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 .
Formal Matters
Applicant’s Response filed 26 May 2026 is acknowledged. Claim 1 and the second numbered claim 10 are cancelled. Claims 2, 12, 18, and 21 are currently amended. Claims 2-22 are pending and under examination.
Objections/Rejections Withdrawn
The rejection of claims 2-7, 11, and 22 under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al., US 20160045222 (18 February 2016) is withdrawn in light of Applicant’s amendments.
The rejection of claims 18-21 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn in light of Applicant’s amendments.
Response to Arguments
Regarding the rejections of over Zemlock, US 20090090763, Applicant argues that the cited “axial drive assembly 213 and ¶82” of Zemlock do not teach that the drive assembly 213 is rotated at any time and rather the axial drive assembly 213 of Zemlock is designed to slide or move proximally and distally along the longitudinal axis, like sled 74. Applicant’s argument has been fully considered and is understood, but is not persuasive.
Applicant’s arguments drew the examiner’s attention to the fact that Zemlock refers to element 213 as both the “axial drive assembly 213” in line 1 of ¶82 and also to “drive beam 213” in ¶82. This double-naming convention in the reference itself is the likely source of confusion as to the rotational ability of the drive assembly.
However, as explained in the rejection, the drive assembly shown in FIGs 4-8 of Zemlock includes drive motor 200 defining a longitudinal axis labeled C-C (¶74). As explained in ¶74 (cited in the rejection along with FIGs 4-8), the drive assembly of instrument 10 includes a drive motor 200 and a drive tube 210. Zemlock teaches that drive tube 210 is rotatable about drive tube axis C-C extending therethrough (¶74). Zemlock teaches that drive motor 200 is disposed in mechanical cooperation with drive tube 210 and is configured to rotate the drive tube 210 about drive gear axis C-C (¶74). Drive motor 200 is also taught as an electrical motor or a gear motor (¶74). Zemlock also teaches that firing rod coupling 190 allows rotation of distal portion 224 of firing rod 220 (FIGs 4, 6, ¶78). The relationship between firing rod 220 and drive tube 210 causes firing rod 220 to move distally and/or proximally in the direction of arrows D and E along threaded portion 212 of drive tube 210 upon rotation of drive tube 210 in response to the rotation of drive motor 200 (¶79). Accordingly, the express teachings of Zemlock cited in the rejection contradict Applicant’s arguments. Further clarification is provided below in light of Applicant’s Amendments.
Claim Rejections Maintained and Modified – Necessitated by Amendment
Claim Rejections - 35 USC § 102
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.
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.
Claims 2 and 3 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zemlock et al., US 20090090763 (9 April 2009) for the reasons of record and the reasons set forth herein.
Regarding independent claim 2, Zemlock teaches a surgical instrument (powered surgical stapler 10), comprising:
a drive motor configured to connect to a source of power (FIGs 4-8, drive motor 200);
a drive assembly (FIGs 4, 6, 7, “drive components (e.g., including a drive motor 200, a drive tube 210 and a firing rod 220, etc.”; ¶¶74, 77) disposed in mechanical cooperation with the drive motor (200; ¶74) and defining a longitudinal axis (FIG 4, axis C-C, ¶74);
a helix assembly (FIGs 5-7, firing rod 220 including threaded portion 226, proximal portion 222, and distal portion 224, ¶¶74, 79) disposed in mechanical cooperation with the drive assembly (FIGs 4-8), the helix assembly including a helical thread (threaded portion 226, ¶79);
and an outer tube (drive tube 210) disposed in mechanical cooperation with the helix assembly (220; ¶79),
the outer tube (210) including a helical groove (internally-threaded portion 212) configured to engage the helical thread of the helix assembly (¶79),
wherein actuation of the drive motor (200) causes rotation of the drive assembly (FIGs 4, 6, 7, “drive components (e.g., including a drive motor 200, a drive tube 210 and a firing rod 220, etc.)”; ¶¶74, 77) about the longitudinal axis (C-C) relative to the outer tube (210) and causes rotation of the helix assembly (220) about the longitudinal axis (C-C) defined by the drive assembly and relative to the outer tube (FIGs 5, 6; ¶79).
