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
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection. The previous claim objections and claim rejections under 35 USC 112 are herein withdrawn, unless repeated and described below.
As stated on page 6 of the Remarks, “[i]n the amendments made by the Applicant to incorporate claims 6 and 7, the claim term ‘pin’ has been replaced with the term ‘projection member’… Similarly, the claim limitation of ‘the stopper’ has been added to more clearly define how the guide engages with the projection member”. By this admission, the subject matter of previous claims 6 and 7 have not been incorporated into amended claim 1. Rather, claim 1 is now different than any previously examined claim. Claim 1 is now broader, as even with this new language, it still reads on multiple different embodiments (i.e., the release is a half nut, a split nut or a torsion spring as in claim 5, or the release comprises a biasing means as in claim 6). Further, the change of “a pin” and “a spring” in claim 6 broadens this claim as well beyond the previous more narrow limitations. As such, new prior art is now applicable for previously allowable claim 19 due to these amendments. The following rejections now apply.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
The following claim limitations have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (any paragraphs cited come from PGPUB 2023/0301737, representative of the specification of the instant application):
Claims 1 and 12
A projection member configured to extend into a raised position…
This limitation utilizes the generic placeholder “member”, transitional phrase “configured to” and functional language “to extend into a raised position”. The preceding term “projection” does not apply specific structure that performs the function.
The specification discusses in paragraph 38 that a second actuator 744 can include a stopping pin (which can be part of a plunger)… when the button 770 is pressed, the plunger and consequently the stopping pin can move upward into a raised position.”
Therefore, the structure from the specification associated with this term is a plunger and/or a stopping pin, and equivalents thereof. Equivalents thereof include, for example, the mechanism of Figure 3E, 3G, 3H, etc.
Claims 6 and 19
biasing means … configured to extend/bias the projection member…
This limitation utilizes the generic placeholder “means”, transitional phrase “configured to” and functional language “extend (or bias) the projection member…”. The preceding term “bias” simply relates to the function and does not impart specific structure.
The specification states the following in paragraph 37: “The second actuator 744 can be biased (for instance, by the spring 746) to facilitate engagement of the half nut 745 with the first actuator 730 in the default configuration.”
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.
Claim 8 is 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 8 is rejected because “the pin” lacks antecedent basis.
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.
Claims 1-3, 5, 9, 11-12, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wixey (US Patent Pub. No. 2018/0073615).
Wixey discloses an instrument manipulator for a robotic surgery system, the instrument manipulator comprising: a housing configured to support at least one surgical instrument (see Fig. 1D (#105), which is magnified in Fig. 2A); an actuator configured to move the housing forward toward a surgical site and backward away from the surgical site (see paragraph 48: “The drive input gear 245 can be connected to a drive input 246 that is coupled with a portion of the drive interface (not shown in FIG. 2B) to allow for control of the drive input gear 245 by a computerized control system, such as a telerobotic surgical system” and “A lead screw 235 can extend through the lever body 210. The drive system can also include a drive gear 240 that is coupled to the lead screw 235, and a drive input gear 245 that is engaged with the drive gear 240”); a release (see Figs. 3A-3B, showing the “release”, which is the same as #210 as shown in Fig. 2B) connected to the housing and configure to: engage with the actuator in a first configuration… (see Fig. 4A, where the release is engaged with the leadscrew/actuator 235); disengage from the actuator in a second configuration… (see Fig. 4B, where the release is disengaged with the leadscrew/actuator 235); and a user interface positioned at least partially on an exterior surface of the housing and configured to permit the user to transition the release from the first configuration to the second configuration, thereby facilitating retraction of the at least one surgical instrument away from the surgical site (see handles 215, 220 in Fig. 2B; “the medical device system 101 can be configured so that proximal movement of the handles 215, 220 and lever body disengages a split nut (shown in FIG. 3F) from the lead screw 235, which can allow a user to manually retract the lever body and connected components, such as a drive member and surgical instrument” (see paragraph 49), also see paragraph 59 – “the split nut 350 can be disengaged from the lead screw by manually pulling up on the lever body”).
