DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This action is responsive to the amendments and remarks received 26 June 2026. Claims 1 - 4 and 6 - 20 are currently pending.
Claim Objections
The objections to claims 1, 9, 11 and 13, due to minor informalities, are hereby withdrawn in view of the amendments and remarks received 26 June 2026.
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.
The rejections to claims 14 - 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are hereby withdrawn in view of the amendments and remarks received 26 June 2026.
Response to Arguments
Applicant’s arguments with respect to claim(s) 13 - 19 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.
Applicant's arguments filed 26 June 2026 have been fully considered but they are not persuasive.
On pages 7 - 9 of the remarks the Applicant’s Representative argues that “the Examiner has not cited to any sections in any references that would disclose or suggest calibrating a relative position based on a determined transition position.” The Applicant’s Representative argues that because Peterson et al. use the sharp drop in intensity “to entirely exclude or ignore data from further processing” that “the Examiner's proposed combinations of the references would not result in a system that calibrates anything-much less ‘a relative position of a distal end of a scope in relation to a distal end of a sheath’-based on that sharp drop in intensity.” Therefore, the Applicant’s Representative argues that the Examiner has not “cited to any sections of any references that discloses or suggests, at least, ‘calibrate a position of the distal end of the scope relative to the distal end of the sheath based at least in part on the transition position,’ as recited in Applicant’s claim 1.”
The Examiner respectfully disagrees.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Furthermore, the Examiner asserts that, at least, Ludwin et al. disclose calibrating a position of the distal end of the scope relative to the distal end of the sheath based at least in part on the transition position, see at least figures 2 - 5, page 2 paragraphs 0030, 0035 and 0037 and page 4 paragraph 0056 - page 5 paragraph 0066 of Ludwin et al. wherein it is disclosed that the “processor may use the change to estimate the position of the probe distal end relative to the sheath distal end, and thus determine the protrusion of the probe distal end from the sheath distal end”, that “proximity may be quantified as a distance Δz of sheath termination 80 from an arbitrary point on the distal end. By way of example, and as illustrated in FIG. 4, distance Δz is assumed to be measured to the distal end of distal tip 52”, that “FIG. 5 is a flowchart 100 describing steps for locating sheath termination 80 with respect to distal end 30”, that in “a first calibration step 102, processor 36 implements the sheath location part of the calibration procedure”, that the probe “is inserted into sheath 40, generally as illustrated in FIG. 2, but with distal ends 44 and 30 outside the body of patient 24 so that distance Δz may be independently measured”, that the “processor records the changes in signals in coils 68 and 70 for different values of distance Δz of the sheath termination, and forms a sheath location calibration relationship, typically using interpolation, between the signal changes and distances Δz. The processor stores the calibration relationship for use during a procedure involving sheath and probe 28”, that “processor 36 estimates the position of sheath termination 80, corresponding to measuring the value of distance Δz” and that “operator 26 may manipulate the proximal ends of the sheath and probe to achieve a desired protrusion of probe distal end 44 from sheath termination 80.”
The Examiner asserts that, as shown herein above and in the cited portions, Ludwin et al. disclose manipulating the proximal ends of the sheath and probe to achieve a desired protrusion of probe distal end from sheath termination, i.e., calibrating a position of the distal end of the probe relative to the distal end of the sheath based at least in part on the transition position, the sheath termination location.
Therefore, the Examiner asserts that Gordon et al. in view of Ludwin et al. in view of Peterson et al. disclose the aforementioned disputed claim limitation.
On pages 11 - 12 of the remarks the Applicant’s Representative argues that “the Examiner has not cited to any sections in any references that would disclose or suggest determining a transition position based on a determination that a filtered portion satisfies a threshold.” The Applicant’s Representative argues that Matey et al. merely use their logic high state “to determine whether to enable or disable power to a cutting tool” and that nowhere does Matey et al. disclose or suggest using its logic high state to determine anything that could be reasonably interpreted as ‘a transition position of a scope relative to a sheath.’" Therefore, the Applicant’s Representative argues that “the Examiner has not cited to any sections in any references that would disclose or suggest” “determining a transition position based at least in part on the determination that the filtered portion satisfies the threshold” or “determining a target protrusion based at least in part on the transition position,”.
The Examiner respectfully disagrees.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Furthermore, the Examiner asserts that Gordon et al. in view of Ludwin et al. in view of Matey et al. disclose the aforementioned disputed claim limitation(s).
