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 .
Pursuant to communications filed on 04/24/2025, this is a First Action Non-Final Rejection on the Merits wherein claims 1-20 are currently pending in the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/25/2025 and 09/04/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Examiner's Note
Examiner has cited particular paragraphs and/or columns / lines numbers or figures in the reference(s) as applied to the claims below for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant, in preparing the responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner. Applicant is reminded that the Examiner is entitled to give the broadest reasonable interpretation to the language of the claims. Examiner has also cited references in PTO-892 but not relied on, which are relevant and pertinent to the applicant’s disclosure, and may also be reading (anticipatory/obvious) on the claims and claimed limitations. Applicant is advised to consider the references in preparing the response/amendments in-order to expedite the prosecution.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 3, and 5 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. In the instant case,
In claim 1: The term "Whereby" Clause Problem (Result vs. Limitation). In claim 1, the phrases "whereby the robotic arm is freely moveable" and "whereby the robotic arm is automatically moved to align the end effector with the target trajectory" are indefinite. It is unclear whether these "whereby" clauses recite active physical steps/positive structural limitations or merely state the intended results or operational outcomes of the preceding positive limitations ("operate the robotic arm in a free mode" and "operate the robotic arm in an automatic mode"). If the language is intended to limit the scope of the claims, the structural components or controller operations required to achieve such movement are not distinctly defined, leaving the boundaries of the claim uncertain.
Accordingly, appropriated correction is earnestly solicited.
In claim 2, 3 and 5: The phrase "whereby movement of the end effector is constrained to the target trajectory" introduces functional outcome language dependent on an unclear mechanism of control. It fails to specify whether the constraint is a positive structural or algorithmic limitation positively executed by the one or more controllers, or merely an inherent result, leaving the metes and bounds of the haptic mode unclear.
Accordingly, appropriated correction is earnestly solicited.
In claims 1 and 2: There is an issue with unclear boundaries: The phrase "responsive to the end effector being within the trajectory selection zone in the free mode" is unclear. It does not state how the system determines the end effector is within the zone.
There is an issue conflicting operational states: Claim 1 defines a "free mode" where the arm is "freely moveable" and an "automatic mode" where the arm is "automatically moved." It is vague if these modes overlap or if entering the automatic mode instantly ends the free mode.
Accordingly, appropriated correction is earnestly solicited.
In claim 2, there is an issue as ambiguous transition: Claim 2 depends on Claim 1 and adds a transition to a "haptic mode" when the end effector is "aligned with the target trajectory." The term "aligned" lacks a clear structural or functional definition (e.g., a specific positional or angular threshold) to show when this alignment happens.
Accordingly, appropriated correction is earnestly solicited.
In claim 3: The is an issue with conflicting spatial terms: Claim 3 recites positions "above the second point" and "above the first point," but fails to define a spatial reference frame or gravitational axis to establish what "above" means relative to the patient anatomy or the target trajectory. Furthermore, claim 3 has unclear haptic constraints: The phrase "constrained to the target trajectory" fails to specify whether the constraint is absolute or allows a predetermined tolerance threshold.
Accordingly, appropriated correction is earnestly solicited.
In Claim 4: There is an indefiniteness issue with the phrase: "detect an input from the input device" is ambiguous. It does not state what kind of input is required to trigger the automatic mode. The link between the notification and the user input is unclear. It does not state what happens if the user inputs a different command or no input at all.
Accordingly, appropriated correction is earnestly solicited.
In claim 7, There is a paradox: Claim 7 requires the controller to respond when the end effector is within both the trajectory selection zone and the prevention zone. It is unclear how a zone defined to "prevent" action co-exists with a selection zone to trigger automatic selection, rendering the functional boundary vague.
Accordingly, appropriated correction is earnestly solicited.
In claims 8 and 9: There is a confusing interdependence: Claim 8 introduces a second target trajectory, and Claim 9 adds a second trajectory selection zone. The claims fail to clearly specify the priority or behavior if the end effector enters overlapping or multiple zones simultaneously in the free mode.
