DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Objections
Claims 23-25 are objected to because of the following informalities: the claims depend from canceled claim 20. Appropriate correction is required.
Claim 35 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 25. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
It is noted both claims 25 and 35 ultimately depend from independent claim 21.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-37, 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Yates et al., (hereinafter ‘Yates,’ U.S. PGPub. No. 2015/0190189) in view of McKenna et al., (hereinafter ‘McKenna,’ U.S. PGPub. No. 2014/0288549) and Mascorro et al., (hereinafter ‘Mascorro,’ U.S. Pat. 8,919,844).
Regarding claim 21, Yates discloses a surgical instrument (106), comprising: a housing (Fig. 4) supporting a movable handle (130); an elongated shaft defining a longitudinal axis and extending distally from the housing, the elongated shaft (shaft 165, translating member 173) configured to be translated along the longitudinal axis by the movable handle ([0053], “motion of the jaw closure trigger 142 may, in turn, cause the translating member 173 to translate within a bore 185 of the shaft 165. A distal portion of the translating member 173 may be coupled to a reciprocating member 197 such that distal and proximal motion of the translating member 173 causes corresponding distal and proximal motion of the reciprocating member”), the elongated shaft (165, 173) defining a distal end and a proximal end positioned within the housing ([0051], “A translating member 173 may extend within the shaft 165 from the end effector 132 to the hand piece 130.” Fig. 4); an end effector (132) disposed at the distal end of the elongated shaft (165) and including first and second jaw members (144, 167, 169), the first and second jaw members (167, 169) defining a gap distance therebetween ([0052], “As illustrated in FIG. 4, the end effector 132 is shown with the jaw members 167, 169 in an open position.”).
Yates further discloses a sensor (1338 in Fig. 13), “in some embodiments, the sensor 1338 comprises a proximity and/or contact sensor to sense a position of the jaw members 167, 169 relative to one another.” ([0083], thereby providing feedback regarding the gap distance). Yates is silent regarding a sensor coupled to the housing, the sensor positioned proximal of the proximal end of the elongated shaft and longitudinally aligned with the proximal end of the elongated shaft along the longitudinal axis, the sensor configured to detect a position of the proximal end of the elongated shaft relative to the housing to determine the size of the gap distance.
However, in the same field of endeavor, Mascorro teaches a similar sensor (108, 142, 144) coupled to the housing (Fig. 1A). Mascorro teaches the sensor is positioned proximal of the proximal end of the elongated shaft (114) and longitudinally aligned with the proximal end of the elongated shaft along the longitudinal axis (Fig. 1A). Further, the sensor (108) is configured to detect a position of the proximal end of the elongated shaft relative to the housing to determine the size of the gap distance (see col. 4, ll. 36-63; also see col. 5, ll. 3-23, for sensor member 108 with first and second sensor elements 142, 144 configured to detect the position of the moveable gripper jaw 104, either opened or closed, i.e., a set gap distance or no gap distance). It is well known in the art (as can be seen in Mascorro) that various position sensors can be provided at a variety of different locations relative to an instrument to determine a jaw position and that these sensors are widely considered interchangeable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the sensor as taught by Yates to include the sensor coupled to the housing, the sensor positioned proximal of the proximal end of the elongated shaft and longitudinally aligned with the proximal end of the elongated shaft along the longitudinal axis, the sensor configured to detect a position of the proximal end of the elongated shaft relative to the housing to determine the size of the gap distance, as taught by Mascorro, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Yates in view of Mascorro are silent regarding wherein, if the size of the gap distance is within a predetermined range, the first and second jaw members are configured to be electrically activated to treat tissue between the first and second jaw members.