The Examiner asserts that, at least, Gordon et al. disclose determining a transition position based at least in part on the determination that a processed portion satisfies the threshold, see at least page 3 paragraph 0034, page 4 paragraphs 0041 - 0042, page 5 paragraph 0050, page 6 paragraphs 0053 - 0055, page 7 paragraphs 0058 - 0059 and 0063, page 8 paragraphs 0066 - 0068 and page 10 paragraphs 0079 - 0084 of Gordon et al. wherein it is disclosed that “the sheath 620 may include one or more identification features 615. An appearance of the identification feature(s) 615 may be detected by the imaging device 635. For example, a shape of the identification feature(s) 615, a location of the identification feature(s) 615, and/or any other component regarding how the identification feature(s) looks may be identified in the imaging data captured by the imaging device 635”, that “a greater contrast may be shown between the identification feature and the sheath 620 and/or a difference in color between the identification feature and the sheath 620 may be more defined”, that “the control system may determine the insertion distance of the imaging probe 630 relative to the sheath 620 based on the appearance of the identification feature (e.g., the elongate wire 650) that is visible in the image captured by the imaging probe 630”, that “the markers 670 may be positioned outside of the sheath 620” and that a “processing system, such as an image processing system, may analyze the captured image to determine the insertion distance of the sheath 620 based on the markers 670.”
The Examiner notes that Gordon et al. fail to disclose explicitly determining a position based at least in part on the determination that a filtered portion satisfies the threshold.
However, pertaining to analogous art, Matey et al. disclose determining a position based at least in part on the determination that a filtered portion satisfies the threshold, see at least the abstract, figures 1 - 5, column 3 lines 10 - 40, column 3 line 60 - column 4 line 13, column 4 lines 50 - 54, column 5 line 60 - column 6 line 29, column 6 lines 60 - 67 column 7 line 66 - column 8 line 46, column 8 line 59 - column 9 line 20, column 14 lines 32 - 53 and column 15 lines 5 - 13 of Matey et al. wherein it is disclosed that a “tubular sheath may be painted or dyed, or a ape may be applied to give it a unique color. Either the entire sheath or a fraction of the distal end (as shown in FIG. 1) may be colored”, that a processing method “involves converting the R, G and B data to hue, saturation, Luminance (HSL) data. A mask is generated from the H plane which isolates the hue(s) of interest. The mask is applied to the L plane, blanking out all regions which do not correspond to the hue(s) of interest. A threshold operator is applied to the L plane, so that only pixels which have the correct hue and a brightness above the threshold remain. An erosion operator is then applied to the L plane, essentially eliminating one pixel from each set of contiguous pixels having the correct hue and brightness. This eliminates all single pixels from the solution set. Only objects larger than one pixel remain. Similarly, if the object is large, then objects smaller than a threshold number of pixels (N) in size may be deleted from the solution set by repeating the erosion step N times. The remaining pixels are identified as the marker 22” and that “a color detection mechanism for supplying color image data from which the position of an object within the field of view of the color detection mechanism may be detected; and (2) an instrument that is either operated by a human operator or automatically controlled, wherein the human or automatic control system uses position data from the color detection mechanism to determine the position of the device.”
The Examiner asserts that Gordon et al. modified as proposed by Matey et al. disclose determining a transition position based at least in part on the determination that the filtered portion satisfies the threshold at least because the color-based sheath detection method of Matey et al. would be used in place of the sheath detection technique of Gordon et al. to detect the sheath in the image data of Gordon et al.
Lastly, the Examiner asserts that, at least, Ludwin et al. disclose determining a target protrusion based at least in part on the transition position, see at least figures 2 - 5, page 2 paragraph 0030 and page 4 paragraph 0056 - page 5 paragraph 0066 of Ludwin et al. wherein it is disclosed that that “processor 36 estimates the position of sheath termination 80, corresponding to measuring the value of distance Δz” and that “operator 26 may manipulate the proximal ends of the sheath and probe to achieve a desired protrusion of probe distal end 44 from sheath termination 80.”
Therefore, the Examiner asserts that Gordon et al. in view of Ludwin et al. in view of Matey et al. disclose the aforementioned disputed claim limitation(s).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 - 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. U.S. Publication No. 2024/0153113 A1 in view of Ludwin et al. U.S. Publication No. 2013/0303886 A1 in view of Peterson et al. U.S. Publication No. 2020/0330070 A1.
