The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 9, 2026 has been entered.
Response to Arguments
On page 9-10 of the remarks, the applicant argues that the previously applied prior art fails to teach the claims as currently amended. Particularly, because the newly added claim limitations incorporate “a transition block [that] is not merely any region between a housing and a shaft. Rather, as now claimed, it is a defined structural component extending form the tubular portion and providing at least one cable passage/conduits that communicate with the elongated shaft assembly. Nothing in Wang teaches or suggest that kind of cable-routing transition block” (see top of page 10).
Firstly, it is noted that the claims as now recited are unclear. Specifically, claim 1 recites “an elongated shaft assembly… the elongated shaft assembly having a distal end portion defining a distal end longitudinal axis…, and a proximal end portion defining a proximal end longitudinal axis, wherein the proximal end longitudinal axis diverges from the distal end longitudinal axis” (see lines 5-9 of claim 1). It can only be assumed that this “divergence” of these two longitudinal axes is illustrated in Figure 6 of the instant application, where the distal end longitudinal axis is marked as “A”, while the proximal longitudinal axis is the longitudinal axis related to tubular portion 105 in figure 6, noting that this is actually illustrated via angle “X” in Figure 7. However, if this is the “proximal longitudinal axis” which relates to the claimed proximal end portion of the elongated shaft assembly, then that means that numeral 105 in Figure 6 is the claimed elongated shaft assembly. However, the specification identifies numeral 105 as “a transition block assembly”. Since the amendment to the claim now require the transition block assembly as a defined structural component that is distinct from the elongated shaft assembly, it has become unclear what exactly is the claimed “proximal end portion of the elongated shaft assembly” versus what is the claimed “transition block assembly”. In other words, if the claimed “transition block assembly” is numeral 105 in Figure 6, then elongated shaft assembly cannot be claimed as having a “proximal end portion” having a “proximal end longitudinal axis [that] diverges from the distal end longitudinal axis” (see claim 1, lines 8-9), because this divergence is between the straight elongated shaft assembly and the transition block assembly. See the following rejection under 35 USC 112(b).
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection.
Claim Rejections - 35 USC § 112
Second Paragraph
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 1-19 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.
Claims 1 and 11 are rejected because it recites “an elongated shaft assembly… the elongated shaft assembly having a distal end portion defining a distal end longitudinal axis…, and a proximal end portion defining a proximal end longitudinal axis, wherein the proximal end longitudinal axis diverges from the distal end longitudinal axis” (see lines 5-9 of claim 1). It can only be assumed that this “divergence” of these two longitudinal axes is illustrated in Figure 6 of the instant application, where the distal end longitudinal axis is marked as “A”, while the proximal longitudinal axis is the longitudinal axis related to tubular portion 105 in figure 6, noting that this is actually illustrated via angle “X” in Figure 7. However, if this is the “proximal longitudinal axis” which relates to the claimed proximal end portion of the elongated shaft assembly, then that means that numeral 105 in Figure 6 is the claimed elongated shaft assembly. However, the specification identifies numeral 105 as “a transition block assembly”. Since the amendment to the claim now require the transition block assembly as a defined structural component that is distinct from the elongated shaft assembly, it has become unclear what exactly is the claimed “proximal end portion of the elongated shaft assembly” versus what is the claimed “transition block assembly”. In other words, if the claimed “transition block assembly” is numeral 105 in Figure 6, then elongated shaft assembly cannot be claimed as having a “proximal end portion” having a “proximal end longitudinal axis [that] diverges from the distal end longitudinal axis” (see claim 1, lines 8-9), because this divergence is between the straight elongated shaft assembly and the transition block assembly.
