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
Examiner notes the submission of a preliminary amendment upon the filing of the application on 12/23/2024. Examiner has examined new claims 16-36.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
Therefore, the last phrase of claim 1 “visually displays at least one guiding axis on the intervention region via projection of the laser radiation in the target orientation” must be shown or the feature(s) canceled from the claim(s). See 112(b) rejection below. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The applicant’s term “laser radiation” is an unusual term that is being interpreted as just laser which stands for Light Amplification by Stimulated Emission of Radiation.
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 16-33 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "a guidance robot" in line 3. There is insufficient antecedent basis for this limitation in the claim. A “laser-guidance robot” was recited in the first and second line in the preamble.
Also, in claim 16 the last phrase “visually displays at least one guiding axis on the intervention region via projection of the laser radiation in the target orientation.” Is this phrase reciting that the guiding axis and the laser are the same thing or can be the same? The examiner will interpret this phrase to mean that they can be the same or coaxial. See drawing objection above.
Claim 19 is confusing with “a first target position and first target orientation”. A second or subsequent “position” or “orientation” is not recited or even discussed in the specification. The examiner will not put any patentable weight in the term “first” and interpret “a first target position and first target orientation” as simply a target position and target orientation.
Claim 20 the “and/or” phrase has made the claim confusing. It is not certain if the claim is reciting that all three of the possibilities are required or just one of them. The examiner will interpret the claim as requiring just one of the possibilities.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-20, 23, 33 (as best understood) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piron et al (US2016/0113728).
A laser-guidance robot (fig. 1) for visually projecting a guiding axis (0010, 0140 1st sentence “visual signal”) onto an intervention region of a patient (0062 last sentence), the laser-guidance robot comprising:
a guidance robot (0029) with a robot arm (“automated arm 102”, “automated arm 1426”) movably articulated to a robot base (fig. 4B at 428) and a robot head (fig. 4A at 104) connected to the robot arm (fig. 4A at 102);
a tracking system (0058 “tracking system”, 111, 113, 200) adapted to detect a position and/or an orientation of the robot head (fig. 4A);
a projection laser (0174) configured to emit laser radiation (“laser pointer”), the projection laser arranged so that a position and orientation (throughout Piron “position and orientation” are “positional orientation” is used) of the projection laser is adjustable indirectly via the robot head (Abstract, 0015, 0044, 0116 “tracking of the access port (target) by the automated arm supporting an imaging device”); and
a control unit (fig. 14A 1400: 0116 “intelligent positioning system”) adapted to determine a target position and target orientation (0019, 0132, 0168 “control system is able to monitor the light delivery and focus on the required area”) of the projection laser in relation to the intervention region of the patient and to control the robot arm (Abstract 2nd sentence) with the robot head and the projection laser in such a way that the projection laser is moved to the target position and target orientation (fig. 8B “position and pose”, fig. 9A “adjustment”, fig. 11 “Position”) and visually displays at least one guiding axis (0044, 0141) on the intervention region via projection of the laser radiation in the target orientation (fig. 6A, claim 1).
Claim 17 Piron discloses the laser-guidance robot according to claim 16, wherein the tracking system comprises an optical navigation system (0061 “…optical tracking device…”).
Claim 18 Piron discloses the laser-guidance robot according to claim 16, wherein the tracking system is adapted to detect a position and/or an orientation of the patient and thus of the intervention region (0068 last two sentences).
Claim 19 Piron discloses the laser-guidance robot according to claim 16, wherein the control unit is adapted to calculate at least a first target position and first target orientation of the projection laser based on a surgery plan (0157 last sentence, 0188 “planning engine 1470”) stored in a memory unit (“processor 1402 and/or memory 1404”) and to control the robot arm so that the projection laser is moved into the first target position and first target orientation (fig. 2; 0157 “… the external imaging device aligned along the intended insertion path, the circular markers 1215 will appear…”) and the laser radiation projects onto a calculated intervention location (fig. 6A) in order to visually display the guiding axis (Abstract 4th sentence).
Claim 20 Piron discloses the laser-guidance robot according to claim 19, wherein the surgery plan (0218 “a system plan indicating the types of movements and adjustments required for each stage of surgery”) comprises an operation trajectory (0116 “the determination of the trajectory of the automated arm...During the execution of the automated arm trajectory”; 0157 “desired trajectory of interest”), intermediate target points and/or outlines of an operation target.
Claim 23 Piron discloses the laser-guidance robot according to claim 19, wherein the surgery plan comprises at least one intervention location (Abstract), an intervention axis (0108, 0157, claim 4) and/or an intervention angle (0010, 0168).
Claim 33 Piron discloses a laser-guidance robot system according to claim 16 comprising: a medical instrument or medical product (0067 “the surgeon 201 to align of the end effector 104 (i.e., a videoscope) of automated arm 102”), wherein the laser-guidance robot projects the guiding axis onto an intervention region via the projection laser (0185 “projection and illumination device(s) 1424”) and the medical instrument or product is alignable with a longitudinal axis along the guiding axis (0032 1st two sentences).
Claims 34-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piron et al (US2016/0113728).
