked, extended position, when the cut button or the coagulate button is released, the electrode tip is deactivated and the sliding apparatus and electrode tip remain in the locked, extended position.
Lee, in a similar field of endeavor, teaches an electrosurgical pencil that includes an adjustable-length suction tube [e.g., Abstract], and further teaches that the electrosurgical pencil (20) receives electrical power from a conventional electrosurgical generator (22) or power source, and that RF current can be used to create an electrosurgical cutting or coagulation effect on tissue via activation of respective cut and coagulation switch buttons (38, 40) [see ¶[0034] (“The characteristics of the waveforms of RF current create an electrosurgical cutting or coagulation effect on the tissue. The characteristics of the waveform of RF current are selected at the electrosurgical generator 22, and the delivery of the RF waveform is controlled by depressing cut and coagulation switch buttons 38 and 40 on the housing 26 of the pencil 20”)].
Lee further teaches that the Cut/Coagulate buttons comprise dome switches (Lee, e.g., ¶‘s [0039] & [0040]) that when depressed, create a circuit to transmit energy [see ¶[0040] (“When the button 38 is depressed, force is transmitted through the sleeve 64 to the dome switch 60, causing the dome switch 60 to deflect and create an electrical contact between circuit traces on the printed circuit board 58. Similarly, depressing the button 40 causes the dome switch 62 to create an electrical circuit”)]. Those skilled in the art will readily appreciate and understand that dome switches comprise “momentary switches,” i.e., wherein depressing a button completes the circuit, and releasing the button breaks the circuit.
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Hufnagel and Shvetsov such that the cut & coagulate buttons comprise dome switches, since such a particular, known activation button/switch arrangement was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Joseph, and one of ordinary skill in the art would have been capable of applying this known actuation activation button/switch arrangement to the known device (of Hufnagel/Shvetsov), and the results [activating and deactivating the cut and coagulation functions] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
As modified, when the dome switch associated with its respective cut button or coagulate button is released, the electrode tip will be deactivated [again, as noted above, this is a known/understood feature of dome switches, which comprise “momentary switches”]. The sliding apparatus and electrode tip will remain in the locked, extended position, as the dome switches of Hufnagel, Shvetsov, & Lee operate independently of the slide control of Hufnagel that effects movement of the electrode tip [Hufnagel, ¶[0044]].
43. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hufnagel and Shvetsov, as applied to claim 1 above, and further in view of U.S. RE42,959 to Saadat et al. ("Saadat").
44. Regarding claim 21, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Hufnagel and Shvetsov does not, however, teach:
wherein the housing unit includes a piston, moveable by a pneumatic force, configured to move a sliding apparatus and the electrode tip between the retracted position and the extended position.
Saadat, in a similar field of endeavor, teaches that it was known to utilize a pneumatic piston to extend and retract an end effector [including an energizable RF electrode] beyond the distal end of a lumen [col. 4, ll. 37-38, & 61-67].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Hufnagel and Shvetsov such that the housing unit includes a piston, moveable by a pneumatic force, configured to move a sliding apparatus and the electrode tip between the retracted position and the extended position, since such a particular, known actuation technique [for deploying/retracting an electrode] was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Saadat, and one of ordinary skill in the art would have been capable of applying this known actuation technique to the known device (of Hufnagel/Shvetsov), and the results [extending and retracting the sliding apparatus/electrode tip of Hufnagel/Shvetsov] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
45. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hufnagel and Shvetsov, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2009/0024125 to Docimo ("Docimo").
46. Regarding claim 22, the combination of Hufnagel and Shvetsov teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Hufnagel and Shvetsov does not, however, teach:
wherein the housing unit includes an electric motor configured to move a sliding apparatus and the electrode tip between the retracted position and the extended position.
Docimo, in a similar field of endeavor, teaches a needle-tipped electrocautery stylus that utilizes a motor to drive/extend the needle beyond the device sheath [see, e.g., ¶[0020] (“In other implementations, the retraction of the sheath or extension of the needle tip could be accomplished electronically by a motor 220 housed within the electrocautery device 200 as shown schematically in FIG. 2… In the embodiment shown in FIG. 2, the motor 220 drives the electrocautery needle 216 from the device 200 beyond the sheath 214. In alternative embodiments, the sheath may be similarly retracted, thereby exposing the needle. One of skill in the art will recognize many motors or motorized components that could be used within the context of the present invention. Examples include linear actuators, solenoids, piezo-driven motors, worm gears, or other common DC motors”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Hufnagel and Shvetsov such that the housing unit includes an electric motor configured to move a sliding apparatus and the electrode tip between the retracted position and the extended position, since such a particular, known actuation technique [for deploying/retracting an electrode] was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Docimo, and one of ordinary skill in the art would have been capable of applying this known actuation technique to the known device (of Hufnagel/Shvetsov), and the results [extending and retracting the sliding apparatus/electrode tip of Hufnagel/Shvetsoz] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
47. Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hufnagel and Shvetsov, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2010/0036374 to Ward ("Ward").