Regarding claim 3, Zemlock teaches the surgical instrument according to claim 2, as set forth above, wherein the helix assembly (220) is movable along the longitudinal axis (FIG 4, C-C) relative to the outer tube (210) (¶79).
Claim Rejections - 35 USC § 103
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.
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 4, 7, 11, 18, 19, and 22 remain rejected under 35 U.S.C. 103 as being unpatentable over Zemlock et al., US 20090090763 (9 April 2009) in view of Ziniti et al., US 20130116709 (9 May 2013), for the reasons of record and the reasons set forth herein.
Regarding claim 4, Zemlock teaches the surgical instrument according to claim 2, as set forth above.
Zemlock does not teach wherein the helix assembly (220) includes at least one longitudinal slot configured to slidingly engage a needle assembly.
Ziniti teaches surgical instrument (200) comprising an elongate shaft (208) that may be operated with a needle drive mechanism included within an actuatable at a handle provided at the proximal end of the shaft (¶44). The end effector comprising the needle assembly (FIG 3, ¶46) comprises at least one longitudinal slot (212) configured to slidingly engage a needle assembly (FIGs 19A, B, demonstrate sliding engagement of the longitudinal slot, ¶111).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Zemlock and Ziniti given that the prior art included each element claimed, although not necessarily in a single reference. Zemlock and Ziniti teach in the field of surgical instruments comprising end effectors.
Although Zemlock discloses the claimed base surgical instrument (drive assembly, drive motor, longitudinal axis, helix assembly, and outer tube), Zemlock does not expressly disclose wherein the helix assembly (220) includes at least one longitudinal slot configured to slidingly engage a needle assembly. However, Zemlock teaches generic end effectors in mechanical cooperation with the firing rod (220) so that the firing rod (220) drives a surgical function of the end effector (Abstract; ¶52). Zemlock teaches that such end effectors may be coupled to endoscopic portion 140 of powered surgical instrument 10 (¶52).
Ziniti specifically addresses rotational drive assembly devices comprising end effectors comprising longitudinal slots configured to slidingly engage a needle assembly. Because Zemlock teaches the base rotational drive assembly, motor, and helix assembly and teaches that different end effectors may be coupled to the base drive assembly unit and connected to the same base firing mechanism, a person of ordinary skill in the art, seeking to utilize a single base drive assembly with multiple end effectors would reasonably look to Ziniti’s rotational needle assembly end effector, which can be incorporated alongside Zemlock’s base rotational drive assembly and firing rod using known assembly methods without redesigning Zemlock’s core rotational drive device.
Because the references address the same engineering problem (rotational drive assembly systems comprising end effectors) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (attaching a compatible end effector connector to the base firing rod), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 7, Zemlock teaches the surgical instrument according to claim 2, as set forth above.
Zemlock does not teach the instrument further including a needle assembly disposed at least partially within the outer tube. However, Zemlock teaches end effector 160 attached to mounting portion 166, which is pivotably attached to a body portion 168. Body portion 168 may be integral with endoscopic portion 140 of powered surgical instrument 10 or may be removably attached to the instrument 10 (¶50).
Ziniti teaches an end effector comprising a needle assembly disposed at least partially within the outer tube (FIG 3, ¶46).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Zemlock and Ziniti given that the prior art included each element claimed, although not necessarily in a single reference. Zemlock and Ziniti teach in the field of surgical instruments comprising end effectors.