- With regards to claim 1, Gordon et al. disclose a robotic system, (Gordon et al., Figs. 1 - 3, 11 & 12, Pg. 2 ¶ 0025 - 0026, Pg. 3 ¶ 0036, Pg. 13 ¶ 0099 - 0106, Pg. 14 ¶ 0110) comprising: an instrument comprising a scope and a sheath, (Gordon et al., Abstract, Figs. 2 - 10B & 12, Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0025 and 0027 - 0029, Pg. 3 ¶ 0033 - 0034, Pg. 4 ¶ 0040 - 0043, Pg. 5 ¶ 0046 - 0050, Pg. 6 ¶ 0053, Pg. 7 ¶ 0058 - 0059, Pg. 8 ¶ 0066 - 0068, Pg. 11 ¶ 0089 - 0091) the sheath aligned with the scope on a coaxial axis and surrounding the scope, (Gordon et al., Figs. 3 & 5A - 9F, Pg. 2 ¶ 0028 - 0029, Pg. 5 ¶ 0047, Pg. 5 ¶ 0050 - Pg. 6 ¶ 0053, Pg. 8 ¶ 0066 - 0068, Pg. 11 ¶ 0089 - 0091) the scope having a sensor proximate a distal end of the scope; (Gordon et al., Abstract, Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0025, Pg. 2 ¶ 0028 - Pg. 3 ¶ 0031, Pg. 3 ¶ 0034 - 0035, Pg. 5 ¶ 0046 - Pg. 6 ¶ 0053) and at least one computer-readable memory in communication with at least one processor, (Gordon et al., Pg. 1 ¶ 0007, Pg. 2 ¶ 0025, Pg. 13 ¶ 0103 - 0106, Pg. 15 ¶ 0116 - 0119) the at least one computer-readable memory having stored thereon computer-executable instructions that when executed cause the at least one processor (Gordon et al., Pg. 1 ¶ 0007, Pg. 2 ¶ 0025, Pg. 13 ¶ 0103 - 0106, Pg. 15 ¶ 0116 - 0119) to: detect a distal end of the sheath based on sensor data captured with the sensor; (Gordon et al., Pg. 2 ¶ 0029, Pg. 3 ¶ 0033 - 0034, Pg. 4 ¶ 0041 - 0042, Pg. 6 ¶ 0051 - 0055, Pg. 7 ¶ 0058 - 0059 and 0063, Pg. 8 ¶ 0066 - 0068, Pg. 10 ¶ 0079 - 0080) determine a transition position for the distal end of the scope relative to the distal end of the sheath based on a detecting the distal end of the sheath; (Gordon et al., Pg. 2 ¶ 0029, Pg. 3 ¶ 0033 - 0034, Pg. 4 ¶ 0041 - 0043, Pg. 5 ¶ 0050 - Pg. 6 ¶ 0055, Pg. 7 ¶ 0058 - 0059 and 0063, Pg. 8 ¶ 0066 - 0068, Pg. 10 ¶ 0079 - 0084) and determining a position of the distal end of the scope relative to the distal end of the sheath based at least in part on the transition position. (Gordon et al., Pg. 2 ¶ 0029, Pg. 3 ¶ 0033 - 0034, Pg. 4 ¶ 0041 - 0042, Pg. 6 ¶ 0051 - 0055, Pg. 7 ¶ 0058 - 0059 and 0063, Pg. 8 ¶ 0066 - 0068, Pg. 10 ¶ 0079 - 0080) Gordon et al. fail to disclose explicitly the transition position representing a threshold position at which the distal end of the sheath is no longer detected based on the sensor data; and calibrating a position of the distal end of the scope relative to the distal end of the sheath. Pertaining to analogous art, Ludwin et al. disclose an instrument comprising a scope and a sheath, (Ludwin et al., Abstract, Figs. 2 - 5, Pg. 1 ¶ 0005 - 0007, 0014 and 0027, Pg. 2 ¶ 0030 - 0034, Pg. 4 ¶ 0049 - 0059, Pg. 5 ¶ 0063 - 0067) the sheath aligned with the scope on a coaxial axis and surrounding the scope, (Ludwin et al., Figs. 2 - 4, Pg. 2 ¶ 0037 - 0039, Pg. 3 ¶ 0041 - 0046, Pg. 4 ¶ 0052 - 0054) the scope having a sensor proximate a distal end of the scope; (Ludwin et al., Abstract, Figs. 2 - 5, Pg. 1 ¶ 0006 - 0007, 0014, 0018 - 0020 and 0027 - 0029, Pg. 2 ¶ 0037 - 0038, Pg. 3 ¶ 0045 - 0048, Pg. 4 ¶ 0051 - 0052, 0055 and 0058, Pg. 5 ¶ 0061 - 0067) and at least one computer-readable memory in communication with at least one processor, (Ludwin et al., Fig. 1, Pg. 2 ¶ 0036) the at least one computer-readable memory having stored thereon computer-executable instructions that when executed cause the at least one processor (Ludwin et al., Fig. 1, Pg. 2 ¶ 0036) to: calibrate a position of the distal end of the scope relative to the distal end of the sheath based at least in part on the transition position. (Ludwin et al., Fig. 5, Pg. 1 ¶ 0027 - Pg. 2 ¶ 0030, Pg. 4 ¶ 0050 - 0052, Pg. 4 ¶ 0056 - Pg. 5 ¶ 0066) Ludwin et al. fail to disclose explicitly the transition position representing a threshold position at which the distal end of the sheath is no longer detected based on the sensor data. Pertaining to analogous art, Peterson et al. disclose determining a transition position for the distal end of the scope relative to the distal end of the sheath based on a detecting the distal end of the sheath, (Peterson et al., Figs. 1A - 2B, 4 & 6 - 8, Pg. 2 ¶ 0016 - 0018, Pg. 4 ¶ 0043 and 0047, Pg. 5 ¶ 0053 - Pg. 6 ¶ 0059, Pg. 6 ¶ 0061 - 0066, Pg. 7 ¶ 0068 - 0070 and 0072, Pg. 8 ¶ 0076, 0080 and 0083) the transition position representing a threshold position at which the distal end of the sheath is no longer detected based on the sensor data. (Peterson et al., Pg. 1 ¶ 0012 - Pg. 2 ¶ 0014, Pg. 4 ¶ 0043 and 0047, Pg. 5 ¶ 0054 - Pg. 6 ¶ 0058) Gordon et al. and Ludwin et al. are combinable because they are both directed towards medical probe control methods and systems that determine the location of a distal end of a probe in relation to a distal end of a sheath being used to guide the probe. