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 .
Claim Objections
Claims 1, 19, and 20 are objected to because of the following informalities:
Regarding claim 1, “Catheter robot comprising…” should read “A catheter robot comprising…”
Regarding claims 19 and 20, “Automatic navigation system…” should read “An automatic navigation system.”
Appropriate correction is required.
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 – 20 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.
Claim 2 recites the limitation "The catheter robot" in line 1. There is insufficient antecedent basis for this limitation in the claim. This should read “A catheter robot.” It is believed that this claim is meant to be an independent claim since it lists all the limitations of claim 1 except “a step of implementing the planned sequence of commands…”
Claims 1 and 2 recite “[A] Catheter robot comprising an automatic navigation system, for an elongate flexible medical instrument that is a catheter or a catheter guide, with free distal end, implementing an automatic navigation method comprising successively…” followed by a number of method steps. It is unclear if Applicant is attempting to claim an apparatus or a method. It is believed that the steps are performed by a processor/controller on the catheter robot. If Applicant wishes to claim an apparatus, it is suggested to positively recite that “the catheter robot comprises a controller, the controller configured to:” before listing the steps performed by the controller. If Applicant wishes to proceed with a device claim, citations of the support for the controller are requested. If Applicant wishes to claim a method, it is suggested to use language that more closely aligns with paragraph 23 of the specification as originally filed. For example: “An automatic navigation method, for use with an elongate flexible medical instrument that is a catheter or a catheter guide, and a catheter robot, the method comprising successively:” before listing the steps.
Similarly, claims 19 and 20 recite “[An] Automatic navigation system for an elongate flexible medical instrument that is a catheter or a catheter guide, of a catheter robot, with free distal end, implementing an automatic navigation method comprising successively:” followed by a number of method steps. It is unclear if Applicant is attempting to claim a system or a method.
Dependent claims 3 – 18 do not cure the deficiencies of independent claim 1.
Appropriate correction is required. The claims have been examined to the best of the Examiner’s ability below.
Additionally, claim 3 recites “for at least 2 or at least 3 or at least 4 different movements.” It is unclear what’s required. “At least 2 different movements” covers the same ranges as “at least 3 or at least 4”. Therefore, “at least 2 or at least 3” does not further limit the claim.
Additionally, claim 10 recites “by attributing marks to each branch of the tree; and then calculating a value for each node in the tree.” The branches and the nodes of the tree have not been previously positively recited. It is unclear what is required by the limitation.
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.
Claim(s) 1 – 4, 8, and 16 – 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roelle et al. (US PGPUB 2011/0319714 – in IDS).
Regarding claims 1, 2, 19, AND 20, Roelle discloses a catheter robot comprising an automatic navigation system, for an elongate flexible medical instrument (e.g. ¶ 124, Figs. 2A, 2B) that is a catheter or a catheter guide, with free distal end (Figs. 2A, 2B), implementing an automatic navigation method comprising successively:
a step of creating a modeling:
of the elongate flexible medical instrument (¶ 218),
of a blood circulatory system of a patient, along which the elongate flexible medical instrument is intended to move (¶ 171; three-dimensional digital model of the pertinent tissue reads on the “blood circulatory system”; and ¶ 124),
of the interaction between this system and this elongate flexible medical instrument, by modeling the contact between this elongate flexible medical instrument and one or more walls of a blood vessel or vessels in this system (e.g. ¶ 223),
from one or more images of the actual blood circulatory system of this patient (e.g. ¶ 218),
a step of determining:
the position of a start point in the modeled system (e.g. ¶ 220, any path will have a start point),
the position of a point of arrival in the modeled system (e.g. ¶ 230; the ablation points would be the end points),
a path to be followed (e.g. ¶ 220), by the elongate flexible medical instrument, between the start point and the point of arrival, by determining a path, along the modeled system, between the start point and the point of arrival, with preferentially obligatory passage points in the modeled system (e.g. ¶ 230),
a step of planning a sequence of commands for movement of the elongate flexible medical instrument, obtained by a tree search procedure which, by using the modeling of the elongate flexible medical instrument and the modeling of said contact (e.g. ¶ 297 – 300):
simulates various possible movements of the elongate flexible medical instrument in the modeled system (e.g. ¶ 293),
evaluates the results of the simulation of these various possible movements (e.g. ¶ 293),
selects the most promising simulated movements among these various possible movements, to best follow the determined path with respect to one or more given criteria (e.g. ¶ 293),
a step of implementing the planned sequence of commands, along the actual blood circulatory system of said patient, with compensation for any differences with respect to the determined path along the modeled system, by closed-loop regulation (e.g. ¶ 290 – 300).
Regarding claim 3, Roelle discloses implementing the method in real time and at least two different movements (e.g. ¶ 259).
Regarding claim 4, Roelle discloses adjusting the modeling by creating a first new step and a new step of planning a new sequence (e.g. ¶ 299).
Regarding claim 8, Roelle discloses positioning at the lesion to be treated (e.g. Figs. 64 A-B).Regarding claim 16, Roelle discloses direct command implementing the movements of the actuators controlling the movements of the elongate flexible medical instrument (e.g. ¶ 259).
Regarding claim 17, Roelle discloses inverse command calculating the movements of the actuators from the movements of the elongate flexible medical instrument (e.g. ¶ 253).
Regarding claim 18, Roelle discloses there are at least a catheter and a catheter guide associated with this catheter, these elongate flexible medical instruments being with a free distal end (e.g. ¶ 38).
Claim Rejections - 35 USC § 103
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) 5 – 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roelle et al.
Regarding claims 5 – 7 and 9, the claims recite different types of modeling (i.e. point clouds, meshings, Dijkstra graph travel algorithm. These are all well known modeling techniques which would arrive at the same three-dimensional model of the pertinent tissue as taught by Roelle. It would have been obvious to one having ordinary skill in the art to modify the modeling as taught by Roelle with any of the well known modeling techniques, since such a modification would provide the predictable results of providing a three-dimensional model of the pertinent tissue (i.e. circulatory system).
Claim(s) 10 – 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roelle et al. in view of Wang et al. (US PGPUB 2019/0371433).
Regarding claims 10 – 15, the claims recite a well known method and system for anatomical tree structure analysis. Wang teaches it is known to use such a system of anatomical tree structure analysis (e.g. ABSTRACT, ¶ 3, 10, claim 1). It would have been obvious to one having ordinary skill in the art to modify the modeling as taught by Roelle with the anatomical tree structure analysis as claimed as taught by Wang, since such a modification would provide the predictable results of improving the efficiency, accuracy, and consistency of the image analysis (e.g. ¶ 4 of Wang).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796