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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 17/810102 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The features of instant claims 25, 28 - 29, and 40 are not disclosed in the prior-filed application. Accordingly, claims 25, 28 - 29, and 40 are not entitled to the benefit of the prior application.
Claims 25, 28 - 29, and 40 are instead afforded an effective filing date of 6/30/2022, which is the filing date of application 17/819,101. Claims 20 - 24, 26 - 27, and 30 - 39 are afforded an effective filing date of 7/1/21, which is the filing date of applicant’s provisional application, US 63/202,963.
Claim Interpretation
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21 - 24 and 26 - 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of US 11,690,683.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed towards systems and methods involving: displaying a two-dimensional fluoroscopic medical image that depicts a medical instrument; determining a roll estimate of the distal portion of the medical instrument; receiving a user input from a user input device configured to allow a user to provide control commands for control of the medical instrument relative to a plane of the medical image, the user input comprising at least one of: a heading command to change a heading of the medical instrument within the plane of the medical image, wherein the heading command comprises a command to cause articulation of the distal end of the medical instrument either in a clockwise or counterclockwise direction within the plane of the medical image, or an incline command to change an incline of the medical instrument into or out of the plane of the medical image, wherein the incline command comprises a command to cause articulation of the distal end of the medical instrument to articulate either into or out of the plane of the medical image; generating one or more motor commands configured to cause a robotic system coupled to the medical instrument to move the medical instrument according to the user input, wherein the one or more motor commands are generated based on (i) the roll estimate and (ii) the user input provided relative to the plane of the medical instrument; and causing the robotic system to move the medical instrument based on the one or more motor commands.
In particular:
All of the features of instant claims 21 and 36 are suggested by reference claim 10.
Instant claims 22 and 37 are not patentably distinct from the reference claims because 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 invention of the reference claims to have the motor commands comprise pull wire commands configured to actuate one or more pull wires of the medical instrument, in order to use conventional robotic hardware mechanisms to control the medical instrument.
All of the features of instant claims 23 and 38 are suggested by reference claim 10.
All of the features of instant claims 24 and 39 are suggested by reference claim 2 and/or 14.
Instant claims 26 - 29 are not patentably distinct from the reference claims because 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 invention of the reference claims to have the commands to change the heading and incline respectively comprise indications of a desired heading and incline, in order to facilitate allowing the user to control the medical instrument in a convenient manner by essentially pointing at where the user wants the instrument to go. Such graphical user interface elements are conventional in the art.
All of the features of instant claims 30 are suggested by reference claim 1.
All of the features of instant claims 31 are suggested by reference claim 11.
All of the features of instant claims 32 are suggested by reference claim 6.
All of the features of instant claims 34 are suggested by reference claim 11.
All of the features of instant claims 35 are suggested by reference claim 1.
Claims 21 - 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of US 11,707,332.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed towards systems and methods involving: displaying a two-dimensional fluoroscopic medical image that depicts a medical instrument; determining a roll estimate of the distal portion of the medical instrument; receiving a user input from a user input device configured to allow a user to provide control commands for control of the medical instrument relative to a plane of the medical image, the user input comprising at least one of: a heading command to change a heading of the medical instrument within the plane of the medical image, wherein the heading command comprises a command to cause articulation of the distal end of the medical instrument either in a clockwise or counterclockwise direction within the plane of the medical image, or an incline command to change an incline of the medical instrument into or out of the plane of the medical image, wherein the incline command comprises a command to cause articulation of the distal end of the medical instrument to articulate either into or out of the plane of the medical image; generating one or more motor commands configured to cause a robotic system coupled to the medical instrument to move the medical instrument according to the user input, wherein the one or more motor commands are generated based on (i) the roll estimate and (ii) the user input provided relative to the plane of the medical instrument; and causing the robotic system to move the medical instrument based on the one or more motor commands. In particular:
All of the features of instant claims 21 and 36 are suggested by reference claim 1 and/or 17.
