DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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.
Response to Amendment
The Response filed March 13, 2026 has been entered. Claims 1, 2, 5, 7, 14, 15, and 21-34 are pending in the application. The previous rejections of claims under 35 U.S.C. 112(b) are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this Office action.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 5, 14, 15, and 22-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton, IV (U.S. Patent Application Publication No. 20120138660; hereinafter “Shelton”).
Regarding claim 1, Shelton discloses a medical device (13200; Fig. 137), comprising:
an end-effector (13212), including a first feature (13224) and a second feature (13222), wherein the first feature and the second feature are pivotably joined to one another (para. [0357]); and
a motor (13360) coupled to a rotatable shaft (13340), wherein the rotatable shaft engages the end-effector (e.g., via connection with rod (13342); Fig. 137; para. [0363]), and wherein the motor is configured to rotate the rotatable shaft in a first direction and a second direction, wherein the second direction is opposite of the first direction (para. [0362]);
wherein a first rotation of the rotatable shaft in the first direction is configured to translate the end-effector proximally to pivot the first feature and the second feature toward one another (para. [0364]), and
wherein a second rotation of the rotatable shaft in the second direction is configured to translate the end-effector distally to pivot the first feature and the second feature away from one another (para. [0364]).
Regarding claim 2, Shelton discloses the device further comprising a connector (13341) coupled to the rotatable shaft, wherein the connector is configured to directly engage the end-effector (Fig. 137; para. [0362]).
Regarding claim 5, Shelton discloses wherein the connector includes
a threaded lumen (13341; para. [0362]),
wherein the end-effector further includes a body (13342) proximal to the first feature and the second feature, wherein the body includes a threaded exterior (para. [0362]),
wherein the threaded lumen of the connector engages the threaded exterior of the body of the end-effector (Fig. 137; para. [0362]), and
wherein the first rotation of the rotatable shaft in the first direction translates the end-effector in a first longitudinal direction, relative to the connector, and wherein second rotation of the rotatable shaft in the second direction translates the end-effector in a second longitudinal direction, relative to the connector (paras. [0362]-[0364]).
Regarding claim 14, Shelton discloses the device further comprising a controller (11001) in communication with the motor, wherein the controller is configured to select and/or change a direction of the rotation of the shaft imparted by the motor (para. [0362]).
Regarding claim 15, Shelton discloses wherein the end-effector is a stapler, wherein the first feature includes an anvil (13224) of the stapler, and wherein the second feature includes a cartridge housing (13222) of the stapler (para. [0357]).
Regarding claim 22, Shelton discloses a medical device (1320 Fig. 137), comprising
an end-effector (13212), including a first feature (13224) and a second feature (13222), wherein the first feature and the second feature are pivotably joined to one another (para. [0357]);
a sheath (13208); and
a motor (13360) coupled to a rotatable shaft (13340), wherein the rotatable shaft engages the end-effector (e.g., via connection with rod (13342); Fig. 137; para. [0363]), and wherein the motor is configured to rotate the rotatable shaft in a first direction and a second direction, wherein the second direction is opposite of the first direction (para. [0362]);
wherein a first rotation of the rotatable shaft in the first direction is configured to pivot the first feature and the second feature toward one another in a closed configuration (para. [0364]),
wherein a second rotation of the rotatable shaft in the second direction is configured to pivot the first feature and the second feature away from one another in an open configuration (para. [0364]), and
wherein the sheath at least partially covers the first feature and the second feature of the end-effector in both the closed configuration (Fig. 138) and the open configuration (Fig. 137).
Regarding claim 23, Shelton discloses wherein the sheath includes a first longitudinal slot (longitudinal lumen of shaft (13208); Fig. 137) through which the first feature extends and retracts, and a second longitudinal slot (13245) through which the second feature extends and retracts (Figs. 137-138; para. [0357]).
Regarding claim 24, Shelton discloses wherein the first longitudinal slot and the second longitudinal slot are diametrically opposite from one another (e.g., on opposite sides of the wall of shaft (13208); Fig. 137).
Regarding claim 25, Shelton discloses wherein each of the first longitudinal slot and the second longitudinal slot extends from a distalmost end of the sheath toward a proximal end of the sheath (e.g., the slots extend in the direction of a distalmost end toward a proximal end of the sheath; Fig. 137).
Claims 1, 2, 14, 22-25, and 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patani et al. (U.S. Patent Application Publication No. 20140107697; hereinafter “Patani”).