Claims 4 and 14 are rejected because “a longitudinal axis of the surgical instrument” in line 5 is unclear. Claim 1 recites “a surgical instrument…” which includes, among other aspects, “an elongated shaft assembly… having a distal end longitudinal axis…, and… a proximal end longitudinal axis…”. Claim 4 now recites that “the proximal end longitudinal axis extends transverse to…” some newly identified longitudinal axis of the overall surgical instrument that has not previously been claimed or identified and is not provided with any additional identification. Especially in view of the immediately preceding rejection of claim 1 under 35 USC 112(b), this is even more unclear in claim 4 because it is not clear where in the disclosure it is taught that the proximal end longitudinal axis is transverse (i.e., at a 90o angle). Arguably, “a longitudinal axis of the surgical instrument” would presumably be longitudinal axis “A” as illustrated in Figure 6. However, assuming that “the proximal end longitudinal axis” is the axis shown in Figure 7, which is offset from axis “A” by angle “X”, this is not transverse to axis “A”. It is unclear if, and what, “a longitudinal axis of the surgical instrument” (in claim 4) would refer to other than axis “A”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 7-13 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN 112370167 A) in view of Wang et al. (CN 108814713).
Regarding claims 1 and 11, Li discloses a robot surgical instrument arm and micro-invasive surgical robot (see Title). Li teaches a robotic surgical system (see Figure 18a), comprising:
a drive unit (see numerals 31-34 in Figure 14); and
a surgical instrument (see “D” in Figures 1 and 18a) removably connected to the drive unit (see Figure 14 illustrating the instrument almost connected to the drive unit, and Figure 1 illustrating it connected, thereby illustrating that it is not always connected and therefore, removable), the surgical instrument having a proximal end portion (see housing 2 at a proximal end in Figures 1 and 2) and a distal end portion (see end effector at a distal end in Figures 1 and 2), the surgical instrument further including:
an elongated shaft assembly that extends between the proximal and distal end portions of the surgical instrument (see numeral 1 in Figure 1), the elongated shaft assembly having a distal end portion defining a distal end longitudinal axis and supporting an end effector (see numerals 11, 12, 13 and 14 in Figure 4), and a proximal end portion defining a proximal end longitudinal axis (see numeral 1 in Figure 1, see length “d” in Figure 2), wherein the proximal end longitudinal axis diverges from the distal end longitudinal axis (note that length “d” in Figure 2 has a longitudinal axis l3 shown in Figure 2, which does not continue past length “d”, and as shown in Figure 4 the distal-most end of the shaft is configured to bend at different degrees of freedom, thereby having a different at least one longitudinal axis from that of the proximal longitudinal axis); and
an instrument cassette assembly supported on the proximal end portion of the elongated shaft assembly (see numeral 2 in Figure 1), the instrument cassette assembly including:
a cassette housing positioned on the proximal end portion of the elongated shaft assembly (see numeral 1 in Figure 1), to define a divergent form factor of the surgical instrument (see the triangular top portion of the cassette housing, clearly illustrated in Figure 12a on page 8/20, which is a divergent form factor that allows for multiples of these surgical instruments to be placed adjacent one another as shown in Figure 3b); and
an actuator system supported on the cassette housing (see Figures 12a and 12b on page 8/20) and operably coupled to the end effector for operating the end effector (see Figure 12b on page 8/20; see Figure 13a on page 9/20, each illustrating the actuator system and pull wires that ultimately lead to the end effector after pulleys 222,224), the actuator system having a plurality of actuator assemblies (see the numerous disks in Figures 12a and 12b on page 8/20) each having a proximal end supported on a proximal surface of the cassette housing for connection with the drive unit (see disks on right side of housing in Figure 12a on page 8/20, also shown in Figure 12b on the same page), and
A distal end operably coupled to the end effector for operating the end effector (see numeral 211 in Figure 13a on page 9/20, illustrating a distal end (left side) of the actuator(s) which are operably coupled to the end effector via wires and pulleys, noting that the ends of the wires at the top-right as shown in Figure 13a extend to the end effector after exiting the mounting hole 261 as shown in Figure 12b on page 8/20), wherein the proximal surface of the cassette housing is oriented orthogonal to the distal end longitudinal axis of the elongated shaft assembly (it can be seen in Figure 12a-12b that the proximal surface of the cassette housing (i.e., the surface on which the actuator disks exist) is in a plane orthogonal to the distal end of the longitudinal axis of the elongated shaft assembly); and
A transition block assembly supported within the cassette housing between the elongated shaft assembly and the actuator system (see the reproduction of Figures 12a and 12b below), the transition block assembly defining at least one passage disposed in communication with the elongated shaft assembly for receiving and routing at least one cable from the actuator system therethrough (the top portion of the cassette housing as illustrated in the reproduction of Figures 12a and 12b below contains pulleys 222 which re-align the control wires to extend directly out of mounting hole 261 to therefore extend through the elongated shaft to the end effector):
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However, it is noted that Li teaches that the actuator disks are on a distal side of the housing (therefore not on a proximal side of the housing as claimed), and it is noted that the elongated shaft assembly as broadly interpreted within Li is different from that of the actual intended invention (although it is noted that the interpretation taken with respect to Li reads on the mere limitations of the “elongated shaft assembly” portion in lines 5-9 of claim 1).