All of the features of instant claims 22 and 37 are suggested by reference claim 2 and/or 18.
All of the features of instant claims 23 and 38 are suggested by reference claim 3 and/or 19.
All of the features of instant claims 24 and 39 are suggested by reference claim 4 and/or 10.
All of the features of instant claims 25 and 40 are suggested by reference claim 5 and/or 21.
All of the features of instant claims 26 - 34 are suggested by reference claims 7 - 15, respectively.
All of the features of instant claims 35 are suggested by reference claim 6.
3. Claims 21 - 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of US 12,121,307.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed towards systems and methods involving: displaying a two-dimensional fluoroscopic medical image that depicts a medical instrument (reference claim 10); determining a roll estimate of the distal portion of the medical instrument (reference claim 1, 11); receiving a user input from a user input device configured to allow a user to provide control commands for control of the medical instrument relative to a plane of the medical image (reference claim 8), the user input comprising at least one of: a heading command to change a heading of the medical instrument within the plane of the medical image, wherein the heading command comprises a command to cause articulation of the distal end of the medical instrument either in a clockwise or counterclockwise direction within the plane of the medical image or an incline command to change an incline of the medical instrument into or out of the plane of the medical image, wherein the incline command comprises a command to cause articulation of the distal end of the medical instrument to articulate either into or out of the plane of the medical image (reference claim 1, 11); generating one or more motor commands configured to cause a robotic system coupled to the medical instrument to move the medical instrument according to the user input, wherein the one or more motor commands are generated based on (i) the roll estimate (reference claim 1, 11) and (ii) the user input provided relative to the plane of the medical instrument (reference claim 8); and causing the robotic system to move the medical instrument based on the one or more motor commands (reference claim 1, 11). The various features of the instant dependent claims are likewise suggested by the reference claims.
4. Claims 21 - 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of US application 18/806,424 (reference application, now US 12,303,656). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed towards systems and methods involving: displaying a two-dimensional fluoroscopic medical image that depicts a medical instrument (reference claim 1); determining a roll estimate of the distal portion of the medical instrument (reference claim 1); receiving a user input from a user input device configured to allow a user to provide control commands for control of the medical instrument relative to a plane of the medical image, the user input comprising at least one of: a heading command to change a heading of the medical instrument within the plane of the medical image, wherein the heading command comprises a command to cause articulation of the distal end of the medical instrument either in a clockwise or counterclockwise direction within the plane of the medical image, or an incline command to change an incline of the medical instrument into or out of the plane of the medical image, wherein the incline command comprises a command to cause articulation of the distal end of the medical instrument to articulate either into or out of the plane of the medical image (reference claim 1); generating one or more motor commands configured to move the medical instrument according to the user input, wherein the one or more motor commands are generated based on (i) the roll estimate and (ii) the user input provided relative to the plane of the medical instrument; and moving the medical instrument based on the one or more motor commands (reference claim 1). The various features of the instant dependent claims are likewise suggested by the reference claims.
The instant and reference claims differ in that the reference claims are directed to the actuation of the medical instrument involving actuation of a manually-controllable steerable catheter, whereas the instant claims require that the actuation of the medical instrument is via a robotic system. However, this distinction does not patentably distinguish the claim sets because 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 invention of the reference claims to have the actuation of the medical instrument be via a robotic system that actuates the manually-controllable steerable catheter, in order to allow the user to robotically control the instrument where such robotic control would be of benefit to the patient and/or surgeon, for example, during active treatment procedures.
