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 .
Claim Rejections - 35 USC § 112
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 1-14, 18 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.
In re claim 1, there is insufficient antecedent basis for the limitation “the actuator engagement members”. For examination purposes, “the actuator engagement members” will be interpreted as “the one or more actuator engagement members”.
Examiner notes that claims 2-14 inherit the same deficiencies.
In re claim 18, there is insufficient antecedent basis for the limitation “the actuator member”. For examination purposes, “the actuator member” will be interpreted as “the actuator engagement member”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 8-11, 13-17, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Grover et al. (US 10,321,964).
In re claim 1, Grover discloses a surgical instrument (FIG. 2: 200) comprising:
an instrument shaft (220) having a proximal end (end of 220 closest to 210) and a distal end (end of 220 closest to 230), the instrument shaft defining an insertion axis (A1);
an end effector (230) coupled to the distal end of the instrument shaft (FIG. 2); and
a proximal end portion (210, shown in greater detail in FIGS. 11 and 12) coupled to the proximal end of the instrument shaft (FIG. 12), the proximal end portion comprising:
an instrument shaft actuator engagement member (portion of 210 that engages with 150) configured to releasably couple (col. 7, lines 46-52; col. 7, lines 16-18) the proximal end portion to an actuator (150) of an instrument drive system (150, 130, 110 and optionally any other elements that result in proximal/distal movement) for moving the surgical instrument at least one of proximally or distally along the insertion axis in relation to the instrument drive system (proximal/distal movement indicated by black double sided arrow, “L5”, shown in FIG. 11); and
one or more actuator engagement members (214a, 214a, 214b, 214b) movably coupled within the proximal end portion (FIG. 12; col. 7, lines 46-52),
the actuator engagement members configured to releasably engage with actuators of the instrument drive system (col. 7, lines 46-52) to be driven linearly along the insertion axis (col. 7, lines 10-13) to articulate the end effector (col. 9, lines 10-15).
In re claim 2, Grover discloses, wherein the proximal end portion defines one or more *outwardly open slots (210a), each one of the one or more actuator engagement members received in and slidable (“L6”) along one of the slots (FIG. 11, FIG. 12; col. 7, lines 18-24).
*Under the broadest reasonable interpretation an “outwardly open slot” is being interpreted as a slot that does not have any type of cover. Examiner asserts that slots 210 are “outwardly open” given that they do not include a cover portion. The lack of cover portion is apparent by the fact that each of the one or more actuator engagement members extend outside of the slots (see Grover, FIG. 12).
In re claim 3, Grover discloses, wherein the one or more actuator engagement members extend radially outward (apparent as components 214b, 214a, 214b, 214a stick out of slot) beyond an outer perimeter (boundary created by top face of slots 210a) of the proximal end portion to engage the actuators of the instrument drive system (col. 7, lines 46-52).
In re claim 4, Grover discloses, further comprising one or more tensioning members (216) extending between the one or more actuator engagement members and the end effector along the instrument shaft (FIG. 12; col. 7, line 64- col. 8, line 7).
In re claim 5, Grover discloses, wherein the one or more actuator engagement members comprise two paired actuator engagement members having corresponding movements via one of the one or more tensioning members extending therebetween (FIG. 12; col. 7, lines 46-48: “a first pair of linear driven members 214a” and “a second pair of linear driven members 214b”) .
In re claim 8, Grover discloses, wherein the one or more actuator engagement members comprise at least four actuator engagement members (214a, 214a, 214b, 214b) to provide the end effector with at least four degrees of freedom (col. 9 , lines 10-15: “imparts movement (e.g. rotation, pivoting, articulation, longitudinal/lateral translation) on end effector”; See Applicant’s specification [0074] which lists different movement patterns as being examples of degrees of freedom).
In re claim 9, Grover discloses, wherein the one or more actuator engagement members comprise a plurality of actuator engagement members (see above (In re claim 1)) disposed in a grouping at a common longitudinal location along the insertion axis (FIG. 12 shows “actuator engagement members” 214a, 214a, 214b, 214b grouped together “along the insertion axis”)
In re claim 10, Grover discloses, wherein the one or more actuator engagement members comprise
a first plurality of actuator engagement members (214a, 214a; col. 7 lines 46-48: “a first pair of linear driven members”) disposed in a first grouping (col. 7, lines 46-48: “a first pair”) at a first *longitudinal location along the insertion axis (FIG. 12) and
a second plurality of actuator engagement members (214b, 214b; col. 7, lines 46-48 : “ a second pair of linear driven members 214b”) disposed in a second grouping (col. 7, lines 46-48: “a second pair”) at a second *longitudinal location along the insertion axis (FIG. 12).
*Examiner notes that “longitudinal” is being interpreted according to its plan meaning, that is, specifying an east and west position. Consequently, the limitation “a first/second longitudinal location along an assertion axis” is being interpreted as a location east/west to the insertion axis.
