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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/06/2025 has been considered by the examiner.
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.
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 limitation(s) is/are: “position determining unit”, and “pivot point determining unit” in claim 1, “energy storage unit” in claims 5 and 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The position determining unit and the pivot point determining unit is a processor (see para. 0036 and 0064). An energy storage unit can comprise a battery (see para. 0030).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/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 limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
In claim 1, line 4-5, “a medical instrument” should be “the medical instrument” for clarity.
In claim 11, “the position indicators” should be “the plurality of position indicators” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hagn et al. (US 20250134609 A1, published May 1, 2025 with a priority date of September 30, 2021), hereinafter referred to as Hagn.
Regarding claim 1, and similarly to claim 15, Hagn teaches a medical system, in particular a system-assisted system for minimally invasive surgery (Fig. 1, surgical robotic system 10), comprising:
a robot configured to hold and move a medical instrument (Fig. 1, robot arm 40 holding and moving instrument 50);
an access device (Fig. 6, access port 55) arrangeable to provide access to a body cavity for a medical instrument held by the robot (see para. 0072 – “…while the access port 55 is already placed in the body wall “BW” [body cavity] of the patient…FIGS. 7 and 8 depicts the configuration of the robotic arm 100 when the instrument 50 is inserted through the port 55.”), wherein the access device comprises at least one position indicator (Fig. 6, port markers 57 and 58 as at least one position indicator);
a measuring unit having at least one sensor configured to carry out a sensor measurement directed at the at least one position indicator (see para. 0076 – “With reference to FIG. 8, the access port 55 may also include one or more sensors 71, which may be a position sensor…”);
a position determining unit configured to determine a position of the access device according to the sensor measurement (see para. 0076 – “With reference to FIG. 8 , the access port 55 [access device] may also include one or more sensors 71, which may be a position sensor…The position sensor is configured to provide accurate location finding without line-of-sight.”);
a pivot point determining unit configured to determine a pivot point for the access device according to the determined position of the access device (see para. 0035 – “In other words, the pivot point “P” is a remote center of motion (RCM) for the robotic arm 40.”; see para. 0048 – “In order to provide for soft RCM [pivot point] control of the robotic arm 100, the location of the incision point “I” [same location as access device 55] in the patient's body wall “BW” is determined in relation to the kinematics of the robotic arm 100…”); and
a robot controller configured to determine control commands for controlling the robot according to the determined pivot point in such a way that the robot carries out pivot movements of the medical instrument about the pivot point (see para. 0050 – “Since the location of the access port 55 coincides to the location of the incision point “I”, knowing the location of the port marker 57 with respect to the kinematics of the robotic arm 100 allows for implementing the limitation in the inverse kinematics such that the motion of the robotic arm 100 is controlled in a way that a longitudinal axis “Z-Z” defined by the instrument 50 always intersects with the incision point “I” (FIG. 7 ).”).
Furthermore, regarding claim 2, Hagn further teaches wherein the access device is free of a connection to the robot (Fig. 6, access port 55 free of connection to robot arm 100).
Furthermore, regarding claim 3, Hagn further teaches wherein the measuring unit is configured to measure a distance to the at least one position indicator (see para. 0054 – “The system 10 also includes one or more external radio frequency (RF) emission detectors 210 configured to detect location and/or distance of a plurality of trackers 211 [position indicator]…”).
Furthermore, regarding claim 4, Hagn further teaches wherein the at least one position indicator comprises a signal generator configured to generate an electromagnetic signal (see para. 0054 – “Trackers 211 [position indicator] may be either active or passive transmitters capable of emitting [generating] electromagnetic energy…”).
Furthermore, regarding claim 5, Hagn further teaches wherein the access device comprises an energy storage unit configured to supply the at least one position indicator with energy (see para. 0054 – “… a plurality of trackers 211, which may be disposed on the access port 55…Trackers 211 may be either active [includes battery/energy storage unit] or passive transmitters capable of emitting electromagnetic energy…”).
Furthermore, regarding claim 6, Hagn further teaches wherein the sensor of the measuring unit is an electromagnetic detection sensor (see para. 0054 – “Trackers 211 may be either active or passive transmitters capable of emitting electromagnetic energy detectable by the RF detectors 210, which may operate using any suitable electromagnetic spectrum transmissions configured to determine location of the trackers 211 using time of flight, triangulation, and other methods.”).
Furthermore, regarding claim 7, Hagn further teaches wherein the at least one position indicator comprises at least one optically detectable marking (Fig. 5; see para. 0069 – “The arm cameras 204 and the RF detectors 212 may be communicatively coupled to the computer 21 and/or the computer 31, allowing for local processing for image and electromagnetic location data from the cameras 204 and the arm RF detectors 212. In particular, the image data may be used to identify the location of access ports 55 via the top marker 58 and one or more of the robotic arms 100 visible through the arm camera 204 [optical detector].”).
Furthermore, regarding claim 8, Hagn further teaches wherein the sensor of the measuring unit is an optical detection sensor (Fig. 5; see para. 0069 – “The arm cameras 204 and the RF detectors 212 may be communicatively coupled to the computer 21 and/or the computer 31, allowing for local processing for image and electromagnetic location data from the cameras 204 and the arm RF detectors 212. In particular, the image data may be used to identify the location of access ports 55 via the top marker 58 and one or more of the robotic arms 100 visible through the arm camera 204 [optical detector].”).