5. Claims 21 - 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of US application 18/806404 (reference application, now US 12,296,117). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed towards systems and methods involving: displaying a two-dimensional fluoroscopic medical image that depicts a medical instrument (reference claim 14); determining a roll estimate of the distal portion of the medical instrument (reference claim 14); receiving a user input from a user input device configured to allow a user to provide control commands for control of the medical instrument relative to a plane of the medical image, the user input comprising at least one of: a heading command to change a heading of the medical instrument within the plane of the medical image, wherein the heading command comprises a command to cause articulation of the distal end of the medical instrument either in a clockwise or counterclockwise direction within the plane of the medical image, or an incline command to change an incline of the medical instrument into or out of the plane of the medical image, wherein the incline command comprises a command to cause articulation of the distal end of the medical instrument to articulate either into or out of the plane of the medical image (reference claim 13); generating one or more motor commands configured to move the medical instrument according to the user input, wherein the one or more motor commands are generated based on (i) the roll estimate and (ii) the user input provided relative to the plane of the medical instrument; and moving the medical instrument based on the one or more motor commands (reference claim 13). The various features of the instant dependent claims are likewise suggested by the reference claims.
The instant and reference claims differ in that the reference claims are directed to the actuation of the medical instrument involving actuation of a manually-controllable steerable catheter, whereas the instant claims require that the actuation of the medical instrument is via a robotic system. However, this distinction does not patentably distinguish the claim sets because 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 invention of the reference claims to have the actuation of the medical instrument be via a robotic system that actuates the manually-controllable steerable catheter, in order to allow the user to robotically control the instrument where such robotic control would be of benefit to the patient and/or surgeon, for example, during active treatment procedures.
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.
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.
Claims 21 - 22, 26, - 30, 34, and 36 - 37 are rejected under 35 U.S.C. 103 as being unpatentable over Camarillo et al. (US 2020/0297444, of record) in view of Ramamurthy et al. (US 9,186,046 of record).
Regarding claims 21 and 36, Camarillo shows a computer-implemented system (processors, [0009]) comprising a processor and an electronic storage medium storing instructions that cause the processor to implement a method comprising:
displaying, on a graphical user interface, a two-dimensional medical image including a view of a distal end of a medical instrument (“two-dimensional (2D) display … position information regarding the medical instrument 202 or component(s) thereof can be overlaid onto such a representation,” [0126] and fig. 21; [0185]);
determining a roll estimate of a current roll angle of the medical instrument (estimated state includes roll, [0152]; roll angle, [0154]);
receiving a user input from a user input device (“console … user interface … designed to provide both robotic controls as well as preoperative and real-time information of the procedure …,” [0055]) configured to allow a user to provide control commands for control of the medical instrument relative to a plane of the medical image, the user input comprising at least one of:
the user input comprising a heading (i.e., yaw) command to change a heading of the medical instrument within a plane of the medical image, wherein the heading command comprises a command to cause articulation of the distal end of the medical instrument either in a clockwise or counterclockwise direction within the plane of the medical image, or an incline (i.e., pitch) command to change an incline of the medical instrument into or out of the plane of the medical image, wherein the incline command comprises a command to cause articulation of the distal end of the medical instrument to articulate either into or out of the plane of the medical image (“ …insert the steerable endoscope 13 into the patient robotically, manually, or a combination thereof,” [0047]; commands from the robotic system, [0048]; pitch and yaw resulting from articulation commands, [0115]; command data instructing the instrument tip to reach a specific anatomical site and/or change its orientation (e.g., with a specific pitch, roll, yaw, insertion, and retraction for one or both of a leader and a sheath of an endoscopic instrument), [0150]; selecting the location of the target … by clicking, [0151]);
generating motor commands to cause a robotic system coupled to the medical instrument to move the robotic medical instrument according to the user input (“… navigation controller 360 … receives data from the state estimator 342… determine a next movement … for the instrument to advance along the navigation path,” [0155] and fig. 22), based on a roll estimate (estimated state includes roll, [0152]; roll angle, [0154]) and the user input relative to the plane of the medical instrument; and
causing the robotic medical system to move the robotic medical system based on the motor commands image (navigating a medical instrument, abstract; “ …insert the steerable endoscope 13 into the patient robotically, manually, or a combination thereof,” [0047]; navigation controller 360 can automatically control the instrument, [0155]).
