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 .
Response to Amendment
The Amendment filed on 01/13/2026 has been entered. Claims 1-24 and 28 are pending in the application. In response to Applicant's amendments, Examiner withdraws the previous objections. Examiner withdraws the previous rejections under 112(b) regarding the dependency of claim 3, the ranges of claim 5, the “stiff wire” of claim 10 and its dependent claims 11 and 12, and the antecedent basis of “surgical table” of claims 17 and 18. The previous rejections under 112(a) and 112(b) as a result of claim limitations interpreted under 112(f) are maintained. All previous objections and rejections pertaining to canceled claims 25-27 are withdrawn.
Response to Arguments
Applicant’s arguments, see Applicant’s Arguments and Remarks, pg. 7, filed 01/13/2026, with respect to the objection to the drawings have been fully considered and are persuasive. The objection to the drawings has been withdrawn.
Regarding the arguments against the rejections of 1-18 under 112(a) and 112(b) as a result of claim limitations interpreted under 112(f), Applicant’s arguments (Arguments and Remarks, pg. 9 and 11) have been fully considered but they are not persuasive.
As explained in the Non-Final Rejection, “Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.” The specification must disclose the corresponding structure, material, or acts and clearly link them to the function.
Regarding the argument that “a person of skill in the art” “would understand that the claimed robotic control systems and method steps can be implemented by programming conventional robotic controllers using standard programming techniques” (Arguments and Remarks, pg. 9), Examiner directs Applicant to MPEP 2181(II)(B):
“In several Federal Circuit cases, the patentees argued that the requirement for the disclosure of an algorithm can be avoided if one of ordinary skill in the art is capable of writing the software to convert a general purpose computer to a special purpose computer to perform the claimed function… Such argument was found to be unpersuasive because the understanding of one skilled in the art does not relieve the patentee of the duty to disclose sufficient structure to support means-plus-function claim terms… The specification must explicitly disclose the algorithm for performing the claimed function, and simply reciting the claimed function in the specification will not be a sufficient disclosure for an algorithm which, by definition, must contain a sequence of steps.”
“When a claim containing a computer-implemented 35 U.S.C. 112(f) claim limitation is found to be indefinite under 35 U.S.C. 112(b) for failure to disclose sufficient corresponding structure (e.g., the computer and the algorithm) in the specification that performs the entire claimed function, it will also lack written description under 35 U.S.C. 112(a).”
The rejections of claims 1-18 under 112(a) and 112(b) due to claim limitations interpreted under 112(f) with insufficient structure recited in the claims or disclosed in the specification are therefore maintained.
Regarding the rejections of claims 1-7, 9, and 13-14 under 102 and 8, 10-12, and 15-18 under 103, Applicant’s arguments have been fully considered but they are not persuasive.
Applicant states that the cited references, either individually or in combination, do not disclose or render obvious every element of amended claim 1 because Yates does not disclose “a central control unit configured to (a) kinematically position the first and second robotic arms… and (b) detect proximity of first and second positioning probes advanced through the first and second working channels” or the amended limitation “kinematically reposition the first and second robotic arms to advance the first and second surgical tools toward the subcutaneous surgical site after proximity has been detected and the probes [have been] removed from the first and second surgical” tools (Arguments and Remarks, pg. 12).
Examiner respectfully disagrees. Yates, in combination with Han, teaches all the limitations of amended claim 1. First, regarding kinematically positioning the robotic arms, Yates discloses control of velocity of a tool held by a robotic arm based on the position of a tool relative to another object, including another tracked tool in [0046] and [0075]. According to the Oxford English Dictionary, “kinematic” has a definition of “Relating to pure motion, i.e. to motion considered abstractly, without reference to force or mass” and “Applied to a set of mechanical elements so disposed in relation to each other that the relative position and motion of each is uniquely determined by the relative position and motion of the other(s).” Since the tool is held by a robotic arm, the position and motion of the robotic arm is determined by the position and motion of the tool, and the tool’s motion (velocity) is controlled based on the relative position of another tool. Under the broadest reasonable interpretation of “kinematically”, Yates discloses kinematically positioning the robotic arms.
Second, Yates discloses detecting the proximity of probes advanced through cannulas. Specifically, Yates discloses “the user can manipulate the robotic arm 420 to introduce the tool assembly 430 through the entry guide 432 (e.g., a cannula mount or cannula). The user can thus direct insertion of the shaft 436 of the tool assembly 430 and the end effector 438 through the entry guide [432] and into the body of a patient” as shown in Fig. 2 [0088]; see also [0051] and [0087]. As explained in the Non-Final Rejection, multiple methods for detection of proximity between tools are disclosed in [0075-0086]. In particular, “FIG. 19 also illustrates tools 2406 and 2408 and a binocular scope 2410 operating within a magnetic field 2404 within a body of a patient and separated from an exterior of the patient (illustrated by a broken line 2415 in FIG. 19)” (emphasis added) [0081], and therefore the tools and scope are advanced through working channels of the entry guides 432. Then “The controller can be configured to monitor [detect] the location of the tools 2406, 2408 and binocular scope 2410 relative to a fixed point and/or each other [based on the detected magnetic field] and reduce the velocities with which the tools 2406, 2408 and binocular scope 2410 move toward each other when the tools 2406, 2408 and binocular scope 2410 move within close proximity of each other” (emphasis added) [0083]. The controller also detects proximity in [0078-0079], [0082-0083], and [0086]. The magnetic field sensors 2412 are clearly on the distal ends of the end-effectors shown in Fig. 19. It is noted that many surgical instruments can be used as probes, including the end-effectors listed in [0055] and [0090], the tool assembly 430 depicted in Fig. 4, and the tools 2406 and 2408 depicted in Fig. 19. Therefore, Yates discloses “a central control unit configured to… (b) detect proximity of first and second positioning probes advanced through the first and second working channels when distal portions of said probes are distally advanced from said the first and second working channels into a subcutaneous surgical site.”
Finally, the combination of Yates and Han teaches the amended claim limitation “kinematically reposition the first and second robotic arms to advance the first and second surgical tools toward the subcutaneous surgical site after proximity has been detected and the probes have been removed from the first and second surgical tools” because Yates discloses kinematically repositioning the first and second robot arms to advance surgical instruments after proximity has been detected ([0046-0048], [0077], [0079]), and Han teaches advancing surgical tools with working channels toward a subcutaneous surgical site after probes have been removed from the surgical tools [p. 183, col. 1].