Although Zemlock discloses the claimed base surgical instrument (drive assembly, drive motor, longitudinal axis, helix assembly, and outer tube), Zemlock does not expressly disclose the instrument further including a needle assembly disposed at least partially within the outer tube. However, Zemlock teaches generic end effectors in mechanical cooperation with the firing rod (220) so that the firing rod (220) drives a surgical function of the end effector (Abstract; ¶52). Zemlock teaches that such end effectors may be coupled to endoscopic portion 140 of powered surgical instrument 10 (¶52).
Ziniti specifically addresses rotational drive assembly devices comprising end effectors comprising a needle assembly disposed at least partially within the outer tube. Because Zemlock teaches the base rotational drive assembly, motor, and helix assembly and teaches that different end effectors may be coupled to the base drive assembly unit and connected to the same base firing mechanism, a person of ordinary skill in the art, seeking to utilize a single base drive assembly with multiple end effectors would reasonably look to Ziniti’s rotational needle assembly end effector, which can be incorporated alongside Zemlock’s base rotational drive assembly and firing rod using known assembly methods without redesigning Zemlock’s core rotational drive device.
Because the references address the same engineering problem (rotational drive assembly systems comprising end effectors) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (attaching a compatible end effector connector to the base firing rod), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 11, Zemlock modified by Ziniti teaches the surgical instrument according to claim 7, as set forth above, for the reasons set forth above.
Ziniti teaches wherein rotation of the drive assembly about the longitudinal axis relative to the outer tube causes a corresponding rotation of the needle assembly about the longitudinal axis relative to the outer tube (¶71).
Regarding independent claim 18, Zemlock teaches a surgical kit, comprising:
a drive motor (200) configured to connect to a source of power (FIG 4, power source 400 (¶89);
a first end effector assembly (160) including a first drive assembly (FIGs 4, 6, 7, “drive components e.g., including a drive motor 200, a drive tube 210 and a firing rod 220, etc.”; ¶¶74, 77),
an outer tube (210), and
the first drive assembly (FIGs 4, 6, 7; ¶¶74, 77) configured to selectively engage the drive motor (200),
an outer tube (210) and in mechanical cooperation (¶81) with the first drive assembly (FIGs 4, 6, 7; ¶¶74, 77), wherein when the first drive assembly is engaged with the drive motor (200) (¶81),
actuation of the drive motor (200) is configured to move an end effector distally (¶81) relative to the outer tube of the first end effector assembly (¶79); and
a second end effector assembly (loading unit, ¶¶50-52) including a second drive assembly (¶88) and an outer tube (endoscopic portion 140), the second drive assembly (¶88) configured to selectively engage the drive motor (200) ,
the outer tube (210) configured to house (cartridge assembly 164) at least one surgical tack (staples 66) at least partially therein (¶49), wherein when the second drive assembly is engaged with the drive motor (¶88),
actuation of the drive motor (200) is configured to move the at least one surgical tack (66) housed at least partially within the outer tube (140) distally relative to the outer tube of the second end effector
Zemlock does not teach a needle assembly.
Ziniti teaches surgical instruments (200) comprising an elongate shaft (208) that may be operated with a needle drive mechanism included within an actuatable at a handle provided at the proximal end of the shaft (¶44). The end effector comprising the needle assembly (FIG 3, ¶46) comprises at least one longitudinal slot (212) configured to slidingly engage a needle assembly (FIGs 19A, B, demonstrate sliding engagement of the longitudinal slot, ¶111).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Zemlock and Ziniti given that the prior art included each element claimed, although not necessarily in a single reference. Zemlock and Ziniti teach in the field of surgical instruments comprising end effectors.
Although Zemlock discloses the claimed base surgical instrument (drive assembly, drive motor, longitudinal axis, helix assembly, and outer tube), Zemlock does not expressly disclose the instrument further including a needle assembly disposed at least partially within the outer tube. However, Zemlock teaches generic end effectors in mechanical cooperation with the firing rod (220) so that the firing rod (220) drives a surgical function of the end effector (Abstract; ¶52). Zemlock teaches that such end effectors may be coupled to endoscopic portion 140 of powered surgical instrument 10 (¶52). Ziniti specifically addresses rotational drive assembly devices comprising end effectors comprising a needle assembly disposed at least partially within the outer tube.
