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 Appeal
Claims 1-4, 7-9, and 12 are pending in the application. Examiner notes that all previous objections and rejections pertaining to canceled claims 5-6, 10-11, and 13-15 are withdrawn.
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
Response to Arguments
Applicant states that the prior art of record does not teach every limitation of amended independent claims 1, 7, and 12, and claims 2-4 and 8-9 by dependency.
Regarding the argument “The Examiner’s Proposed Modification Implicitly Admits a Missing Claim Feature and Relies on a Factually Unsupported Reorientation of Tsao’s System That Breaks Tsao’s Enforced Geometry and Alters Its Principle of Operation” (Appeal Brief, pages 6-9), this argument has been considered but is moot. The rejection of claim 1 below does not rely on a reorientation of Tsao’s system.
Regarding the other arguments with respect to the rejection of independent claim 1 under 103 (Appeal Brief, pages 9-11), these arguments have been considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Ramirez (US 20190327394 A1), which teaches pivoting about a point inside the eye [0565]. In combination, Tsao/Ramirez/Meenink/Kostrzewski, teaches “a pivot mechanism of the hardware configured to rotate the device and tool about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis from the one of the nasal and temporal eye side locations to the other of the locations.”
Regarding the arguments with respect to the rejection of claim 12 (Appeal Brief, pages 12-13), these arguments have been considered. However, upon further consideration, a new ground of rejection is made in view of Ramirez (US 20190327394 A1), which teaches pivoting about a point inside the eye [0565] and saving sites/robot poses to return to later in the procedure [0399]. In combination, Cehajic-Kapetanovic/Ramirez/Cooper/Meenink teaches “pivoting hardware of the system to reposition the tool through the other of the temporal and nasal side positioned cannulas; wherein the pivoting of the hardware is about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis relative to the patient.”
Claim Objections
Claims 3-4 and 12 are objected to because of the following informalities:
In claims 3 and 4, “a coronal plane” should read “the coronal plane” because a coronal plane is previously recited in claim 2.
Claim 12 recites “the system” in the utilizing and pivoting steps. There is insufficient antecedent basis for this limitation. Both “a surgical support system” in the preamble and “a surgical system” in the performing step have been recited.
Appropriate correction is required.
Applicant is advised that should claim 1 be found allowable, claim 7 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Interpretation
Regarding claims 1, 7, and 12, rotation or pivoting “about” an angle “along” an axis is interpreted as rotating around the axis, where the angle specifies the amount of rotation.
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:
“a pivot mechanism of the hardware configured to rotate the device and tool about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis from the one of the nasal and temporal eye side locations to the other of the locations” in claims 1 and 7.
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.
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.
Claims 1 and 7 recite the generic placeholder “pivot mechanism” plus functional language “rotate the device and tool about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis from the one of the nasal and temporal eye side locations to the other of the locations” linked by “configured to”. In paragraph [0009], the specification discloses “the system is configured such that a surgeon may manually direct an implement of the system to control movement of the device and tool, including the ability to pivot a mechanism of the hardware to rotate the device and tool about 180° along one of a vertical axis and a horizontal axis. Therefore, the device and tool may be controllably moved from the one of the nasal and temporal eye side locations to the other of the locations.” However, no structure corresponding to the pivot mechanism is recited.
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 1-4, 7-9, and 12 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.
In claims 1 and 7, the limitation “a pivot mechanism of the hardware configured to rotate the device and tool about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis from the one of the nasal and temporal eye side locations to the other of the locations” does not have support in the disclosure of application 18/303,190 as originally filed on 04/19/2023 nor in the disclosure of the provisional application 63/363,744. The closest support found in the specification of the instant application 18/303,190 is copied below:
[0009] The surgical tool is positioned by the securing device at a stable predetermined orientation relative one of a nasal and a temporal eye side location. Once more, the system is configured such that a surgeon may manually direct an implement of the system to control movement of the device and tool, including the ability to pivot a mechanism of the hardware to rotate the device and tool about 180° along one of a vertical axis and a horizontal axis. Therefore, the device and tool may be controllably moved from the one of the nasal and temporal eye side locations to the other of the locations.