It is noted that the recitations following “to allow” in lines 7 and 10 are functional and a mere repercussion of the engaged or disengaged configuration, both of which are taught by the prior art. Additionally, paragraph 40 states “sliding the pieces away from the lead screw, the drive system can be disengaged from the lead screw, which can enable manual retraction of portions of the drive system… This can be important, for example, during robot-assisted surgery, to allow manual retraction of a surgical tool…”.
Wixey teaches a guide configured to facilitate manual movement of the housing (e.g., the lead screw; “In an example, a first lead screw interface portion 351 in first nut portion 340 can be sized and shaped to align with a second lead screw interface portion 352 in second nut portion 341 to form an engagement passage 353 through the split nut 350” see paragraph 55); wherein the release includes a projection member (see threads 416/417 in Figure 4A) configured to extend into a raised position when the release is in a second configuration (see Figure 4B, illustrating the threads in a position raised off the lead screw, as compared to Figure 4A where they are in contact with the lead screw threading); wherein the guide includes a stopper configured to engage the projection member to limit manual movement of the housing backwards away from the surgical site (see “[t]he lead screw can include an engagement portion 412, which can include threads” (paragraph 58), such that the threads of the lead screw engage with the threads 416/417 and limit manual movement of the housing backwards (and forwards)).
Regarding claim 2, it is clear from the description of Wixey that by disengaging the split nut from the leadscrew allows “a user to manually retract the lever body and connected components, such as a drive member and surgical instrument” (see paragraph 49). Contrarily, it is clear that this is not allowed when the split nut is engaged with the leadscrew.
Regarding claim 3, Wixey teaches that “An example medical device drive system can include a lead screw and a nut that can be selectively engaged with the lead screw” (see paragraph 39).
Regarding claim 5, Wixey teaches two half nuts, a dual split nut, and/or radial split nut (see paragraph 40 – “In some examples, the nut can include a split nut, i.e. a nut component that is divided into two more pieces”).
Regarding claim 9, it is noted that Wixey teaches a leadscrew, which is a rail with threading.
Regarding claim 11, see Figure 1A, numerals 111, 113, 120, which shows the surgical robot comprising four central units which each hold an instrument housing, which are taught by Wixey as being the structure used to reject claim 1 above.
Regarding claim 12, Wixey teaches a “medical device system 101 can be configured so that proximal movement of the handles 215, 220 and lever body disengages a split nut (shown in FIG. 3F) from the lead screw 235, which can allow a user to manually retract the lever body and connected components, such as a drive member and surgical instrument” (see paragraph 49). The handles and lever body are “an emergency release” which when activated disengage a split nut from the leadscrew, “which can allow a user to manually retract the … surgical instrument” (see quote from paragraph 49 above). Wixey explicitly teaches this retraction is the purpose of the disclosed invention.
Wixey teaches a guide configured to facilitate manual movement of the housing (e.g., the lead screw; “In an example, a first lead screw interface portion 351 in first nut portion 340 can be sized and shaped to align with a second lead screw interface portion 352 in second nut portion 341 to form an engagement passage 353 through the split nut 350” see paragraph 55); wherein the release includes a projection member (see threads 416/417 in Figure 4A) configured to extend into a raised position when the release is in a second configuration (see Figure 4B, illustrating the threads in a position raised off the lead screw, as compared to Figure 4A where they are in contact with the lead screw threading); wherein the guide includes a stopper configured to engage the projection member to limit manual movement of the housing away from the surgical site (see “[t]he lead screw can include an engagement portion 412, which can include threads” (paragraph 58), such that the threads of the lead screw engage with the threads 416/417 and limit manual movement of the housing away (and toward) the surgical site).
Regarding claim 18, Wixey teaches that “An example medical device drive system can include a lead screw and a nut that can be selectively engaged with the lead screw” (see paragraph 39).
Regarding claim 20, Wixey teaches two half nuts, a dual split nut, and/or radial split nut (see paragraph 40 – “In some examples, the nut can include a split nut, i.e. a nut component that is divided into two more pieces”).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wixey alone.
