DETAILED ACTION
Applicant's amendments and remarks, filed 11/21/25, are fully acknowledged by the Examiner. Currently, claims 1, 4, 6, 8-13, 15-19, and 21-26 are pending with claim 14 canceled, claim 26 added, and claims 1, 15, 24, and 25 amended. The following is a complete response to the 11/21/25 communication.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 13, 19, and 23-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krom (US 9,138,284).
Regarding claim 1, Krom teaches an end effector, comprising: a wrist (54) having a distal clevis (distal clevis proximal to jaw members as in fig. 10) rotatably coupled to a proximal clevis (proximal clevis 531); a shaft coupled to the proximal clevis (shaft 53 coupled to proximal clevis 531); one or more jaw members rotatably mounted to the distal clevis (jaw members as in col. 9, lines 53-60); a protective sleeve extendable over portions of the wrist and the shaft or the shaft adapter (base cover 3 over the wrist and shaft 53 as in Fig. 10) and providing a cylindrical body having a distal end and a proximal end (proximal end 32 and distal end 31); forming an interference fit with an outer surface of the portion of the shaft (inner surface of 3 can be smooth as in col. 20, lines 22-27 and mates with seals 52 of the opposing outer surface of the shaft portion, as in Fig. 10), wherein the protective sleeve provides: a first section made of a first material with a first coefficient of elasticity and a second section made of a second material with a second coefficient of elasticity less than the first coefficient of elasticity (second section 3, labeled 32 in Fig. 3b, and first, thinner portion of section 3, labeled 31 in Fig. 3b, is more elastic than 32); and a third section made of a third material different from the first and second materials with a third coefficient of elasticity that is different than the first and second coefficients of elasticity (section 2 with a different material as in col. 13, lines 22-29 with a silicone having different material properties than sections 31 and 32); anda positive indicator discernible during use of the end effector that the protective sleeve has moved from an assembled position to a migrated position (signage at 5321 as in Fig. 10, if visible, would be an indicator that the protective sleeve has moved to a migrated position), wherein the shaft defines a radial shoulder (5321) and the proximal end engages the radial shoulder when the protective sleeve is in the assembled position (proximal end 323 contacts 5321 when attached as in col. 20, lines 9-11), wherein, when the protective sleeve is in the assemble position, the one or more jaw members protrude through an aperture defined in the cylindrical body at the distal end (aperture 6 where the jaws protrude as in Figs. 7b),
the first section is radially aligned with the wrist (Fig. 11, 2 aligned with the wrist 54); and the second section is in contact with the radial shoulder (3 in contact with 5321 as in Figs. 10-11).
Regarding claim 4, Krom teaches wherein the positive indicator comprises a pattern, provided on the shaft adjacent to the radial shoulder that becomes exposed when the protective sleeve moves to the migrated position (signage at 5321 is a pattern).
Regarding claim 13, Krom teaches wherein the positive indicator comprises an over-assembled indicator provided on the shaft and is occluded when the protective sleeve moves proximally to the migrated position (signage on shaft 53 is occluded when 3 is moved proximally over the shaft), the over-assembled indicator being a pattern (signage on shaft 53).
Regarding claim 19, Krom teaches the method further comprising ensuring that the protective sleeve is in the assembled position based on an inability to perceive or detect the positive indicator (signage at 5321, if the signage is not detected then 1 has moved over the shaft 53).
Regarding claim 23, Krom teaches wherein the first section has a first diameter and the second section has a second diameter greater than the first diameter (2 and 3 have different diameters such that the diameter of 2 at the distal tip is less than the diameter of 3 at the proximal end).
Regarding claim 24, Krom teaches where the protective sleeve further provides a third section made of a third material with a third coefficient of elasticity less than the first coefficient of elasticity and greater than the second coefficient of elasticity (thinner section of 3, labelled 31, is more elastic than 32 but less than 2).
Claims 2 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krom in view of Cox (US 2004/0204701).
Regarding claim 2, Krom is not explicit wherein the positive indicator comprises a color at the
shaft on the radial shoulder that becomes exposed when the protective sleeve moves to the migrated position, but teaches a pattern (signage as in Fig. 10 at radial shoulder 5321, signage on shaft 53 is occluded when 3 is moved proximally over the shaft). Cox teaches an indicator sleeve that has a
contrasting cover with a color of a retention sleeve (par. [0066]) color of 70 contrast with color of 12), allowing for easy visualization. It would have been obvious to one of ordinary skill in the art to modify Krom with the color contrasts between the signage and the sleeve, to easily visually determine when the sleeve is removed.