In conclusion, the combination of Yates and Han as a whole teaches all the claim limitations of amended claim 1. For similar reasons, dependent claims 2-18 are also rejected.
Regarding the rejections of claims 19-28 under 103, Applicant’s arguments have been fully considered. The arguments against Nixon are not persuasive. The arguments against Yates and Iida (Arguments and Remarks, pg. 14) are moot because the amendment necessitates new grounds of rejection.
Regarding Nixon, the depiction in Fig. 13 and description of tools 1200 used to determine a distance describe probes: “a tool 1200 which may be used to indicate the two points (X1, Y1, Z1), (X2, Y2, Z2) on the surface of the anatomic structure 520… The tip has a contact surface area of proper size to provide accurate position indications without damaging tissue that it may come into contact with” [0072]. Nixon further discloses surgical instruments/tools are “inserted into the cannulae and properly positioned and oriented in order to perform the procedure” [0006] with measurements taken during a procedure [0007]; see also [0035]. Indeed, Nixon discloses “(a) removing the probes from the working channels; (b) advancing the cannulas into the surgical space; (c) inserting working tools into the working channels; and (d) performing the robotic surgical procedure using the working tools” in [0006].
It is noted that the features upon which applicant relies (i.e., “placing probes into the working channels and using those probes to determine a distance between the probe ends to confirm proper kinematic alignment of the working channels prior to performing a procedure with working tools subsequently placed in those working channels”, Arguments and Remarks, pg. 14) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The combination of Nixon and Arata as a whole teaches all the limitations of claim 19. Claims 19-24 and 28 stand rejected for similar reasons as claim 19.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/20/2026 was filed after the mailing date of the Non-Final Rejection on 12/16/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
In [00028], “the operative” should read “the operative tools”.
In [00057], "canula 40" should read "cannula 40".
Appropriate correction is required.
Claim Objections
Claims 19 and 28 are objected to because of the following informalities:
Claim 19 recites the limitations “the first cannula at a kinematically determined location in the surgical robotic coordinate space” and “the second cannula at a kinematically determined location in the surgical robotic coordinate space”. It is not clear if the two kinematically determined locations are the same location or different locations. For the purpose of examination, it has been assumed that the locations may be different locations.
In claim 28, “working tools” should read “the working tools”. Working tools are previously recited in claim 19.
Appropriate correction is required.
Claim Interpretation
In claim 1, “detect proximity of first and second positioning probes” has been interpreted as detecting the proximity of first and second positioning probes to each other in view of claims 7 and 8, which specify detecting proximity comprises detecting contact between the probes.
In view of [00077], claim 5 has been interpreted such that “at least 2 mm” means “2 mm or less”.
In view of [00012], [00023], and [00077], the “threshold amount” recited in claim 19 is interpreted as the detected or kinematically determined proximity (e.g., 2 mm, 5 mm, etc.) and not the “threshold” recited in [00077], which refers to the allowable positioning error of the measured distance as compared to the kinematically determined distance, for the purpose of compliance with the written description requirement.
In claim 21, the limitation “the threshold distance” has been interpreted as the “threshold amount”, which is compared to a determined distance, recited in claim 19.
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.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
a central control unit configured to (a) kinematically position the first and second robotic arms in a surgical robotic coordinate space, (b) detect proximity of first and second positioning probes advanced through the first and second working channels when distal portions of said probes are distally advanced from said the first and second working channels into a subcutaneous surgical site, and (c) kinematically reposition the first and second robotic arms to advance the first and second surgical tools toward the subcutaneous surgical site after proximity has been detected and the probes have been removed from the first and second surgical tools in claim 1;
wherein the central control unit is configured to detect a proximity of at least 2 mm in claim 5;
wherein the central control unit is configured to detect contact of first and second elongate probes in claim 6; and
wherein the central control unit is configured to measure electrical resistance between the first and second probes in claim 8.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. For example, amending “central control unit” in claim 1 to “controller” would avoid the control limitations in claim 1 from being interpreted under 35 U.S.C. 112(f).
Claim 1 recites the generic placeholder “a central control unit” plus functional language “(a) kinematically position the first and second robotic arms in a surgical robotic coordinate space, (b) detect proximity of first and second positioning probes advanced through the first and second working channels when distal portions of said probes are distally advanced from the first and second working channels into a subcutaneous surgical site, and (c) kinematically reposition the first and second robotic arms to advance the first and second surgical tools toward the subcutaneous surgical site…” linked by “configured to”. In paragraph [00011], the specification discloses the central control unit performs functions (a) and (b). Additionally, in paragraphs [00056] and [00062], the specification discloses the “robotic controller”, which is assumed to be a generic computer or processor, kinematically positions the surgical arms. In [00073-00077], the specification discloses proximity of positioning probes may be detected by proximity detectors/sensors comprised in positioning probes, but these detectors/sensors do not seem to be “a central control unit”. In [00041], the specification discloses the ports, which are the first and second surgical tools and positioned via the robotic arms, are advanced toward the surgical site. Therefore, a generic computer or processor has been interpreted as the corresponding hardware structure to perform “kinematically position[ing] the first and second robotic arms in a surgical robotic coordinate space” and “kinematically reposition the first and second robotic arms to advance the first and second surgical tools toward the subcutaneous surgical site”. However, it is not clear if the robotic controller also “detect[s] proximity of first and second positioning probes advanced through the first and second working channels…”. Also, the specification does not disclose the necessary software structure (steps or algorithm) to perform the entire claimed functions and clearly link the software structure to the functions.
Claim 5 recites the generic placeholder “the central control unit” plus functional language “detect a proximity of at least 2 mm” linked by “configured to”. In paragraph [00012], the specification discloses the central control unit performs this function. Paragraph [00077] states “the probe tips 154 can be brought into proximity… preferably within 2 mm as kinematically determined by the controller 32” but not that the controller detects the proximity. Therefore, the specification does not disclose the necessary hardware and software structure (steps or algorithm) to perform the entire claimed function and clearly link the hardware and software structure to the function.