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Gordon et al. with the teachings of Ludwin et al. This modification would have been prompted in order to enhance the base device of Gordon et al. with the well-known and applicable technique Ludwin et al. applied to a similar device. Calibrating a position of the distal end of the scope relative to the distal end of the sheath based at least in part on the transition position, as taught by Ludwin et al., would enhance the base device of Gordon et al. by allowing for end users to utilize the determined position to quickly and easily achieve and maintain a desired protrusion of the distal end of the scope in relation to the distal end of the sheath so as to provide assurance to end users that the scope is appropriately positioned during medical procedures. Furthermore, this modification would have been prompted by the teachings and suggestions of Gordon et al. that the control system may determine registrations between the catheter and captured images while a user is manipulating the catheter, that a user may insert the imaging probe by a known insertion distance and/or that the control system may provide instructions to a user to insert the imaging probe by a specified insertion distance, see at least page 11 paragraph 0085 and page 12 paragraphs 0094 - 0097 of Gordon et al. This combination could be completed according to well-known techniques in the art and would likely yield predictable results, in that the base device of Gordon et al. would calibrate the position of the distal end of the scope relative to the distal end of the sheath based at least in part on the transition position so as to allow for end user to quickly and easily achieve and maintain a desired protrusion of the distal end of the scope in relation to the distal end of the sheath during medical procedures. In addition, Gordon et al. in view of Ludwin et al. and Peterson et al. are combinable because they are all directed towards medical probe positioning methods and systems and, similar to Gordon et al., Peterson et al. is also directed towards detecting a catheter being used to guide a probe based on image data captured by the probe. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined teachings of Gordon et al. in view of Ludwin et al. with the teachings of Peterson et al. This modification would have been prompted in order to enhance the combined base device of Gordon et al. in view of Ludwin et al. with the well-known and applicable technique Peterson et al. applied to a comparable device. Determining a transition position representing a threshold position at which the distal end of the sheath is no longer detected based on the sensor data, as taught by Peterson et al., would enhance the combined base device by allowing for it to determine and calibrate the position of the distal end of the scope relative to the distal end of the sheath as soon as it possibly can thereby improving the overall throughput of the combined base device. Furthermore, this modification would enhance the combined base device by enabling a position of the furthest distal point of the distal end of the scope to be detected and utilized when determining and calibrating the relative position of the distal end of the scope in relation to the distal end of the sheath so as to improve the accuracy and reliability of the determined and calibrated relative position. This combination could be completed according to well-known techniques in the art and would likely yield predictable results, in that the combined base device would determine a transition position representing a threshold position at which the distal end of the sheath is no longer detected based on the sensor data so as to allow for it to determine and calibrate the position of the distal end of the scope relative to the distal end of the sheath as soon as it possibly can and to enable the combined base device to detect and utilize a position of the furthest distal point of the distal end of the scope when determining and calibrating the position of the distal end of the scope relative to the distal end of the sheath. Therefore, it would have been obvious to combine Gordon et al. with Ludwin et al. and Peterson et al. to obtain the invention as specified in claim 1.