Camarillo also discusses that “a C-arm for providing fluoroscopic imaging may be positioned over the patient's upper abdominal area” ([0067]), but does not explicitly state that the displayed 2D image is fluoroscopic.
Ramamurthy discloses robotic instrument systems. Ramamurthy teaches a displayed 2D image that is fluoroscopic (a two-dimensional image … generated using fluoroscopy and displayed, col. 18, lines 37 - 49).
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 invention of Camarillo to have the displayed 2D image be fluoroscopic, as taught by Ramamurthy, in order to allow the user to use the C-arm to generate the 2D image and to visualize the path of the instrument using conventional visualization techniques that are familiar to those in the art.
Regarding claims 22 and 37, the combined invention of Camarillo and Ramamurthy discloses the claimed invention substantially as noted above. Camarillo further shows that the motor commands comprise pull wire commands configured to actuate pull wires of the instrument (pull wires individually anchored to individual drive inputs within the instrument handle, [0091]; 0092]; [0093]; [0150]; [0155]).
Regarding claim 26, the combined invention of Camarillo and Ramamurthy discloses the claimed invention substantially as noted above. Further, in the combined invention of Camarillo and Ramamurthy, “the heading command to change the heading of the medical instrument comprises an indication to move the distal end of the medical instrument to the left or to the right within the plane of the medical image relative to a current heading of the medical instrument,” as the heading command controls the heading of the medical instrument, including its distal end as the instrument is directed to the target anatomical site.
Regarding claim 27, the combined invention of Camarillo and Ramamurthy discloses the claimed invention substantially as noted above. Further, in the combined invention of Camarillo and Ramamurthy, “the incline command to change the incline of the medical instrument comprises an indication to move the distal end of the medical instrument into or out of the plane of the medical image relative to the current heading of the medical instrument,” as the incline command controls the incline of the medical instrument, including its distal end as the instrument is directed to the target anatomical site.
Regarding claim 28, the combined invention of Camarillo and Ramamurthy discloses the claimed invention substantially as noted above. Further, in the combined invention of Camarillo and Ramamurthy, “the heading command to change the heading of the medical instrument comprises an indication of a desired heading for the distal end of the medical instrument within the plane of the medical image,” as the heading command is applied by the system to direct the medical instrument, including its distal end as the instrument is directed to the target anatomical site.
Regarding claim 29, the combined invention of Camarillo and Ramamurthy discloses the claimed invention substantially as noted above. Further, in the combined invention of Camarillo and Ramamurthy, “the incline command to change the incline of the medical instrument comprises an indication of a desired incline of the distal end of the medical instrument into or out of the plane of the medical image,” as the incline command is applied by the system to direct the medical instrument, including its distal end as the instrument is directed to the target anatomical site.
Regarding claim 30, the combined invention of Camarillo and Ramamurthy discloses the claimed invention substantially as noted above. Camarillo further shows determining a current incline of the distal end of the medical instrument into or out of the plane of the medical image ([0150]; [0152]).
Regarding claim 34, the combined invention of Camarillo and Ramamurthy discloses the claimed invention substantially as noted above. Camarillo further shows that the graphical user interface comprises the user input device ([0055]).
Claims 23 - 24, 32, 35, and 38 - 39 are rejected under 35 U.S.C. 103 as being unpatentable over Camarillo and Ramamurthy as applied to claims 21 and 36 above, and further in view of Liu et al. (US 2020/0405397, of record).
Regarding claims 23 - 24, 35, and 38 - 39, the combined invention of Camarillo and Ramamurthy discloses the claimed invention substantially as noted above.
Camarillo fails to show that the roll estimate is determined based on a computer vision analysis of a two-dimensional appearance of a fiducial in the medical image.