Claim 6 recites the generic placeholder “the central control unit” plus functional language “detect contact of first and second elongate probes” linked by “configured to”. In paragraph [00013], the specification discloses the central control unit performs this function. Additionally, paragraphs [00064] and [00072] discuss contact of probes, but this is not linked to the central control unit. Therefore, the specification does not disclose the necessary hardware and software structure (steps or algorithm) to perform the entire claimed function and clearly link the hardware and software structure to the function.
Claim 8 recites the generic placeholder “the central control unit” plus functional language “measure electrical resistance between the first and second probes” linked by “configured to”. In paragraph [00013], the specification discloses the central control unit may perform this function. However, the specification does not disclose the necessary hardware and software structure (steps or algorithm) to perform the entire claimed function and clearly link the hardware and software structure to the function.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-24 and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the limitation “(c) kinematically reposition the first and second robotic arms to advance the first and second surgical tools toward the subcutaneous surgical site after proximity has been detected and the probes have been removed from the first and second surgical tools” does not have support in the disclosure of application 18/742,817 as originally filed on 06/13/2024. Though Applicant states support for the amendment to claim 1 is present in [0006] and [0008], Examiner disagrees. Paragraphs [0006] and [0008] describe the state of the art and the problem to solve, not the invention of the instant application. Support is also not found in the disclosure of the provisional application 63/291,460 nor the publication WO 2023118985 A1 of PCT/IB2022/058982 (both applications incorporated by reference). The closest support found in the specification of the instant application 18/742,817 is quoted below:
“In some instances, the methods further comprise removing the first and second positioning probes from the working channels of the first and second surgical tools and advancing one or more operative tools through at least one of the working channels and using the operative to perform a surgical procedure.” [00028]
“In other instances, proper orientation of the cannulas will allow the cannulas themselves to be further advanced toward the surgical target site while minimizing the risk of damage of sensitive tissues, such as nerves.” [00031]
“The robotic system can determine that the guide wires have come into contact with each other by electrical conductivity for example. This will, in turn, allow the robotic system together with the surgeon to determine that it is safe to advance the ports further into the surgical field to the point where relevant tools or end effectors can be advanced through the ports to perform the surgical procedure.” [00041]
“For performing tool alignment in accordance with the disclosed technology, the robotic surgical arms can be… moved kinematically… under the control of a surgical robotic controller...” [00055]
Specifically, the “first and second surgical tools” recited in claim 1 are the same “first and second surgical tools” recited in paragraph [00028]: cannulas/ports having working channels. Paragraph [00028] recites “removing the first and second positioning probes from the working channels of the first and second surgical tools and advancing one or more operative tools through at least one of the working channels” (of the surgical tools); therefore, the operative tools are not the surgical tools. Thus paragraph [00028] does not provide support for advancing the surgical tools after removing the positioning probes.
Since paragraph [00028] is the only paragraph that discloses removing probes/tools, the specification does not provide sufficient support for the particular limitation of “(c) kinematically reposition the first and second robotic arms to advance the first and second surgical tools toward the subcutaneous surgical site after proximity has been detected and the probes have been removed from the first and second surgical tools” (emphasis added). Accordingly, claim 1 is rejected under 35 U.S.C. 112(a).
Claims 2-18 are rejected for depending upon the rejected independent claim 1.
In claim 19, the limitation “if the determined distance is less than a threshold amount: (a) removing the probes from the working channels…” does not have support in the disclosure of application 18/742,817 as originally filed on 06/13/2024. Support is also not found in the disclosure of the provisional application 63/291,460 nor the publication WO 2023118985 A1 of PCT/IB2022/058982 (both applications incorporated by reference). Applicant states support is found in the specification of the instant application 18/742,817 in paragraph [00028]: “In some instances, the methods further comprise removing the first and second positioning probes from the working channels of the first and second surgical tools and advancing one or more operative tools through at least one of the working channels and using the operative to perform a surgical procedure.”
In paragraph [00028], there is no connection or limitation to removing the probes from the working channels under a threshold condition. Therefore, there is not sufficient support for the particular limitation of “if the determined distance is less than a threshold amount: (a) removing the probes from the working channels.” Accordingly, claim 19 is rejected under 35 U.S.C. 112(a).
Claims 20-24 and 28 are rejected for depending upon the rejected independent claim 19.
Regarding claim 1, the claim limitation “(a) kinematically position the first and second robotic arms in a surgical robotic coordinate space, (b) detect proximity of first and second positioning probes advanced through the first and second working channels when distal portions of said probes are distally advanced from the first and second working channels into a subcutaneous surgical site, and (c) kinematically reposition the first and second robotic arms to advance the first and second surgical tools toward the subcutaneous surgical site after proximity has been detected and the probes have been removed from the first and second surgical tools” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification merely recites the function and does not identify specific steps or an algorithm sufficient to perform the function, as described above in the Claim Interpretation section. Therefore, the claim lacks an adequate written description as required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because an indefinite, unbounded functional limitation would cover all ways of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention. See MPEP 2163.03 and 2181.
Claims 2-18 are rejected for depending upon the rejected independent claim 1.
Regarding claim 5, the claim limitation “wherein the central control unit is configured to detect a proximity of at least 2 mm” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification merely recites the function and does not identify specific steps or an algorithm sufficient to perform the function, as described above in the Claim Interpretation section. Therefore, the claim lacks an adequate written description as required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because an indefinite, unbounded functional limitation would cover all ways of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention. See MPEP 2163.03 and 2181.
Regarding claim 6, the claim limitation “wherein the central control unit is configured to detect contact of first and second elongate probes” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification merely recites the function and does not identify specific steps or an algorithm sufficient to perform the function, as described above in the Claim Interpretation section. Therefore, the claim lacks an adequate written description as required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because an indefinite, unbounded functional limitation would cover all ways of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention. See MPEP 2163.03 and 2181.
Claims 7-8 are rejected for depending upon the rejected claim 6.
Regarding claim 8, the claim limitation “wherein the central control unit is configured to measure electrical resistance between the first and second probes” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification merely recites the function and does not identify specific steps or an algorithm sufficient to perform the function, as described above in the Claim Interpretation section. Therefore, the claim lacks an adequate written description as required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because an indefinite, unbounded functional limitation would cover all ways of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention. See MPEP 2163.03 and 2181.
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 1-18 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.