A projecting method for visually projecting a guiding axis (0010, 0140 1st sentence “visual signal”) onto an intervention region of a patient (0062 last sentence) with a projection laser (0174) arranged on a robot head of a robot arm (“automated arm 102”, “automated arm 1426”), the projecting method comprising the steps of:
detecting a position and/or an orientation of the projection laser in space by a tracking system (0058 “tracking system”, 111, 113, 200);
calculating an intervention axis (0178 1st sentence; claim 72);
calculating a target position and target orientation (fig. 8B “position and pose”, fig. 9A “adjustment”, fig. 11 “Position”) of the projection laser by a control unit (fig. 14A 1400: 0116 “intelligent positioning system”);
moving the robot head (fig. 4A) with the projection laser to the target position and target orientation (fig. 6A, claim 1) by the robot arm; and
projecting laser radiation (0185 “projection and illumination device(s) 1424”) in the target orientation by the projection laser, so that a guiding axis (0044, 0141) projected by the projection laser indicates the intervention axis (0174).
Claim 35 Piron discloses a computer-readable storage medium (0190, 0192) comprising instructions which (0191), when executed by a computer, cause the computer to perform the projecting method (fig. 8B at 845; fig. 9A) according to claim 34.
Claim 36 Piron discloses a computer program comprising instructions which, when executed by a computer (0188-0191), cause the computer to perform the projecting method (projection and illumination device(s) 1424) according to claim 34.
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.
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 25, 27 (as best understood) is/are rejected under 35 U.S.C. 103 as being unpatentable over Piron et al (US2016/0113728) in view of Chumas et al (US2003/0164172).
Piron discloses “alignment markers” that help display “the depth to the target plane so that the insertion distance can be seen by the surgeon on the same screen as the targeting overlay” (0158 & 0159).
However, Piron does not disclose that the laser visually indicates a focal point at a predetermined intervention depth.
Chumas discloses a laser guided surgical invention wherein the laser emitted by the projection laser is adapted in such a way that the laser visually indicates a focal point at a predetermined intervention depth (fig. 1, 0024 & 0025). At the time the invention was made it would have been well known to one of ordinary skill in this art to modify Piron so that laser indicated focal point reveals a depth as taught by Chumas. A motivation for this would be to help the surgeon with his actions. This combination follows the KSR case law rationale A: Combining prior art elements according to known methods to yield predictable results.
Claim 27 Piron in view of Chumas discloses the laser-guidance robot according to claim 25, Chumas further discloses wherein the projection laser emits at least two laser beams that have an angle to each other and intersect each other, wherein an intersection point of the at least two laser beams indicates the predetermined intervention depth (figures 1, 4 & 5).
Claim(s) 29 (as best understood) is/are rejected under 35 U.S.C. 103 as being unpatentable over Piron et al (US2016/0113728).
Piron discloses 29 the laser-guidance robot according to claim 16, wherein a position and orientation of the robot head (fig. 4A at 104) and thus a pose of the projection laser are detected via motors of the laser-guidance robot (fig. 14A at 1420 & 1464; fig. 8B at 865 & 875). Piron however does not specify that the motors are servomotors.
Piron however does not specify that the motors are servomotors.
At the time the invention was made it would have been well known to convert the motors of Piron to servomotors. A motivation for this is well known in the motor arts and would be to have more fine tuning control with a servomotor.
This combination follows the KSR case law rationale B: Simple substitution of one known element for another to obtain predictable results.
Claim(s) 30-31 (as best understood) is/are rejected under 35 U.S.C. 103 as being unpatentable over Piron et al (US2016/0113728) in view of Dozeman et al (US 20250221782 A1).
Piron discloses motors to aid in adjusting the head (0139 & figure 14A at 1420) but does not disclose adjustment with a bearing (claim 30) and servomotor (claim 31).
Dozeman discloses a laser guided robotic device that makes use of a servomotor (0108 “The motors may be any suitable type of motor, including brushless DC servomotors”) and bearing (0106 “The lead screw 150 is supported for rotation in the housing by one or more bushings and/or bearings.”) to adjust components.
At the time the invention was made it would have been well known to one of ordinary skill to convert the motors of Piron to servomotors and also to use bearings for movement facilitation. A motivation for this is well known in the motor arts and would be to have more fine tuning control with a servomotor and bearings. This combination follows the KSR case law rationale B: Simple substitution of one known element (bearings and servomotors are ubiquitous) for another to obtain predictable results.
Allowable Subject Matter
Claim 21-22, 24, 26, 28, 32 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Beyl US 20240407883 A1, Rahimian et al US 8758263 B1, Richter et al US 20200315711 A1, teach robotic surgery devices with laser target spotting.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C Zarroli whose telephone number is (571)272-2101. The examiner can normally be reached Monday-Friday 9-5 ET IFP.
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, Ramon Mercado can be reached at 5712705744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MICHAEL C. ZARROLI
Primary Examiner
Art Unit 3658B
/MICHAEL C ZARROLI/Primary Examiner, Art Unit 3658 /M.C.Z/Primary Examiner, Art Unit 3658 .