48. Regarding claim 23, the combination of Hufnagel and Shvetsov teaches a method of utilizing the electrosurgical device of claim 1 [see the rejection of claim 1 above which is incorporated herein], the method comprising:
removing the suction tube from the housing unit [Hufnagel, ¶[0061]].
While Hufnagel further teaches tissue dissection via the electrode tip in the extended position [Hufnagel, e.g., Abstract, ¶[0007]], as well as smoke evacuation [e.g., ¶’s [0005], [0047], [0048]] or suction [e.g., ¶’s [0005], [0037]] via the suction tube, the combination of Hufnagel and Shvetsov does not explicitly teach that such operations are performed independently when the suction tube has been removed from the housing unit.
As such, the combination of Hufnagel and Shvetsov does not teach the following emphasized claim limitations:
removing the suction tube from the housing unit to perform independent operations of the electrosurgical device, wherein the independent operations comprise:
tissue dissection via the electrode tip in the extended position; and
smoke evacuation or suction via the suction tube.
However, use of an electrode and suction tube, independent of one another, during an electrosurgical procedure was well known in the art, before the effective filing date of the claimed invention.
As one example, Ward, in a similar field of endeavor, teaches an electrosurgical system including an evacuator apparatus that evacuates aerosol and smoke generated during application of electrosurgical energy [Abstract].
More particularly, Ward teaches an electrosurgical instrument (104) that may comprise any type of electrosurgical instrument (e.g., monopolar or bipolar) and may include active electrodes designed for a wide variety of electrosurgical procedures (e.g., electrosurgical cutting, ablation, etc.) [see ¶[0025]]. Ward further teaches an evacuator apparatus (302) comprising a hose (304) [suction tube] connected to a pump (306) for removing air with aerosol or smoke generated during an electrosurgical procedure [see ¶[0034]]. The electrosurgical instrument (104) and hose (304) [suction tube] are useable and positionable independent of one another during a procedure [see, e.g., FIG. 3].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Hufnagel and Shvetsov such that the electrode tip and suction tube be used independently when the suction tube has been removed from the housing unit or, more particularly, wherein the method includes removing the suction tube from the housing unit to perform independent operations of the electrosurgical device, wherein the independent operations comprise: tissue dissection via the electrode tip in the extended position; and smoke evacuation or suction via the suction tube, since such a modification would provide the benefit/advantage of allowing for greater flexibility and maneuverability in the positioning of the suction tube relative to the electrode tip during a procedure (e.g., at different angles and distances from one another) to efficiently remove smoke and other gases from the operating environment.
49. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hufnagel and Lee, and further in view of Joseph.
50. Regarding claim 11, Hufnagel teaches an electrosurgical device with integrated smoke evacuation and suction, the electrosurgical device comprising:
an assembled unit [instrument (400) - ¶[0053]; FIGS. 8A-8C] connected to an external generator [electrosurgical generator - ¶’s [0012], [0013]; see also electrosurgical generator (140) - FIG. 1] …;
an electrode tip [electrode (435) - ¶[0053]; FIGS. 8A-8C] disposed within the assembled unit [within instrument (400) - ¶[0053]; FIGS. 8A-8C], which is supported and configured for translation such that the electrode tip [(435)] is configured to transition from a retracted position to an extended position, relative to the assembled unit [relative to the housing (415) of instrument (400) - see ¶[0053] (“…an electrode 435 coaxially disposed within the first and second cannulas 420, 425 and selectively extendable from a distal end of the housing 415”), & ¶’s [0058]-[0060]];
the assembled unit [(400)] comprises a housing unit [housing (415) - ¶[0053]; FIGS. 8A-8C] comprising a channel [interior or inner surface of housing (415) that receives first cannula (420) - ¶’s [0053], [0056]; FIGS. 8A-8C] for a smoke evacuation suction tube [comprising first cannula (420) & second cannula (425) - see ¶’s [0053]-[0056] and [0061] (“In addition, electrode 435 may be replaceable to enable electrodes of differing lengths and profiles to be utilized, and first cannula 420 and/or second cannula 425 may be replaceable to enable use of aspiration tubes of differing lengths and/or diameter, having one or more pre-aspiration ports, having an elastomeric or rigid aspiration tip, and so forth”)] with a suction tip [the distal end of second cannula (425) - ¶’s [0053]-[0057]], which suction tube [(420)/(425)] is fixed and locked into place [¶’s [0056]-[0057] with a connection to an external vacuum source [to vacuum source - ¶[0054]; see also vacuum (150) - FIG. 1], and which suction tube [(420)/(425)] is insertable and interchangeable with respect to the channel of the housing unit [(415)] [see ¶[0061] (“In addition… first cannula 420 and/or second cannula 425 may be replaceable to enable use of aspiration tubes of differing lengths and/or diameter, having one or more pre-aspiration ports, having an elastomeric or rigid aspiration tip, and so forth”)].
