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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/2/2026 has been entered.
Response to Amendment
In response to the amendment filed on 3/2/2026, Claims 1, 5, 10, 11, 17 and 22-25 have been amended and Claim 26 is newly added. Thus claims 1-12, 14-20 and 22-26 are pending.
Response to Arguments
Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive. In regards to claims 1, 10 and 17, applicant argues that Scirica does not disclose or suggest a distal end of a handle shaft of a surgical handle assembly positioned distal to an articulation assembly of the surgical handle assembly, to which an extender with a proximal end portion couples to. However, examiner respectfully disagrees and submits that Scirica does disclose a handle shaft (see annotated Fig. 4-5 below) of a surgical handle assembly (12) positioned distal to an articulation assembly (see annotated Fig. 5 below, the articulation assembly being the assembly of the components within housing 38 to actuate the cartridge), to which an extender (14) with a proximal end portion couples to.
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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 1-3, 5-9, 17-20, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over US 20080179375 A1 Scirica in view of US20200100805A1 Snow et al. (hereinafter Snow).
Regarding claim 1, Scirica discloses an extender (14, Fig. 1), comprising:
a proximal end portion configured to couple the extender to a distal end of a handle shaft (see annotated Fig. 4-5 above) of a surgical handle assembly (as seen in Fig. 1-6, 16, extender 14 has a proximal portion 32 that couples to a distal end the handle shaft of a surgical handle assembly 12) positioned distal to an articulation assembly (see annotated Fig. 5 above, the articulation assembly being the assembly of the components within housing 38 to actuate a cartridge 16) of the surgical handle assembly;
a distal end portion configured to removably couple the extender to a reloadable cartridge assembly (16, Fig. 1, 6, paragraph 45); and
an extender drive rod (58, Fig. 4-6, 16) extending from the proximal end portion to the distal end portion (as seen in Fig. 5, 16), wherein the extender drive rod is configured, at least when the extender is coupled to the surgical handle assembly, to (a) move axially in response to axial movement produced at the surgical handle assembly (paragraph 48, actuation shaft 52 is slidably supported between retracted and advanced positions within barrel portion 30 of housing 38…When movable handle 28 is actuated, i.e., is compressed towards stationary handle 26 against the bias of spring 42, engagement finger 62 of pawl 48 engages toothed rack 60 of actuation shaft 52 to advance actuation shaft 52 and firing rod 58 distally) and (b) transfer power from the surgical handle assembly to the reloadable cartridge assembly (paragraph 48, 55-58).
Scirica discloses that the extender (14) is its own separate piece (seen in Fig. 16), however does not specifically state that the proximal end portion of the extender is configured to removably couple to the distal end of the handle shaft of the surgical handle assembly (12).
Snow discloses an extender (adapter assembly 200, Fig. 1), comprising: a proximal end (drive coupling assembly 210 at proximal end, Fig. 1) configured to removably couple to a distal end of a handle shaft of a surgical handle assembly (handle shaft of surgical instrument 100 as pointed out in the below screenshot; surgical instrument 100 is configured for selective connection with adapter assembly 200, paragraph 87, Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Scirica with the teachings of Snow to achieve wherein the extender comprises a proximal end portion configured to removably couple to a distal end of a handle shaft of a surgical handle assembly, in order to provide the surgical instrument with selective connection with the extender and selective connection with end effectors as disclosed by Snow (paragraph 62).
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Regarding claim 2, the combination of Scirica and Snow teach the limitations of claim 1 as above. Snow further discloses the extender further comprising an extender articulation arm (drive bar 258, Fig. 13) configured to transfer articulation movement from the surgical handle assembly to the reloadable cartridge assembly (“as drive shaft 214 is rotated due to a rotation of second connector sleeve 220, as a result of the rotation of the second drive connector 120 of surgical instrument 100... coupling cuff 254 to be translated axially... As coupling cuff 254 is translated axially, drive bar 258 is caused to be translated axially ... drive bar 258 causes concomitant axial translation of articulation link 366 of end effector 300 to effectuate an articulation of tool assembly 304”, paragraph 107, Figs. 10-19).