[0024] Continuing with reference to Fig. 1, recall that the depicted tool (vitrectomy probe 190), may be limited to movement along a single axis or plane, into or out of the eye interior. Limiting movement in this manner may serve as a safety feature, for example, to prevent other needle movements within the eye 157 from unintentionally harming a side of the eye interior at the underside of the sclera 370, for example (see Figs. 3A and 3B). This means that the angle between the tool 190 and the eye 157 is fixed. For example, note the angle 240 (θ) of Fig. 2A that is less than about 90°, likely to be between about 30° and 60° with respect to intersecting a temporal side cannula 225.
[0025] As detailed below, the system 100 is uniquely configured to allow for a stabilized pivot to another fixed angle 245 of roughly the same degree (θ) as shown at Fig. 2B, at a nasal side cannula 250, when the procedure at the temporal side is complete or otherwise calls for interruption with nasal side intervention. As also detailed below, this pivot 201 may be about 180° about a y-axis 200 as shown in Figs. 2A and 2B.
[0029] With added reference to the schematic of Fig. 2B, notice that the system hardware 180, 145 has been rotated (201) about the y-axis 200 such that the device support 145 is now located in alignment with the nasal side cannula 250 for the vitrectomy probe 190. The offset for the nasal side cannula 250 is such that another angular interface 245 is presented for the probe 190. However, this angle 245 roughly matches that of the temporal side cannula 225. For example, in one embodiment, both angles 240, 245 may be about 45°. Of course, any number of other roughly matching acute angle presentations may be utilized. Furthermore, following completion of the depicted vitrectomy procedure at Fig. 2B, there may be a desire to return to an application at the temporal side cannula 225. Thus, the patient 150 may again be slightly moved (see 285) in order to return to temporal side positioning with another rotation 205 of the hardware 180 about the y-axis 200.
[0030] The above movement of the system 100 about the axis 200 involves the rotation or pivot of hardware (e.g., 180) about a y-axis. However, in another embodiment, the system 100 may instead rotate 260 about a z-axis point (z) (see Fig. 2A). For example, consider a rotation or pivot 260 about the z-axis point (z) of about 180° from the position shown in Fig. 2A. This would leave the device support hardware 145 in a roughly upside down position. Thus, for this embodiment, a support interface 275 may be rotated so as to re-orient the support hardware 145 into a position for supporting the illustrated nasal side application of Fig. 2B.
Specifically, paragraph [0009] is the only paragraph to recite the word “predetermined”, and, in paragraph [0009], the “stable predetermined orientation” is the angle between a horizontal plane and the long axis of the surgical tool 190 held by the securing device 110. This is the angle 240 in Fig. 2A and angle 245 in Fig. 2B, not the angle amount of the pivot 201 or 205. Similarly, paragraphs [0024] and [0025] are the only paragraphs to recite the word “fixed”, and again, the fixed angle is the angle 240 or 245 between a horizontal plane and the long axis of the surgical tool 190, not the angle of the pivot. While claims are not limited to the nomenclature used in the specification, no other paragraphs appear to support the claim limitation of “rotat[ing] the device and tool about a fixed, predetermined angle”. Paragraphs [0009], [0025], [0030], and [0033] describe rotating “about 180°” only, so a generalized angle is not supported; see MPEP 2163.05. Therefore, the particular limitation “a pivot mechanism of the hardware configured to rotate the device and tool about a fixed, predetermined angle” is not supported.