Regarding claim 1, Patani discloses a medical device (200; Figs. 3A-3B), comprising:
an end-effector (202), including a first feature (208a) and a second feature (208b), wherein the first feature and the second feature are pivotably joined to one another (e.g., via clamping mechanism (212); para. [0107]; see also para. [0093]); and
a motor (216) coupled to a rotatable shaft (244), wherein the rotatable shaft engages the end-effector (via clamping force regulator (228) and shaft (226); para. [0108]), and wherein the motor is configured to rotate the rotatable shaft in a first direction and a second direction, wherein the second direction is opposite of the first direction (para. [0107]; see also para. [0096]);
wherein a first rotation of the rotatable shaft in the first direction is configured to translate the end-effector proximally to pivot the first feature and the second feature toward one another (para. [0107]), and
wherein a second rotation of the rotatable shaft in the second direction is configured to translate the end-effector distally to pivot the first feature and the second feature away from one another (para. [0107]); see also para. [0096]).
Regarding claim 2, Patani discloses the device further comprising a connector (combination of clamping force regulator (228) and shaft (226); para. [0108]) coupled to the rotatable shaft, wherein the connector is configured to directly engage the end-effector (para. [0107]).
Regarding claim 14, Patani discloses the device further comprising a controller (direction switch; para. [0093]) in communication with the motor, wherein the controller is configured to select and/or change a direction of the rotation of the shaft imparted by the motor (para. [0107]; see also para. [0093]).
Regarding claim 22, Patani discloses a medical device (200; Figs. 3A-3B), comprising
an end-effector (202; Fig. 3A; para. [0107]), including a first feature (116a’; Fig. 1E) and a second feature(116b’; Fig. 1E), wherein the first feature and the second feature are pivotably joined to one another (para. [0101]);
a sheath(138’; Fig. 1E; para. [0101]); and
a motor (216) coupled to a rotatable shaft (244), wherein the rotatable shaft engages the end-effector (via clamping force regulator (228) and shaft (226); para. [0108]), and wherein the motor is configured to rotate the rotatable shaft in a first direction and a second direction, wherein the second direction is opposite of the first direction (para. [0107]; see also para. [0096]);
wherein a first rotation of the rotatable shaft in the first direction is configured to pivot the first feature and the second feature toward one another in a closed configuration (para. [0107]),
wherein a second rotation of the rotatable shaft in the second direction is configured to pivot the first feature and the second feature away from one another in an open configuration (para. [0107]; see also para. [0096]), and
wherein the sheath (138’; Fig. 1E) at least partially covers the first feature and the second feature of the end-effector in both the closed configuration and the open configuration (e.g., via tracks (122b’, 122a’); Fig. 1E; para. [0101]).
Regarding claim 23, Patani discloses wherein the sheath (138’; Fig. 1E) includes a first longitudinal slot (122a’) through which the first feature (116a’) extends and retracts, and a second longitudinal slot (122b’) through which the second feature (116b’) extends and retracts (Fig. 1E; para. [0101]).
Regarding claim 24, Patani discloses wherein the first longitudinal slot and the second longitudinal slot are diametrically opposite from one another (Fig. 1E).
Regarding claim 25, Patani discloses wherein each of the first longitudinal slot and the second longitudinal slot extends from a distalmost end of the sheath toward a proximal end of the sheath (Fig. 1E).
Regarding claim 27, Patani discloses the device further comprising: a first cable (120a’), including a first end coupled to the sheath and a second end coupled to the first feature (Fig. 1E; para. [0101]); and a second cable (120b’), including a first end coupled to the sheath and a second end coupled to the second feature (Fig. 1E; para. [0101]).
Regarding claim 28, Patani discloses wherein the first cable and the second cable are configured to pivot the first feature and the second feature away from one another (para. [0101]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 21, 26, 29-31, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Sklar (U.S. Patent No. 5350355).
Regarding claim 21, Shelton discloses the device further comprising a sheath (13208; Fig. 137) including an interior surface. The device of Shelton is not explicitly disclosed with the interior surface of the sheath having a tapered shape.
Sklar, a reference in the medical device field of endeavor, teaches providing a sheath (66) with an interior surface (82) having a tapered shape configured to transition a first feature (92) and a second feature (92) to a closed configuration (Figs. 6a-6b) to abut the first and second features and move them toward each other to grasp an object (col. 5, ll. 35-68).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the interior surface of the sheath of Shelton with a tapered shape configured to transition the first feature and the second feature to a closed configuration, in view of Sklar, in order to facilitate moving the first and second features toward each other to grasp tissue during a procedure.