Liu discloses augmented reality guidance for interventional surgery. Liu teaches a roll estimate (“… calculate the roll of the catheter 200,” [0043] and figs. 2A, 3B) that is determined based on a computer vision (“segmentation engine 114 to segment the medical device, target anatomy, and fiducial markers from the background or other contents of imaging data,” [0024]; “… computer vision to identify and segment objects from the image data sets 134,” [0028]) analysis of a two-dimensional appearance of a fiducial in a medical image (“radiopaque marker 202 … coupled toward the distal tip of the catheter 200 … visualized in a fluoroscopic image to enable the catheter 200 to be visualized in situ,” [0041] and figs. 2A - 2B).
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 combined invention of Camarillo and Ramamurthy to have the roll estimate be determined based on a computer vision analysis of a two-dimensional appearance of a fiducial in the medical image, as taught by Liu, in order to provide confirmation of the roll angle via an alternate modality, to thereby facilitate ensuring accurate guidance of the instrument to the target anatomical site.
In the combined invention of Camarillo, Ramamurthy, and Liu, the fiducial is configured such that the two-dimensional appearance of the fiducial within the medical image is visually distinguishable for different roll angles and different inclines of the medical instrument, as the appearance of the fiducial can be used to calculate the roll angle and incline (Liu: [0042] - [0043]).
Regarding claim 32, the combined invention of Camarillo and Ramamurthy discloses the claimed invention substantially as noted above.
Camarillo fails to show determining a heading of the distal end of the instrument within the plane of the medical image based on the medical image.
Liu teaches determining a heading of the distal end of the instrument within the plane of the medical image based on the medical image (calculation of the yaw angle 312, [0044] and figs. 2A, 3C).
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 combined invention of Camarillo and Ramamurthy to include determining a heading of the distal end of the instrument within the plane of the medical image based on the medical image, as taught by Liu, in order to provide confirmation of the heading via an alternate modality, to thereby facilitate ensuring accurate guidance of the instrument to the target anatomical site.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Camarillo and Ramamurthy as applied to claim 30 above, and further in view of Fine et al. (US 10,529,088, of record).
Regarding claim 31, the combined invention of Camarillo and Ramamurthy discloses the claimed invention substantially as noted above.
Camarillo fails to show displaying an indication of the current incline on the graphical user interface.
Fine discloses automatically determining the position and orientation of an invasive medical device via image processing. Fine teaches displaying an indication of a current incline on a graphical user interface (output roll, pitch, and yaw information, col. 6, lines 5 - 15; “images can be annotated with 3D orientation information (e.g., (roll, pitch, yaw),” col. 6, lines 45 - 50; claim 13: “… visual pitch information, and visual yaw information that is presented in the display with the one or more 2D images…”).
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 combined invention of Camarillo and Ramamurthy to include displaying an indication of the current incline on the graphical user interface, as taught by Fine, in order to allow practitioners to more quickly and safely perform medical procedures, as suggested by Fine (col. 3, lines 8 - 30).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Camarillo, Ramamurthy, and Liu, as applied to claim 32 above, and further in view of Fine et al. (US 10,529,088, of record).
Regarding claim 33, the combined invention of Camarillo, Ramamurthy, and Liu discloses the claimed invention substantially as noted above.
Camarillo fails to show displaying an indication of the current heading on the graphical user interface.
Fine discloses automatically determining the position and orientation of an invasive medical device via image processing. Fine teaches displaying an indication of a current heading on a graphical user interface (output roll, pitch, and yaw information, col. 6, lines 5 - 15; “images can be annotated with 3D orientation information (e.g., (roll, pitch, yaw),” col. 6, lines 45 - 50; claim 13: “… visual pitch information, and visual yaw information that is presented in the display with the one or more 2D images…”).
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 combined invention of Camarillo, Ramamurthy, and Liu to include displaying an indication of the current incline on the graphical user interface, as taught by Fine, in order to allow practitioners to more quickly and safely perform medical procedures, as suggested by Fine (col. 3, lines 8 - 30).