Furthermore, paragraph [0009] states the system has “the ability to pivot a mechanism of the hardware to rotate the device and tool about 180° along one of a vertical axis and a horizontal axis”, but not “along only one of a vertical axis and a horizontal axis from the one of the nasal and temporal eye side locations to the other of the locations” (emphasis added). According to paragraph [0030], rotation around the z-axis also requires rotation of the support interface 275 “to re-orient the support hardware 145 into a position for supporting the illustrated nasal side application of Fig. 2B.” In Fig. 2B, the support interface 275 is clearly not aligned with a vertical or horizontal axis, so its rotation includes at least some rotation of the tool securing device 110 and surgical tool 190 around both the vertical y-axis 200 and horizontal x-axis. There is no horizontal axis where the disclosed system can rotate the device and tool along only the horizontal axis “from the one of the nasal and temporal eye side locations to the other of the locations.” Even in the case of only rotation around the vertical y-axis 200, paragraphs [0028-0029] disclose that the patient is moved (arrows 280 and 285 in Figs. 2A and 2B) relative to the system to align the surgical tool 190 with the cannulas 225, 250, so it is not clear that the recited mechanism can actually perform its claimed function. Therefore, the particular limitation “a pivot mechanism of the hardware configured to rotate the device and tool about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis from the one of the nasal and temporal eye side locations to the other of the locations” is not supported.
As explained above, the disclosure as originally filed does not provide sufficient support for the particular limitation of “a pivot mechanism of the hardware configured to rotate the device and tool about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis from the one of the nasal and temporal eye side locations to the other of the locations”. Accordingly, claims 1 and 7 are rejected under 35 U.S.C. 112(a).
Claims 2-4 and 8-9 are rejected for depending upon the rejected independent claims 1 and 7, respectively.
Claim 12 recites the limitation “pivoting hardware of the system to reposition the tool through the other of the temporal and nasal side positioned cannulas; wherein the pivoting of the hardware is about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis relative to the patient,” which is similar to the limitation of claims 1 and 7 discussed above. Specifically, claim 12 recites the same limitation of pivoting hardware “about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis” to reposition a surgical tool from one of the temporal and nasal side positioned cannulas to the other cannula, which was determined to have insufficient support as explained above with respect to claims 1 and 7 above. Therefore, the particular limitation “pivoting hardware of the system to reposition the tool through the other of the temporal and nasal side positioned cannulas; wherein the pivoting of the hardware is about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis relative to the patient” does not have sufficient support in the disclosure as originally filed. Accordingly, claim 12 is rejected under 35 U.S.C. 112(a).
Regarding claims 1 and 7, the claim limitation “a pivot mechanism of the hardware configured to rotate the device and tool about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis from the one of the nasal and temporal eye side locations to the other of the locations” 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 mechanism is disclosed to perform the claimed function, no structure corresponding to the “mechanism” is recited. 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 2-4 and 8-9 are rejected for depending upon the rejected independent claims 1 and 7, respectively.
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 1-4, 7-9, and 12 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 claims 1, 7, and 12, the term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the limitation “about a fixed, predetermined angle” is rendered indefinite, and claims 1, 7, and 12 are rejected.
Claims 2-4 and 8-9 are rejected for depending upon the rejected independent claims 1 and 7, respectively.
Regarding claim 12, the claim limitation “wherein the pivoting of the hardware is about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis relative to the patient” renders the claim indefinite because axes may be defined arbitrarily relative to the patient. For example, it is not clear if “a vertical axis relative to the patient” is the vertical y-axis 200 as shown in Figs. 2A and 2B or an axis of the patient that is vertical when the patient is standing (but horizontal when the patient is lying down). For the purpose of examination, the claimed vertical axis is assumed to be the vertical y-axis 200, and the claimed horizontal axis is assumed to be the horizontal z-axis as shown in Fig. 2A.
Regarding claims 1 and 7, the claim limitation “a pivot mechanism of the hardware configured to rotate the device and tool about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis from the one of the nasal and temporal eye side locations to the other of the locations” 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 mechanism is disclosed to perform the claimed function, no structure corresponding to the “mechanism” 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 2-4 and 8-9 are rejected for depending upon the rejected independent claims 1 and 7, respectively.
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.
Claims 1-4 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Tsao et al. (US 20190380795 A1; hereafter “Tsao”) in view of Ramirez et al. (US 20190327394 A1; hereafter “Ramirez”), Meenink (U.S. Patent No. 9,655,681), and Kostrzewski et al. (US 20150196365 A1; “Kostrzewski”).