Regarding claim 1, the claim limitation “(a) kinematically position the first and second robotic arms in a surgical robotic coordinate space, (b) detect proximity of first and second positioning probes advanced through the first and second working channels when distal portions of said probes are distally advanced from the first and second working channels into a subcutaneous surgical site, and (c) kinematically reposition the first and second robotic arms to advance the first and second surgical tools toward the subcutaneous surgical site after proximity has been detected and the probes have been removed from the first and second surgical tools” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While a robotic controller, interpreted as a generic computer or processor, is disclosed to perform “kinematically position[ing] the first and second robotic arms in a surgical robotic coordinate space” and “kinematically reposition the first and second robotic arms to advance the first and second surgical tools toward the subcutaneous surgical site,” it is not clear if the robotic controller also “detect[s] proximity of first and second positioning probes advanced through the first and second working channels…”. Also, the specification does not disclose the necessary software structure (steps or algorithm) to perform the entire claimed function and clearly link the software structure to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claims 2-18 are rejected for depending upon the rejected independent claim 1.
Regarding claim 5, the claim limitation “wherein the central control unit is configured to detect a proximity of at least 2 mm” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While a central control unit is disclosed to perform the claimed function, no structure corresponding to “central control unit” is recited. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Regarding claim 6, the claim limitation “wherein the central control unit is configured to detect contact of first and second elongate probes” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While a central control unit is disclosed to perform the claimed function, no structure corresponding to “central control unit” is recited. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claims 7-8 are rejected for depending upon the rejected claim 6.
Regarding claim 8, the claim limitation “wherein the central control unit is configured to measure electrical resistance between the first and second probes” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While a central control unit is disclosed to perform the claimed function, no structure corresponding to “central control unit” is recited. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
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.
Claims 1-7, 9-11, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yates et al. (US 20180049830 A1; hereafter “Yates”) in view of Han et al. (US 20100228240 A1; hereafter “Han”).
Regarding claim 1, Yates discloses
A robotic surgical system comprising: a chassis (See surgical robotic system 300 mounted to a surgical table 314 in Fig. 1. See also “in some embodiments, the patient-side portion 310 can be mounted to a wall, to the ceiling, to the floor, or to other operating room equipment… Alternatively, the patient-side portion 310 can include a single assembly that includes one or more robotic arms 320 extending therefrom” [0049].);
a first surgical robotic arm disposed on the chassis and configured to hold a first surgical tool having a first working channel; a second surgical robotic arm disposed on the chassis and configured to hold a second surgical tool having a second working channel (See two robotic arms 320 each coupled to a tool assembly 330 and mounted on surgical table 314 in Fig. 1. The robotic arms comprise “an entry guide 432 (e.g., a cannula mount or cannula) [working channel]… A shaft 436 of the tool assembly 430 can be inserted through the entry guide [432] for insertion into a patient” [0051].); and
a central control unit configured to (a) kinematically position the first and second robotic arms in a surgical robotic coordinate space (See “The control system 315 can include components that enable a user… to control one or more parts of the patient-side portion 310 (e.g., to perform a surgical procedure at the surgical site 312)… These input devices can control teleoperated motors which, in turn, control the movement of the surgical system, including the robotic arms 320 and tool assemblies 330” [0048]. This control is based on the velocity and position (kinematics) of the tools [0046]. The arms move in a coordinate space of the surgical robotic system, specifically “along one or [more] mechanical degrees of freedom (e.g., all six Cartesian degrees of freedom, five or fewer Cartesian degrees of freedom, etc.)” [0050]. See computer system 100, including the controller (processor), in Fig. 21 [0096]. See also [0014], [0061-0063], [0075], [0078-0079], and [0082-0083].),
(b) detect proximity of first and second positioning probes advanced through the first and second working channels when distal portions of said probes are distally advanced from said the first and second working channels into a subcutaneous surgical site (Various methods of detecting proximity of surgical tools/end-effectors (probes) inside and outside of a patient are described in [0075-0086]. For example, see “FIG. 19 also illustrates tools 2406 and 2408 and a binocular scope 2410 operating within a magnetic field 2404 within a body of a patient” (subcutaneous surgical site) [0081] and “The controller can be configured to monitor the location of the tools 2406, 2408 and binocular scope 2410 relative to a fixed point and/or each other [based on the detected magnetic field] and reduce the velocities with which the tools 2406, 2408 and binocular scope 2410 move toward each other when the tools 2406, 2408 and binocular scope 2410 move within close proximity of each other” [0083]. See “The user [via the control system] can thus direct insertion of the shaft 436 of the tool assembly 430 and the end effector 438 through the entry guide [432] [working channel] and into the body of a patient” [0088]; insertion is distal advancement. See also Figs. 2, 4, and 19, and [0052], [0055], [0087], and [0090].), and
(c) kinematically reposition the first and second robotic arms to advance [surgical instruments] after proximity has been detected… (See “By tracking the motion of the tools 2302, 2304, the controller can be configured to determine when one tool assembly, for example, tool 2302, is within a general proximity zone of another tool assembly, for example, tool 2304, or another object having a known location… When the tool 2302 is within a close proximity zone of another tool or object, the controller can be configured to reduce the velocity of the tool 2302 to a close proximity velocity… Upon a detection that the tool 2302 has collided with another tool, object, or patient tissue, the controller can be configured to stop the motion of the tool. A person skilled in the art will appreciate that the motion of the tool is controlled by the robotic arm coupled thereto” [0079]. After proximity is detected in a general proximity zone, the tools are repositioned by the robotic arms, and close proximity or collision is subsequently detected: in Fig. 18, “a graph 2322 illustrat[es] the velocity of the tools 2302, 2304, as they move from outside of the general proximity zone, enter [advance into] the general proximity zone at 2326, pass through the general proximity zone, enter the close proximity zone at 2328, and pass through the close proximity zone” [0077]. As with step (a), the arms are (re)positioned kinematically by the controller [0046-0048]. See also [0071], [0075] and [0086].).
However, Yates does not explicitly teach “advance the first and second surgical tools toward the subcutaneous surgical site after… the probes have been removed from the first and second surgical tools.”