Wixey discloses an instrument manipulator for a robotic surgery system including a leadscrew as an actuator, along with a release in the form of a split nut (see rejection of claims 1 and 3 above). While Wixey does not explicitly state that there is a motor, Wixey does describe the state of the art in paragraph 2 by teaching that “Medical device systems can include components that are driven by drive mechanisms such as electric motors.” Wixey also teaches that “A lead screw 235 can extend through the lever body 210. The drive system can also include a drive gear 240 that is coupled to the lead screw 235, and a drive input gear 245 that is engaged with the drive gear 240. The drive input gear 245 can be connected to a drive input 246 that is coupled with a portion of the drive interface (not shown in FIG. 2B) to allow for control of the drive input gear 245 by a computerized control system, such as a telerobotic surgical system” (see paragraph 48).
It would have been obvious to one of ordinary skill in the art at the time of the invention that the drive interface that utilizes a computerized control system as taught by Wixey includes a motor to move the gears, such as the specifically cited system – “The telerobotic surgical system can, for example, be the da Vinci® surgical system available from Intuitive Surgical®” (see paragraph 48).
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wixey in view of Kim (KR 20160114224).
Wixey discloses an instrument manipulator for a robotic surgery system including a leadscrew as an actuator, along with a release in the form of a split nut (see rejection of claim 1 above). However, Wixey does not teach a button as the emergency release.
Kim teaches “a break-releasing device for back driving a robot arm… By pressing the cancelling button installed on the shaft of the robot arm in case of emergency, it is possible to simply carrying out back driving operation for corresponding shaft” (see Abstract).
It would have been obvious to one ordinary skill in the art at the time of the invention to utilize a button, as taught by Kim, as the user interface for an emergency situation in robotic arms to cause back-driving of the arm (see paragraphs 1-3 under “Background-Art”) as a functional alternative to the type of user interface taught by Wixey, because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Regarding claim 16, see the rejection immediately above with respect to the use of a button as the user interface. It is noted that Kim illustrates the buttons on the exterior of each segment of the robotic arm. However, Wixey provides its user interface on the exterior surface of the instrument manipulator (see handles 215,220 in Fig. 2A). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention that the combined teaching of using a button as the user interface, as taught by Kim, within the system and methods of Wixey would provide a button located on the instrument manipulator.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wixey in view of Beckman et al. (US Patent Pub. No. 2022/0096067).
Wixey discloses an instrument manipulator for a robotic surgery system including a leadscrew as an actuator, along with a release in the form of a split nut (see rejection of claim 12 above). However, Wixey is silent with regard to removing the surgical instrument manipulator after manually retracting the manipulator.
Beckman teaches a decoupling mechanism for surgical tools (see Title). It is evident from the figures that the tool being described is a surgical tool associated with a robotic system. Beginning with Fig. 30, a surgical tool 1600 is shown having a latch 3010 which is operatively coupled to a “fifth layer” (see paragraph 232). “n some embodiments, the fifth layer 1628e may be unlocked (detached) from the distal layers 1628a-d of the carriage 1626 and, together with the end effector 1604 (FIG. 16) and the shaft 1602 operatively coupled thereto, may be removed from the drive housing 1614. In embodiments where the surgical tool 1600 is a surgical stapler having a staple cartridge included with the end effector 1604 (FIG. 16), this may prove advantageous in allowing a user to detach the fifth layer 1628e and remove the end effector 1604 to change the end effector or replace (replenish) the staple cartridge” (see paragraph 262). Therefore, this reads on the claimed removing the at least one surgical instrument from the instrument manipulator subsequent to manually moving the instrument manipulator.
It would have been obvious to one of ordinary skill in the art at the time of the invention to remove the instrument from the manipulator for changing the end effector or replenishing staple cartridges, as taught by Beckman, after manually withdrawing the end effector/instrument via the methods of Wixey, because in the case where the surgical robot of Wixey is using a stapling instrument, “staple cartridges often need to be replaced or reloaded multiple times during a surgical procedure” (see last sentence of paragraph 262 of Beckman). Additionally, when not using a stapling instrument, it would increase the utility of the surgical robot to quickly be able to exchange the end effector during a surgical procedure, as unexpected situations may arise in operative surgery that might require a different end effector than was originally planned for, thereby increasing safety of the overall procedure.
With regard to claim 14, it is noted that the rejection above with respect to claim 13 is applicable to “removing the at least one surgical instrument from the instrument manipulator”. The further recitation of claim 14 that requires that this “is performed subsequent to manually retracting the instrument manipulator to a threshold distance away from the surgical site” would be obvious to one of ordinary skill in the art, as a threshold distance equal to fully extracting the instrument from the patient’s body would need to be reached prior to removing the end effector.