Regarding claim 1, Tsao discloses
An automated surgical support system to facilitate eye surgery, the system comprising: a tool securing device supported by hardware of the system (See in Fig. 1, a tool securing device: tool carriage 110; hardware: for example, manipulator arm 106 and XYZ stage 120 and connections therebetween.);
a surgical tool accommodated by the device at a predetermined orientation relative to one of a nasal and a temporal eye side location (See in Fig. 1, labeled surgical tool 112 and tool carriage 110 depicted at a temporal side of the patient’s left eye and an unlabeled surgical tool and tool carriage at a nasal side of the left eye. The orientation is predetermined by the surgeon and implemented by the disclosed alignment procedure; see paragraph [0023].);
a pivot mechanism of the hardware configured to rotate the device and tool about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis… (Pivot mechanism: semi-circular track 108 and its connection to tool carriage 110. See Fig. 2: tool carriage 110 securing surgical tool 112 to semi-circular track 108 can rotate an amount θ1 around only horizontal axis
Z
^
using rotational joint 114 and actuator 118 [0021]. Tool carriage 110 and surgical tool 112 can also rotate an amount θ2 around only vertical axis
Y
^
using semi-circular track 108 and another actuator [0021]. Actuators are controlled by the controller 104 [0019]. A procedure to align the surgical tool 112 to a selected surgical incision site (e.g., at a nasal- or temporal-side eye location; see Fig. 1) is disclosed in [0023-0028]. The angle θ1 would be fixed and predetermined by the selected surgical locations at the nasal and temporal sides, for example, to position the surgical tool at each side.);
wherein… the system limits a range of movement for the tool… relative to the eye (Limitation of a range of motion in an apparatus capable of a greater range of motion is a design choice, and Tsao teaches limiting the range of motion of a surgical tool [0049]. Since “Robotic motion of various components of the manipulator arms 106 is driven by actuators, such as motors and associated drive electronics, as directed by the controller 104” [0019], limiting a range of movement to a single axis of movement of a surgical tool can be accomplished by software limiting a range of the actuators.).
Tsao discloses that the system may be manually or automatically controlled [0024], however Tsao does not explicitly teach “a surgeon directed manipulatable toggle to control movement of the device and tool” and “a pivot mechanism of the hardware configured to rotate the device and tool about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis from the one of the nasal and temporal eye side locations to the other of the locations; wherein, after placement on the nasal or temporal eye side location, the system limits a range of movement for the tool to a single axis of ingress and egress relative to the eye; wherein the tool securing device is coupled to a plurality of different surgical tools through a universal drive with multiple tool connections.”
Ramirez, in the same field of endeavor (robotic surgery systems), teaches
a surgeon directed manipulatable toggle to control movement of the device and tool (See “The touch screen input device 1410a is configured to provide one or more user interfaces for receiving user inputs related to the control of the stereoscopic visualization camera 300, the coupling plate 3304, and/or the robotic arm 506. The input device 1410a may include one or more graphical control buttons, sliders, etc. …for controlling the robotic arm 506 and/or the coupling plate 3304, including options for controlling operational parameters such as speed, motion, deployment/stowing, calibration, target-lock, storing a view position, and/or changing or inputting a new orientation of the camera 300” [0433]. See also [0434-0435] for additional input devices, including joysticks, to control robotic arm 506 and camera 300.);
a pivot mechanism of the hardware configured to rotate the device and tool about a fixed, predetermined angle… from the one of the nasal and temporal eye side locations to the other of the locations (See “by programming the processor 4102 and/or the robotic arm controller 4106 to pivot about a point inside the eye… the robotic arm 506 sweeps the camera 300 in a generally conical motion such that the patient's eye is viewed from a plethora of viewing angles” [0565]. Such a conical sweep rotates the tool-securing device (e.g., mounting bracket 402 [0098]) and surgical tool (camera 300) 360° (a fixed, predetermined angle) around the eye, which includes “from the one of the nasal and temporal eye side locations to the other of the locations.” See also [0103] and Fig. 5.);
wherein… the system limits a range of movement for the tool… (See brakes for the joints of robotic arm 506 in [0404] and boundaries relative to the robotic arm 506, 3D surgical space, and patient in [0516-0519]. See also [0443].).