Regarding claim 34, Sklar discloses wherein a diameter of a passage defined by the interior surface gradually decreases from a distal portion of the interior surface to a proximal portion of the interior surface (e.g., having a frustoconical shape; Figs 6a-6b; col. 5, ll. 46-12).
Regarding claim 26, Shelton discloses the sheath (13208; Fig. 137) including an interior surface. The device of Shelton is not explicitly disclosed with the interior surface of the sheath having a tapered shape.
Sklar, a reference in the medical device field of endeavor, teaches providing a sheath (66) with an interior surface (82) having a tapered shape configured to transition a first feature (92) and a second feature (92) to a closed configuration (Figs. 6a-6b) to abut the first and second features and move them toward each other to grasp an object (col. 5, ll. 35-68).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the interior surface of the sheath of Shelton with a tapered shape configured to transition the first feature and the second feature to a closed configuration, in view of Sklar, in order to facilitate moving the first and second features toward each other to grasp tissue during a procedure.
Regarding claim 29, Shelton discloses a medical device (1320; Fig. 137), comprising:
an end-effector 13212), including a first feature (13224) and a second feature (13222), wherein the first feature and the second feature are pivotably joined to one another (para. [0357]);
a sheath (13208) including an interior surface; and
a motor (13360) coupled to a rotatable shaft (13340), wherein the rotatable shaft engages the end-effector (e.g., via connection with rod (13342); Fig. 137; para. [0363]), and wherein the motor is configured to rotate the rotatable shaft in a first direction and a second direction, wherein the second direction is opposite of the first direction (para. [0362]);
wherein a first rotation of the rotatable shaft in the first direction is configured to pivot the first feature and the second feature toward one another (para. [0364]), and
wherein a second rotation of the rotatable shaft in the second direction is configured to pivot the first feature and the second feature away from one another (para. [0364).
The device of Shelton is not explicitly disclosed with the interior surface of the sheath having a tapered shape.
Sklar, a reference in the medical device field of endeavor, teaches providing a sheath (66) with an interior surface (82) having a tapered shape configured to transition a first feature (92) and a second feature (92) to a closed configuration (Figs. 6a-6b) to abut the first and second features and move them toward each other to grasp an object (col. 5, ll. 35-68).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the interior surface of the sheath of Shelton with a tapered shape configured to transition the first feature and the second feature to a closed configuration, in view of Sklar, in order to facilitate moving the first and second features toward each other to grasp tissue during a procedure.
Regarding claim 30, Sklar discloses wherein a diameter of a passage defined by the interior surface gradually decreases from a distal portion of the interior surface to a proximal portion of the interior surface (e.g., having a frustoconical shape; Figs 6a-6b; col. 5, ll. 46-12).
Regarding claim 31, Sklar discloses wherein the interior surface defines an approximately cone-shaped passage (e.g., having a frustoconical shape; Figs 6a-6b; col. 5, ll. 46-12).
Allowable Subject Matter
Claims 7, 32, and 33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 7, the prior art fails to disclose alone or in combination the medical device including “a sheath, sheathing at least a portion of the connector and at least a portion of the end-effector, wherein the sheath includes a first longitudinal slot through which the first feature of the end-effector extends and retracts, and a second longitudinal slot through which the second feature of the end-effector extends and retracts; a first cable, including a first end coupled to the sheath and a second end coupled to the first feature; and a second cable, including a first end coupled to the sheath and a second end coupled to the second feature; wherein a first translation of the end-effector in the first longitudinal direction pivots the first feature and the second feature toward one another, and wherein a second translation of the end-effector in the second longitudinal direction pivots the first feature and the second feature away from another,” as read with all the limitations of the claim.
Regarding claim 32, the prior art fails to disclose alone or in combination, the medical device including “a first cable, including a first end coupled to the sheath and a second end coupled to the first feature; and a second cable, including a first end coupled to the sheath and a second end coupled to the second feature,” as read with all the limitations of the claim.
Claim 33 would be allowable as depending from claim 32.
Response to Arguments
Applicant’s arguments with respect to claims 1, 2, 5, 14-15, and 21-34 (Response pp. 9-11) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the new grounds of rejection are over the teachings of Shelton and/or Patani, as presented above in this Office Action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.A.H./Jonathan HollmExaminer, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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