Han, in the same field of endeavor (spinal surgery), teaches
advance the first and second surgical tools toward the subcutaneous surgical site after… the probes have been removed from the first and second surgical tools (See “Once bony contact [of the obturator] is established, the new guide wire [probe] is removed and the tip of the obturator should be directed towards the ventral border of the facet by elevating the other end of the obturator. The obturator is slid into [advanced toward] the triangular working zone [surgical site] by twisting back and forth while pushing it against the facet (Fig. 3)... Based on this engagement, the working sheath is introduced” [p. 183, col. 1]. The surgical site is clearly subcutaneous; see Fig. 3 and Table 1.).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the robotic surgical system of Yates to advance surgical tools after removing probes as taught by Han. One of ordinary skill in the art would have been motivated to make this modification to perform a safer discectomy procedure (Han; p. 182, col. 1, “Introduction”).
Regarding claim 2, Yates/Han discloses the limitations of claim 1 as addressed above, and Yates additionally discloses
wherein the working channels are aligned on an axis of their respective surgical tools (See Fig. 2: entry guide 432 with a working channel aligned on the longitudinal axis of the tool assembly 430.).
Regarding claim 3, Yates/Han discloses the limitations of claim 2 as addressed above, and Yates additionally discloses
wherein the working channels and probes are straight (See Figs. 2 and 4: entry guide 432 (working channel) and tool assembly 430 are straight. Additional surgical tools disclosed in [0055] and [0090] are straight.).
See also a straight obturator and guide wire in Figs. 1-3 and 5 of Han.
Regarding claim 4, Yates/Han discloses the limitations of claim 1 as addressed above, and Yates additionally discloses
wherein at least one of the first and second positioning probes comprises a proximity sensor at a tip thereof (Various methods of detecting proximity of surgical tools/end-effectors (probes) comprising sensors are described in [0075-0086]. For example, see “Each tool 2302, 2304 can include a sensor 2308. The sensor 2308 can be configured to facilitate a determination by a controller, such as controller 2306, of the location of one or more of the tools 2302, 2304” [0078]. As shown in Fig. 17, the sensors 2308 are disposed on the tips of the tools.),
wherein the central control unit detects proximity based on a signal from the proximity sensor (See “The sensor 2308 can be configured to detect motion of the tools 2302, 2304 and continually transmit motion information back to a controller” [0078]. “By tracking the motion of the tools 2302, 2304, the controller can be configured to determine when one tool assembly, for example, tool 2302, is within a general proximity zone of another tool assembly, for example, tool 2304” [0079]. See also [0082-0083] and [0085-0086].).
Regarding claim 5, Yates/Han discloses the limitations of claim 4 as addressed above, and Yates additionally discloses
wherein the central control unit is configured to detect a proximity of at least 2 mm (See “in response to a determination that the tool 2302 is within a threshold distance of another tool… the controller can be configured to reduce the velocity of the tool 2302 to a collision velocity… at which collisions would not cause damage to the tool(s)… Upon a detection that the tool 2302 has collided with another tool… the controller can be configured to stop the motion of the tool” [0079]. When the controller detects tools 2302 and 2304 have collided, the controller detects a proximity of at least (less than) 2 mm.).
Regarding claim 6, Yates/Han discloses the limitations of claim 1 as addressed above, and Yates additionally discloses
wherein the central control unit is configured to detect contact of first and second elongate probes (See “in response to a determination that the tool 2302 is within a threshold distance of another tool… the controller can be configured to reduce the velocity of the tool 2302 to a collision velocity… at which collisions would not cause damage to the tool(s)… Upon a detection that the tool 2302 has collided with another tool… the controller can be configured to stop the motion of the tool” [0079]. When the controller detects tools 2302 and 2304 have collided, the controller detects contact of the elongate probes.).
Regarding claim 7, Yates/Han discloses the limitations of claim 6 as addressed above, and Yates additionally discloses
wherein detecting proximity comprises detecting contact of the first and second probes based upon one or more of electrical, mechanical, visual, and fluoroscopic assessment (The sensors 2308 used to detect when tools 2302 and 2304 have collided “can be a six-axis sensor. A six-axis sensor can include a multi-axis accelerometer, a multi-axis magnetic sensor, or the like” [0078]. See also magnetic field sensors 2412 in Fig. 19 [0081-0083] and transmitting motion sensors 2614, 2616 in Fig. 20 [0085]. See also [0014].).
Regarding claim 9, Yates/Han discloses the limitations of claim 1 as addressed above, and Yates additionally discloses
further comprising the first and second probes (See tools 2302 and 2304 in Fig. 17. See also [0055], [0075], and [0090].).
See also new guide wire a in Fig. 1 of Han.
Regarding claim 10, Yates/Han discloses the limitations of claim 9 as addressed above, and Yates additionally discloses the use of multiple tools (see two tools 2302, 2304 in Fig. 17) and that “Any end effector can be utilized with the surgical systems described herein” [0090].
Han additionally discloses
wherein the first and second probes comprise straight, stiff wires (See Fig. 1 where new guide wire a is straight. The wire is stiff enough to not bend under the force of the skin and underlying tissue; see Figs. 2 and 5. Also note new guide wire “is thicker than conventional guide wire” [p. 183, col. 1].).
Therefore, the combination of Yates/Han as a whole teaches the claim.
Regarding claim 11, Yates/Han discloses the limitations of claim 10 as addressed above, and Han additionally discloses
wherein the wires have a diameter in a range from 1 mm to 5 mm and a length from 10 cm to 50 cm (See “New guide wire has a diameter of 1.22 mm” and is inserted “8-14 cm from the midline” [p. 183, col. 1]. See also “Inserting a guide needle into the disc space has been a universal feature of all endoscopic lumbar discectomy. Usually, it is a 6-10 inch long 18-G needle” [p. 184, col. 1]. 18-gauge is approximately 1.2 mm in width, and 6-10 inches is approximately 15-25 cm.).
Regarding claim 13, Yates/Han discloses the limitations of claim 1 as addressed above, and Yates additionally discloses
further comprising a third robotic arm (See “while the patient-side portion 310 is shown as including two robotic arms 320, more or fewer robotic arms 320 may be included” [0049]. See also Fig. 19, in which two tools 2406, 2408 and binocular scope 2410 are located and controlled by the controller, suggesting the use of three robotic arms to control the motion of the three tools [0083].).