Regarding claim 11, Krom is silent wherein the positive indicator comprises a reflective covering
provided on the shaft adjacent to the radial shoulder that becomes exposed when the protective sleeve moves to the migrated position.
However, Cox teaches an indicator sleeve that has a contrasting cover with a color of a retention sleeve (par. [0066]) color of 70 contrast with color of 12, color being the light reflected off a surface), allowing for easy visualization.
It would have been obvious to one of ordinary skill in the art to modify Krom with the color contrasts between the signage and the sleeve, to easily visually determine when the sleeve is removed.
Claims 12, 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krom in view of Cox, in further view of Manzo (US 2006/0079884) in view of Benamou (US 2017/0303990).
Regarding claim 12, Krom is silent regarding the reflective surface is capable of being perceived
by a camera, which sends an alert signal upon detection of the reflective covering. Manzo teaches a camera for viewing an instrument as in par. [0030]. It would have been obvious to one of ordinary skill in the art to modify Krom with the camera of Manzo for viewing target area including the instrument.
Benamou teaches alerting a user if a component is out of position during treatment (par. [0049)).
It would have been obvious to one of ordinary skill in the art to modify Krom with the cessation of treatment and alert based on component position as in Benamou, so as to allow for alerting the user if the device is made inoperable.
Regarding claim 15, Krom teaches a method of operating a surgical tool, comprising: positioning
the surgical tool adjacent a patient for operation (using wrist 54), the surgical tool including:
a wrist having a distal clevis rotatably coupled to a proximal clevis (54 with distal clevis proximal to jaw members and proximal clevis 531);
a shaft coupled to the proximal clevis and providing a radial shoulder (shaft 53 coupled to clevis 531 with radial shoulder 5321);
and an end effector having one or more jaw members rotatably mounted to the distal clevis (jaw members as in col. 9, lines 53-60);
insulating the wrist and a portion of the end effector with a protective sleeve (protective sleeve 3 as in Fig. 10), the protective sleeve having opposing distal and proximal ends (31 and 32 opposing each other); the protective sleeve forming an interference fit with an outer surface of the portion of the shaft (inner surface of 3 can be smooth as in col. 20, lines 22- 27 and mates with seals 52 of the opposing outer surface of the shaft portion, as in Fig. 10); and including:a first section made of a first material with a first coefficient of elasticity and a second section made of a second material with a second coefficient of elasticity less than the first coefficient of elasticity (second section 3, labeled 32 in Fig. 3b, and first, thinner portion of section 3, labeled 31 in Fig. 3b, is more elastic than 32); and a third section made of a third material different from the first and second materials with a third coefficient of elasticity that is different than the first and second coefficients of elasticity (section 2 with a different material as in col. 13, lines 22-29 with a silicone having different material properties than sections 31 and 32); andmoving the protective sleeve axially from an assembled position, where the proximal end of the protective sleeve engages the radial shoulder (proximal end 323 contacts 5321 when attached as in col. 20, lines 9-11), to a migrated position (disconnecting the sleeve 1), thereby exposing a positive indicator (signage of 5321 is visible when in the migrated position);
wherein, when the protective sleeve is in the assemble position, the one or more jaw members protrude through an aperture defined in the cylindrical body at the distal end (aperture 6 where the jaws protrude as in Figs. 7b) and the wrist is housed entirely within the protective sleeve (Fig. 10 with wrist member as in Fig. 10).
Krom is silent regarding detecting the positive indicator with a camera; and
autonomously cutting electrical energy to the one or more jaw members based on detecting the indicator.
Manzo teaches a camera for viewing an instrument as in par. [0030]. It would have been obvious to one of ordinary skill in the art to modify Krom with the camera of Manzo for viewing target area including the instrument.
Benamou teaches alerting a user if a component is out of position during treatment (par. [0049)).
It would have been obvious to one of ordinary skill in the art to modify Krom with the cessation of treatment and alert based on component position as in Benamou, so as to allow for alerting the user if the device is made inoperable.