- With regards to claim 2, Gordon et al. in view of Ludwin et al. in view of Peterson et al. disclose the robotic system of claim 1, wherein the computer-executable instructions further cause the at least one processor (Gordon et al., Pg. 1 ¶ 0007, Pg. 2 ¶ 0025, Pg. 13 ¶ 0103 - 0106, Pg. 15 ¶ 0116 - 0119) to: execute a movement of the scope on the coaxial axis relative to the sheath, (Gordon et al., Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0024 - 0025 and 0027 - 0029, Pg. 5 ¶ 0046 - 0047, Pg. 5 ¶ 0049 - Pg. 6 ¶ 0051, Pg. 6 ¶ 0053, Pg. 8 ¶ 0068, Pg. 10 ¶ 0080 - 0082, Pg. 11 ¶ 0085, Pg. 12 ¶ 0094 - 0096) wherein the detection is determined during the movement. (Gordon et al., Pg. 2 ¶ 0029, Pg. 3 ¶ 0033 - 0036, Pg. 4 ¶ 0041 - 0042, Pg. 5 ¶ 0046 - 0047, Pg. 5 ¶ 0049 - Pg. 6 ¶ 0051, Pg. 6 ¶ 0053, Pg. 7 ¶ 0058 - 0060, Pg. 8 ¶ 0067 - 0069, Pg. 9 ¶ 0071, Pg. 10 ¶ 0079 - 0082, Pg. 11 ¶ 0085 - 0086, Pg. 12 ¶ 0094 - 0096, Pg. 13 ¶ 0106, Pg. 14 ¶ 0109 [“As the imaging probe 630 is extended from the catheter 610 and/or from the sheath 620, the user and/or the control system may analyze the markers at the proximal end of the imaging probe 630 to determine the insertion distance of the imaging probe 630.”]) In addition, analogous art Ludwin et al. disclose wherein the computer-executable instructions further cause the at least one processor (Ludwin et al., Fig. 1, Pg. 2 ¶ 0036) to: execute a movement of the scope on the coaxial axis relative to the sheath, (Ludwin et al., Fig. 5, Pg. 1 ¶ 0027, Pg. 2 ¶ 0030 and 0032 - 0034, Pg. 3 ¶ 0042 - 0047, Pg. 4 ¶ 0050 - 0052, Pg. 4 ¶ 0059 - Pg. 5 ¶ 0064) wherein the detection is determined during the movement. (Ludwin et al., Fig. 5, Pg. 1 ¶ 0027, Pg. 2 ¶ 0030 and 0032 - 0034, Pg. 3 ¶ 0042 - 0047, Pg. 4 ¶ 0050 - 0052, Pg. 4 ¶ 0059 - Pg. 5 ¶ 0064)
- With regards to claim 3, Gordon et al. in view of Ludwin et al. in view of Peterson et al. disclose the robotic system of claim 2, wherein the detection is determined during a retraction of the scope on the coaxial axis relative to the sheath. (Gordon et al., Pg. 2 ¶ 0024 - 0026 and 0028 - 0029, Pg. 3 ¶ 0033 - 0036, Pg. 5 ¶ 0046 - 0047, Pg. 5 ¶ 0049 - Pg. 6 ¶ 0051, Pg. 6 ¶ 0053, Pg. 8 ¶ 0067 - 0069, Pg. 10 ¶ 0079 - 0082, Pg. 11 ¶ 0085 - 0086, Pg. 13 ¶ 0103 and 0105 - 0106, Pg. 14 ¶ 0109 [“the imaging probe 340 may be removed (e.g., retracted) from the imaging probe sheath 342” and “As the imaging probe 630 is extended from the catheter 610 and/or from the sheath 620, the user and/or the control system may analyze the markers at the proximal end of the imaging probe 630 to determine the insertion distance of the imaging probe 630.” Gordon et al. disclose that the insertion distance, relative position of the distal end of the scope in relation to the distal end of the sheath, is tracked in real time, thus Gordon et al. detect the distal end of the sheath during a retraction.]) In addition, analogous art Ludwin et al. disclose wherein the detection is determined during a retraction of the scope on the coaxial axis relative to the sheath. (Ludwin et al., Fig. 5, Pg. 1 ¶ 0027 - Pg. 2 ¶ 0030, Pg. 2 ¶ 0033 - 0035, Pg. 3 ¶ 0042 - 0047, Pg. 4 ¶ 0057 - Pg. 5 ¶ 0065)
- With regards to claim 4, Gordon et al. in view of Ludwin et al. in view of Peterson et al. disclose the robotic system of claim 1, wherein the calibration comprises executing an extension of the scope on the coaxial axis after the detection to position the distal end of the scope at a standard protrusion in relation to the distal end of the sheath. (Gordon et al., Pg. 5 ¶ 0047, Pg. 5 ¶ 0049 - Pg. 6 ¶ 0051, Pg. 6 ¶ 0053, Pg. 7 ¶ 0057 - 0059, Pg. 8 ¶ 0067, Pg. 12 ¶ 0094 - 0096) In addition, analogous art Ludwin et al. disclose wherein the calibration comprises executing an extension of the scope on the coaxial axis after the detection to position the distal end of the scope at a standard protrusion in relation to the distal end of the sheath. (Ludwin et al., Fig. 5, Pg. 5 ¶ 0064 - 0066)
- With regards to claim 12, Gordon et al. in view of Ludwin et al. in view of Peterson et al. disclose the robotic system of claim 1, wherein the computer-executable instructions further cause the at least one processor (Gordon et al., Pg. 1 ¶ 0007, Pg. 2 ¶ 0025, Pg. 13 ¶ 0103 - 0106, Pg. 15 ¶ 0116 - 0119) to: maintain an alignment between the scope and the sheath on a coaxial axis based on the relative position. (Gordon et al., Abstract, Pg. 1 ¶ 0005 - 0006, Pg. 3 ¶ 0032 - 0035, Pg. 4 ¶ 0041 - 0043, Pg. 5 ¶ 0046 - 0047 and 0049 - 0050, Pg. 6 ¶ 0053, Pg. 7 ¶ 0059 - 0061, Pg. 8 ¶ 0066 - 0069, Pg. 11 ¶ 0085, Pg. 12 ¶ 0092 - 0096) In addition, analogous art Ludwin et al. disclose wherein the computer-executable instructions further cause the at least one processor (Ludwin et al., Fig. 1, Pg. 2 ¶ 0036) to: maintain an alignment between the scope and the sheath on a coaxial axis based on the relative position. (Ludwin et al., Fig. 5, Pg. 5 ¶ 0064 - 0066)
Claims 6 - 11 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. U.S. Publication No. 2024/0153113 A1 in view of Ludwin et al. U.S. Publication No. 2013/0303886 A1 in view of Peterson et al. U.S. Publication No. 2020/0330070 A1 as applied to claim 1 above, and further in view of Matey et al. U.S. Patent No. 5,649,021.