However, in the same field of endeavor, McKenna (Fig. 1) teaches a similar surgical instrument (10) comprising an end effector (electrode sealing assembly 100) disposed at the distal end (14) of the elongated shaft (12) and including first and second jaw members (110, 120), the first and second jaw members (110, 120) defining a gap distance therebetween (see Fig. 1A for jaw angle “α” between jaw members 110, 120). McKenna further teaches the use of a variable capacitor (520), in connection with the drive actuator (560 in Fig. 5), to determine the jaw angle “α” between the two opposing jaw members (110, 120). The “variable capacitor 520 includes a fixed conductor, e.g., a conductive ring 540 disposed on a forceps housing (not shown) . . . that encapsulates a second conductor, e.g., a conductive ring 530, disposed on the drive actuator 560. Movement of the drive actuator 560 moves the conductive ring 530 relative to the conductive ring 540.” A change in capacitance of the two rings can be detected to determine the jaw closure angle “α” between the two jaw members (110, 120) ([0034]). The sensor may act as a safety mechanism to determine whether the two opposing jaw members are in a close enough proximity, (e.g., have moved past a threshold angle) for application of electrical energy, or conversely if the gap is closed to an angle less than desired or less than appropriate to commence sealing ([0028]), thereby preventing premature or undesired activation of energy and increased safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the surgical instrument as taught by Yates in view of Mascorro to include wherein, if the size of the gap distance is within a predetermined range, the first and second jaw members are configured to be electrically activated to treat tissue between the first and second jaw members, as taught by McKenna. Doing so provides a safety mechanism to determine whether the two opposing jaw members are in a close enough proximity, (e.g., have moved past a threshold angle) for application of electrical energy, or conversely if the gap is closed to an angle less than desired or less than appropriate to commence sealing ([0028]), thereby preventing premature or undesired activation of energy and increased safety.
Regarding claim 22, Yates discloses wherein the elongated shaft (shaft 165, translating member 173) is translatable along the longitudinal axis to move the first and second jaw members relative to one another from a first configuration wherein the first and second jaw members are spaced relative to one another, to a second configuration wherein the first and second jaw members are closer to one another for approximating tissue ([0051], “A translating member 173 may extend within the shaft 165 from the end effector 132 to the hand piece 130.” [0053], “To close the jaws 144 of the end effector 132, a clinician may cause the jaw closure trigger 142 to pivot along arrow 183 from a first position to a second position. This may cause the jaws 144 to open and close according to any suitable method. For example, motion of the jaw closure trigger 142 may, in turn, cause the translating member 173 to translate within a bore 185 of the shaft 165.”).
Regarding claim 23, Yates discloses wherein the proximal end of the elongated shaft (shaft 165, translating member 173) is positioned proximal of the movable handle ([0051]; [0053]; [0071], “Although the motor 1204 is illustrated in the context of the ultrasonic surgical device 104, it will be appreciated that a similar arrangement may be created with respect to devices, such as the electrosurgical device 106. For example, the rack gear 1203 may be coupled to the translating member 173 to close the jaw members 167, 169 and/or drive the blade 175.” As broadly claimed, jaw closure member ).
Regarding claim 24, Yates discloses further including a drive assembly disposed within the housing and operatively associated with the moveable handle to longitudinally translate the elongated shaft ([0071], “Although the motor 1204 is illustrated in the context of the ultrasonic surgical device 104, it will be appreciated that a similar arrangement may be created with respect to devices, such as the electrosurgical device 106. For example, the rack gear 1203 may be coupled to the translating member 173 to close the jaw members 167, 169 and/or drive the blade 175.”).
Regarding claim 25, Yates discloses wherein the drive assembly includes a tube (jaw closure member 141, translating member 173) having a distal end coupled to the proximal end of the elongated shaft and a proximal end longitudinally aligned with the sensor along the longitudinal axis ([0071], “A gear 1202 is positioned to contact the rack gear 1203 such that rotation of the gear 1202 causes linear translation of the rack gear 1203 and jaw closure member 141. The motor 1204 may be coupled to the gear 1202 such that rotation of the motor 1204 causes rotation of the gear 1202 and, consequently, linear translation of the jaw closure member 141 along alternately distal and proximal directions depending on the direction of rotation of the motor 1204. The motor 1204 may be configured to be actuated when the clinician actuates the jaw closure trigger 138. The jaw closure trigger 138 may be mechanically coupled to the jaw closure member 141 such that the motor 1204 provides an “assist” to the closing of the clamp arm 155. . . . Although the motor 1204 is illustrated in the context of the ultrasonic surgical device 104, it will be appreciated that a similar arrangement may be created with respect to devices, such as the electrosurgical device 106. For example, the rack gear 1203 may be coupled to the translating member 173 to close the jaw members 167, 169 and/or drive the blade 175.”).