In re claim 11, Grover discloses, wherein the instrument shaft actuator engagement member is **configured to releasably couple the proximal end portion to the actuator of the instrument drive system for moving the surgical instrument both proximally and distally along the insertion axis in relation to the instrument drive system (col. 7, lines 46-52: Examiner notes that “instrument shaft actuator engagement member” includes element 154a which “couples to” the “proximal end portion” via elements 214a, 214b, 214a, 214b; As indicated above proximal/distal movement is represented by double sided black arrows shown in FIG. 11).
**Although disclosed by Grover, Examiner notes that the limitation “configured to releasably couple the proximal end portion to the actuator of the instrument drive system for moving the surgical instrument both proximally and distally along the insertion axis in relation to the instrument drive system”, comprises functional language and is given patentable weight only in how it materially alters or adds structure to the apparatus of the claims. See MPEP 2115. The prior art need only be able to perform these functions in order to anticipate the claimed invention.
In re claim 13, Grover discloses, wherein the instrument shaft actuator engagement member, when coupled with an actuator of the instrument drive system (col. 7, 13-30: Examiner notes that the “instrument shaft engagement member” (see above In re claim 1) is “operably coupled to rotatable members 130 for linear translation”; ) ***is configured to balance proximally directed forces applied by actuators of the instrument drive system to the one or more actuator engagement members (see *** below).
***Regarding the instrument shaft actuator engagement member being “configured to balance proximally directed forces applied by actuators of the instrument drive system to the one or more actuator engagement members”, this limitation comprises functional language and is given patentable weight only in how it materially alters or adds structure to the apparatus of the claims. See MPEP 2115. The prior art need only be able to perform these functions in order to anticipate the claimed invention. It is clear that the system of Grover could be operated in the claimed manner if desired.
In re claim 14, Grover discloses, wherein the surgical instrument is linearly movably coupled to the instrument drive system such that the movement of the surgical instrument along the insertion axis is relative to the instrument drive system while the instrument drive system ****remains fixed (col. 5, lines 48-59: movement of surgical instrument indicated by “L1” in FIG. 2).
****Examiner notes that under the broadest reasonable interpretation the limitation “remains fixed” is being interpreted to require at least one component of the instrument drive system remains fixed/stationary during movement of the surgical instrument along the insertion axis. This interpretation is supported by Applicant’s specification [0139-144] which describes the instrument drive system, 700, as including components that are both fixed (710, 705) and not fixed (730, 740).
In re claim 15, Grover discloses, a method (col. 1, lines 51-55) of operating a telesurgical system (FIG. 2, FIG. 3) including an instrument drive system (110, shown in greater detail in FIG. 4A; Examiner notes “instrument drive system 110” includes elements 114 and 116; col. 6, lines 5-6 and 21-23) and an instrument (200, shown in greater detail in FIG. 12), the method comprising:
moving the surgical instrument proximally or distally (proximal/distal movement indicated by black double-sided arrows, “L1”) along an insertion (“A1”) axis relative to the instrument drive system with a first actuator (any of 114 illustrated in FIG. 4A) of the instrument drive system while the first actuator of the instrument drive system remains axially fixed (FIG. 2, FIG. 3),
wherein the surgical instrument is releasably coupled to the instrument drive system (col. 5, lines 48-59); and
moving an end effector (230) of the instrument by driving an actuator engagement member (one of 214a, 214b, 214a, 214b) of the instrument linearly along the insertion axis relative to a proximal end portion (210) of the instrument with a second actuator (any other of 114 illustrated in FIG. 4A) of the instrument drive system (col. 8, lines 64- col. 9, line 4; col. 9, lines 10-15)
In re claim 16, Grover discloses, wherein moving the end effector of the instrument by driving the actuator engagement member comprises transferring movement of the actuator engagement member to the end effector via a tensioning member (216) extending therebetween (col. 7, line 65- col. 8 line 7).
In re claim 17, Grover discloses, wherein moving the end effector of the instrument by driving the actuator engagement member comprises driving one of paired actuator engagement members of the instrument (col. 7, line 65- col. 8, line 7), the tensioning member extending between the paired actuator engagement members and the end effector (FIG. 12).
In re claim 20, Grover discloses, wherein moving the end effector of the instrument comprises one or more of: steering, grasping, cutting or stapling (col. 7 lines 55-58 : “fire surgical staples supported in end effector”).
Claim Rejections - 35 USC § 102/103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 19 is rejected under 35 U.S.C. 102(a)(1)/103 as being unpatentable over Grover et al. (US 10,321,964) [in view of Olson et al. (US 2006/0011699)].