Regarding claim 14, Yates/Han discloses the limitations of claim 13 as addressed above, and Yates additionally discloses
wherein the third surgical robot arm is configured to hold an imaging device or sensor (See “The patient-side portion 310 generally includes one or more robotic arms 320 and one or more tool assemblies 330 that are configured to releasably couple to a robotic arm 320” [0047]. See also Fig. 19, in which two tools 2406, 2408 and binocular scope 2410 are located and controlled by the controller, suggesting the use of three robotic arms to control the motion of the three tools [0083]. The tools comprise magnetic field sensors 2412, and the binocular scope 2410 is an imaging device. See also imaging devices in [0055], [0060-0062], [0071-0072], and [0081-0083] and other sensors in tools in [0014] and [0077-0086].).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yates in view of Han, and further in view of Iida et al. (US 20150335388 A1; hereafter “Iida”).
Regarding claim 8, Yates/Han discloses the limitations of claim 7 as addressed above. However, Yates/Han does not explicitly teach “wherein the central control unit is configured to measure electrical resistance between the first and second probes, wherein a drop in the measured resistance indicates contact between the probes.”
Iida, in the same field of endeavor (robotic surgical systems), teaches
wherein the central control unit is configured to measure electrical resistance between [two instruments], wherein a drop in the measured resistance indicates contact between the [instruments] (See “The grip detector 110 can detect the gripping state where the manipulator 19A grips the hook-shaped knife 112 in a state where the gripper-side electrode 111 and the sheath-side electrode 115 [of the hook-shaped knife 112] come into contact with each other, using well-known methods, such as measuring the electric resistance between the gripper-side electrode 111 and the sheath-side electrode 115” [0169]. In Fig. 12, the grip detector 110 is in the control apparatus 70 (central control unit). A person of ordinary skill in the art would recognize that a drop in the measured electric resistance indicates contact between the instruments. See also [0088], [0095], [0120], and [0192].).
Given Yates discloses detecting contact of the first and second probes (see rejection of claim 6 above), the combination of Yates/Han and Iida teaches “wherein the central control unit is configured to measure electrical resistance between the first and second probes.” Thus, the combination as a whole teaches the claim.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the robotic surgical system of Yates/Han to measure electrical resistance to detect contact between instruments as taught by Iida. One of ordinary skill in the art would have been motivated to make this modification to confirm instrument contact when performing a surgery with a high-frequency current (Iida, [0170]). Detecting electrical resistance through otherwise necessary parts eliminates the need for a separate sensor and simplifies the surgical instrument.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Yates in view of Han, and further in view of Henriksson and Tranberg (US 20100228240 A1; hereafter “Henriksson”).
Regarding claim 12, Yates/Han discloses the limitations of claim 11 as addressed above. However, Yates/Han does not explicitly teach “wherein the wires are electrically conductive.”
Henriksson, also solving insertion of surgical tools, teaches
wherein the wires are electrically conductive (See “Each electrode ring 37-43 is connected by its respective electrical conductor 45, 47, 49, 51 [of leads 5, 7] to the switchable output of a current generator 50 and the switchable inputs of a measuring circuit 52 preferably able to measure an electrical property of the electrical path between any pair of electrode rings” [p. 184, col. 1]. See also [0022] and Fig. 1.).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the surgical instruments of Yates with the leads of Henriksson. One of ordinary skill in the art would have been motivated to make this modification to thermally treat diseased tissue (Henriksson, [0034]).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Yates in view of Han, and further in view of Purohit et al. (WO 2020264418 A1; hereafter “Purohit”).
Regarding claim 15, Yates/Han discloses the limitations of claim 1 as addressed above, and additionally discloses the robotic arms can be mounted in various positions and on various structures [0049].
However, Yates/Han does not explicitly teach “wherein the chassis comprises a mobile cart.”
Purohit, in the same field of endeavor (robotic surgical systems), teaches
wherein the chassis comprises a mobile cart (See Fig. 14 where robotic arms 142A and 142B are attached to a wheeled base 103. See also Fig. 6 and [0072] and [0075]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the robotic surgical system of Yates/Han with the cart base of Purohit. One of ordinary skill in the art would have been motivated to make this modification for the benefit of allowing the cart base “to easily move around the room prior to a procedure” (Purohit, [0066]).
Regarding claim 16, Yates/Han/Purohit discloses the limitations of claim 15 as addressed above, and Purohit additionally discloses
wherein the mobile cart is configured to be positioned beneath a surgical table so that the first and second surgical robotic arms are configured to lie on opposite sides of the surgical table (See wheeled base 103 under table 101 with robotic arm 142A on the left side of the table and robotic arm 142B on the right side of the table in Fig. 14. See also Fig. 6 and [0072], [0075], [0083], and [0088].).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Yates in view of Han and Purohit, and further in view of Mantri et al. (US 20210401522 A1, filed 07/27/2020; hereafter “Mantri”).
Regarding claim 17, Yates/Han/Purohit discloses the limitations of claim 16 as addressed above. However, Yates/Han/Purohit does not explicitly teach “wherein the mobile cart includes a single structure configured to be removably positioned beneath the surgical table.”
Mantri, in the same field of endeavor (robotic surgical systems), teaches
wherein the mobile cart includes a single structure configured to be removably positioned beneath the surgical table (See Fig. 4A: the mobile base 470 is a single structure and would be positioned lower than a surgical table in a typical surgery. See also “Coarse motion capability [of instruments, e.g., probe 460 in Fig. 4A] allows for storage below and adjacent to the table and during patient positioning” [0043]. See also [0078].).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the robotic surgical system of Yates/Han/Purohit with the mobile base of Mantri. One of ordinary skill in the art would have been motivated to make this modification so that the robotic surgical system is “independently positionable around a patient” (Mantri, [0078]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Yates in view of Han and Purohit, and further in view of Romo et al. (US 9737371 B2, hereafter “Romo”).
Regarding claim 18, Yates/Han/Purohit discloses the limitations of claim 16 as addressed above. However, Yates/Han/Purohit does not explicitly teach “wherein the chassis comprises two or more mobile structures configured to be assembled beneath the surgical table.”
Romo, in the same field of endeavor (robotic surgical systems), teaches
wherein the chassis comprises two or more mobile structures configured to be assembled beneath the surgical table (See Fig. 7: “two sets of robotic subsystems 701 and 704, each with a pair of robotic arms 702, 703 and 705, 706 respectively” are mounted on two mobile carts assembled beneath the surgical table [col. 18, lines 3-9]. See also Figs. 2A-2C and col. 2, lines 53-59.).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the robotic surgical system of Yates/Han/Purohit with the mobile base of Romo. One of ordinary skill in the art would have been motivated to make this modification because “mobile carts permit transporting the arms [separately] between procedure rooms or moving within a procedure room to better accommodate necessary equipment and the patient” bed (Romo; col. 2, lines 53-59).
