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 .
Status of Claims
Applicant’s amendments filed 01/16/2026 have been entered. Claims 1-5, 7-14, 18-20, and 22-24 are pending and currently under consideration for patentability under 37 CFR 1.104. Previous rejection under 35 USC 112(b) has been withdrawn in light of Applicant’s amendments. Response to arguments below.
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.
Claim 7 is 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. MPEP 2161.01 I. 6TH para states, “original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.” Claim 7 recites, “registering the external imaging data to the 3D anatomic model; and estimating a location of the one or more sensitive tissue structures relative to the anatomic cavity based, at least in part the external imaging data.” This appears to contradict the specification at paragraphs [0033] and [0034] (published version) which teach that the 3d model is generated from the external imaging data and not generated before the external imaging data as would be required in claim 7. Examiner notes that there are several incorporations by reference in the specification, 37 C.F.R. 1.57 (d) requires essential material only be incorporated via US patent or US patent application.
Claim Rejections - 35 USC § 102
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)(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.
Claim(s) 1-5, 7, 9, 11, 18-20, 22, and 23 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ayvali et al. (U.S. 2021/0298590).
With respect to claim 1, Ayvali et al. teaches a system for performing a medical procedure, the system comprising:
an elongate flexible device (32/440) including a distal end portion;
an imaging device (448) coupled to the distal end portion of the elongate flexible device (FIG. 4 for example), wherein the imaging device is configured to obtain at least one image viewed from the distal end portion of the elongate flexible device (para [0101]);
a sensor system including at least one first sensor carried by the elongate flexible device, wherein the at least one first sensor is configured to obtain location data of the elongate flexible device (para [0105]);
a processor (FIG. 3) operably coupled to the elongate flexible device and the sensor system; and
a memory (304) operably coupled to the processor, the memory storing instructions that, when executed by the processor, cause the system to perform operations comprising:
generating a three-dimensional (3D) anatomic model (para [0080], [0084]-[0087]) including an object (kidney stone) within an anatomic cavity (calyx) and one or more sensitive tissue structures (blood vessels para [0104] for example) near the anatomic cavity; and
providing guidance for deploying an access tool along at least one percutaneous access path through a patient's skin to the object (para [0090]-[0093] for example) based, at least in part, on the 3D anatomic model (para [0138]-[0140], [0174] for example).
With respect to claim 2, Ayvali et al. teaches the one or more sensitive tissue structures are outside of the anatomic cavity (para [0116] for example).
With respect to claim 3, Ayvali et al. teaches the operations further comprise estimating a location of the one or more sensitive tissue structures relative to the anatomic cavity based, at least in part, on preoperative data (para [0085]).
With respect to claim 4, Ayvali et al. teaches the preoperative data includes one or more patient characteristics (para [0085]).
With respect to claim 5, Ayvali et al. teaches the operations further comprise determining a location of the one or more sensitive tissue structures relative to the anatomic cavity based, at least in part, on intraoperative data (FIG. 5-1 for example).
With respect to claim 7, Ayvali et al. teaches the operations further comprise:
receiving external imaging data;
registering the external imaging data to the 3D anatomic model; and
estimating a location of the one or more sensitive tissue structures relative to the anatomic cavity based, at least in part the external imaging data (para [0087], [0174]).
With respect to claim 9, Ayvali et al. teaches the 3D anatomic model is based, at least in part, on first location data from the at least one first sensor as the elongate flexible device is navigated within an interior space of an anatomic cavity (para [0195]) and the object is based on second location data from the at least one first sensor when the object is within the at least one image (504, para [0114]).
With respect to claim 11, Ayvali et al. teaches identifying a location of the object within the anatomic cavity based, at least in part, on the image of the object and on the location data obtained by the at least one first sensor.
With respect to claim 18, Ayvali et al. teaches the sensor system includes at least one of a shape sensor or an electromagnetic (EM) sensor (para [0105]).
With respect to claim 19, Ayvali et al. teaches the percutaneous access path is different from an endoluminal access path for introducing the elongate flexible device into the anatomic cavity (FIG. 6-2 for example).
With respect to claim 20, Ayvali et al. teaches the at least one percutaneous access path is a linear or curved path (FIG. 6-2 for example), and wherein the at least one percutaneous access path is chosen to avoid the one or more sensitive tissue structures (para [0104] for example).
With respect to claim 22, Ayvali et al. teaches the sensor system further includes at least one second sensor carried by the access tool (para [0110]).