Because Zemlock teaches the base rotational drive assembly, motor, and helix assembly and teaches that different end effectors may be coupled to the base drive assembly unit and connected to the same base firing mechanism, a person of ordinary skill in the art, seeking to utilize a single base drive assembly with multiple end effectors would reasonably look to Ziniti’s rotational needle assembly end effector, which can be incorporated alongside Zemlock’s base rotational drive assembly and firing rod using known assembly methods without redesigning Zemlock’s core rotational drive device. Because the references address the same engineering problem (rotational drive assembly systems comprising end effectors) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (attaching a compatible end effector connector to the base firing rod), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 19, Zemlock modified by Ziniti teaches the surgical kit according to claim 18, as set forth above, for the reasons set forth above.
Zemlock teaches wherein the first end effector assembly (160) further includes a helix assembly (FIG 7, firing rod 220, ¶79) disposed in mechanical cooperation with the first drive assembly (210).
Ziniti teaches that the assembly is disposed in mechanical cooperation with the needle assembly (¶44).
Regarding claim 22, Zemlock modified by Ziniti teaches the surgical instrument according to claim 7, as set forth above, for the reasons set forth above.
Ziniti teaches the instrument further including a biasing element (spring 454; compression spring not shown) disposed in mechanical cooperation with the needle assembly, the biasing element configured to bias the needle assembly distally relative to the drive assembly (¶77).
Claims 5 and 6 remain rejected under 35 U.S.C. 103 as being unpatentable over Zemlock et al., US 20090090763 (9 April 2009) in view of Triplett et al., US 20120116422 (10 May 2012), for the reasons of record and the reasons set forth herein.
Regarding claim 5, Zemlock teaches the surgical instrument according to claim 2, as set forth above, wherein the drive assembly includes a body portion (168; ¶50).
Zemlock does not teach a first arm extending distally from the body portion, and a second arm extending distally from the body portion.
Triplett teaches suture passers comprising a handle assembly, a shaft assembly, a jaw assembly, and a needle assembly wherein a clevis and pin assembly is used as a connector (FIG 11, clevis 274) such that the clevis comprises a first arm and a second arm extending distally from the body portion (FIG 11, ¶78).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Zemlock and Triplett given that the prior art included each element claimed, although not necessarily in a single reference. Zemlock and Triplett teach in the field of surgical instruments comprising end effectors.
Although Zemlock discloses the claimed base surgical instrument (drive assembly, drive motor, longitudinal axis, helix assembly, and outer tube), Zemlock does not expressly disclose a first arm extending distally from the body portion, and a second arm extending distally from the body portion. However, Zemlock teaches end effector 160 attached to mounting portion 166, which is pivotably attached to a body portion 168. Body portion 168 may be integral with endoscopic portion 140 of powered surgical instrument 10, or may be removably attached to the instrument 10 (¶50).
Triplett specifically addresses surgical device comprising end effectors comprising a clevis and pin assembly used as a connector such that the clevis comprises a first arm and a second arm extending distally from the body portion (FIG 11, ¶78). Because Zemlock teaches the base rotational drive assembly, motor, and helix assembly and teaches that different end effectors may be coupled to the base drive assembly unit and connected to the same base firing mechanism, a person of ordinary skill in the art, seeking to utilize a single base drive assembly with multiple end effectors would reasonably look to Triplett’s clevis connector solution, which can be incorporated alongside Zemlock’s base rotational drive assembly and firing rod using known assembly methods without redesigning Zemlock’s core rotational drive device.
Because the references address the same engineering problem (drive assembly systems comprising end effectors) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (attaching a compatible end effector connector using a clevis to the base firing rod), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 6, Zemlock modified by Triplett teaches the surgical instrument according to claim 5, as set forth above, for the reasons set forth above.