Regarding claim 3, the combination of Scirica and Snow teach the limitations of claim 1 as above. Scirica further discloses wherein the extender drive rod is configured to transfer the power from the surgical handle assembly to the reloadable cartridge assembly by moving axially (paragraph 48, 55-58). Additionally, Snow further discloses wherein the extender drive rod is configured to transfer the power from the surgical handle assembly to the reloadable cartridge assembly by moving axially (“as first rotatable proximal drive shaft 212 is rotated, due to a rotation of first connector sleeve 218, as a result of the rotation of the first respective drive connector 118 of surgical instrument 100... thereby causing first distal drive shaft 242 to rotate... drive coupling nut 244 is caused to be translated axially along first distal drive shaft 242”, paragraph 101; “drive coupling nut 244 is caused to be translated axially... drive tube 246 is caused to be translated axially... As drive tube 246 is translated axially, with connection member 247 connected thereto... causes concomitant axial translation of drive member 374 of end effector 300”, paragraph 102).
Regarding claim 5, the combination of Scirica and Snow teach the limitations of claim 1 as above. Snow further discloses the extender further comprising a blade lock assembly (lock mechanism 280, Fig. 10) configured to lock the extender drive rod when the surgical handle assembly is not coupled to the proximal end portion of the extender (paragraph 113, lock mechanism 280 fixes the axial position and radial orientation of drive tube 246, and as seen in Fig. 10 the adapter 200 is not coupled to the surgical handle assembly 100 and Snow does not mention the adapter must be coupled to the surgical handle assembly to actuate the lock mechanism, therefore suggesting that the lock mechanism can be actuated to lock the drive tube when the proximal portion of the adapter is not coupled to the surgical handle assembly).
Regarding claim 6, the combination of Scirica and Snow teach the limitations of claim 5 as above. Snow further discloses wherein the blade lock assembly comprises a blade lock (lock release button 282, Fig. 11) and a lock slider (release button 282 slidably supported on knob housing 202, paragraph 113, Fig. 11).
Regarding claim 7, the combination of Scirica and Snow teach the limitations of claim 1 as above. Snow further discloses the extender further comprising a tab (tab 286a, Fig. 18), wherein the tab is configured to prevent the extender drive rod from rotating (the actuation bar 284 is moved proximally, the cam surface 284c of actuation bar 284 engages the lock arm 286... such that tab 286a of lock out 286 is received in cut-out 247a formed in connection member 247 of drive tube 246... drive tube 246 is prevented from distal and/or proximal movement”, paragraph 120; the tab 286a is capable of preventing rotational movement of drive tube 256).
Regarding claim 8, the combination of Scirica and Snow teach the limitations of claim 1 as above. Scirica further discloses further comprising a connector (56, Fig. 4), wherein the connector is positioned on a proximal end of the extender drive rod (as seen in Fig. 4, paragraph 48) and is configured to connect to a drive rod (52, Fig. 4) of the surgical handle assembly (paragraph 48). Additionally, Snow further discloses the extender further comprising a connector (drive coupling assembly 210, Fig. 1), wherein the connector is positioned on a proximal end of the extender drive rod (coupling assembly 210 is positioned at the proximal end of drive tube 246, Figs. 14-17) and is configured to connect to a drive rod (drive shaft 212, Fig. 14,16) of the surgical handle assembly (the coupling assembly 210 is shown to connect to the drive shaft 212, Fig. 16).
Regarding claim 9, the combination of Scirica and Snow teach the limitations of claim 1 as above. Scirica further discloses further comprising a temporary lock mechanism (513, Fig. 19). Additionally, Snow further discloses the extender further comprising a temporary lock mechanism (“lock mechanism 280 further includes a lock out 286 supported on distal coupling assembly 230... a biasing member 288 tending to maintain lock out 286 and tab 286a”, paragraph 117, Figs. 13,15-16).
Regarding claim 17, Scirica discloses a method of using a surgical stapler (paragraph 8-13), comprising:
connecting a reloadable cartridge assembly (16, Fig. 1, 6, paragraph 45) to a distal end of an extender (14, Fig. 1);
producing axial movement at a surgical handle assembly (12, Fig. 1) (paragraph 48, actuation shaft 52 is slidably supported between retracted and advanced positions within barrel portion 30 of housing 38…When movable handle 28 is actuated, i.e., is compressed towards stationary handle 26 against the bias of spring 42, engagement finger 62 of pawl 48 engages toothed rack 60 of actuation shaft 52 to advance actuation shaft 52 and firing rod 58 distally);
and providing, via the surgical handle assembly, the axial movement to an extender drive rod (58, Fig. 4-6, 16) of the extender (paragraph 48, 55-58), wherein the extender drive rod extends from (i) a proximal end portion of the extender that is coupled to the distal end of a handle shaft (see annotated Fig. 4-5 above) of the surgical handle assembly to (ii) the distal end of the extender (as seen in Fig. 5, 16).