A. Cutting & Coagulation Functionality & Buttons
While Hufnagel teaches the use of electrosurgical energy [¶’s [0010], [0054]], along with a push-button [electrosurgical actuator (430) - ¶[0054]; FIGS. 8A-8C] for controlling electrosurgical energy, as well as the ability to vary a property of the delivered electrosurgical energy [¶[0054]], Hufnagel does not teach the following emphasized claim limitations:
an assembled unit connected to an external generator that produces electrical currents in at least one waveform for cutting and coagulating tissue, which electrical currents are activated via two respective buttons.
However, the use of an electrosurgical device for cutting and coagulation, activated via respective buttons, was well known in the art, before the effective filing date of the claimed invention.
As one example, Lee in a similar field of endeavor, teaches an electrosurgical pencil that includes an adjustable-length suction tube [e.g., Abstract], and further teaches that the electrosurgical pencil (20) receives electrical power from a conventional electrosurgical generator (22) or power source, and that RF current can be used to create an electrosurgical cutting or coagulation effect on tissue via activation of respective cut and coagulation switch buttons (38, 40) [see ¶[0034] (“The characteristics of the waveforms of RF current create an electrosurgical cutting or coagulation effect on the tissue. The characteristics of the waveform of RF current are selected at the electrosurgical generator 22, and the delivery of the RF waveform is controlled by depressing cut and coagulation switch buttons 38 and 40 on the housing 26 of the pencil 20”)].
Given that Hufnagel already contemplates the ability to vary a property of the delivered electrosurgical energy [¶[0054]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Hufnagel such that the generator be configured to produce electrical currents in at least one waveform for cutting and coagulating tissue, which electrical currents are activated via two respective buttons, since such a modification would provide the benefit/advantage of enabling a practitioner to perform different electrosurgical operations (i.e., cutting and coagulation) on target tissue during a surgical procedure without having to switch instruments, thereby facilitating (and increasing the overall efficiency of) the surgical procedure.
B. Solenoid Subassembly
The combination of Hufnagel and Lee does not, however, teach:
wherein a solenoid subassembly disposed within the housing unit is connected to a sliding apparatus which exerts a spring force to maintain the sliding apparatus and the inserted electrode tip in the retracted position.
Joseph, in a similar field of endeavor, teaches a surgical instrument comprising a housing [FIGS. 3-4], a sleeve (210) extending distally therefrom, and an energizable member (220) having an electrically conductive tip (224) that extends through sleeve (210), and distally therefrom [¶[0046]; FIGS. 3-4].