Ramirez additionally teaches “a specific visualization site position, direction, and/or orientation can be saved, and then returned to later in the procedure” and “pre-programmed waypoints can be set, thereby permitting an operator to change a position and/or orientation of the robotic arm 506 based upon which step is being performed during a medical procedure” [0399]; see also [0434]. Setting the pivot point (RCM) inside the eye as taught by Ramirez [0565] allows Tsao’s RCM-constrained surgical system to rotate along the surface of the eye, rather than just about a point on the surface of the eye. Since Tsao discloses selecting surgical sites [0023] and surgical sites on both the nasal and temporal sides of an eye (Fig. 1), the combination of Tsao/Ramirez teaches “a pivot mechanism of the hardware configured to rotate the device and tool about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis from the one of the nasal and temporal eye side locations to the other of the locations.”
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 surgery system of Tsao to be configured to rotate around the eye as taught by Ramirez. One of ordinary skill in the art would have been motivated to make this modification for the benefit of “enable[ing] the surgeon to examine a peripheral retina during vitreo-retinal procedures” and “to select the best angle to preclude spurious reflections from illumination or to see around obstructions in alternative viewing angles” (Ramirez, [0103] and [0565]).
However, Tsao/Ramirez does not explicitly teach “wherein, after placement on the nasal or temporal eye side location, the system limits a range of movement for the tool to a single axis of ingress and egress relative to the eye; wherein the tool securing device is coupled to a plurality of different surgical tools through a universal drive with multiple tool connections.”
Meenink, in the same field of endeavor (robotic surgery systems), teaches
a surgeon directed manipulatable toggle to control movement of the device and tool (toggle: “controllers”. See “The surgical (slave) robot 1 comprises a supporting frame 8 which is connected to a proximal end of the operating table 6, and two instrument manipulators 20 connected to the frame 8, representing the hands of the surgeon, by which is meant that the surgeon controls the motion of the instruments present on the respective instrument manipulators 20 of the slave robot 1 by manually actuating the controllers on the master system with both his hands,” [col. 5, line 62 to col. 6, line 2].)
wherein the tool securing device is coupled to a plurality of different surgical tools through a universal drive with multiple tool connections (See instrument receiver 34 [tool securing device] coupled to instrument container 30 in Fig. 6. See “The instrument container 30 [universal drive] as shown in FIG. 3 has four container holders 32 [multiple tool connections] for receiving therein four respective instruments 42 and has one container holder 32’ for receiving therein one instrument 42’” [col. 6, lines 61-65]. Instruments 42 and 42’ are “a plurality of different surgical tools.”).
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 implemented the controls of the robotic surgery system of Tsao/Ramirez with the universal drive of Meenink. One of ordinary skill in the art would have been motivated to make this modification for the benefit of allowing safe switching between multiple surgical tools (Meenink, col. 6, lines 21-30).
However, Tsao/Ramirez/Meenink does not explicitly teach “wherein, after placement on the nasal or temporal eye side location, the system limits a range of movement for the tool to a single axis of ingress and egress relative to the eye.”
Kostrzewski, in the same field of endeavor (robotic surgery systems), teaches
wherein, after placement on the [desired] location, the system limits a range of movement for the tool to a single axis of ingress and egress… (See “The position of the robotic arm and, therefore, the position of the surgical instrument guide is fixed (808) after the robotic arm is maneuvered to the desired position. …movement of the tool support is constrained in all directions except along the axis defined by the guide,” which permits “the tool support to slide along the axis defined by the guide while the guide is held in a fixed position by the robotic surgical system” [0081]. This axis is an axis of ingress and egress, as shown in Figs. 7A and 7B (the patient is depicted more fully in Fig. 4B). See also “Insertion Distance” along the guide in Fig. 10B.).