Zemlock does not teach wherein each of the first arm and the second arm of the drive assembly is configured to contact a needle assembly.
Triplett teaches wherein each of the first arm and the second arm (clevis 274) of the drive assembly is configured to contact a needle assembly (FIGs 11, 12A, 12B, ¶21; where FIG 12B is a superior view of the lower jaw of FIG 12A which is a side view of the lower jaw of FIG 11 and the dotted line D in FIG 12B represents the path of a needle through the lower jaw).
Claims 8-10, 12-17, 20, and 21 remain rejected under 35 U.S.C. 103 as being unpatentable over Zemlock et al., US 20090090763 (9 April 2009) in view of Ziniti et al., US 20130116709 (9 May 2013) and further in view of Triplett et al., US 20120116422 (10 May 2012), for the reasons of record and the reasons set forth herein.
Regarding claim 8, Zemlock modified by Ziniti teaches the surgical instrument according to claim 7, as set forth above, for the reasons set forth above.
Zemlock does not teach wherein the needle assembly includes a pin, and the helix assembly includes a longitudinal slot configured to slidingly engage the pin of the needle assembly.
However, Zemlock teaches other means of connecting end effector 160 to endoscopic portion 140 to allow articulation may be used, such as a flexible tube or a tube comprising a plurality of pivotable members (¶51).
Ziniti teaches surgical instruments (200) comprising an elongate shaft (208) that may be operated with a needle drive mechanism included within an actuatable at a handle provided at the proximal end of the shaft (¶44). The end effector comprising the needle assembly (FIG 3, ¶46) comprises at least one longitudinal slot (212) configured to slidingly engage a needle assembly (FIGs 19A, B, demonstrate sliding engagement of the longitudinal slot, ¶111).
Neither Zemlock nor Ziniti teach wherein the needle assembly includes a pin.
Triplett teaches suture passers comprising a handle assembly, a shaft assembly, a jaw assembly, and a needle assembly wherein a clevis and pin assembly is used as a connector (FIG 11, clevis 274) such that the clevis comprises a first arm and a second arm extending distally from the body portion (FIG 11, ¶78) and wherein connections between the needle assembly includes a pin (360, 362, 364; ¶78), and the helix assembly includes a longitudinal slot (in clevis 274) configured to slidingly engage the pin of the needle assembly (FIG 11, ¶¶76, 78).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Zemlock, Ziniti, and Triplett, given that the prior art included each element claimed, although not necessarily in a single reference. Zemlock, Ziniti, and Triplett teach in the field of surgical instruments comprising end effectors.
Although Zemlock discloses the claimed base surgical instrument (drive assembly, drive motor, longitudinal axis, helix assembly, and outer tube), Zemlock does not expressly disclose wherein the helix assembly (220) includes at least one longitudinal slot configured to slidingly engage a needle assembly. However, Zemlock teaches generic end effectors in mechanical cooperation with the firing rod (220) so that the firing rod (220) drives a surgical function of the end effector (Abstract; ¶52). Zemlock teaches that such end effectors may be coupled to endoscopic portion 140 of powered surgical instrument 10 (¶52).
Ziniti specifically addresses rotational drive assembly devices comprising end effectors comprising longitudinal slots configured to slidingly engage a needle assembly. Because Zemlock teaches the base rotational drive assembly, motor, and helix assembly and teaches that different end effectors may be coupled to the base drive assembly unit and connected to the same base firing mechanism, a person of ordinary skill in the art, seeking to utilize a single base drive assembly with multiple end effectors would reasonably look to Ziniti’s rotational needle assembly end effector, which can be incorporated alongside Zemlock’s base rotational drive assembly and firing rod using known assembly methods without redesigning Zemlock’s core rotational drive device.
