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 .
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 - 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of U.S. Patent No. 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 analyzing a medical image that depicts a medical instrument that includes fiducials, to determine information about an incline of the distal portion of the medical instrument, based on a two-dimensional appearance of the fiducials, generating motor commands configured to cause a robotic system coupled to the medical instrument to move the medical instrument, and causing the robotic system to move the medical instrument based on the more motor commands. In general, the instant claims are broader than the reference claims, in that they are directed towards use of a determined “incline” to generate the motor commands, whereas the reference claims require both the “incline” and a “roll angle”. In detail:
Instant claim 21 is suggested by reference claim 1.
Instant claims 22 - 23 are suggested by reference claims 2 - 3, respectively.
Instant claim 24 is suggested by reference claim 1.
Instant claims 25 - 27 are suggested by reference claim 1.
Instant claims 28 - 29 are suggested by reference claims 4 - 5, respectively.
Instant claims 30 - 31 are suggested by reference claims 6 - 7, respectively.
Instant claims 32 - 33 are suggested by reference claims 8 - 9, respectively.
Instant claim 34 is suggested by reference claim 1.
Instant claim 35 is suggested by reference claim 10.
Instant claims 36 - 37 are suggested by reference claims 11 - 12, respectively.
Instant claim 38 is suggested by reference claim 13.
Claims 21 - 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of U.S. Patent No. 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 analyzing a medical image that depicts a medical instrument that includes fiducials, to determine information about an incline of the distal portion of the medical instrument, based on a two-dimensional appearance of the fiducials. In particular:
All of the features of instant claims 21 and 38 are included in or suggested by reference claim 11.
Instant claims 22 - 23 are suggested by reference claim 4. 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 detection of the appearance be based on a computer vision algorithm or neural network, in order to facilitate the detection using conventional algorithms.
Instant claim 24 is suggested by reference claim 1.
Instant claims 25 - 27 are suggested by reference claim 1 and/or 6.
Instant claims 28 - 29 are suggested by reference claim 11 and/or 13. 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 tip be detected in the manner recited, in order to effectively determine the position of the tip in a robust and repeatable manner.
Instant claims 30 - 31 are suggested by reference claim 13. 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 heading be determined in the manner recited, in order to effectively determine the position of the heading in a robust and repeatable manner.
Instant claims 32 - 33 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 medical instrument be endoluminal or comprise a catheter, in order to implement conventional image guided surgical procedures using imaging guidance that is routine in the art to thereby treat a patient in need.
Instant claim 34 is suggested by reference claim 1.
Instant claim 35 is suggested by reference claim 1.
Instant claim 36 is suggested by reference claim 12.
Instant claim 37 is suggested by reference claim 1.
Claims 21 - 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of U.S. Patent No. 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 analyzing a medical image that depicts a medical instrument that includes fiducials, to determine information about the distal portion of the medical instrument, based on a two-dimensional appearance of the fiducials. In particular:
Instant claims 21 and 38 are suggested by reference claim 1. 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 include determining the incline of the distal portion with respect to the image plane, the incline comprising a sign, in order to control the robot properly to position the instrument relative to the patient’s body as needed for the medical procedure.
Instant claims 22 - 23 are suggested by reference claims 2 - 3, respectively.
Instant claim 24 is suggested by reference claim 1.
Instant claims 25 - 27 are suggested by reference claim 1. 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 appearance be distinguishable for the recited roll angles, in order to accurately detect the instrument’s current roll angle.
Instant claims 28 - 29 are suggested by reference claims 4 - 5, respectively.
Instant claims 30 - 31 are suggested by reference claim 1.
Instant claims 32 - 33 are suggested by reference claims 6 - 7, respectively.
Instant claim 34 is suggested by reference claim 1.
Instant claim 35 is suggested by reference claim 1.
Instant claims 36 - 37 are suggested by reference claims 9 - 10, respectively.
Claims 21 - 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21 - 40 of copending Application No. 18/352491 (reference application). 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 analyzing a medical image that depicts a medical instrument that includes fiducials, to determine information about the distal portion of the medical instrument, based on a two-dimensional appearance of the fiducials. In particular:
Instant claims 21 and 38 are suggested by reference claim 31.
Instant claims 22 - 23 are suggested by reference claim 24. 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 detection of the appearance be based on a computer vision algorithm or neural network, in order to facilitate the detection using conventional algorithms.