Claims 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Nixon et al. (US 20090171371 A1; hereafter “Nixon”) in view of Arata et al. (US 20080004633 A1; hereafter “Arata”).
Regarding claim 19, Nixon discloses
A method for positioning first and second cannulas prior to performing a robotic surgical procedure in a surgical robotic coordinate space, said method comprising: positioning a first robotic arm of a surgical robot to locate a distal portion of a first positioning probe carried in a working channel of the first cannula at a kinematically determined location in the surgical robotic coordinate space; positioning a second robotic arm of the surgical robot to locate a distal portion of a second positioning probe carried by a working channel of the second cannula at a kinematically determined location in the surgical robotic coordinate space (See “Prior to making a measurement using the two tools 1200-1, 1200-2, the operator may first touch their tip/sensors together in order to define an absolute zero point for displacement/measurement purposes” [0074]. This absolute zero point is in the surgical robotic coordinate space. The two tools 1200-1,1200-2 (probes) are “are coupled to and robotically manipulated by slave manipulators of their respective robotic arm assemblies 128, 139” [0072]. Kinematically-determined location: see [0048-0057] for kinematic control of the slave manipulators. Specifically, “A simulated slave processor 308 receives desired slave tool frame position and velocity commands… and limits the desired slave tool frame position, orientation, and velocities to assigned Cartesian Limits” [0051] via inverse kinematics (Fig. 3), then “A joint control unit 320 receives the slave joint positions from the slave input processor 309 and the simulated joint position commands provided from the simulated slave processor 308 and generates slave torque command signals for the slave joint motors” [0054]. The probes are inserted through cannulas having working channels attached to each of the slave manipulators to perform a surgery [0006]. See also Figs. 1, 11, 13 and 19, and [0061], [0073], [0091], and [0094-0095].);
determining a distance between the distal portion of the first probe and the distal portion of the second probe (See “Prior to making a measurement using the two tools 1200-1, 1200-2, the operator may first touch their tip/sensors together in order to define an absolute zero point for displacement/measurement purposes” [0074]. The tips of the tools are the distal portions of the probes, and the determined distance is zero. See also “when two tools are used by the operator to indicate a distance to be determined (such as described in reference to FIG. 11), the distance between corresponding reference points on the two tools is determined” [0095]. See also [0072], [0091], [0094-0095], and Figs. 11, 13, and 19.); and…
(a) removing the probes from the working channels (See “Each of the tools 138, 139, as well as the Endoscope 140, is conventionally inserted through a tool guide [cannula] into the Patient so as to extend down to the surgical site through a corresponding minimally invasive incision… If it is necessary to change a tool being used during a procedure, the Assistant may remove the tool no longer being used from its robotic arm assembly, and replace it with another tool 131 from a Tray ("T") in the operating room” [0035]. Removing a tool (probe) from the surgical site inside the patient involves removing the tool from the tool guide/cannula having a working channel. See also [0006].);
(b) advancing the cannulas into the surgical space (See “To perform a minimally invasive surgical procedure on a patient, one or more incisions are first made in the patient and cannulae inserted therein to gain access to a surgical site within the patient” [0006].);
(c) inserting working tools into the working channels (See “Surgical instruments engaged on the slave manipulators are then inserted into the cannulae and properly positioned and oriented in order to perform the procedure” [0006]. See also [0035].); and
(d) performing the robotic surgical procedure using the working tools (See “A surgeon may then manipulate… the slave manipulators and their respective surgical instruments through one or more controllers to perform the surgical procedure” [0006]. See also [0034-0035].).
However, Nixon does not explicitly teach “if the determined distance is less than a threshold amount: (a) removing the probes from the working channels; (b) advancing the cannulas into the surgical space; (c) inserting working tools into the working channels; and (d) performing the robotic surgical procedure using the working tools.”
Arata, in the same field of endeavor (robotic surgical systems), teaches
if the determined distance is less than a threshold amount… performing the robotic surgical procedure using the working tools (See “contacting the mechanical interface with an instrument can verify whether or not a position of the surgical tool has an expected correspondence to a position of the checkpoint (or datum)” [0093]. The mechanical interface is itself a surgical tool, with its position registered in [0090-0092]. See “the verification checkpoint system compares an actual offset (the distance between the tip of the instrument or the center of the tip of the instrument and the checkpoint of the mechanical interface)) to an ideal offset (a predetermined distance between the expected (or ideal) position of the tip of the instrument or the center of the tip of the instrument and the checkpoint of the mechanical interface when all three conditions are met)… the difference between the actual offset and the ideal offset should be below a predetermined threshold. For example, a predetermined threshold of 1.0 mm could be used to verify” the position of the instrument is correct [0094]. When the expected distance is zero—the tip of the instrument is expected to touch the checkpoint of the mechanical interface, the measured distance is compared to the predetermined threshold (threshold amount), for example 1.0 mm. See also “a distance between a position of the checkpoint of the mechanical interface and a position of the instrument, such as a position of the tip of the instrument or the center of the tip of the instrument, can be calculated. If this calculated distance is less than a predetermined value, the verification checkpoint system will determine that the surgical procedure is proceeding accordingly” [0097]. After verification, the verified instrument is used to perform a robotic surgical procedure: “In operation, the user can contact the femoral and tibial checkpoint verification interfaces any time the user wants to validate the configuration of the surgical system 10, such as when the tool 50 is withdrawn from and then reinserted into the patient” [0121]. For example, a working tool inserted into a patient: “In step S11, the first bone (e.g., the tibia T) is prepared to receive the first implant (e.g., the tibial component 74) by manipulating the tool 50 to sculpt the first bone” [0129]. Examples of tools, including probes and burrs, are given in [0063] and [0092]. See also [0093] and [0124]).