Regarding claim 26, Yates discloses wherein the drive assembly includes a biasing member (gear 1202) configured to bias the elongated shaft distally (as broadly claimed, rotation of the gear 1202 bias the translating member 173 distally).
Regarding claim 27, Yates further discloses wherein the sensor (1338 in Fig. 13) is configured to provide feedback of the size of the gap distance ([0083], “in some embodiments, the sensor 1338 comprises a proximity and/or contact sensor to sense a position of the jaw members 167, 169 relative to one another.”).
Regarding claim 28, Yates in view of Mascorro and McKenna teach each and every limitation of the surgical instrument according to claim 21. Yates discloses wherein the first and second jaw members (110, 120) are configured to deliver electrosurgical energy to tissue between the first and second jaw members ([0052], jaw members 167, 169, comprise respective electrodes 177, 179 connected to generator 102). In view of the prior modification of Yates in view of Mascorro and McKenna, McKenna teaches wherein the sensor (520) is configured to provide feedback when the size of the gap distance is suitable for applying electrosurgical energy to tissue. The sensor may act as a safety mechanism to determine whether the two opposing jaw members are in a close enough proximity, (e.g., have moved past a threshold angle) for application of electrical energy, or conversely if the gap is closed to an angle less than desired or less than appropriate to commence sealing ([0028]), thereby preventing premature or undesired activation of energy and increased safety. See rejection of claim 21 above for obviousness rationale.
Regarding claim 29, Yates discloses wherein the sensor (1338 in Fig. 13)is at least one of optical, magnetic, inductive, or mechanical ([0083]).
Regarding claim 30, Yates in view of Mascorro and McKenna teach each and every limitation of the surgical instrument according to claim 21. In view of the prior modification of Yates in view of Mascorro and McKenna, Mascorro teaches the sensor (144, 142) is fixedly coupled to the housing (Fig. 1A).
Regarding claim 31, Yates discloses a surgical instrument (106), comprising: a housing (Fig. 4) supporting a movable handle (130); an elongated shaft (shaft 165, translating member 173) defining a longitudinal axis and extending distally from the housing, the elongated shaft (165, 173) configured to be translated along the longitudinal axis by the movable handle ([0053], “motion of the jaw closure trigger 142 may, in turn, cause the translating member 173 to translate within a bore 185 of the shaft 165. A distal portion of the translating member 173 may be coupled to a reciprocating member 197 such that distal and proximal motion of the translating member 173 causes corresponding distal and proximal motion of the reciprocating member”), the elongated shaft (165, 173) defining a distal end and a proximal end positioned within the housing ([0051], “A translating member 173 may extend within the shaft 165 from the end effector 132 to the hand piece 130.” Fig. 4); an end effector (132) disposed at the distal end of the elongated shaft (165) and including first and second jaw members (144, 167, 169), the first and second jaw members (167, 169) defining a gap distance therebetween ([0052], “As illustrated in FIG. 4, the end effector 132 is shown with the jaw members 167, 169 in an open position.”).
Yates further discloses a sensor (1338 in Fig. 13), “in some embodiments, the sensor 1338 comprises a proximity and/or contact sensor to sense a position of the jaw members 167, 169 relative to one another.” ([0083], thereby providing feedback regarding the gap distance). Yates is silent regarding a sensor coupled to the housing, the sensor positioned proximal of the proximal end of the elongated shaft and longitudinally aligned with the proximal end of the elongated shaft along the longitudinal axis, the sensor configured to detect a position of the proximal end of the elongated shaft relative to the housing to determine the size of the gap distance.
However, in the same field of endeavor, Mascorro teaches a similar sensor (108, 142, 144) coupled to the housing (Fig. 1A). Mascorro teaches the sensor is positioned proximal of the proximal end of the elongated shaft (114) and longitudinally aligned with the proximal end of the elongated shaft along the longitudinal axis (Fig. 1A). Further, the sensor (108) is configured to detect a position of the proximal end of the elongated shaft relative to the housing to determine the size of the gap distance (see col. 4, ll. 36-63; also see col. 5, ll. 3-23, for sensor member 108 with first and second sensor elements 142, 144 configured to detect the position of the moveable gripper jaw 104, either opened or closed, i.e., a set gap distance or no gap distance). It is well known in the art (as can be seen in Mascorro) that various position sensors can be provided at a variety of different locations relative to an instrument to determine a jaw position and that these sensors are widely considered interchangeable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the sensor as taught by Yates to include a sensor coupled to the housing, the sensor positioned proximal of the proximal end of the elongated shaft and longitudinally aligned with the proximal end of the elongated shaft along the longitudinal axis, the sensor configured to detect a position of the proximal end of the elongated shaft relative to the housing to determine the size of the gap distance, as taught by Mascorro, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Yates in view of Mascorro are silent regarding wherein, if the size of the gap distance is within a predetermined range, the first and second jaw members are configured to be electrically activated to treat tissue between the first and second jaw members.