- With regards to claim 6, Gordon et al. in view of Ludwin et al. in view of Peterson et al. disclose the robotic system of claim 1, wherein the detection comprises: processing one or more images from the sensor that is a camera based on a color of the sheath; (Gordon et al., Pg. 4 ¶ 0041 - 0042, Pg. 6 ¶ 0053 - 0055, Pg. 7 ¶ 0059 and 0063, Pg. 8 ¶ 0067 - 0069, Pg. 9 ¶ 0072, Pg. 10 ¶ 0083 [“sheath 620 may include one or more identification features 615. An appearance of the identification feature(s) 615 may be detected by the imaging device 635. For example, a shape of the identification feature(s) 615, a location of the identification feature(s) 615, and/or any other component regarding how the identification feature(s) looks may be identified in the imaging data captured by the imaging device 635” and “a greater contrast may be shown between the identification feature and the sheath 620 and/or a difference in color between the identification feature and the sheath 620 may be more defined”]) and determining that a processed portion of the one or more images satisfies a threshold condition. (Gordon et al., Abstract, Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0029, Pg. 4 ¶ 0041 - 0042, Pg. 6 ¶ 0053 - 0055, Pg. 7 ¶ 0059 and 0063, Pg. 8 ¶ 0067 - 0069, Pg. 9 ¶ 0072, Pg. 10 ¶ 0083, Pg. 12 ¶ 0092 - 0093) Gordon et al. fail to disclose explicitly filtering one or more images based on a color; and determining that a filtered portion satisfies a threshold condition. Pertaining to analogous art, Matey et al. disclose wherein the detection comprises: filtering one or more images from the sensor that is a camera based on a color of the sheath; (Matey et al., Abstract, Figs. 1 - 5, Col. 2 Lines 1 - 29, Col. 2 Line 61 - Col. 3 Line 14, Col. 3 Line 60 - Col. 4 Line 54, Col. 5 Line 63 - Col. 6 Line 29, Col. 7 Lines 26 - 51, Col. 7 Line 66 - Col. 8 Line 11, Col. 14 Lines 37 - 53) and determining that a filtered portion of the one or more images satisfies a threshold condition. (Matey et al., Abstract, Col. 3 Lines 20 - 40, Col. 3 Line 60 - Col. 4 Line 54, Col. 5 Lines 22 - 26, Col. 5 Line 60 - Col. 6 Line 29, Col. 6 Lines 60 - 67, Col. 7 Line 66 - Col. 8 Line 46, Col. 8 Line 59 - Col. 9 Line 20, Col. 14 Lines 32 - 53) Gordon et al. in view of Ludwin et al. in view of Peterson et al. and Matey et al. are combinable because they are all directed towards medical probe control methods and systems and, similar to Gordon et al. and Peterson et al., Matey et al. is also directed towards detecting a sheath being used to guide a probe based on image data captured by the probe. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined teachings of Gordon et al. in view of Ludwin et al. in view of Peterson et al. with the teachings of Matey et al. This modification would have been prompted in order to substitute the sheath detection technique of Gordon et al. for the color-based sheath detection method of Matey et al. The color-based sheath detection method could be substituted in place of the sheath detection technique of Gordon et al. using well-known techniques in the art and would likely yield predictable results, in that, in the combination, the color-based sheath detection method of Matey et al. would be utilized to detect the sheath in the image data. Furthermore, this modification would have been prompted by the teachings and suggestions of Gordon et al. that the sheath may include one or more identification features with detectable appearances, such as a shape or color, see at least page 6 paragraphs 0053 and 0055, page 7 paragraphs 0059 and 0063, page 8 paragraph 0066, page 9 paragraphs 0072 and 0075 and page 10 paragraphs 0079 - 0083 of Gordon et al. This combination could be completed according to well-known techniques in the art and would likely yield predictable results, in that the combined base device would utilize the color-based sheath detection method of Matey et al. to detect the sheath in captured image data. Therefore, it would have been obvious to combine Gordon et al. in view of Ludwin et al. in view of Peterson et al. with Matey et al. to obtain the invention as specified in claim 6.