Accordingly, appropriated correction is earnestly solicited.
In Claim 13: The claim uses the open-ended phrase "at least one of" combined with multiple complex display states and highlighting options. It is unclear whether the highlighting applies to all displayed virtual representations or just a subset.
Accordingly, appropriated correction is earnestly solicited.
In claim 14: The claim recites a display configured to "indicate that the end effector is aligned," which lacks objective boundaries for when alignment is technically achieved.
Accordingly, appropriated correction is earnestly solicited.
In claim 15: The claim recites "temporarily affixed”. This is a relative term failing to define the structural interface for instrument attachment.
Accordingly, appropriated correction is earnestly solicited.
In claim 16: The claim is indefinite due to contradictory, ambiguous functional constraints in haptic mode, specifically regarding simultaneous constraint to a trajectory and prevention of movement away from anatomy.
Accordingly, appropriated correction is earnestly solicited.
In claim 17: the controllers are recited as being responsive to "detecting a first input" and "detecting a second input" from the input device to perform two divergent operational constraints (constraining to the target trajectory vs. constraining independent of the tracked pose). However, the claim fails to recite what distinguishes the "first input" from the "second input" (e.g., a differing duration, a distinct signal characteristic, or distinct actuation states), rendering the metes and bounds of when each operational mode is triggered unclear to a person of ordinary skill in the art.
Accordingly, appropriated correction is earnestly solicited.
In Claim 18: The claim specifies constraining the end effector independent of the tracked pose of the anatomy "such that an orientation of the end effector does not change when the pose of the target trajectory changes." This introduces internal logical friction and functional ambiguity with claim 1, which defines the target trajectory as being "associated with the anatomy" and claim 17, where the pose of the target trajectory is "dependent on the tracked pose of the anatomy." It is unclear how a trajectory pose remains dependent upon a tracked anatomical pose while simultaneously undergoing changes in pose while the end effector orientation remains static, leaving the bounds of the control algorithm functionally indeterminate.
Accordingly, appropriated correction is earnestly solicited.
In Claim 20: The claim states the controllers "monitor input from the navigation system to determine the pose of the target trajectory." Claim 20 contradicts or confuses how claim 17 operates independently of the tracked anatomy pose. Hence, the metes and bounds of these constraints are vague and confusing.
Accordingly, appropriated correction is earnestly solicited.
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, 2, 5-8, and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pithon et al (US 2022/0168055-From IDS), “Pithon”.
Regarding claim 1, Pithon discloses a surgical system (e.g., via a hybrid control of a surgical robot for fast positioning onto planned trajectories) comprising:
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FIGURE 1
a robotic arm (102) comprising a plurality of links and joints and being configured to support an end effector (see configuration of figure 1 and see paragraphs 26-27);
a navigation system (via display device 106) configured to track a pose of an anatomy of a patient (see paragraphs 15, 26 and 28); and
one or more controllers (control system – see para. 27) configured to:
associate a target trajectory with the anatomy of the patient (paragraph 33: "based on the received key points, a trajectory may be determined for a robotic arm to move an end effector to or from during a surgical procedure. The trajectory may include a position and orientation of an initial or final position of the end effector […] plurality of trajectories may be determined for a surgical procedure"; see also fig. 2, workflow 200: "from the key points, the system computes trajectories […]'');
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define a trajectory selection zone associated with the target trajectory (see paragraph 54: ''[…] influence zone may include […] an automatically generated volume around the key point based on safety zone areas […]"; see also paragraphs 40, 41, 43: "robotic arm may align itself with the planned trajectory automatically once in range of the elected planned object […] the range surrounding the elected planned object may be called an influence zone […] influence zone may be located […] on each planned trajectory'');
operate the robotic arm in a free mode, whereby the robotic arm is freely moveable (see paragraph 14: "cooperative mode […] may include a force assist type of movement, where a light touch by the surgeon is augmented by the power control of the robotic arm to move the robotic arm in a particular direction of the light touch, which may be identified from a sensor of the robotic surgical device''), whereby the robotic arm is freely moveable;
responsive to the end effector being within the trajectory selection zone in the free mode, automatically select the target trajectory associated with the trajectory selection zone; and operate the robotic arm in an automatic mode, whereby the robotic arm is automatically moved to align the end effector with the target trajectory (paragraphs 54-55, and figure 7).
