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 17 November 2025 is acknowledged. Claim 1 and the second numbered claim 10 are cancelled. New claim 22, comprising the language of prior examined second claim numbered 10, is added. Claims 2-22 are pending and under examination.
Advisory Notice
This Office Action is NON-FINAL.
Objections/Rejections Withdrawn
The objection to the second claim numbered “10” is withdrawn in light of Applicant’s amendments.
The rejection of claims 6, 7, and 11 under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al., US 20160045222 18 February 2016, is withdrawn. A new rejection is set forth below.
The indication of allowable subject matter is withdrawn.
Response to Arguments
Applicant argues that FIGs 63-64 show that both the drive assembly 2710 and the helix assembly 2740 occur about the same longitudinal axis of drive assembly 2710 (Remarks, numbered p. 6). Applicant argues that Lee’s device comprises a helical gear shaft 44 configured to rotate about an axis which is not the longitudinal axis of the output shaft 32 (Remarks, numbered p. 7). Applicant argues that because the longitudinal output shaft 32 and the helical gear shaft 44 of Lee do not share the same longitudinal axis, Lee does not properly anticipate independent claim 2 (Remarks, numbered page 9). Applicant argues that all claims are allowable over Lee (Remarks, numbered page 9).
Applicant’s arguments have been fully considered, but they are not persuasive. Applicant’s arguments focus on two embodiments in the disclosure, but these are not consistent with the breadth of the claims, as written. The claims do not require the drive assembly, the motor, and the helix assembly to be coaxial with respect to the longitudinal axis of the drive assembly. The limitation of “and defining a longitudinal axis” applies to the drive assembly and not to the drive motor. The claim establishes that the drive assembly defines a longitudinal axis. The last limitation (claim 2, lines 9-11) only requires that there is rotation about the longitudinal axis of the drive assembly, but not necessarily that the motor and helix assembly share the same longitudinal axis. Accordingly, the rejection is maintained.
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 2-7, and 11 remain rejected and new claim 22 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al., US 20160045222 (18 February 2016).
Regarding independent claim 2, Lee teaches a surgical instrument (Abstract; ¶6 apparatus comprising stereotactic positioning system, a power propulsion system of an invasive tubular devoice, and a non-reusable invasive tubular device), comprising:
a drive motor configured to connect to a source of power (FIG 2, ¶42, servomotor 7);
a drive assembly disposed in mechanical cooperation with the drive motor and defining a longitudinal axis (FIG 2, ¶42 servomotor 7 and gearbox assembly 6, longitudinal output shaft enclosure 5);
a helix assembly disposed in mechanical cooperation with the drive assembly, the helix assembly including a helical thread (FIGs 5B, 5C longitudinal helical gear shaft 44; ¶13 “[t]he helical gear of the helical gear shaft coaxially meshes with the internal threads of the propulsion block”);
and an outer tube disposed in mechanical cooperation with the helix assembly (FIGs 5A, 8, ¶45 longitudinal overture 39 and upper slide rail 41),
the outer tube including a helical groove configured to engage the helical thread of the helix assembly (FIGs 5A-5C, ¶45 “longitudinal overture 39 having internal threads on an inner wall of said overture … helical gear shaft 44 which has a continuous helical gear on an outer surface of said shaft between a distal end of the spur gear 47 and the distal rotating shaft 46”),
wherein actuation of the drive motor causes rotation of the drive assembly about the longitudinal axis relative to the outer tube and causes rotation of the helix assembly about the longitudinal axis relative to the outer tube (¶13).
Regarding claim 3, Lee teaches the surgical instrument according to claim 2, as set forth above, wherein the helix assembly is movable along the longitudinal axis relative to the outer tube (FIGs 5A-5C, ¶45).
Regarding claim 4, Lee teaches the surgical instrument according to claim 2, as set forth above, wherein the helix assembly includes at least one longitudinal slot configured to slidingly engage a needle assembly (¶13; FIG 8, ¶50).
Regarding claim 5, Lee teaches the surgical instrument according to claim 2, as set forth above, wherein the drive assembly includes a body portion (FIG 7, ¶48 central portion 92), a first arm (FIG 7, ¶48, vertical slide rails 88, 89) extending distally from the body portion (FIG 7, ¶48 central portion 92), and a second arm (FIG 7, ¶48 horizontal slide rails 90, 91) extending distally from the body portion (FIG 7, ¶48 central portion 92).
Regarding claim 6, Lee teaches the surgical instrument according to claim 5, as set forth above, wherein each of the first arm (FIG 7, ¶48, vertical slide rails 88, 89) and the second arm (FIG 7, ¶48 horizontal slide rails 90, 91) of the drive assembly is configured to contact a needle assembly (FIG 7, ¶48 central portion 92, tubular shaft 79).