Regarding claim 15, see the rejections of claims 13 and 14. Furthermore, Beckman teaches a cap 1906 (see Figs. 36 and 37), which reads on the claimed “stopper”. In other words, while the cap is down (as shown in Fig. 36), the fifth layer cannot be fully removed from the system. However, “after removing the cap 1906 from the second end 1618b, as shown by arrow 3710, the fifth layer 1628e, together with the elongate shaft 1602 and the end effector 1604 (FIG. 16) coupled thereto, may be removed from the shroud 1640” (see paragraph 273). As such, the cap is “a stopper… configured to limit backward movement of the at least one surgical instrument”, as claimed.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wixey in view of Prisco et al. (US Patent Pub. No. 2007/0142823).
Wixey discloses an instrument manipulator for a robotic surgery system including a leadscrew as an actuator, along with a release in the form of a split nut (see rejection of claim 12 above). However, Wixey is silent with regard to removing the surgical instrument manipulator after manually retracting the manipulator.
Prisco teaches a control system for reducing internally degenerated frictional and inertial resistance to manual positioning of a surgical manipulator (see Title). Prisco teaches that an “assistant depresses a second button on or proximate to its slave manipulator, which disengages active joints of the slave manipulator from being controlled by their associated master manipulator. This allows the assistant to freely move the slave manipulator… the assistant may then stop depressing the second button, which allows the surgeon to re-engage control of the active joints of the slave manipulator through the master manipulator so that the surgeon may perform the surgical procedure by manipulating the master manipulator” (see paragraph 8; also see paragraph 38, which states “the Assistant may then release the second Button 168 to re-engage computer control of the slave manipulator 128”). Figure 1 shows the button 168 on an outside portion of the robot, thereby reading on claim 16.
It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize a “button on or proximate to its slave manipulator” and to provide for depressing the button to disengage, and subsequently releasing the button to re-engage the master controls, as taught by Prisco, into the teachings of a methods of Wixey, as a functional alternative to the type of user interface taught by Wixey, because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395). The automatic re-engagement upon no longer pressing the button would increase ease of use, as it would prevent multiple buttons or interfaces needed to re-engage the system.
Claims 6, 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wixey in view of Solomon et al. (US Patent Pub. No. 2016/0184036) – herein referred to as Solomon.
Wixey is described above with respect to claims 1 and 12. However, Wixey teaches a release that is a split nut.
Regarding claims 6 and 19, Solomon teaches a surgical system that includes a surgical instrument (see Abstract) which is a robotic system (see paragraph 11). Solomon teaches that “If insertion assembly 331 jams, the high preload force must be released so that surgical instrument 260 can be removed” (see paragraph 324). Paragraph 324 continues to state that “To remove surgical instrument 260, a user pushes preload release button 2382 (FIG. 24A). In response to the force provided by the user, preload release button 2382 applies a force to the second end of preload release lever 2385. The force on the second end preload release lever 2385 causes preload release lever 2385 to rotate about pivot pin 2388 and disengage the hook on the second end of preload release lever 2385 from rolling pin 2386P that is mounted in the second end of preload engagement arm 2386.” It is additionally noted that paragraph 326 teaches that “If the distal end of surgical instrument 260 is not straight, as a person withdraws the surgical instrument, the cannula forces the distal end of surgical instrument 260 to straighten”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a release button that biases a pin, as taught by Solomon, as an alternative to the use of a split nut type mechanism for engaging and disengaging with a guide, such as in the system and methods of Wixey, as mere functional equivalents and/or because such a modification amounts to substitution of known equivalents for engaging a guide rail to yield predictable results (KSR v. Teleflex).
Regarding claim 8, it is noted that Solomon teaches at least one engagement ridge 2326 (see Figure 24B) illustrates a “cutout” along the rail that limits movement along the guide.
Conclusion
The following prior art is herein made of record as being considered pertinent to applicant's disclosure, but not relied upon:
WO 2015/010189 to Anvari et al.: see Figures 7A and 7B, illustrating views from the underside of the end effector assembly of Figure 3 showing locked and unlocked positions of a movement locking mechanism.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792