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FIGURE 7
Regarding claim 2, Pithon discloses wherein the one or more controllers are further configured to, responsive to the end effector being aligned with the target trajectory, operate the robotic arm in a haptic mode, whereby movement of the end effector is constrained to the target trajectory (see para. 35: While aligning the robotic arm (in a cooperative mode) with a next trajectory, a user interface may display a representation of the robotic arm to indicate where the robotic arm is located relative to planned key points. In another example, no representation of the robotic arm may be displayed. In either case, an indication may be provided when the robotic arm is near a key point, at a key point, aligned along a trajectory, or within a particular key point zone. The indication may include a visual indication on a user interface, such as a flashing light or written indication, an audible indication (e.g., audio tone), haptic feedback, or the like.).
Regarding claim 5, Pithon discloses further comprising an input device (e.g. via display device 106 – see para. 26), and
wherein the one or more controllers are further configured to:
detect an input from the input device (see para. 26, 30, 33); and
responsive to detection of the input and responsive to the end effector being aligned with the target trajectory, operate the robotic arm in a haptic mode, whereby movement of the end effector is constrained to the target trajectory (see para. 26, 30, 33).
Regarding claim 6, Pithon discloses wherein the one or more controllers are further configured to implement haptic feedback to indicate that the target trajectory is selected (see para. 35-36 – see workflow fig 2).
Regarding claim 7, Pithon discloses wherein the one or more controllers are further configured to:
associate a prevention zone with the target trajectory (see para 13-14, see figure 4 disclosing the influence zone 402), and
responsive to the end effector being within the trajectory selection zone and the prevention zone in the free mode, automatically select the target trajectory associated with the trajectory selection zone (see fig 4- see para. 43).
Regarding claim 8, Pithon discloses wherein the target trajectory is further defined as a first target trajectory, and wherein the one or more controllers are further configured to associate a second target trajectory with the anatomy of the patient (see para 19-20, 38; see fig. 4).
Regarding claim 13, Pithon discloses further comprising a display configured to present the selected target trajectory, wherein: the display is configured to provide at least one of a virtual representation of the selected target trajectory (see para. 15), a virtual representation of a planned screw corresponding to the selected target trajectory (see para. 51 and fig. 6), a virtual representation of the anatomy associated with the selected target trajectory (see para. 26), and a virtual representation of the trajectory selection zone associated with the selected target trajectory (see para. 37; see fig. 3); and
the display is configured to highlight the at least one of the virtual representation of the selected target trajectory, the virtual representation of the planned screw corresponding to the selected target trajectory, the virtual representation of the anatomy associated with the selected target trajectory, and the virtual representation of the trajectory selection zone associated with the selected target trajectory (see para. 24).
Regarding claim 14, Pithon discloses further comprising a display configured to indicate that the end effector is aligned with the target trajectory (see para. 35).
Regarding claim 15, Pithon discloses wherein the end effector includes a guide tube configured to support an instrument temporarily affixed to the guide tube (see para. 27).
Regarding claim 16, Pithon discloses wherein the one or more controllers are configured to:
determine whether an instrument is temporarily affixed to the guide tube (see para. 27); and
responsive to determining that an instrument is temporarily affixed to the guide tube and responsive to the guide tube being aligned with the target trajectory, operate the robotic arm in a haptic mode to constrain movement of the guide tube to the target trajectory and prevent movement of the guide tube away from the anatomy of the patient (see para. 27-28).
Allowable Subject Matter
It appears claims 3-4, 9-12, 17-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action, however, further search and consideration may be required upon the submission of claim amendments.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached form PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jaime Figueroa whose telephone number is (571)270-7620. The examiner can normally be reached on Monday-Friday 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wade Miles can be reached on 571-270-7777. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAIME FIGUEROA/Primary Patent Examiner, Art Unit 3656
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