In re claim 19, regarding the limitations “further comprising balancing proximally directed forces applied by the second actuator of the instrument drive system to the one or more actuator engagement members with the instrument shaft actuator engagement member coupled to the first actuator”, as discussed above (In re claim 13) it is clear that Grover includes the structural features required to perform the operation of “balancing proximally directed forces applied by the second actuator of the instrument drive system to the one or more actuator engagement members”. However, in so far as this step is not explicitly stated claim 19 is alternatively rejected under 35 U.S.C. 103 as follows:
Olson discloses an analogous surgical instrument (abstract; Fig. 1A) that maintains balance of proximally actuated forces to assure an end effector performs uniform and consistent stapling and cutting of tissue [0083].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method of Grover to further comprise balancing proximally directed forces applied by the second actuator of the instrument drive system to the one or more actuator engagement members, as taught by Olson. One would have been motivated to make this modification to ensure uniform and consistent stapling and cutting of tissue by the end effector (Olson, [0083]). Accordingly, such a modification would yield further comprising balancing proximally directed forces applied by the second actuator of the instrument drive system to the one or more actuator engagement members “with the instrument shaft actuator engagement member coupled to the first actuator”, given that Grover discloses the instrument shaft actuator engagement member being coupled to the first actuator.
Claim Rejections - 35 USC § 103
Claims 6, 7, and 18 are under 35 U.S.C. 103 as being unpatentable over Grover et al. (US 10, 321,964), in view of Marczyk et al. (US 2013/0123783).
In re claim 6, Grover does not disclose, wherein the one or more tensioning members comprise a flexible tensioning member, such that distal movement of a coupled one of the one or more actuator engagement members does not move the end effector.
Marczyk discloses an analogous surgical instrument (abstract, FIG. 1) that comprises an instrument shaft (16), an end effector (12), and a proximal end portion (14). As disclosed by Marczyk, mechanical motion is transmitted through the instrument shaft to the end effector via tensioning members ([0055]: “cables”). Marczyk further discloses the tensioning members being flexible or rigid [0055].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more tensioning members of Grover to comprise a flexible tensioning member, as taught by Marczyk. One would have been motivated to make this modification because using flexible tensioning members in such surgical instruments is known, as evidenced by Marczyk [0055]. Moreover, Examiner asserts that one of ordinary skill in the art would be able to choose the type of tensioning member that would best meet their needs. Accordingly, such a modification would yield “such that distal movement of a coupled one of the one or more actuator engagement members does not move the end effector” given that, as indicated by Applicant, the one or more tensioning members comprising a flexible tensioning member is what yields distal movement of a coupled one of the one or more actuator engagement members not moving the end effector.
In re claim 7, regarding the limitation “wherein the one or more tensioning members comprise a rigid tensioning member, such that proximal movement of a coupled one of the one or more actuator engagement members moves the end effector and distal movement of the coupled one of the one or more actuator engagement members moves the end effector”, for substantially the same reasons as described above In re claim 6, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more tensioning members of Grover to comprise a rigid tensioning member. Accordingly, such a modification would yield “such that proximal movement of a coupled one of the one or more actuator engagement members moves the end effector and distal movement of the coupled one of the one or more actuator engagement members moves the end effector” given that, as indicated by Applicant, the one or more tensioning members comprising a rigid tension member is what yields proximal movement of a coupled one of the one or more actuator engagement members to move the end effector and distal movement of the coupled one of the one or more actuator engagement members to move the end effector.
In re claim 18, Grover discloses, wherein the tensioning member comprises a tensioning member (216) such that moving the end effector of the instrument by driving the actuator engagement member comprises driving the actuator member proximally (col. 7, line 64- col. 8, line 7; col. 7, lines 48-52; col. 7, lines 18-24; Regarding the limitation “the actuator member”, see above section Claim Rejections 112)
Grover does not disclose wherein the tensioning member comprises a flexible tensioning member.
For substantially the same reasons as described above In re claim 6, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tensioning member of Grover to comprise a flexible tensioning member, as taught by Marczyk.
Claim 12 is under 35 U.S.C. 103 as being unpatentable over Grover et al. (US 10,321,964), in view of Devengenzo et al. (US 8,529,582).
In re claim 12, Grover does not disclose, wherein the instrument shaft actuator engagement member comprises a latch mechanism pivotably coupled to the proximal end portion.
Devengenzo discloses an analogous surgical instrument (FIG. 3) that like Grover comprises a shaft (23), an end effector (28), and an end portion (24, shown in greater detail in FIGS. 16A-16B). As shown in FIGS. 16A-16B, the end portion includes a first engagement member (109) with a latch (511) for easy installment (col. 10, lines 47-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the instrument shaft actuator engagement member of Grover to comprise a latch mechanism, as taught by Devengenzo. One would have been motivated to make this modification to make installment and engagement of the instrument shaft actuator engagement member easier (Devengenzo, col. 10, lines 47-53).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gombert et al. (US 2016/000512) discloses an analogous surgical instrument (Figs. 8-10) that comprises a shaft (11), an end effector (13) and a proximal end portion (23).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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