Using the positioning probes of Nixon as the mechanical interface and surgical instrument of Arata, the position of the probes is verified by comparing the measured distance between the probes to the predetermined threshold when the expected distance is zero. After the verification, the surgical procedure is performed/continued.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the robotic positioning method of Nixon with the instrument verification method of Arata. One of ordinary skill in the art would have been motivated to make this modification “quickly provide a user with information useful for determining if the system is performing as intended and/or being used properly before any non-reversible cuts are made to the patient's anatomy,” including verifying “if an instrument is in the correct position relative to a patient's anatomy” (Arata, [0093]).
Regarding claim 20, Nixon/Arata discloses the limitations of claim 19 as addressed above, and Nixon additionally discloses
wherein determining the distance comprises detecting the distance between said distal portions using at least one sensor on at least one of the first and second positioning probes (See “Prior to making a measurement using the two tools 1200-1, 1200-2, the operator may first touch their tip/sensors together in order to define an absolute zero point for displacement/measurement purposes” [0074]. The distance sensed at this touch point is zero. A distance is also sensed after moving at least one of the tools from the absolute zero point “to indicate the points (X1, Y1, Z1), (X2, Y2, Z2) that are to be used by the distance determination processor 402 for its distance calculation” [0074]. See also Fig. 13 and [0072], [0091], and [0094-0095].).
Regarding claim 21, Nixon/Arata discloses the limitations of claim 20 as addressed above, and Nixon additionally discloses
wherein the threshold distance between said distal portions is 2 mm or less (See “Prior to making a measurement using the two tools 1200-1, 1200-2, the operator may first touch their tip [distal portion]/sensors together in order to define an absolute zero point for displacement/measurement purposes” [0074]. The determined distance and the threshold distance are a distance of zero, which is less than 2 mm.).
Arata discloses the threshold distance is 1 mm; see [0094], [0121], and [0124].
Regarding claim 22, Nixon/Arata discloses the limitations of claim 19 as addressed above, and Nixon additionally discloses
wherein determining the distance comprises detecting contact between said distal portions (See “Prior to making a measurement using the two tools 1200-1, 1200-2, the operator may first touch [contact] their tip/sensors together in order to define an absolute zero point for displacement/measurement purposes” [0074].).
See also “different-sized instruments can be contacted with the mechanical interface to determine if a distance between a tip of the instrument… and the checkpoint is less than a predetermined tolerance” (Arata, [0093]).
Regarding claim 23, Nixon/Arata discloses the limitations of claim 22 as addressed above, and Nixon additionally discloses
wherein detecting contact of the first and second probes comprises assessing one or more of electrical, mechanical, visual, and fluoroscopic characteristics (See “Prior to making a measurement using the two tools 1200-1, 1200-2, the operator may first touch [contact] their tip/sensors together in order to define an absolute zero point for displacement/measurement purposes” [0074]. Mechanical characteristics: the sensors are force sensors 1202 [0072]. See also electrical and mechanical characteristics in [0076]. See also visual displays in [0076] and Figs. 15-18.).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Nixon in view of Arata, and further in view of Iida.
Regarding claim 24, Nixon/Arata discloses the limitations of claim 22 as addressed above. However, Nixon/Arata does not explicitly teach “wherein detecting contact of the first and second probes comprises measuring electrical resistance between the first and second probes, wherein a drop in the measured resistance indicates contact between the probes is present.”
Iida, in the same field of endeavor (robotic surgical systems), teaches
wherein detecting contact of the first and second probes comprises measuring electrical resistance between the first and second probes, wherein a drop in the measured resistance indicates contact between the probes is present (See “The grip detector 110 can detect the gripping state where the manipulator 19A grips the hook-shaped knife 112 in a state where the gripper-side electrode 111 and the sheath-side electrode 115 [of the hook-shaped knife 112] come into contact with each other, using well-known methods, such as measuring the electric resistance between the gripper-side electrode 111 and the sheath-side electrode 115” [0169]. In Fig. 12, the grip detector 110 is in the control apparatus 70 (central control unit). A person of ordinary skill in the art would recognize that a drop in the measured electric resistance indicates contact between the instruments. See also [0088], [0095], [0120], and [0192].).
Given Nixon discloses detecting contact of the first and second probes (see rejection of claim 22 above), the combination of Nixon/Arata and Iida teaches “wherein the central control unit is configured to measure electrical resistance between the first and second probes.” Thus, the combination as a whole teaches the claim.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the robotic surgical method of Nixon/Arata to measure electrical resistance to detect contact between instruments as taught by Iida. One of ordinary skill in the art would have been motivated to make this modification to confirm instrument contact when performing a surgery with a high-frequency current (Iida, [0170]). Detecting electrical resistance through necessary parts eliminates the need for a separate sensor and simplifies the surgical instrument.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Nixon in view of Arata, and further in view of Han.
Regarding claim 28, Nixon/Arata discloses the limitations of claim 19 as addressed above, and Nixon further discloses
wherein the cannulas are advanced… before performing the robotic surgical procedure… with working tools introduced through the working channels of the cannulas (See “one or more incisions are first made in the patient and cannulae inserted [advanced] therein to gain access to a surgical site within the patient… Surgical instruments [working tools] engaged on the slave manipulators [of the robotic arms] are then inserted into the cannulae and properly positioned and oriented in order to perform the procedure. A surgeon may then manipulate… the slave manipulators and their respective surgical instruments… to perform the surgical procedure” [0006]. See also [0035].).
However, Nixon/Arata does not explicitly teach “wherein the cannulas are advanced beneath a patient's nerve root in the patient's spine.”
Han, in the same field of endeavor (spinal surgery), teaches
wherein the cannulas are advanced beneath a patient's nerve root in the patient's spine before performing the… procedure on the spine with working tools introduced through the cannulas (A cannula is inserted to a disc before performing a discectomy (spinal procedure) with an endoscope [p. 184, col. 2 to p. 185, col. 1]. See “when the obturator is inserted between the exiting nerve root and the facet” [p. 184, col. 2]. There exists at least one point of view where the cannula is inserted over the obturator and beneath the nerve root. See also p. 183, col. 1, “Surgical procedure”, Fig. 6, and Table 1.).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the robotic surgical method of Nixon/Arata to advance cannulas under a nerve root as taught by Han. One of ordinary skill in the art would have been motivated to make this modification to perform a safer discectomy procedure (Han; p. 182, col. 1, “Introduction”).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MOYA LY/Examiner, Art Unit 3658
/Ramon A. Mercado/Supervisory Patent Examiner, Art Unit 3658