Wang discloses an operation device for minimally invasive surgery (see Abstract). It is noted initially that Figure 4 of Wang illustrates a surgical instrument nearly identical to that which is illustrated in Figure 1 of Li. However, rather than a “flexible” elongated shaft which described by Li with respect to Figure 2, where the angle between l3 and l1 is illustrated as α, Wang provides a different approach, which is illustrated in Figures 8 and 9, where there is:
an elongated shaft assembly that extends between the proximal and distal end portions of the surgical instrument (see numeral 200 in Figure 8), the elongated shaft assembly having a distal end portion defining a distal end longitudinal axis and supporting an end effector (see numeral 220, where Figure 8 illustrates the longitudinal axis continuing to the shell 110 with dotted line), and a proximal end portion defining a proximal end longitudinal axis (see numeral 210), wherein the proximal end longitudinal axis diverges from the distal end longitudinal axis (see dotted line in Figure 8, which illustrates the continued longitudinal axis of distal end portion, which is divergent relative to the longitudinal axis of the proximal portion 210).
It is also noted that Wang teaches an actuator system supported on the cassette housing (see numeral 120 in Figures 6 and 7), the actuator system having a plurality of actuator assemblies (see that there are four (4) actuator assemblies illustrated in each of Figures 6 and 7) each having a proximal end supported on a proximal surface of the cassette housing for connection with the drive unit (note: Wang teaches that “It should be noted that connecting rod 200 also can be located on the housing 110 of the side 111, and the shell 110 for connecting surface of power mechanism can [be] on the one side 111, also can be the bottom surface 112, or the surface opposite to the bottom surface 112” (see page 5 of machine translation in the third-to-last paragraph - emphasis added), noting that the underlined portion teaches to have the “connecting surface of power mechanism [i.e., connecting plate 120] can [be] on… the surface opposite to the bottom surface 112”, which is illustrated below):
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Regarding claim 2, as illustrated in the reproduction of Figures 12b above in the rejection of claim 1, the identified transition block assembly contains pulleys 222 which re-align the control wires to extend directly out of mounting hole 261 to therefore extend through the elongated shaft to the end effector
Regarding claim 3, it can easily be seen in Figure 2 of Li (as compared to Figure 12b of Li) that the elongated shaft enters the cassette through the mounting hole 261, through which Figure 12b illustrates the wires extending out.
Regarding claims 7 and 17, it is re-iterated that Figure 8 of Wang illustrates a proximal end portion 210 of the shaft assembly 200 disposed at an angle relative to the distal end portion of the shaft assembly 220. Additionally, it is re-iterated that Wang teaches the orthogonal nature of the housing/shell surfaces as required by the last wherein clause of claim 1. Therefore, Wang teaches the structural configurations of the shaft assembly with respect to the housing/shell, and therefore also reads on “to position the cassette housing at an angle relative to the distal end longitudinal axis of the elongated shaft assembly.”