Since Tsao/Ramirez/Meenink teaches placement of the surgical tool at the nasal- and temporal-side locations of the eye and Kostrzewski teaches limiting movement of the tool to a single axis of ingress and egress after moving the tool to the desired location, the combination of Tsao/Ramirez/Meenink/Kostrzewski teaches “wherein, after placement on the nasal or temporal eye side location, the system limits a range of movement for the tool to a single axis of ingress and egress relative to the eye.” 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 surgery system of Tsao/Ramirez/Meenink with a tool guide to limit motion to an insertion axis as taught by Kostrzewski. One of ordinary skill in the art would have been motivated to make this modification for the benefit of having “a rigid structure that allows for precise preparation of patient tissue” (Kostrzewski, [0008]).
Regarding claim 2, Tsao/Ramirez/Meenink/Kostrzewski discloses the limitations of claim 1 as addressed above, and Tsao additionally discloses
wherein the predetermined orientation is of an angle that is less than 90˚ relative to a coronal plane (See Fig. 1 of Tsao, where a surgical tool 112 is oriented at an angle less than 90° relative to a patient’s coronal plane. The surgical tool 112 may be rotated up to 180° along a horizontal axis
Z
^
from a location at a nasal side of an eye to a location at a temporal side of an eye, which includes an orientation less than or equal to 90˚ relative to a patient’s coronal plane. Limitation of the predetermined orientation to a specific angle(s) is a design choice, and Tsao/Ramirez teaches limiting to any particular angle or angle range (see at least [0049] of Tsao and [0404], [0443], and [0516-0519] of Ramirez).).
Regarding claim 3, Tsao/Ramirez/Meenink/Kostrzewski discloses the limitations of claim 2 as addressed above, and Tsao additionally discloses
wherein the angle is between 30˚ and 60˚ relative to a coronal plane (See Fig. 1 of Tsao, where a surgical tool 112 is oriented at an angle between 30˚ and 60˚ relative to a patient’s coronal plane. The surgical tool 112 may be rotated up to 180° along a horizontal axis
Z
^
from a location at a nasal side of an eye to a location at a temporal side of an eye, which includes an orientation less than or equal to 90˚ relative to a patient’s coronal plane. Limitation of the predetermined orientation to a specific angle(s) is a design choice, and Tsao/Ramirez teaches limiting to any particular angle or angle range (see at least [0049] of Tsao and [0404], [0443], and [0516-0519] of Ramirez).).
Regarding claim 4, Tsao/Ramirez/Meenink/Kostrzewski discloses the limitations of claim 3 as addressed above, and Tsao additionally discloses
wherein the angle is at 45° relative to a coronal plane (See Fig. 1 of Tsao, where a surgical tool 112 is oriented at an angle 45° relative to a patient’s coronal plane. The surgical tool 112 may be rotated up to 180° along a horizontal axis
Z
^
from a location at a nasal side of an eye to a location at a temporal side of an eye, which includes an orientation less than or equal to 90° relative to a patient’s coronal plane. Limitation of the predetermined orientation to a specific angle(s) is a design choice, and Tsao/Ramirez teaches limiting to any particular angle or angle range (see at least [0049] of Tsao and [0404], [0443], and [0516-0519] of Ramirez).).
Regarding claim 7, these claim limitations are significantly similar to those of claim 1; and, thus, are rejected on the same grounds.
Regarding claim 8, Tsao/Ramirez/Meenink/Kostrzewski discloses the limitations of claim 7 as addressed above, and Tsao additionally discloses
further comprising one of a light instrument and an infusion port to interface with another location of the eye (“Examples of the surgical tool 112 include… an infusion-aspiration probe [comprises an infusion port], a light pipe [light instrument], a vitreous cutter, a cannula [infusion port], and other microsurgical instruments,” [0019]. Fig. 1 shows that surgical tools can be used at separate locations of an eye at the same time.).