Furthermore, regarding claim 9, Hagn further teaches wherein the access device is free of an energy storage unit (see para. 0054 – “… a plurality of trackers 211, which may be disposed on the access port 55…Trackers 211 may be either active or passive [free of battery/energy storage unit] transmitters capable of emitting electromagnetic energy…”).
Furthermore, regarding claim 10, Hagn further teaches wherein the measuring unit is configured to carry out an image detection of the at least one position indicator (Fig. 5; see para. 0069 – “The arm cameras 204 and the RF detectors 212 may be communicatively coupled to the computer 21 and/or the computer 31, allowing for local processing for image and electromagnetic location data from the cameras 204 and the arm RF detectors 212. In particular, the image data may be used to identify the location of access ports 55 via the top marker 58 and one or more of the robotic arms 100 visible through the arm camera 204.”).
Furthermore, regarding claim 11, Hagn further teaches wherein the access device comprises a plurality of position indicators arranged at different positions of the access device (Fig. 5, port marker 57 and top port marker 58 of access port 55 as position indicators), and wherein the position determining unit is configured to take into account the different positions of the position indicators when determining the position of the access device (see para. 0051 – “The position of the incision point “I” [position of access port 55] may be determined based on a position of the port marker 57 and/or the top marker 58 of the access port.”).
Furthermore, regarding claim 12, Hagn further teaches wherein the robot controller is configured to generate control commands for controlling the robot with respect to a robot coordinate system, and wherein the pivot point determining unit is configured to determine the pivot point in relation to the robot coordinate system (see para. 0084 – “Because the instrument marker 59 has a fixed relation to the kinematics of the robotic arm 100 [pivot point determined in relation to an inherent robot coordinate system] and the top of the access port 55 has a fixed relation to the incision point “I” [predefined target pivot point], the relation between the incision point “I” and the robot kinematics is identified by the controller 21 a and may be used further on to apply the soft-RCM approach.”).
Furthermore, regarding claim 13, Hagn further teaches wherein the access device has a predefined and/or predefinable target pivot point, wherein it is provided that the target pivot point substantially coincide with the pivot point during a performance of the pivot movements of the medical instrument, and wherein the pivot point determining unit is configured to take into account a geometric relationship between the position indicator and the target pivot point when determining the pivot point for the access device (see para. 0084 – “Because the instrument marker 59 has a fixed relation to the kinematics of the robotic arm 100 [the pivot movements of medical instrument] and the top of the access port 55 [position indicator] has a fixed relation to the incision point “I” [predefined target pivot point], the relation between the incision point “I” and the robot kinematics is identified by the controller 21 a and may be used further on to apply the soft-RCM approach.”).
Furthermore, regarding claim 14, Hagn further teaches a user interface via which a user can predefine the target pivot point and in particular a distance of the target pivot point from the at least one position indicator (see para. 0074 – “In embodiments, the robotic arm 100 may include a user interface (not shown) configured to display a GUI to accomplish various tasks such as identify the location of the access port 55.”).
Furthermore, regarding claim 16, Hagn further teaches program code comprising instructions that, when executed by a processor, cause a method according to claim 15 to be carried out (see claim 15 above; see para. 0031 – “The processor may be any suitable processor (e.g., control circuit) adapted to perform the operations, calculations, and/or set of instructions described in the present disclosure…”).
Furthermore, regarding claim 17, Hagn further teaches computer program product comprising a machine-readable medium on which program code according to claim 16 is stored (see claim 15 above; see para. 0031 – “The computers 21, 31, 41 may include any suitable processor (not shown) operably connected to a memory (not shown), which may include one or more of volatile, non-volatile, magnetic, optical, or electrical media, such as read-only memory (ROM), random access memory (RAM), electrically-erasable programmable ROM (EEPROM), non-volatile RAM (NVRAM), or flash memory. The processor may be any suitable processor (e.g., control circuit) adapted to perform the operations, calculations, and/or set of instructions described in the present disclosure…”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Borchard et al. (DE 102015212199 A1, published January 19, 2017) discloses instruments can be pivoted by the robot arm about two, preferably normally aligned, tilting or pivoting axes, which are located in the region of the access or the access device.
Shelton, IV et al. (US 20200405417 A1, published December 31, 2020) discloses robotic arm can pivot about the access device, and kinematic calculations from the control device mapped to each of the robotic arms mounted on the surgical platform can be used to maintain the pivot and relative position of access ports secured by the corresponding arm.
Diaz-Chiosa (US 20230363834 A1, published November 16, 2023 with a priority date of May 11, 2022) discloses a plurality of secondary robotic arms each of which is configured to hold an instrument access port of a plurality of instrument access ports and a surgical instrument of a plurality of surgical instruments, each of which is configured to be inserted into one instrument access port of the plurality of instrument access ports.
Troxell et al. (US 20210007811 A1, published January 14, 2021) discloses a surgical robot system allowing the navigation of access instruments.
DiMaio et al. (US 20190231460 A1, published August 1, 2019) discloses the processor may determine the location of the access port from the port data and use the location of the access port as an input indicative of the reference point about which the distal portion (or an item supported by the remotely controllable arm such as a cannula or a surgical tool) should rotate.
Wood et al. (US 20220031422 A1, published February 3, 2022) discloses a positioning system, e.g., a controllable and adjustable robotic arm, and the position and orientation of the positioning system, imaging system, and/or access port may be tracked using a tracking system.
Charron et al. (US 20190117318 A1, published April 25, 2019) discloses markers enables the tracking system to discern both the position and orientation of the access port.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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/N.C./Examiner, Art Unit 3798
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