Regarding claim 16, Krom is not explicit wherein the positive indicator comprises a color;
Perceiving the color with a camera; and
sending an alert signal based the camera perceives the color, but Krom teaches a pattern (signage as in Fig. 10 at radial shoulder 5321, signage on shaft 53 is occluded when 3 is moved proximally over the shaft).
Cox teaches an indicator sleeve that has a contrasting cover with a color of a retention sleeve (par. [0066]) color of 70 contrast with color of 12), allowing for easy visualization.
It would have been obvious to one of ordinary skill in the art to modify Krom with the color contrasts between the signage and the sleeve, to easily visually determine when the sleeve is removed.
Manzo teaches a camera for viewing an instrument as in par. [0030]. It would have been obvious to one of ordinary skill in the art to modify Krom with the camera of Manzo for viewing target area including the instrument.
Benamou teaches alerting a user if a component is out of position during treatment (par. [0049)).
It would have been obvious to one of ordinary skill in the art to modify Krom with the cessation of treatment and alert based on component position as in Benamou, so as to allow for alerting the user if the device is made inoperable.
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krom in view of Manzo (US 2006/0079884) in view of Benamou (US 2017/0303990).
Regarding claim 17, Krom teaches wherein the positive indicator comprises a pattern (signage as in Fig. 10 at radial shoulder 5321, signage on shaft 53 is occluded when 3 is moved proximally over the shaft); but is silent regarding perceiving the pattern with the camera; and sending an alert signal based on the camera perceiving the pattern.
Manzo teaches a camera for viewing an instrument as in par. [0030]. It would have been obvious to one of ordinary skill in the art to modify Krom with the camera of Manzo for viewing target area including the instrument.
Benamou teaches alerting a user if a component is out of position during treatment (par. [0049)).
It would have been obvious to one of ordinary skill in the art to modify Krom with the cessation of treatment and alert based on component position as in Benamou, so as to allow for alerting the user if the device is made inoperable.
Claim 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krom in view of Overmyer (US 2015/0272557).
Regarding claim 6, Krom is silent wherein the positive indicator comprises electromagnetic radiation emitted from the shaft that becomes exposed when the protective sleeve moves to the migrated position.
However, Overmyer teaches indicators as light sources (an electromagnetic radiation) to provide visual cues or alert an operator (par. [0144)).
It would have been obvious to one of ordinary skill in the art to modify Krom with the light indicators of Overmyer as the signage, allowing for a visually apparent way of visualizing when the sleeve is removed.
Claims 8-10, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krom in view of Overmyer, in view of Manzo, in view of Benamou.
Regarding claim 8, Krom is silent regarding the electromagnetic radiation.
However, Overmyer teaches visible light via light sources (par. [0144]).
It would have been obvious to one of ordinary skill in the art to modify Krom with the light indicators as the signage as in Overmyer, allowing for a visually apparent way of visualizing when the sleeve is removed.
Regarding claim 9, Krom is silent the electromagnetic radiation.
However, Overmyer teaches a light indicator as an LED (par. [0110)]).
It would have been obvious to one of ordinary skill in the art to modify Krom with the light indicators as LEDs of Overmyer as the signage, allowing for a visually apparent way of visualizing when the sleeve is removed.
Regarding claim 10, Krom is silent regarding the electromagnetic radiation.
However, Overmyer teaches the electromagnetic radiation comprises visible light that flash in a specific frequency (light that displays at a visible frequency).
It would have been obvious to one of ordinary skill in the art to modify Krom with the light indicators of Overmyer as the signage, allowing for a visually apparent way of visualizing when the sleeve is removed.
Manzo teaches a camera for viewing an instrument as in par. [0030]. It would have been obvious to one of ordinary skill in the art to modify Krom with the camera of Manzo for viewing target area including the instrument.
Regarding claim 18, Krom is silent, but Manzo teaches a camera for viewing an instrument as in par. [0030].
It would have been obvious to one of ordinary skill in the art to modify Krom with the camera of Manzo for viewing target area including the instrument.
However, Overmyer teaches visible light via light sources (par. [0144]).
It would have been obvious to one of ordinary skill in the art to modify Krom with the light indicators of Overmyer as the signage, allowing for a visually apparent way of visualizing when the sleeve is removed.
Benamou teaches alerting a user if a component is out of position during treatment (par. [0049)).