Scirica discloses the handle shaft of the surgical handle assembly is positioned distal to an articulation assembly of the surgical handle assembly (see annotated Fig. 5 above, the articulation assembly being the assembly of the components within housing 38 to actuate the cartridge 16) and that the extender (14) is its own separate piece (seen in Fig. 16), however does not specifically state that the extender is connected to the distal end of the handle shaft of the surgical handle assembly (12).
Snow discloses an extender (adapter assembly 200, Fig. 1), configured to connect to a distal end of a handle shaft of a surgical handle assembly (handle shaft of surgical instrument 100 as pointed out in above screenshot; surgical instrument 100 is configured for selective connection with adapter assembly 200, paragraph 87, Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Scirica with the teachings of Snow to achieve wherein the extender is configured to connect to a distal end of a handle shaft of a surgical handle assembly, in order to provide the surgical instrument with selective connection with the extender and selective connection with end effectors as disclosed by Snow (paragraph 62).
Regarding claim 18, the combination of Scirica and Snow teach the limitations of claim 17 as above. Scirica further discloses further comprising advancing a distal end of the surgical stapler to a target site in a patient (paragraph 3, 45, 55). Additionally, Snow further discloses the method of using a surgical stapler further comprising advancing a distal end of the surgical stapler to a target site in a patient (“anvil assembly 306 and the cartridge assembly 308 of end effector 300 are closed to contact tissue therebetween prior to engaging the firing mode”, paragraph 155).
Regarding claim 19, the combination of Scirica and Snow teach the limitations of claim 18 as above. Scirica further discloses using a movable handle (28, Fig. 1) on the surgical stapler to clamp tissue at the target site and deliver staples to staple tissue at the target site (paragraph 48, 55-58).
Regarding claim 20, the combination of Scirica and Snow teach the limitations of claim 17 as above. Scirica further discloses wherein the extender drive rod provides the axial movement to a blade assembly of the reloadable cartridge assembly to deliver the staples (paragraph 55-58). Additionally, Snow further discloses wherein the extender drive rod provides the axial movement to a blade assembly of the reloadable cartridge assembly to deliver the staples (“drive tube 246 causes concomitant axial translation of drive member 374 of end effector 300 to effectuate a closure of tool assembly 304 and a firing of tool assembly 304 of end effector 300”, paragraph 102).
Regarding claim 22, the combination of Scirica and Snow teach the limitations of claim 1 as above. The combination further discloses wherein the proximal end portion includes a connector (56, Fig. 4 of Scirica) configured to removably couple the extender to the distal end of the handle shaft of the surgical handle assembly (paragraph 48 of Scirica, the extender 14 of Scirica modified with the removable coupling of Snow would still allow the connector 56 of Scirica to removably couple with the recess 54 of the actuation shaft 52 of Scirica), and wherein the extender drive rod extends from the connector to the distal end portion (as seen in Fig. 5, 16).
Regarding claim 23, the combination of Scirica and Snow teach the limitations of claim 22 as above. Scirica further discloses wherein the connector is integral with the extender drive rod (as seen in Fig. 4-5).
Regarding claim 24, the combination of Scirica and Snow teach the limitations of claim 22 as above. Snow further discloses a connector (drive coupling assembly 210, Fig. 1) of the extender being discrete from an extender drive rod (242, Fig. 13-16). Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the connector be discrete from the extender drive rod, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177 (BdPatApp&Int 1969).
Regarding claim 25, the combination of Scirica and Snow teach the limitations of claim 1 as above. Scirica further discloses wherein the extender drive rod includes an integral component extending from the proximal end portion to the distal end portion of the extender (as seen in Fig. 4-5, extender drive rod 58 has an integral body that extends from the proximal end portion to the distal end of the extender).
Regarding claim 26, the combination of Scirica and Snow teach the limitations of claim 1 as above. Scirica further discloses wherein the handle shaft of the surgical handle assembly is positioned distal to a radial position of the surgical handle assembly (the surgical device 10 has a longitudinal axis along the length of the extender 14 (paragraph 45, Fig. 1), and it can be inferred that as the surgical handle assembly 12 is rotated radially about the longitudinal axis to another different position, the handle shaft is maintained at a distal position of the new radial position of the surgical handle assembly).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Scirica in view of Snow and further in view of US20120253329A1 Zemlok et al. (hereinafter Zemlok).