- With regards to claim 7, Gordon et al. in view of Ludwin et al. in view of Peterson et al. in view of Matey et al. disclose the robotic system of claim 6, wherein determining that the filtered portion of the one or more images satisfies the threshold condition comprises analyzing a single image. (Gordon et al., Abstract, Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0029, Pg. 3 ¶ 0032 - 0036, Pg. 4 ¶ 0042, Pg. 5 ¶ 0049 - 0050, Pg. 6 ¶ 0053 - 0055, Pg. 7 ¶ 0057 - 0060 and 0063, Pg. 8 ¶ 0066 - 0069, Pg. 9 ¶ 0072 and 005, Pg. 10 ¶ 0079 - 0084, Pg. 11 ¶ 0086, Pg. 12 ¶ 0092 - 0093, Pg. 13 ¶ 0103 and 0106, Pg. 14 ¶ 0109) In addition, analogous art Matey et al. disclose wherein determining that the filtered portion of the one or more images satisfies the threshold condition comprises analyzing a single image. (Matey et al., Abstract, Col. 3 Lines 20 - 40, Col. 3 Line 60 - Col. 4 Line 54, Col. 5 Lines 22 - 26, Col. 5 Line 60 - Col. 6 Line 29, Col. 6 Lines 60 - 67, Col. 7 Line 66 - Col. 8 Line 46, Col. 8 Line 59 - Col. 9 Line 20, Col. 14 Lines 32 - 53)
- With regards to claim 8, Gordon et al. in view of Ludwin et al. in view of Peterson et al. in view of Matey et al. disclose the robotic system of claim 6, wherein determining that the filtered portion of the one or more images satisfies the threshold condition comprises analyzing multiple images. (Gordon et al., Abstract, Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0029, Pg. 3 ¶ 0032 - 0036, Pg. 4 ¶ 0042, Pg. 5 ¶ 0049 - 0050, Pg. 6 ¶ 0053 - 0055, Pg. 7 ¶ 0057 - 0060 and 0063, Pg. 8 ¶ 0066 - 0069, Pg. 9 ¶ 0072 and 005, Pg. 10 ¶ 0079 - 0084, Pg. 11 ¶ 0086, Pg. 12 ¶ 0092 - 0093, Pg. 13 ¶ 0103 and 0106, Pg. 14 ¶ 0109 [“the shape of the elongate device may be determined using other techniques. For example, a history of the distal end pose of flexible body 1016 can be used to reconstruct the shape of flexible body 1016 over the interval of time.”]) In addition, analogous art Matey et al. disclose wherein determining that the filtered portion of the one or more images satisfies the threshold condition comprises analyzing multiple images. (Matey et al., Col. 8 Line 50 - Col. 9 Line 20)
- With regards to claim 9, Gordon et al. in view of Ludwin et al. in view of Peterson et al. in view of Matey et al. disclose the robotic system of claim 6. Gordon et al. fail to disclose explicitly wherein determining that the filtered portion of the one or more images satisfies the threshold condition comprises comparing a pixel count of the filtered portion remaining after the filtering to a threshold pixel count. Pertaining to analogous art, Matey et al. disclose wherein determining that the filtered portion of the one or more images satisfies the threshold condition comprises comparing a pixel count of the filtered portion remaining after the filtering to a threshold pixel count. (Matey et al., Col. 3 Lines 20 - 40, Col. 4 Lines 35 - 54, Col. 5 Lines 22 - 26, Col. 5 Line 53 - Col. 6 Line 29, Col. 6 Lines 60 - 67, Col. 7 Lines 26 - 51, Col. 14 Lines 37 - 53)
- With regards to claim 10, Gordon et al. in view of Ludwin et al. in view of Peterson et al. in view of Matey et al. disclose the robotic system of claim 6. Gordon et al. fail to disclose explicitly wherein determining that the filtered portion of the one or more images satisfies the threshold condition comprises: detecting a geometrical shape in the filtered portion. Pertaining to analogous art, Matey et al. disclose wherein determining that the filtered portion of the one or more images satisfies the threshold condition comprises: detecting a geometrical shape in the filtered portion. (Matey et al., Col. 8 Line 27 - Col. 9 Line 20, Col. 14 Lines 32 - 53)
- With regards to claim 11, Gordon et al. in view of Ludwin et al. in view of Peterson et al. in view of Matey et al. disclose the robotic system of claim 10. Gordon et al. fail to disclose explicitly wherein determining that the filtered portion of the one or more images satisfies the threshold condition further comprises: determining a center position of the geometrical shape that is circular; and determining that the center position is within a range of variance. Pertaining to analogous art, Matey et al. disclose wherein determining that the filtered portion of the one or more images satisfies the threshold condition further comprises: determining a center position of the geometrical shape that is circular; (Matey et al., Col. 7 Line 66 - Col. 8 Line 46) and determining that the center position is within a range of variance. (Matey et al., Col. 7 Line 66 - Col. 8 Line 46 [“Another method for identifying the marker 22 is to compute first and second order area moments of the portion of the image comprising the marker 22. The first order moment defines the area and centroid of the marker 22. The second order moment (the area moment of inertia) defines the variance of the contour of marker 22 with respect to each axis. When an object is viewed during the video assisted procedure, the first and second moments of the object may be computed and compared to the known first and second order moments for the marker”])
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. U.S. Publication No. 2024/0153113 A1 in view of Ludwin et al. U.S. Publication No. 2013/0303886 A1 in view of Romo et al. U.S. Publication No. 2023/0075251 A1.