With reference to FIGS. 3-4, Joseph teaches the use of a solenoid subassembly [broadly comprising, inter alia, electromagnet (82), actuator (84) coupled to energizable member (220), and biasing member (spring) (88) [see ¶’s [0051], [0052]] to axially translate energizable member [(220/224)] between a storage (or proximal) position [FIGS. 2B, 3] and a deployed (or distal position) [FIGS. 2D, 4] [see ¶’s [0051]-[0054] (“Biasing member 88 is configured to bias electromagnet 82 apart from actuator 84. Thus, in order for actuator 84 to translate towards electromagnet 82, the magnetic field produced around at least a portion of electromagnet 82 has to be such that it overcomes the spring force of biasing member 88. On the other hand, when the magnetic field is insufficient to overcome the spring force of biasing member 88, e.g., when the magnetic field is removed, actuator 84 is urged proximally by the bias of biasing member 88 to its initial position relative to electromagnet 82 (see FIG. 3). Return of actuator 84 proximally from the distal position (FIG. 4) to the proximal position (FIG. 3) transitions monopolar assembly 200 from the deployed position (FIG. 2D) back to the storage position (FIGS. 2A and 2B)”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Hufnagel and Lee such that a solenoid subassembly disposed within the housing unit is connected to a sliding apparatus which exerts a spring force to maintain the sliding apparatus and the inserted electrode tip in the retracted position, since such a particular known actuation technique [for deploying/retracting an electrode] was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Joseph, and one of ordinary skill in the art would have been capable of applying this known actuation technique to the known device (of Hufnagel/Lee), and the results [extending and retracting the sliding apparatus/electrode tip of Hufnagel/Lee] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Response to Arguments
51. As noted above, the 12/22/25 Amendment has overcome the claim objections, and the rejections under §§ 112(b) & 103 previously set forth in the 10/01/25 Action, with the exception of those that have been reiterated herein.
52. New claim objections, and new rejections under §§ 112(b) & 103 are set forth herein, necessitated by Applicant’s Amendment.
53. Independent Claims 1 & 24
54. In the 12/22/25 Amendment, independent claims 1 and 24 were each amended to include the new limitation “the suction tube is offset from the electrode tip in a radial direction with respect to an axis of the electrode tip.” New grounds of rejection under § 103 based on the combination of Hufnagel and Shvetsov are set forth in detail herein, addressing this new limitation.
55. Independent Claim 11
56. In the 12/22/25 Amendment, claim 11 was rewritten in independent form to include substantially similar limitations as amended claim 1. In arguing the propriety of the rejection of claim 11 under § 103 based on the combination of Hufnagel, Lee, and Joseph, Applicant first provides an initial overview of the invention:
The present application discloses an electrosurgical instrument that integrates a solenoid-driven smoke evacuation control subassembly within the handpiece. In an embodiment, pressing a control button on the instrument causes an electrical circuit to energize a solenoid coil, which in turn mechanically moves a valve or suction tube. This movement either opens a suction pathway or extends a suction tube to evacuate smoke, and reverses (closes/retracts) when de-energized. As such, the instrument provides on-demand, electrically actuated smoke/suction control, synchronized with the electrosurgical operation.
12/22/25 Amendment, pg. 13, emphasis added.
While Applicant’s foregoing remarks focus on the movement of the suction tube, Examiner notes that independent claim 11 clearly focuses on movement of the electrode tip. For example, claim 11 includes the following limitations directed to translation of the electrode tip:
an electrode tip disposed within the assembled unit, which is supported and configured for translation such that the electrode tip is configured to transition from a retracted position to an extended position, relative to the assembled unit; and
***
wherein a solenoid subassembly disposed within the housing unit is connected to a sliding apparatus which exerts a spring force to maintain the sliding apparatus and the electrode tip in the retracted position.
Amended claim 11, emphasis added.
When addressing the relied-upon references, Applicant again focuses on alleged deficiencies concerning movement/control of the suction tube, rather than the claimed movement of the electrode tip. As an example, with regard to Hufnagel, Applicant argues:
Hufnagel discloses an electrosurgical dissection instrument with a telescoping suction/aspiration cannula for removing smoke/fluid. The instrument includes a housing, a vacuum source connection, an electrode, and manually adjustable cannulas. Hufnagel mentions a "vacuum actuator" on the instrument housing to activate an external vacuum source, as well as a "cannula slide control" to manually move the suction cannula in and out. In other words, the operator can slide the suction tube and presumably press a switch to turn suction on, but all adjustments are manual and no specific internal actuation mechanism is described. There is no disclosure of any solenoid or powered actuator controlling the cannula motion or valve in Hufnagel.
The claimed solenoid subassembly is absent from Hufnagel's device. In Hufnagel, the suction tube's position is changed by the user via a mechanical slider on the handle (a purely manual operation), whereas in the Applicant's invention the suction tube or valve is actuated by an electromagnetically driven plunger.
It would not have been obvious to modify Hufnagel's device to include the claimed solenoid subassembly. Hufnagel gives no indication that the manual slide and switch are deficient or could be improved by automation. On the contrary, a person of ordinary skill reading Hufnagel would understand that the suction control is meant to be achieved through simple manual means. Incorporating a solenoid would require significant redesign with no hint or motivation in Hufnagel to do so. Therefore, Hufnagel et al. fails to render the solenoid-actuated invention obvious, even when combined with other references.