Instant claims 25 - 27 are suggested by reference claim 35. 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 appearance be distinguishable for the recited roll angles, in order to accurately detect the instrument’s current roll angle.
Instant claims 28 - 29 are suggested by reference claim 31. 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 tip be detected in the manner recited, in order to effectively determine the position of the tip in a robust and repeatable manner.
Instant claims 30 - 31 are suggested by reference claim 32. 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 heading be determined in the manner recited, in order to effectively determine the position of the heading in a robust and repeatable manner.
Instant claims 32 - 33 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 medical instrument be endoluminal or comprise a catheter, in order to implement conventional image guided surgical procedures using imaging guidance that is routine in the art to thereby treat a patient in need.
Instant claim 34 is suggested by reference claim 21.
Instant claim 35 is suggested by reference claim 21.
Instant claim 36 is suggested by reference claim 31.
Instant claim 37 is suggested by reference claim 21.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 - 35 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2020/0405397, of record) in view of Camarillo et al. (US 2020/0297444, of record) and Kwak et al. (US 2014/0316252).
Regarding claims 21 and 38, Liu shows a computer-implemented system (computer, [0025]) comprising a processor and electronic storage medium storing instructions that cause the processor to implement a method comprising:
receiving, from a medical imaging device (fluoroscopic imaging device, [0037]) a two-dimensional medical image (2D images, [0037]) including a view of a distal portion of a medical instrument (catheter 200, [0039]), the distal portion including a fiducial positioned thereon (“radiopaque marker 202 … coupled toward the distal tip of the catheter 200,” [0041] and figs. 2A - 2B), the fiducial being radio-opaque and visible in the medical image;
detecting, within the medical image, a two-dimensional appearance of the fiducial (“when imaged with a 2D imaging system … marker 202 is projected onto a 2D image plane … measure the segments of the radiopaque marker 202 in the image plane …” [0041]); and
based on the appearance, determine an incline of the distal portion with respect to an image plane of the image (“… out-of-plane angle … determine the pitch angle 302 of the catheter 200,” [0042] and figs. 2A, 3A).
Liu fails to show, based on the incline, generating a motor command configured to cause a robotic system coupled to the medical instrument to move the medical instrument; and causing the robotic system to move the medical instrument based on the motor command. In addition, Liu fails to show that the incline includes a sign of the incline.
Camarillo discloses medical robotics ([0002]). Camarillo teaches, based on an incline (“command data instructing the instrument tip … pitch…”, [0150]; estimated state includes pitch, [0152]), generating a motor command configured to cause a robotic system coupled to a medical instrument to move the medical instrument (commands from the robotic system, [0048]; “… 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); and causing the robotic system to move the medical instrument based on the motor command (navigating a medical instrument, abstract; “ …insert the steerable endoscope 13 into the patient robotically, manually, or a combination thereof,” [0047]; [0150]; navigation controller 360 can automatically control the instrument, [0155]).
Kwak discloses a marker shaped to facilitate detection of rotation information and surgical instrument pose ([0003]). Kwak teaches an incline that includes a sign of the incline (“… pitch-direction rotation angle … positive … negative value …”, [0152]; “…distinction between the two cases, the pitch-direction rotation angle … positive value … negative value …”, [0111]).
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 Liu to include, based on the incline, generating a motor command configured to cause a robotic system coupled to the medical instrument to move the medical instrument; and causing the robotic system to move the medical instrument based on the motor command, as taught by Camarillo, in order to provide the physician with the ability to perform the procedure from an ergonomic position without the need for awkward arm motions and positions and/or provide the physician with the ability to perform the procedure with improved ease of use such that one or more of the instruments of the system can be controlled by a single user, as discussed by Camarillo ([0044]).
It also 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 Liu and Camarillo to have the incline include a sign of the incline, as taught by Kwak, in order to distinguish between positive and negative pitch as suggested by Kwak ([0111]).
Regarding claim 22, the combined invention of Liu, Camarillo, and Kwak discloses the claimed invention substantially as noted above. Liu further shows that computer vision is used to detect the two-dimensional appearance of the fiducial (“segmentation engine 114 to segment …,” [0024]; “… computer vision to identify and segment objects from the image data sets 134,” [0028]).