wherein, if the size of the gap distance is within a predetermined range, the first and second jaw members are configured to be electrically activated to treat tissue between the first and second jaw members, wherein the sensor is configured to provide feedback that the size of the gap distal is within the predetermined range.
However, in the same field of endeavor, McKenna (Fig. 1) teaches a similar surgical instrument (10) comprising an end effector (electrode sealing assembly 100) disposed at the distal end (14) of the elongated shaft (12) and including first and second jaw members (110, 120), the first and second jaw members (110, 120) defining a gap distance therebetween (see Fig. 1A for jaw angle “α” between jaw members 110, 120). McKenna further teaches the use of a variable capacitor (520), in connection with the drive actuator (560 in Fig. 5), to determine the jaw angle “α” between the two opposing jaw members (110, 120). The “variable capacitor 520 includes a fixed conductor, e.g., a conductive ring 540 disposed on a forceps housing (not shown) . . . that encapsulates a second conductor, e.g., a conductive ring 530, disposed on the drive actuator 560. Movement of the drive actuator 560 moves the conductive ring 530 relative to the conductive ring 540.” A change in capacitance of the two rings can be detected to determine the jaw closure angle “α” between the two jaw members (110, 120) ([0034]). The sensor may act as a safety mechanism to determine whether the two opposing jaw members are in a close enough proximity, (e.g., have moved past a threshold angle) for application of electrical energy, or conversely if the gap is closed to an angle less than desired or less than appropriate to commence sealing ([0028]), thereby preventing premature or undesired activation of energy and increased safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the surgical instrument as taught by Yates in view of Mascorro to include wherein, if the size of the gap distance is within a predetermined range, the first and second jaw members are configured to be electrically activated to treat tissue between the first and second jaw members, wherein the sensor is configured to provide feedback that the size of the gap distal is within the predetermined range, as taught by McKenna. Doing so provides a safety mechanism to determine whether the two opposing jaw members are in a close enough proximity, (e.g., have moved past a threshold angle) for application of electrical energy, or conversely if the gap is closed to an angle less than desired or less than appropriate to commence sealing ([0028]), thereby preventing premature or undesired activation of energy and increased safety.
Regarding claim 32, Yates discloses wherein the elongated shaft (shaft 165, translating member 173) is translatable along the longitudinal axis to move the first and second jaw members relative to one another from a first configuration wherein the first and second jaw members are spaced relative to one another, to a second configuration wherein the first and second jaw members are closer to one another for approximating tissue ([0051], “A translating member 173 may extend within the shaft 165 from the end effector 132 to the hand piece 130.” [0053], “To close the jaws 144 of the end effector 132, a clinician may cause the jaw closure trigger 142 to pivot along arrow 183 from a first position to a second position. This may cause the jaws 144 to open and close according to any suitable method. For example, motion of the jaw closure trigger 142 may, in turn, cause the translating member 173 to translate within a bore 185 of the shaft 165.”).
Regarding claim 33, Yates discloses wherein the proximal end of the elongated shaft (shaft 165, translating member 173) is positioned proximal of the movable handle ([0051]; [0053]; [0071], “Although the motor 1204 is illustrated in the context of the ultrasonic surgical device 104, it will be appreciated that a similar arrangement may be created with respect to devices, such as the electrosurgical device 106. For example, the rack gear 1203 may be coupled to the translating member 173 to close the jaw members 167, 169 and/or drive the blade 175.” As broadly claimed, jaw closure member ).