Regarding claim 9, Tsao/Ramirez/Meenink/Kostrzewski discloses the limitations of claim 7 as addressed above and Tsao additionally discloses “other microsurgical instruments” [0019], including
wherein the tool is selected from a group consisting of a vitrectomy probe… (“Examples of the surgical tool 112 include… an infusion-aspiration probe” and/or “a vitreous cutter” [0019].),
a light instrument (“Examples of the surgical tool 112 include… a light pipe,” [0019].).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Cehajic-Kapetanovic et al. (“First-in-Human Robot-Assisted Subretinal Drug Delivery Under Local Anesthesia”, published online 01/15/2022; hereafter “Cehajic-Kapetanovic) in view of Ramirez, Cooper et al. (U.S. Patent No. 10,898,281; hereafter “Cooper”), and Meenink.
Regarding claim 12, Cehajic-Kapetanovic discloses
A method of performing a robotically assisted eye surgery with a surgical support system, the method comprising: performing a surgical procedure with a surgical tool accommodated by a surgical system (The surgeon performs a procedure with the Preceyes robotic system which controls “the intraocular injection system [surgical tool] held by the instrument manipulator;” see Figure 1 and its caption.),
the tool positioned through one of a temporal and a nasal side positioned cannula at an eye of a patient (See “The surgeon... was able to guide the motion of the tip of the canula of the intraocular injection system [tool]… through the scleral port [cannula] fitted with a custom-made adaptor (Figure 1, C) into the intraocular workspace,” page 104. From Figure 1, the tool is positioned through a temporal-side cannula; there is also a nasal-side cannula.);
utilizing a surgeon directed manipulatable toggle of the system to control movement of the tool during the performing (See Figure 1 and its caption: “Robotic retinal surgery setup in the operating theatre… B. The surgeon manipulates the handheld motion controller [manipulatable toggle] in 4 possible axes, generating large-scale movements that are translated into precise micromovements of the tip of the cannula of the intraocular injection system [tool] held by the instrument manipulator.”).
However, Cehajic-Kapetanovic does not explicitly teach “pivoting hardware of the system to reposition the tool through the other of the temporal and nasal side positioned cannulas; wherein the pivoting of the hardware is about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis relative to the patient; accommodating a plurality of additional surgical tools allowing exchange of the surgical tool for an additional surgical tool; and performing further eye surgery with the additional surgical tool.”
Ramirez, in the same field of endeavor (robotic surgery systems), teaches
pivoting hardware of the system to reposition the tool… wherein the pivoting of the hardware is about a fixed, predetermined angle… (See “by programming the processor 4102 and/or the robotic arm controller 4106 to pivot about a point inside the eye… the robotic arm 506 sweeps the camera 300 in a generally conical motion such that the patient's eye is viewed from a plethora of viewing angles” [0565]. Such a conical sweep rotates the tool-securing device (e.g., mounting bracket 402 [0098]) and surgical tool (camera 300) 360° (a fixed, predetermined angle) around the eye, which includes pivoting from a nasal-side to a temporal-side location. See also [0103] and Fig. 5.).
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 eye surgery method of Cehajic-Kapetanovic to pivot a surgical tool around an eye as taught by Ramirez. One of ordinary skill in the art would have been motivated to make this modification for the benefit of “enable[ing] the surgeon to examine a peripheral retina during vitreo-retinal procedures” and “to select the best angle to preclude spurious reflections from illumination or to see around obstructions in alternative viewing angles” (Ramirez, [0103] and [0565]).
However, Cehajic-Kapetanovic/Ramirez does not explicitly teach “pivoting hardware of the system to reposition the tool through the other of the temporal and nasal side positioned cannulas; wherein the pivoting of the hardware is about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis relative to the patient; accommodating a plurality of additional surgical tools allowing exchange of the surgical tool for an additional surgical tool; and performing further eye surgery with the additional surgical tool.”
Cooper, in the same field of endeavor (surgery systems), teaches
pivoting hardware of the system to reposition the tool… (See “the manipulators 32, 34 [holding a surgical tool 5; see Fig. 5A] may be quickly repositioned mid-operation to alternative surgical sites” in col. 13, lines 8-13. There are many possible axes of rotation (pivots), as can be seen in Figs. 5A and 9A. See “the user has only to align each remote center of the patient side manipulator with each incision. This may be done by attaching each patient side manipulator to the associated cannula which is already positioned within the incision,” in col. 14, lines 41-45.).