12/22/25 Amendment, pgs. 14-15, emphasis added.
These arguments are not persuasive, as they fail to address the claimed invention. Nowhere does claim 11 recite that motion of the “suction tube” is controlled by a solenoid or other powered actuator. Rather, as noted above, claim 11 focuses on translation of the electrode tip.
57. In the Remarks, Applicant presents additional arguments questioning the modification of Hufnagel to include the actuator assembly of Joseph:
Specifically, referring to the Figures of both Hufnagel and Joseph, Applicant questions how a person having ordinary skill in the art would find it obvious to take the entire powered deployment assembly (80) and integrate that into the housings disclosed in Hufnagel. Specifically, Joseph discloses a gun-shaped housing with a handle and trigger that is presumably about the size of a person's hand. In contrast, each of the housings in Hufnagel are generally the shape and size of an ordinary pencil, pen, or marker.
Again, Applicant questions how a person having ordinary skill in the art would find it obvious to take the entire powered deployment assembly (80) and integrate that into the housings disclosed in Hufnagel. The powered deployment assembly (80) of Joseph is significantly larger than the housings in Hufnagel, and Applicant submits that it would be nearly, if not completely, impossible to integrate the powered deployment assembly (80) of Joseph in the housings in Hufnagel. As such, Applicant respectfully disagrees and Applicant submits that it would not be obvious to combine Hufnagel with Joseph to realize the claimed electrosurgical device with the solenoid subassembly required by the present application.
12/22/25 Amendment, pgs. 16-17, emphasis added.
This argument is likewise not persuasive. As established in the body of the rejection, Joseph teaches a powered deployment assembly, recognized in the electrosurgical art, for selectively extending/retracting an energizable member (including an electrically-conductive tip) relative to a housing. Applicant’s argument concerns the “size” of the assembly taught by Joseph. As an initial matter, while Joseph may teach “a gun-shaped housing with a handle and trigger that is presumably about the size of a person's hand” (as Applicant recites above), the powered deployment assembly of (80) of Joseph clearly does not occupy the entirety of the housing interior, as is plainly evident in, e.g., FIGS. 3-4 of Joseph.
Regardless, Examiner notes that merely adjusting the size of the deployment assembly to fit within the space of a given housing of an electrosurgical device that similarly utilizes a deployable electrode tip (in this case, scaling down the size of the assembly) would have been an exercise of ordinary creativity employed by a skilled artisan. It is noted that "[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). Office personnel may… take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. Joseph arguably echoes this sentiment when describing how different considerations would apply when contemplating use with different devices [see Joseph, e.g., ¶[0040] (“Although the present disclosure is shown and described with respect to the forceps 10, the aspects and features of the present disclosure are equally applicable for use with any suitable surgical instrument or portion(s) thereof. Obviously, different connections and considerations apply to each particular instrument and the assemblies and/or components thereof; however, the aspects and features of the present disclosure remain generally consistent regardless of the particular instrument, assemblies, and/or components provided”)].
Further, Applicant’s contention that “it would be nearly, if not completely, impossible to integrate the powered deployment assembly (80) of Joseph in the housings in Hufnagel” amounts merely to an unsupported, conclusory assertion. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.”).
There is no evidence of record establishing that scaling down the size of the solenoid assembly of Joseph would have been “nearly, if not completely, impossible” as Applicant alleges. In fact, one of the references of record, Docimo (which is relied upon elsewhere herein), teaches a needle-tipped electrocautery device, in the shape of a stylus [Abstract], that discloses the use of motorized components to extend and retract the needle tip [see Docimo, e.g., ¶[0020] (“In other implementations, the retraction of the sheath or extension of the needle tip could be accomplished electronically by a motor 220 housed within the electrocautery device 200 as shown schematically in FIG. 2…. One of skill in the art will recognize many motors or motorized components that could be used within the context of the present invention. Examples include linear actuators, solenoids, piezo-driven motors, worm gears, or other common DC motors.”)]. As such, the use of such components sized to be disposed within the housing of a hand-held electrosurgical stylus were known and appreciated in the art, contrary to Applicant’s assertions.
For each of the foregoing reasons, the rejection of claim 11 under § 103 based on the combination of Hufnagel, Lee, and Jospeh has been maintained.
Conclusion
58. 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 extension fee 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 date of this final action.
59. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
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/Bradford C. Blaise/Examiner, Art Unit 3794