Regarding claim 7, Lee teaches the surgical instrument according to claim 2, as set forth above, further including a needle assembly (stylet 123) disposed at least partially within the outer tube (FIG 9, ¶20; FIGs 9B, 9C, ¶51).
Regarding claim 11, Lee teaches the surgical instrument according to claim 7, as set forth above, 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 (¶13 “the propulsion assembly is configured to convert rotational torque of the helical gear shaft to axial movement of the propulsion block of said propulsion assembly … [r]otation of the helical gear shaft transmits rotational torque to the internal threads of the propulsion block which moves axially in the longitudinal rail slots”; ¶51 “[s]equence of actuation of the stylet 123 for obtaining tissue samples starts with the two-part coupling block 81 and 124 separated by the pivotable separator panel 120 moving toward the depth lock 87 in a locked position, driven by the propulsion block 39 of FIG 8).
Regarding new claim 22 (formerly numbered second claim 10), Lee teaches the surgical instrument according to claim 7, as set forth above, further including a biasing element (FIG 9, ¶51 compression spring 122) disposed in mechanical cooperation with the needle assembly (¶51), the biasing element configured to bias the needle assembly distally relative to the drive assembly (¶20).
New Claim Rejections
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18-21 are rejected 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.
Claim 18, line 9 recites “an outer tube” that is associated with a second end effector assembly including a second drive assembly, but it is unclear whether this is the same outer tube at the outer tube of the first end effector assembly (see claim 18, line 8).
Claims 19-21 are rejected as being dependent on a rejected claim.
Applicant is referred to Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (2008). A five member expanded panel of the Board held that "if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 USC 112, second paragraph, as indefinite."
Applicant is also referred to Nautilus Inc., v. Biosig Instruments, Inc., 572 U.S. 898, 908-909 (2014) in which the Court held that a claim is indefinite if the specification and prosecution history fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. The Court also held that a patent must be precise enough to afford clear notice of what is claimed thereby "appris[ing] the public of what is still open to them (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (1996)), in a manner that avoids "[a] zone of uncertainty which enterprise and experimentation may enter only at the risk of infringement claims," (citing United Carbon Co., v. Binney & Smith Co., 317 U.S. 228, 236 (1942)) (Nautilus 909).
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zemlock et al., US 20090090763 (9 April 2009).
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 (axial drive assembly 213, ¶82) 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) disposed in mechanical cooperation with the drive assembly (210), 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 (212; ¶79),
the outer tube (drive 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 (213) about the longitudinal axis (C-C) relative to the outer tube (210) and causes rotation of the helix assembly (212) about the longitudinal axis (C-C) 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 relative to the outer tube (¶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 are 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).
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 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).
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).
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.
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 configured to connect to a source of power (FIGs 4-8, drive motor 200);
a first end effector assembly (160) including a first drive assembly (213),
an outer tube (210), and
the first drive assembly (213) configured to selectively engage the drive motor (200),
the needle assembly disposed at least partially within the outer tube (210) and in mechanical cooperation with the first drive assembly (213) (¶81), 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 (¶54) relative to the outer tube of the first end effector assembly (¶79); and
a second end effector assembly (¶¶50-52) including a second drive assembly (axial drive assembly, ¶88) and an outer tube (140), the second drive assembly (loading unit 169, ¶52) configured to selectively engage the drive motor,
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 assembly (¶54).
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).
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, 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 new claim 22, Zemlock modified by Ziniti teaches the surgical instrument according to claim 7, as 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 are 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).
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).
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.
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 are 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).
Regarding claim 8, Zemlock modified by Ziniti teaches the surgical instrument according to claim 7, as 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).
Zemlock, Ziniti, and Triplet 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.
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.
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 (axial drive assembly 213, ¶82) 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 (213) about the longitudinal axis (C-C),
causes rotation of the helix assembly about the longitudinal axis (212) 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).
Zemlock, Ziniti, and Triplet 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.
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, ¶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).
Regarding claim 15, Zemlock modified by Ziniti and Triplett teaches the surgical instrument according to claim 12, as 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.
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.
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.
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).
Zemlock, Ziniti, and Triplet 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.
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. This Office Action is NON-FINAL.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Shelton et al., US 20150272603 (1 October 2015) teaches surgical devices with articulating end effectors (¶8). However, Shelton does not expressly teach a drive assembly disposed in mechanical cooperation with the drive motor and defining a longitudinal axis.
Zemlock et al., US 20130292450 (7 November 2013) teaches powered surgical instruments.
Milliman et al., US 6,953,139 (11 October 2005) teaches surgical stapling apparatus.
Sato, US 20160302824 (20 October 2016) teaches puncture treatment tools.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771