Ramirez additionally teaches “a specific visualization site position, direction, and/or orientation can be saved, and then returned to later in the procedure” and “pre-programmed waypoints can be set, thereby permitting an operator to change a position and/or orientation of the robotic arm 506 based upon which step is being performed during a medical procedure” [0399]; see also [0434]. When these saved sites/waypoints include the position and orientation of a surgical tool through nasal-side and temporal-side cannulas (see two in-use cannulas placed in the temporal side of an eye and a vacant cannula placed in the nasal side of the eye in Fig. 1 of Cehajic-Kapetanovic), repositioning a surgical tool to a pre-placed cannula as taught by Cooper results in repositioning the surgical tool from a temporal-side cannula to the nasal-side cannula. This repositioning is accomplished by pivoting about a point inside the eye (Ramirez, [0565]). Thus, the combination of Cehajic-Kapetanovic/Ramirez/Cooper teaches “pivoting hardware of the system to reposition the tool through the other of the temporal and nasal side positioned cannulas.”
Cooper additionally teaches
wherein the pivoting of the hardware is about a fixed, predetermined angle along only one of a vertical axis and a horizontal axis relative to the patient (Where an arm is positioned such that a vertical axis of rotation runs through the center of an eye, retracting the surgical tool/instrument from a temporal- or nasal-side cannula then pivoting the arm around that vertical axis of rotations results in pivoting from the temporal- or nasal-side cannula to the other cannula. For example, in Fig. 9A, the pivoting from one side of an eye to another can be accomplished by rotation of the set-up joint center arm 38 about the vertical axis (relative to the patient) of fixable rotational joint 50, without any rotation around a horizontal axis [col. 9, lines 32-63]. The fixed angle of rotation would be predetermined by the positions of the temporal-side and nasal-side cannulas, and these positions would be saved to return to during the surgery as taught by Ramirez [0399]. See also col. 10, lines 23-42 for locking of rotational joint 50.).
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 eye surgery method of Cehajic-Kapetanovic/Ramirez to reposition surgical tools through cannulas as taught by Cooper. One of ordinary skill in the art would have been motivated to make this modification for the benefit of “performing complicated and lengthy procedures” with “enhanced range of motion” (Cooper, col. 13, lines 8-13).
However, Cehajic-Kapetanovic/Ramirez/Cooper does not explicitly teach “accommodating a plurality of additional surgical tools allowing exchange of the surgical tool for an additional surgical tool; and performing further eye surgery with the additional surgical tool.”
Meenink in the same field of endeavor (eye surgery systems; note that Meenink is an author of the article by Cehajic-Kapetanovic et al.), teaches
accommodating a plurality of additional surgical tools allowing exchange of the surgical tool for an additional surgical tool (See “The instrument container 30 [universal drive] as shown in FIG. 3 has four container holders 32 [multiple tool connections] for receiving [accommodating] therein four respective instruments 42 and has one container holder 32’ for receiving therein one instrument 42’” [col. 6, lines 61-65]. See col. 10, lines 1-67 for details of automated switching operation between the surgical tool (instrument 42') and an additional surgical tool (one of other instruments 42). See also Fig. 3 and Fig. 4.); and
performing further eye surgery with the additional surgical tool (See “The switched instrument 42 [additional surgical tool] can now be moved (further) downwards into the eye of the patient and the surgery can continue,” [col. 10, lines 64-66].).
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 eye surgery method of Cehajic-Kapetanovic/Ramirez/Cooper to use the instrument exchange method as taught by Meenink. One of ordinary skill in the art would have been motivated to make this modification so that “instruments can be switched automatically… in a safe and quick manner, in which the focus of the surgeon is not taken away from the point of operation” (Meenink, col. 1, line 65 to col. 2, line 3).
Conclusion
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/MOYA LY/Examiner, Art Unit 3658
/Ramon A. Mercado/Supervisory Patent Examiner, Art Unit 36580
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