Regarding claim 34, Yates discloses further including a drive assembly disposed within the housing and operatively associated with the moveable handle to longitudinally translate the elongated shaft ([0071], “Although the motor 1204 is illustrated in the context of the ultrasonic surgical device 104, it will be appreciated that a similar arrangement may be created with respect to devices, such as the electrosurgical device 106. For example, the rack gear 1203 may be coupled to the translating member 173 to close the jaw members 167, 169 and/or drive the blade 175.”).
Regarding claim 35, Yates discloses wherein the drive assembly includes a tube (jaw closure member 141, translating member 173) having a distal end coupled to the proximal end of the elongated shaft and a proximal end longitudinally aligned with the sensor along the longitudinal axis ([0071], “A gear 1202 is positioned to contact the rack gear 1203 such that rotation of the gear 1202 causes linear translation of the rack gear 1203 and jaw closure member 141. The motor 1204 may be coupled to the gear 1202 such that rotation of the motor 1204 causes rotation of the gear 1202 and, consequently, linear translation of the jaw closure member 141 along alternately distal and proximal directions depending on the direction of rotation of the motor 1204. The motor 1204 may be configured to be actuated when the clinician actuates the jaw closure trigger 138. The jaw closure trigger 138 may be mechanically coupled to the jaw closure member 141 such that the motor 1204 provides an “assist” to the closing of the clamp arm 155. . . . Although the motor 1204 is illustrated in the context of the ultrasonic surgical device 104, it will be appreciated that a similar arrangement may be created with respect to devices, such as the electrosurgical device 106. For example, the rack gear 1203 may be coupled to the translating member 173 to close the jaw members 167, 169 and/or drive the blade 175.”).
Regarding claim 36, Yates discloses wherein the drive assembly includes a biasing member (gear 1202) configured to bias the elongated shaft distally (as broadly claimed, rotation of the gear 1202 bias the translating member 173 distally).
Regarding claim 37, Yates further discloses wherein the feedback is audible, visual, or tactile ([0083], “in some embodiments, the sensor 1338 comprises a proximity and/or contact sensor to sense a position of the jaw members 167, 169 relative to one another.”).
Regarding claim 39, Yates further discloses wherein the sensor is at least one of optical, magnetic, inductive, or mechanical ([0083], “in some embodiments, the sensor 1338 comprises a proximity and/or contact sensor to sense a position of the jaw members 167, 169 relative to one another.”).
Regarding claim 40, Yates in view of Mascorro and McKenna teach each and every limitation of the surgical instrument according to claim 31. In view of the prior modification of Yates in view of Mascorro and McKenna, Mascorro teaches the sensor (144, 142) is fixedly coupled to the housing (Fig. 1A).
Claims 38 is rejected under 35 U.S.C. 103 as being unpatentable over Yates in view of Mascorro and McKenna as applied to claim 31 above, and further in view of Kimball et al., (hereinafter ‘Kimball,’ U.S. PGPub. No. 2013/0253480).
Regarding claim 38, Yates in view of Mascorro and McKenna teach each and every limitation of the surgical instrument according to claim 31, but are silent regarding a rotating assembly operably coupled with the elongated shaft to rotate the end effector with respect to the housing.
However, in the same field of endeavor, Kimball teaches a similar surgical instrument (159 in Fig. 4) comprising a rotating assembly operably coupled with the elongated shaft (170) to rotate the end effector (180) with respect to the housing (160) ([0047]-[0048]). Kimball teaches “shaft (170) is [] rotatable about the longitudinal axis defined by sheath (172), relative to handpiece (160), via a knob (174). Such rotation may provide rotation of end effector (180) and shaft (170) unitarily.” ([0048]). This configuration is advantageous because it “may enable insertion to a desired depth and rotation about the longitudinal axis of the shaft, thereby facilitating positioning of the end effector within the patient.” ([0001], thereby increasing accuracy, safety and overall control). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the surgical instrument as taught by Yates in view of Mascorro and McKenna to include a rotating assembly operably coupled with the elongated shaft to rotate the end effector with respect to the housing, as taught by Kimball, in order to “enable insertion to a desired depth and rotation about the longitudinal axis of the shaft, thereby facilitating positioning of the end effector within the patient.” ([0001]), and subsequently increasing accuracy, safety and overall control.
Conclusion
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/C.A.D./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794