Regarding claim 4, The combination of Scirica and Snow teach the limitations of claim 1 as above.
The combination is silent on wherein the extender drive rod is configured to transfer the power from the surgical handle assembly to the reloadable cartridge assembly by moving rotationally.
However, Zemlok discloses an extender (adapter assembly 200, Fig. 1) having an extender drive rod (drive shaft 242, Fig. 13) wherein the extender drive rod is configured to transfer power from the surgical handle assembly to the reloadable cartridge assembly by moving rotationally (“as first rotatable proximal drive shaft 212 is rotated, due to a rotation of first connector sleeve 218, as a result of the rotation of the first respective drive connector 118 of surgical device 100... to also rotate thereby causing first distal drive shaft 242 to rotate. As first distal drive shaft 242 is rotated, drive coupling nut 244 is caused to be translated axially along first distal drive shaft 242”, paragraph 115; “As drive coupling nut 244 is caused to be translated axially along first distal drive shaft 242, drive tube 246 is caused to be translated axially ... causes concomitant axial translation of drive member 374 of end effector 300 to effectuate a closure of tool assembly 304 and a firing of tool assembly 304 of end effector 300”, paragraph 116).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Scirica and Snow with the teachings of Zemlok to achieve an extender wherein the extender drive rod is configured to transfer power from the surgical handle assembly to the reloadable cartridge assembly by moving rotationally. One of ordinary skill in the art would have been motivated to make this change to make linear driven end effectors compatible with surgical devices and/or handle assemblies that use a rotary motion to deliver power as disclosed by Zemlok (paragraph 13).
Claims 10-12 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Scirica in view of Snow and further in view of US 20100010298 A1 Bakos et al. (hereinafter Bakos).
Regarding claim 10, Scirica discloses a surgical stapler (10, Fig. 1), comprising:
a surgical handle assembly (12, Fig. 1) including a drive mechanism (52, 60, Fig. 4), an articulation assembly (see annotated Fig. 5 above, the articulation assembly being the assembly of the components within housing 38 to actuate a cartridge 16), and a handle shaft positioned distal to the articulation assembly (see annotated Fig. 4-5 above), wherein the drive mechanism is configured to produce axial movement at the surgical handle assembly (paragraph 48, actuation shaft 52 is slidably supported between retracted and advanced positions within barrel portion 30 of housing 38…When movable handle 28 is actuated, i.e., is compressed towards stationary handle 26 against the bias of spring 42, engagement finger 62 of pawl 48 engages toothed rack 60 of actuation shaft 52 to advance actuation shaft 52 and firing rod 58 distally).
an extender (14, Fig. 1) including a proximal end portion configured to couple the extender to a distal end of the handle shaft of the surgical handle assembly (as seen in Fig. 1-6, 16, extender 14 has a proximal portion 32 that couples to a distal end of the handle shaft of the surgical handle assembly 12), wherein the extender further includes an extender drive rod (58, Fig. 4-6, 16) configured to move axially in response to the axial movement produced by the drive mechanism at the surgical handle assembly (paragraph 48, 55-58), and wherein the extender drive rod extends from the proximal end portion to a distal end of the extender (as seen in Fig. 5, 16); and
a reloadable cartridge assembly (16, Fig. 1, 6) configured to removably couple to the distal end of the extender (paragraph 45).
Scirica discloses that the extender (14) is its own separate piece (seen in Fig. 16), however does not specifically state that the extender is configured to removably couple to the distal end of the handle shaft of the surgical handle assembly (12), and is silent on the reloadable cartridge assembly (16) configured to removably couple to the distal end of the handle shaft of the surgical handle assembly directly without use of the extender.
However, Snow discloses an extender (adapter assembly 200, Fig. 1), configured to removably couple to a distal end of a handle shaft of a surgical handle assembly (handle shaft of surgical instrument 100 as pointed out in above screenshot; handle shaft of surgical instrument 100 is configured for selective connection with adapter assembly 200, paragraph 87, Fig. 1).