Response to Arguments
Applicant's arguments filed 8/21/2025 have been fully considered but they are not persuasive.
Applicant argues on page 7, with respect to the 103 rejections, that Camarillo does “not teach or specific the specific heading and incline commands, recited in Claim 21, which are defined with respect to the plane of the medical image.” Applicant further argues on page 7 with respect to [0047] - [0048], [0055], [0115], and [0150] - [0151].
Examiner respectfully disagrees. The “heading command” of claim 21 reads on any command received from the user input device that somehow results in articulation of the distal end of the medical instrument either in a clockwise or counterclockwise direction within the plane of the medical image. In [0047] - [0048] and [0055], Camarillo teaches receiving user input commands from a user input device to control the instrument, for example to navigate through a patient's lung network and/or reach the desired target. In [0115], Camarillo teaches that the received commands include a heading (i.e., yaw) command. In [0150], Camarillo teaches that the command data includes data instructing the instrument tip to reach a specific anatomical site and/or change its orientation. In [0151], Camarillo teaches that the user may select the location of the target by clicking. In light of the fact that the system is designed to use specific heading commands to navigate tortuous networks, such as a lung system, simply by having a user click on a target or otherwise use a user interface for navigation, it is understood that the command(s) received from the user to navigate the device to the target must result in articulation of the distal end of the medical instrument in numerous different directions, and that such articulation would entail at list some miniscule amount of motion that is “either in a clockwise or counterclockwise direction within the plane of the medical image”. Similarly, the articulation would entail at list some miniscule amount of motion that causes “the distal end of the medical instrument to articulate either into or out of the plane of the medical image”. The claim limitations thus appear to read on Camarillo, lacking any further detail in the claim that limits the nature of the heading and/or incline command.
Applicant further argues on page 7 (bottom) - page 8, that claim 21 “specifically recites that the heading and incline commands are commands provided with respect to the plane of the image”.
Examiner respectfully disagrees. The claim does not recite that the commands are “provided with respect to the plane of the image”. In contrast, the claim requires that articulation that results from the commands is ‘with respect to the plane of the image’.
Applicant argues on page 8, with respect to the double patenting rejections in view of US 11,690,683, that the patent claims do “not recite heading and incline commands [as] cited in the present application”.
In response, it is noted that the rejections do not assert that the patent claims “recite heading and incline commands [as] cited in the present application”. Instead, the rejections assert that the instant claims are suggested by the reference claims, at least because reference claim 10 recites limitations directed towards determining motor controls that direct the heading and incline of the medical instrument. The rejections are deemed proper for the reasons detailed above, and are therefore maintained.
Applicant argues on page 8, with respect to the double patenting rejections in view of US 11,707,332, that Applicant will consider filing a terminal disclaimer.
These comments are acknowledged. The rejections are deemed proper for the reasons detailed above, and are therefore maintained.
Applicant argues on page 8, with respect to the double patenting rejections in view of US 12,121,307, that the patent claims do “not recite heading and incline commands [as] cited in the present application”.
In response, it is noted that the rejections do not assert that the patent claims “recite heading and incline commands [as] cited in the present application”. Instead, the rejections assert that the instant claims are suggested by the reference claims, at least because reference claim 8 recites limitations directed towards determining motor controls that direct the heading and incline of the medical instrument. The rejections are deemed proper for the reasons detailed above, and are therefore maintained.
Applicant argues on page 9, with respect to the double patenting rejection in view of US 12,303,656 and US 12,296,117, that ‘each of the reference applications or patents relate to a "manually-controllable steerable catheter" where user inputs are provided on a handle of the steerable catheter.’
However, the rejections address the contested distinction, and explain this difference does not patentably distinguish the claim sets. The rejections are deemed proper for the reasons detailed above, and are therefore maintained
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.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798