Triplett specifically addresses surgical device comprising end effectors comprising a clevis and pin assembly used as a connector such that the clevis comprises a first arm and a second arm extending distally from the body portion (FIG 11, ¶78) and uses a pin. Because Zemlock teaches the base rotational drive assembly, motor, and helix assembly and teaches that different end effectors may be coupled to the base drive assembly unit and connected to the same base firing mechanism, including by other means of connecting end effector 160 to endoscopic portion 140 to allow articulation may be used, such as a flexible tube or a tube comprising a plurality of pivotable members (¶51), a person of ordinary skill in the art, seeking to utilize a single base drive assembly with multiple end effectors would reasonably look to Triplett’s clevis connector solution, which can be incorporated alongside Zemlock’s base rotational drive assembly and firing rod using known assembly methods without redesigning Zemlock’s core rotational drive device.
Because the references address the same engineering problem (rotational drive assembly systems comprising end effectors) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (attaching a compatible end effector connector to the base firing rod where the connector is a dual-armed clevis comprising a pin), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 9, Zemlock modified by Ziniti and Triplett teaches the surgical instrument according to claim 8, as set forth above, for the reasons set forth above.
Triplett teaches wherein the needle assembly is movable relative to the helix assembly from a first position where the pin is out of alignment with the longitudinal slot of the helix assembly, to a second position where the pin is aligned with the longitudinal slot of the helix assembly (FIG 11; pins 360, 362, 364; ¶¶76, 78).
Regarding claim 10, Zemlock modified by Ziniti and Triplett teaches the surgical instrument according to claim 9, as set forth above, for the reasons set forth above.
Triplett teaches wherein the needle assembly is movable relative to the helix assembly from the second position to a third position where the pin has been distally translated relative to the helix assembly (FIG 11; pins 360, 362, 364; ¶¶76, 78).
Regarding independent claim 12, Zemlock teaches a surgical instrument, comprising:
a drive motor configured to connect to a source of power (FIGs 4-8, drive motor 200);
a drive assembly (FIGs 4, 6, 7, “drive components e.g., including a drive motor 200, a drive tube 210 and a firing rod 220, etc.”; ¶¶74, 77) disposed in mechanical cooperation with the drive motor (200; ¶74) and defining a longitudinal axis (axis C-C, ¶74);
a helix assembly (FIG 7, firing rod 220, ¶79)
wherein actuation of the drive motor (200) causes rotation of the drive assembly (FIGs 4, 6, 7; ¶¶74, 77) about the longitudinal axis (C-C),
causes rotation of the helix assembly (220) about the longitudinal axis (C-C; FIGs 5, 6; ¶79).
Zemlock does not teach a needle assembly including a pin, the needle assembly disposed in mechanical cooperation with the drive assembly; the helix assembly disposed in mechanical cooperation with the needle assembly, the helix assembly including a longitudinal slot configured to slidingly engage the pin of the needle assembly, and wherein the actuation of the drive motor causes the needle assembly to move relative to the helix assembly from a first position where the pin is out of alignment with the longitudinal slot of the helix assembly, to a second position where the pin is aligned with the longitudinal slot of the helix assembly.
Ziniti teaches surgical instruments (200) comprising an elongate shaft (208) that may be operated with a needle drive mechanism included within an actuatable at a handle provided at the proximal end of the shaft (¶44). The end effector comprising the needle assembly (FIG 3, ¶46) comprises at least one longitudinal slot (212) configured to slidingly engage a needle assembly (FIGs 19A, B, demonstrate sliding engagement of the longitudinal slot, ¶111).