Regarding claim 23, the combined invention of Liu, Camarillo, and Kwak discloses the claimed invention substantially as noted above. Liu further shows that a neural network detects the two-dimensional appearance of the fiducial (“segmentation engine 114 to segment …,” [0024]; “… convolutional neural network to identify the objects in the image data sets 134,” [0028]).
Regarding claim 24, the combined invention of Liu, Camarillo, and Kwak discloses the claimed invention substantially as noted above. Liu further shows that both the roll (roll, [0043] and fig. 4B), and incline (pitch angle 302, [0042] and figs. 3A) are determined.
Regarding claim 25, the combined invention of Liu, Camarillo, and Kwak discloses the claimed invention substantially as noted above. Liu further shows that 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 is used to calculate the roll angle and incline ([0042] - [0043]).
Regarding claims 26 - 27, the combined invention of Liu, Camarillo, and Kwak discloses the claimed invention substantially as noted above. Further, the two-dimensional appearance of the fiducial is at least physically capable of being visually distinguished for different roll angles and different inclines of the medical instrument for incremental changes of less than or about 40 degrees and therefore meets the claims, as the appearance of the fiducial is used to calculate the roll angle and incline in individual degrees ([0042] - [0043]).
Regarding claim 28, the combined invention of Liu, Camarillo, and Kwak discloses the claimed invention substantially as noted above. Liu further shows detecting, within the medical image, a distal tip of the medical instrument (“detecting the medical device … the end of the catheter 702,” [0054]); and based on the detected tip, determining a two-dimensional position of the distal tip within a plane of the medical image (2D image that illustrates the real-time position of the medical device, [0032]).
Regarding claim 29, the combined invention of Liu, Camarillo, and Kwak discloses the claimed invention substantially as noted above. Liu further shows that detecting the tip comprises determining, based on the medical image, a centerline of the distal portion of the medical instrument, and determining an endpoint for the centerline (“segmentation engine … generate a center line … until the region of interest 704 reaches the end of the catheter 702,” [0054] and center line 710 in figs. 7A - 7F).
Regarding claim 30, the combined invention of Liu, Camarillo, and Kwak discloses the claimed invention substantially as noted above. Liu further shows detecting, within the medical image, the distal portion of the medical instrument (“detecting the medical device … the end of the catheter 702,” [0054]); and based on the detected distal portion, determining a heading of the medical instrument within a plane of the medical image (calculation of the yaw angle 312, [0044] and figs. 2A, 3C).
Regarding claims 32 - 33, the combined invention of Liu, Camarillo, and Kwak discloses the claimed invention substantially as noted above. Liu further shows that the medical instrument comprises an endoluminal (heart/vasculature, [0027]) catheter (catheter 200, [0039]).
Regarding claim 34, the combined invention of Liu, Camarillo, and Kwak discloses the claimed invention substantially as noted above. Liu further shows that the medical imaging device comprises an X- ray device (fluoroscopic imaging device, [0037]).
Regarding claim 35, the combined invention of Liu, Camarillo, and Kwak discloses the claimed invention substantially as noted above.
Liu fails to show that the motor control is based on user input.
Camarillo teaches that the motor controls are determined based on user input (user-guided navigation, [0159]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have further modified the invention of Liu have the motor controls be determined based on user input, as taught by Camarillo, in order to facilitate user-guided navigation, as suggested by Camarillo ([0155]).
Claims 36 - 37 are rejected under 35 U.S.C. 103 as being unpatentable over Liu, Camarillo, and Kwak as applied to claim 21 above, and further in view of Onishi et al. (US 2012/0287238, of record).
Regarding claims 36 - 37, the combined invention of Liu, Camarillo, and Kwak discloses the claimed invention substantially as noted above.
Liu fails to show displaying the roll angle or incline and the medical image.
Onishi discloses an endoluminal medical device ([0003]). Onishi teaches displaying a roll angle and a medical image (“… superimposed image PW1D having the axial image PA … display the roll angle of the distal end portion 2C…,” [0090] and fig. 13).
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 Liu, Camarillo, and Kwak to include displaying the roll angle and the medical image, as taught by Onishi, in order to inform a user of the calculated roll angle and help the user visualize the orientation of the instrument relative to the patient’s anatomy.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Kwak is introduced to address the amended features of the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
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