It would have been obvious to one of ordinary skill in the art to modify Krom with the cessation of treatment and alert based on component position as in Benamou, so as to allow for alerting the user if the device is made inoperable.
Claims 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krom in view of Weber (US 2012/0209167).
Regarding claim 21, Krom is silent wherein the positive indicator comprises non-visible light emitted from the shaft when the protective sleeve moves to the migrated position.
However, Weber teaches a position indicator to indicate the position of a device, such a non-visible light is emitted (par. [0051] infrared or ultraviolet).
It would have been obvious to one of ordinary skill in the art to modify Krom with the indicator as in Weber, as an alternative way for an indicator to be displayed to the user.
Regarding claim 22, Krom is silent wherein the positive indicator comprises a photoluminescent or phosphorescent material provided on the shaft that become exposed when the protective sleeve moves to the migrated position.
However, Weber teaches a position indicator to indicate the position of a device, such a non-visible light is emitted (par. [0015] phosphorescence as an indication system).
It would have been obvious to one of ordinary skill in the art to modify Krom with the indicator as in Weber, as an alternative way for an indicator to be displayed to the user.
Claims 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krom in view of Masuda US 2012/0101493).
Regarding claim 25, Krom teaches an end effector, comprising:
a wrist having a distal clevis rotatably coupled to a proximal clevis (wrist 54 with distal clevis proximal to jaw members as in Fig 10, and proximal clevis 531);
a shaft coupled to the proximal clevis and defining a radial shoulder (shaft 43 coupled to 531 with radial shoulder 5321);
one or more jaw members rotatably mounted to the distal clevis (jaw member as in col. 9, lines 53-60);a protective sleeve extendable over the wrist and a portion of the shaft and providing a body having opposing distal and proximal ends (3 extends over wrist and has a body with proximal and distal ends as in Fig. 3b), wherein the protective sleeve forms an interference fit with an outer surface of the portion of the shaft (inner surface of 3 can be smooth as in col. 20, lines 22-27 and mates with seals 52 of the opposing outer surface of the shaft portion, as in Fig. 10),
wherein, when the protective sleeve is in the assembled position:
the one or more jaw members protrude through an aperture defined in the body at the distal end (aperture 6 where the jaws protrude as in Figs. 7b).
Krom is not explicit regarding a first contact coupled to the wrist and electrically connected to the one or more jaw members;
a second contact radially offset from the first contact and electrically connected to an electrical conductor;
wherein the protective sleeve comprises a contact strip; andthe contact strip contacts the first and second contacts, thereby allowing current to flow from the electrical conductor to the one or more jaw members; and wherein, when the protective sleeve is in the migrated position, the contact strip is displaced from the first and second contacts, thereby preventing current from flowing from the electrical conductor to the one or more jaw members.
However, Masuda teaches two contacts, with one contact radially offset form the other contact and connected to a conductor (par. [0097] with electrical paths 99f and 99s radially offset). Contact between inner sheath 41i and 99f with conductive section 87 determines use of instrument 21 as in par. [0097].
It would have been obvious to one of ordinary skill in the art to modify Krom with the conductive elements of Masuda, as a way of using electrical contacts to determine when to stop current flow. One of ordinary skill in the art would appreciate that the shorting may also work in reverse, with conductivity ending when conductivity is not detected.
Regarding claim 26, Krom teaches a positive indicator discernible during use of the end effector to indicate when the protective sleeve has moved from an assembled position where the proximal end of the protective sleeve engages the radial shoulder, to a migrated position (signage at 5321 as in Fig. 10, if visible, would be an indicator that the protective sleeve has moved to a migrated position).
Response to Arguments
Applicant’s arguments, see the arguments, filed 11/21/25, with respect to the rejection(s) of claim(s) 1 and 15 and their dependents under 35 USC 102(a)(1) or 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a new interpretation of Krom switching the materials.
Applicant's arguments filed 11/21/25 have been fully considered but they are not persuasive. Applicant argues to claim 25 that Masuda teaches contact that results in short detection and does not teach "the contact strip contacts the first and second contacts, thereby allowing current to flow fr However, given that Masuda teaches disabling or enabling current flow based on electrical communication between the contacts, one of ordinary skill in the art would appreciate that the shorting may also work in reverse, with conductivity ending when conductivity is not detected.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794