Triplett teaches suture passers comprising a handle assembly, a shaft assembly, a jaw assembly, and a needle assembly wherein a clevis and pin assembly is used as a connector (FIG 11, clevis 274) such that the clevis comprises a first arm and a second arm extending distally from the body portion (FIG 11, ¶78) and wherein connections between the needle assembly includes a pin (360, 362, 364; ¶78), and the helix assembly includes a longitudinal slot (in clevis 274) configured to slidingly engage the pin of the needle assembly (FIG 11, ¶¶76, 78). Triplett teaches wherein the needle assembly is movable relative to the helix assembly from a first position where the pin is out of alignment with the longitudinal slot of the helix assembly, to a second position where the pin is aligned with the longitudinal slot of the helix assembly (FIG 11; pins 360, 362, 364; ¶¶76, 78).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Zemlock, Ziniti, and Triplett, given that the prior art included each element claimed, although not necessarily in a single reference. Zemlock, Ziniti, and Triplett teach in the field of surgical instruments comprising end effectors. Although Zemlock discloses the claimed base surgical instrument (drive assembly, drive motor, longitudinal axis, helix assembly, and outer tube). Ziniti specifically addresses rotational drive assembly devices comprising end effectors comprising longitudinal slots configured to slidingly engage a needle assembly. Because Zemlock teaches the base rotational drive assembly, motor, and helix assembly and teaches that different end effectors may be coupled to the base drive assembly unit and connected to the same base firing mechanism, a person of ordinary skill in the art, seeking to utilize a single base drive assembly with multiple end effectors would reasonably look to Ziniti’s rotational needle assembly end effector, which can be incorporated alongside Zemlock’s base rotational drive assembly and firing rod using known assembly methods without redesigning Zemlock’s core rotational drive device.
Triplett specifically addresses surgical device comprising end effectors comprising a clevis and pin assembly used as a connector such that the clevis comprises a first arm and a second arm extending distally from the body portion (FIG 11, ¶78) and uses a pin. Because Zemlock teaches the base rotational drive assembly, motor, and helix assembly and teaches that different end effectors may be coupled to the base drive assembly unit and connected to the same base firing mechanism, a person of ordinary skill in the art, seeking to utilize a single base drive assembly with multiple end effectors would reasonably look to Triplett’s clevis connector solution, which can be incorporated alongside Zemlock’s base rotational drive assembly and firing rod using known assembly methods without redesigning Zemlock’s core rotational drive device.
Because the references address the same engineering problem (rotational drive assembly systems comprising end effectors) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (attaching a compatible end effector connector to the base firing rod where the connector is a dual-armed clevis comprising a pin), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 13, Zemlock modified by Ziniti and Triplett teaches the surgical instrument according to claim 12, as set forth above, for the reasons set forth above.
Zemlock teaches end effector 160 attached to mounting portion 166, which is pivotably attached to a body portion 168. Body portion 168 may be integral with endoscopic portion 140 of powered surgical instrument 10, or may be removably attached to the instrument 10 (¶50).
Triplett teaches suture passers comprising a handle assembly, a shaft assembly, a jaw assembly, and a needle assembly wherein a clevis and pin assembly is used as a connector (FIG 11, clevis 274) such that the clevis comprises a first arm and a second arm extending distally from the body portion (FIG 11, ¶78).
Regarding claim 14, Zemlock modified by Ziniti and Triplett teaches the surgical instrument according to claim 13.
Triplett teaches wherein each of the first arm and the second arm (clevis 274) of the drive assembly is configured to contact a needle assembly (FIGs 11, 12A, 12B; “FIG 12B is a superior view of the lower jaw of FIG 12A which is a side view of the lower jaw of FIG 11 and the dotted line D in FIG 12B represents the path of a needle through the lower jaw”, ¶21).
Regarding claim 15, Zemlock modified by Ziniti and Triplett teaches the surgical instrument according to claim 12, as set forth above, for the reasons set forth above.
Triplett teaches wherein the needle assembly is movable relative to the helix assembly from the second position to a third position where the pin has been distally translated relative to the helix assembly (FIG 11; pins 360, 362, 364; ¶¶76, 78).
Regarding claim 16, Zemlock modified by Ziniti and Triplett teaches the surgical instrument according to claim 12, as set forth above, for the reasons set forth above.
Ziniti teaches the instrument further including a biasing element (spring 454; compression spring not shown) disposed in mechanical cooperation with the needle assembly, the biasing element configured to bias the needle assembly distally relative to the drive assembly (¶77).