With respect to claim 23, Ayvali et al. teaches the operations further comprise registering the at least one second sensor to the at least one first sensor (para [0140], [0181], see also FIG.14-1,14-2).
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayvali et al. (U.S. 2021/0298590) in view of Prisco (U.S. 2010/0249506).
Ayvali et al. teaches a system as set forth above. However, Ayvali et al. does not teach the operations further comprise estimating a location of the one or more sensitive tissue structures relative to the anatomic cavity based, at least in part, on general anatomic information.
With respect to claim 8, Prisco teaches using general anatomic information for navigation (para [0039]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify to include general anatomic information in the manner taught by Prisco in order to allow for the system to still function when CTY is not available (para [0039] of Prisco).
Claim(s) 10 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayvali et al. (U.S. 2021/0298590) in view of Hsu et al. (U.S. 2019/0269468).
With respect to claim 10, Ayvali et al. teaches another embodiment where the at least one first sensor is configured to obtain location data of an interior space of an anatomic structure, wherein the location data includes point cloud data, and a 3D anatomic model is generated based, at least in part, on the point cloud data. (FIG. 16-17 for example).
However, Ayvali et al. does not teach the point cloud data being combined with the cited embodiment of a 3d model generated from CT data.
With respect to claim 10, Hsu et al. teaches a system wherein point cloud data is registered to preoperative CT scan data (para [0098], [0115]-[0122], FIGS. 16 and 17).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Ayvali et al. to create a 3D model generated at least in part by point cloud data in order to provide a model of the interior region that can aid the physician with navigation during the procedure (para [0126] of Hsu et al.).
With respect to claim 13, Hsu et al. teaches the operations further comprise updating the 3D anatomic model (FIG. 16, 17).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Ayvali et al. to update the 3d model in order to provide a model of the interior region that can aid the physician with navigation during the procedure (para [0126] of Hsu et al.).
With respect to claim 14, Hsu et al. teaches updating the 3D anatomic model comprises updating a location of the object based, at least in part, on the location data from the at least one first sensor (FIG. 16,17).
With respect to claim 15, this is considered intended use since there is no language requiring the system to modify or use the image data in any way.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayvali et al. (U.S. 2021/0298590) in view of Leparmentier et al. (U.S. 2020/0100855).
Ayvali et al. teaches a system as set forth above. However, Ayvali et al. does not teach identifying the location comprises determining a distance between the object and a distal end portion of the elongate flexible device.
With respect to claim 12, Leparmentier et al. teaches a system wherein identifying the location comprises determining a distance between the object and a distal end portion of the elongate flexible device (para [0187] for example).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Ayvali et al. to include the distance measurement as taught by Leparmentier et al. so that the target location can be determined at positions that cannot be directly accessed by the first medical instrument (para [0138] of Leparmentier et al.).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayvali et al. (U.S. 2021/0298590) in view of Tang et al. (U.S. 2020/0375664).
Ayvali et al. teaches a system as set forth above. However, Ayvali et al. does not teach guidance a target position and a target angle for the access tool to create the percutaneous access path, and a current position and a current angle of the access tool obtained from the at least one second sensor.
With respect to claim 24, Tang et al. teaches guidance includes a target position and a target angle for the access tool to create the percutaneous access path, and
a current position and a current angle of the access tool obtained from the at least one second sensor (FIG. 6).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Ayvali et al. to include the guidance as taught by Tang et al. in order to generate instructions to guide the clinician on how to adjust the position of treatment tool (para [0075] of Tang et al.).
Response to Arguments
Applicant's arguments filed 01/16/2026 have been fully considered but they are not persuasive.
On page 6, Applicant argues claim 7 does not require that the 3D anatomical model is generated from the external imaging data, this is not persuasive. There is no support in the specification for registering the external imaging data to the 3D anatomic model as required by claim 7. Specifically, there is no support in the specification for registering external imaging data to an already formed 3D anatomical model. The rejection is maintained.