Furthermore, Bakos teaches a modular endoscopic overtube (Fig. 9) comprising a removable cartridge assembly, a removable extender section and a handle shaft of a surgical handle assembly (see annotated figure below). Joining elements 98 and 102 of the cartridge assembly and extender respectively can be screw threads (paragraph 62) and the cartridge assembly can be seen in Fig. 9 to attach to the handle assembly without the extender as the receiving joining member 102 also has a screw thread. The removable cartridge assembly and extender may be removed or added to adjust the length of the overtube before or during a procedure (paragraph 63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Scirica with the teachings of Snow and Bakos to achieve wherein the extender is configured to removably couple to a distal end of a handle shaft of a surgical handle assembly, in order to provide the surgical instrument with selective connection with the extender and selective connection with end effectors as disclosed by Snow (paragraph 62), and to allow flexibility in adjusting the length of the cartridge assembly from the surgical handle assembly while performing a surgical procedure at the worksite as disclosed by Bakos (paragraph 63).
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Regarding claim 11, the combination of Scirica, Snow and Bakos teach the limitations of claim 10 as above. Scirica further discloses wherein the extender drive rod is configured to transfer force from the surgical handle assembly to the reloadable cartridge assembly (paragraph 48, 55-58).
Regarding claim 12, the combination of Scirica, Snow and Bakos teach the limitations of claim 10 as above. Snow further discloses the surgical stapler further comprising an extender articulation arm (drive bar 258, Fig. 13) configured to transfer articulation movement from the surgical handle assembly to the reloadable cartridge assembly (“as drive shaft 214 is rotated due to a rotation of second connector sleeve 220, as a result of the rotation of the second drive connector 120 of surgical instrument 100... coupling cuff 254 to be translated axially... As coupling cuff 254 is translated axially, drive bar 258 is caused to be translated axially... drive bar 258 causes concomitant axial translation of articulation link 366 of end effector 300 to effectuate an articulation of tool assembly 304”, paragraph 107, Figs. 10-19).
Regarding claim 15, the combination of Scirica, Snow and Bakos teach the limitations of claim 10 as above. Snow further discloses wherein the extender further comprises a blade lock assembly (lock mechanism 280, Fig. 10; release button 282 slidably supported on knob housing 202, paragraph 113, Fig. 11).
Regarding claim 16, the combination of Scirica, Snow and Bakos teach the limitations of claim 10 as above. Scirica further discloses wherein the extender further comprises a load detection mechanism (510, Fig. 17, 19).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Scirica in view of Snow, further in view of Bakos and further in view of Zemlok.
Regarding claim 14, the combination of Scirica, Snow and Bakos teach the limitations of claim 11 as above.
The combination is silent on wherein a drive mechanism of the surgical handle assembly is configured to produce rotational movement and wherein the extender drive rod is configured to move rotationally in response to the rotational movement produced by the drive mechanism of the surgical handle assembly.
However, Zemlok discloses a surgical stapler (abstract) wherein a drive mechanism of the surgical handle assembly (drive mechanism 160, Figs. 3,5) is configured to produce rotational movement (“when adapter 200 is coupled to surgical device 100, rotational force(s) are selectively transferred from drive mechanism 160 of surgical device 100 to adapter 200”, paragraph 91) and wherein the extender drive rod (drive shaft 242, Fig. 13) is configured to move rotationally in response to the rotational movement produced by the drive mechanism of the surgical handle assembly (“when drive mechanism 160 of surgical device 100 is engaged, drive connectors 118, 120, 122 of surgical device 100 will rotate”, paragraph 109; “as first rotatable proximal drive shaft 212 is rotated, due to a rotation of first connector sleeve 218, as a result of the rotation of the first respective drive connector 118 of surgical device 100... causing first distal drive shaft 242 to rotate”, paragraph 115).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Scirica with Snow and Bakos with the teachings of Zemlok to achieve a surgical stapler wherein a drive mechanism of the surgical handle assembly is configured to produce rotational movement and wherein the extender drive rod is configured to move rotationally in response to the rotational movement produced by the drive mechanism of the surgical handle assembly. One of ordinary skill in the art would have been motivated to make this change to make linear driven end effectors compatible with surgical devices and/or handle assemblies that use a rotary motion to deliver power as disclosed by Zemlok (paragraph 13).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHOA TAN LE/ Examiner, Art Unit 3771
/MOHAMED G GABR/ Primary Examiner, Art Unit 3771