Regarding claim 17, Zemlock modified by Ziniti and Triplett teaches the surgical instrument according to claim 12, as set forth above, for the reasons set forth above.
Ziniti teaches wherein rotation of the drive assembly about the longitudinal axis relative to the outer tube causes a corresponding rotation of the needle assembly about the longitudinal axis relative to the outer tube (¶71).
Regarding claim 20, Zemlock modified by Ziniti teaches the surgical kit according to claim 19, as set forth above, for the reasons set forth above.
Zemlock modified by Ziniti does not teach wherein needle assembly of the first end effector assembly (160) includes a pin, and the helix assembly (FIG 7, firing rod 220, ¶79) includes a longitudinal slot configured to engage the pin of the needle assembly.
Triplett teaches suture passers comprising a handle assembly, a shaft assembly, a jaw assembly, and a needle assembly wherein a clevis and pin assembly is used as a connector (FIG 11, clevis 274) such that the clevis comprises a first arm and a second arm extending distally from the body portion (FIG 11, ¶78) and wherein connections between the needle assembly includes a pin (360, 362, 364; ¶78), and the helix assembly includes a longitudinal slot (in clevis 274) configured to slidingly engage the pin of the needle assembly (FIG 11, ¶¶76, 78). Triplett teaches wherein the needle assembly is movable relative to the helix assembly from a first position where the pin is out of alignment with the longitudinal slot of the helix assembly, to a second position where the pin is aligned with the longitudinal slot of the helix assembly (FIG 11; pins 360, 362, 364; ¶¶76, 78).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Zemlock, Ziniti, and Triplett, given that the prior art included each element claimed, although not necessarily in a single reference.
Zemlock, Ziniti, and Triplett teach in the field of surgical instruments comprising end effectors. Although Zemlock discloses the claimed base surgical instrument (drive assembly, drive motor, longitudinal axis, helix assembly, and outer tube). Ziniti specifically addresses rotational drive assembly devices comprising end effectors comprising longitudinal slots configured to slidingly engage a needle assembly. Because Zemlock teaches the base rotational drive assembly, motor, and helix assembly and teaches that different end effectors may be coupled to the base drive assembly unit and connected to the same base firing mechanism, a person of ordinary skill in the art, seeking to utilize a single base drive assembly with multiple end effectors would reasonably look to Ziniti’s rotational needle assembly end effector, which can be incorporated alongside Zemlock’s base rotational drive assembly and firing rod using known assembly methods without redesigning Zemlock’s core rotational drive device.
Triplett specifically addresses surgical device comprising end effectors comprising a clevis and pin assembly used as a connector such that the clevis comprises a first arm and a second arm extending distally from the body portion (FIG 11, ¶78) and uses a pin. Because Zemlock teaches the base rotational drive assembly, motor, and helix assembly and teaches that different end effectors may be coupled to the base drive assembly unit and connected to the same base firing mechanism, a person of ordinary skill in the art, seeking to utilize a single base drive assembly with multiple end effectors would reasonably look to Triplett’s clevis connector solution, which can be incorporated alongside Zemlock’s base rotational drive assembly and firing rod using known assembly methods without redesigning Zemlock’s core rotational drive device.
Because the references address the same engineering problem (rotational drive assembly systems comprising end effectors) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (attaching a compatible end effector connector to the base firing rod where the connector is a dual-armed clevis comprising a pin), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 21, Zemlock modified by Ziniti and Triplett teaches the surgical kit according to claim 20, as set forth above, for the reasons set forth above.
Zemlock teaches wherein the helix assembly (FIG 7, firing rod 220, ¶79) includes a helical thread (threaded portion 226, ¶79), and the outer tube (210) includes a helical groove (internally-threaded portion 212) configured to engage the helical thread of the helix assembly (¶79).
Conclusion
No claim is allowed.
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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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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