On page 9 Applicant argues that paragraphs [0080] and [0084]-[0087] of Ayvali do not disclose that the data storage 304 and control circuitry 302 of the control system 340 generate such a model. This is not persuasive. Paragraph [0075] states, “the control system can include various components (sometimes referred to as “subsystems”). For example, the control system 50 can include the control electronics/circuitry 302, as well as one or more power supplies/interfaces 308, pneumatic devices, optical sources, actuators, data storage devices 304, and/or communication interfaces 306. In some embodiments, the control system 50 includes control circuitry comprising a computer-based control system that is configured to store executable instructions, that when executed, cause various operations to be implemented relating to the functionality described herein. In some embodiments, the control system 50 is movable, while in other embodiments, the control system 50 is a substantially stationary system. Although various functionality and components are discussed as being implemented by the control system 50, any of such functionality and/or components can be integrated into and/or performed by other systems and/or devices, such as the robotic system 10, the table 15, or others, for example.”
On page 10 Applicant argues paragraphs [0080] and [0084]-[0087] do not mention a kidney stone. This is not persuasive. Examiner also cites paragraph [0104] which recites a urinary stone.
On page 11 Applicant argues the Office Action fails to establish that Ayvali discloses “a three-dimensional model including…one or more sensitive tissue structures near the anatomic cavity.” This is not persuasive. Paragraph [0104] states:
In some procedures, the physician(s) study a patient's preoperative computed tomography (CT) images to determine the location of the urinary stone, the location of surrounding organs and bony structures, and examine the morphometry of the calyces. With this knowledge, the physician(s) may mentally generate a pre-operative plan for the percutaneous needle path. Typically, physicians must identify a posterior calyx to puncture to accommodate a rigid instrument. Specifically, a posterior calyx generally provides a relatively straight shot into the renal pelvis. Physicians must try to insert the needle into the kidney through the papilla to avoid damaging renal vasculature and cause bleeding. Intraoperatively, physicians in some procedures rely on fluoroscopy or ultrasound to guide the alignment and insertion of the needle to the target calyx. However, the resolution and interpretation difficulty associated with such imaging techniques can result in a relatively high degree of difficulty in satisfactorily executing the needle puncture. Therefore, embodiments of the present disclosure that provide improved tracking and visualization of target anatomical features, such as papillas and calyces, can improve operational results and appeal to a larger subset of physicians than other PCNL methodologies.
The recitation of “the location of surrounding organs and bony structures, and examine the morphometry of the calyces” meets the plain meaning of sensitive tissue structures.
On page 12 Applicant argues none of the paragraphs recited in the rejection of claim 9 pertains to a model at all. This is not persuasive. First, it is noted that there is a typographical error: the citation of paragraph [0095] should be paragraph [0195]. Paragraph [0195] states:
FIG. 15 shows a scope device 1550 disposed within target renal anatomy for calyx mapping in accordance with one or more embodiments. With reference to FIG. 15, mapping of the calyces of the kidney can involve advancing and/or maneuvering a ureteroscope 1550 within the calyx network. For example, the ureteroscope 1550 may be advanced to the termination points (e.g., at the respective papillae) of one or more calyces and/or against the walls or other boundaries of the calyces, wherein periodic or sporadic position tagging/recording 1501-1504 may be implemented to generate a skeletal mapping of the traversed area of the calyces. For example, the operator of the ureteroscope 1540 may be directed to articulate the scope to tag multiple points 1501-1504 inside the target calyx. Such points 1501-1504 may be used to construct the shape of the calyx, wherein the center of the constructed calyx can be used as a percutaneous access target and/or can be followed when translating the present scope position by an offset distance/position to localize the papilla. In some implementations, the scope 1550 may be articulated in sweeping motions, as shown, to outline/cover the traversed area.
On page 13 Applicant argues Hsu teaches that the positional data may be registered to a reference image, and such a reference image is not analogous to the “image-based models” mentioned in para [0098]. This is not persuasive. Paragraph [0098] of Hsu teaches pre-operative CT scans are reconstructed into three-dimensional images, which are visualized, e.g., as “slices” of a cutaway view of the patient's internal anatomy. A three-dimensional image meets the broadest reasonable interpretation of a three-dimensional model. It would be obvious to one of ordinary skill in the art that the reference image would be such a three-dimensional image slice in view of the disclosure of paragraph [0118] that the mesh is three-dimensional.
On page 13 Applicant argues that registration of data points to a model is not analogous to generating the model based on the data points. This is not persuasive. The act of registering data points with a pre-existing model with thereby create a new model, such that the new model was generated using the data points and the pre-existing model.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexandra Newton Surgan whose telephone number is (571)270-1618. The examiner can normally be reached Monday-Friday 8am-4pm EST.
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/ALEXANDRA L NEWTON/Primary Examiner, Art Unit 3799
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