Regarding claims 8 and 18, it is re-iterated that Figure 11 of Wang illustrates a plurality of cable actuator assemblies that connect to the end effector, and Figures 6 and 7 illustrate that there are four connecting discs 120 in a rectilinear arrangement.
Regarding claim 9, it is noted that Li illustrates a total of seven (7) connecting discs, while Wang illustrates four (4). However, there is no discussion of this being actuated by an actuator connected to the robotic drive unit, nor its location with respect to the cable actuators. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that the rotation of the shaft of Li and/or Wang would be controlled via the robotic drive unit 20 as shown in Figure 1 of Wang, since the robot is clearly in control of the surgical instrument unit 30 in full (as is the case in Li. Additionally, it would have been obvious to move the actuator to any desired position within the housing/shell 110 of Wang (or the shell of Li), since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPC 70 (see MPEP 2144(VI)(C)). The specification does not appear to disclose any criticality to this actuator being located as claimed, and instead illustrates it in the various figures and embodiments in multiple different locations with no clear reason or benefits to the various positions.
Regarding claims 10 and 19, it is noted that Li illustrates a total of seven (7) connecting discs, while Wang illustrates four (4). In each reference, all of these actuators are aligned and laid out in such a way that they work together to provide functionality to the surgical robotic system. Li illustrates a single actuator/connecting disc at the bottom (see Figure 12a of Li) which is aligned down the middle of the other discs, while the other discs are in rectilinear alignment in a vertical direction. it would have been obvious to move the actuator to any desired position within the housing/shell 110 of Wang (or the shell of Li), since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPC 70 (see MPEP 2144(VI)(C)). The specification does not appear to disclose any criticality to this actuator being located as claimed, and instead illustrates it in the various figures and embodiments in multiple different locations with no clear reason or benefits to the various positions.
Claims 4-6 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Wang as applied to claim 3 above, and further in view of Liu et al. (CN 112022238).
Li in combination with Wang is discussed above in the rejections of claims 3 and 13. It is noted that the elongated shaft taught by Wang teaches a proximal end longitudinal axis that is not parallel with a longitudinal axis of the surgical instrument, while the distal end longitudinal axis of the shaft is parallel to a longitudinal axis of the surgical instrument. Arguably, these references each teach that the distal end longitudinal axis is “spaced a distance” from at least one outer side of the cassette housing. However, to further prosecution, neither of these references teach that the distal end longitudinal axis is spaced a distance from an outer side of the cassette housing (i.e., Wang illustrates in Figure 8 that the distal end longitudinal axis is directly aligned with the top outer side of the cassette housing, but it is noted that it is not aligned with the bottom outer side of the cassette housing). Additionally, Li and Wang fail to teach a tubular portion for the transition block assembly, as well as a tubular portion that has a curve with a first portion connected to the shaft assembly and a second portion connected to the housing/shell.
Liu teaches a surgical instrument for minimally invasive surgery robot (see Abstract). As shown in Figure 7, a shaft 705 comprises a straight portion 7051 and a second portion 7052 whose longitudinal axis diverges from that of portion 7051 (see portions below indicated by the bold arrows below).
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Figure 1 illustrates that the longitudinal axis of the distal end of the shaft is spaced a distance from the outer side (i.e., the top side) of the cassette housing, as required by claims 4 and 14. Figure 6, however, illustrates a driving tendon integrated block which rests over shaft just distal to the area indicated by bold-arrowed 7052 in the reproduction above (see Figures 1 and 2 to better illustrate the location of this component). This driving tendon block contains tubular portions therein which direct tendons from within the cassette and into the shaft (see Figures 2 and 6), thereby reading on claims 5-6 and 15-16.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to include a driving tendon integrated block, as taught and illustrated by Liu, within the system and methods of Li combined with Wang in order to provide additional support and strength to the curved shaft assembly, including improved support for actuators therein.
Conclusion
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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