- With regards to claim 13, Gordon et al. disclose a system for an endoscope, (Gordon et al., Figs. 1 - 3, 11 & 12, Pg. 2 ¶ 0024 - 0027, Pg. 3 ¶ 0031 - 0032 and 0036, Pg. 13 ¶ 0099 - 0106, Pg. 14 ¶ 0110) the system comprising: a scope; (Gordon et al., Abstract, Figs. 2 - 10B & 12, Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0025 and 0027 - 0029, Pg. 3 ¶ 0033 - 0034, Pg. 4 ¶ 0040 - 0043, Pg. 5 ¶ 0046 - 0050, Pg. 6 ¶ 0053, Pg. 7 ¶ 0058 - 0059, Pg. 8 ¶ 0066 - 0068, Pg. 11 ¶ 0089 - 0091) a camera proximate a distal end of the scope; (Gordon et al., Abstract, Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0025, Pg. 2 ¶ 0028 - Pg. 3 ¶ 0031, Pg. 3 ¶ 0034 - 0035, Pg. 5 ¶ 0046 - Pg. 6 ¶ 0053) a sheath surrounding and coaxially aligned with the scope; (Gordon et al., Abstract, Figs. 2 - 10B & 12, Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0025 and 0027 - 0029, Pg. 3 ¶ 0033 - 0034, Pg. 4 ¶ 0040 - 0043, Pg. 5 ¶ 0046 - 0050, Pg. 6 ¶ 0053, Pg. 7 ¶ 0058 - 0059, Pg. 8 ¶ 0066 - 0068, Pg. 11 ¶ 0089 - 0091) and at least one computer-readable memory in communication with at least one processor, (Gordon et al., Pg. 1 ¶ 0007, Pg. 2 ¶ 0025, Pg. 13 ¶ 0103 - 0106, Pg. 15 ¶ 0116 - 0119) the at least one computer readable memory having stored thereon computer-executable instructions that when executed cause the at least one processor (Gordon et al., Pg. 1 ¶ 0007, Pg. 2 ¶ 0025, Pg. 13 ¶ 0103 - 0106, Pg. 15 ¶ 0116 - 0119) to: determine a transition position representing a position of a distal end of the scope relative to a distal end of the sheath (Gordon et al., Pg. 2 ¶ 0029, Pg. 3 ¶ 0033 - 0034, Pg. 4 ¶ 0041 - 0042, Pg. 6 ¶ 0051 - 0055, Pg. 7 ¶ 0058 - 0059 and 0063, Pg. 8 ¶ 0066 - 0068, Pg. 10 ¶ 0079 - 0080) where the sheath becomes detectable in a first image captured by the camera; (Gordon et al., Pg. 2 ¶ 0029, Pg. 3 ¶ 0033 - 0034, Pg. 4 ¶ 0041 - 0042, Pg. 6 ¶ 0051 - 0055, Pg. 7 ¶ 0058 - 0059 and 0063, Pg. 8 ¶ 0066 - 0068, Pg. 10 ¶ 0079 - 0080) and cause a coaxial movement of the scope relative to the sheath. (Gordon et al., Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0024 - 0025 and 0027 - 0029, Pg. 3 ¶ 0032, Pg. 5 ¶ 0046 - 0047, Pg. 5 ¶ 0049 - Pg. 6 ¶ 0051, Pg. 6 ¶ 0053, Pg. 8 ¶ 0068, Pg. 10 ¶ 0080 - 0082, Pg. 11 ¶ 0085, Pg. 12 ¶ 0094 - 0096, Pg. 13 ¶ 0101) Gordon et al. fail to disclose expressly calibrating an endoscope, and causing an automated coaxial movement of the scope relative to the sheath based at least in part on the transition position and an offset. Pertaining to analogous art, Ludwin et al. disclose a system for calibrating an endoscope, (Ludwin et al., Abstract, Figs. 1 - 5, Pg. 1 ¶ 0027 - Pg. 2 ¶ 0031, Pg. 2 ¶ 0036, Pg. 4 ¶ 0057 - Pg. 5 ¶ 0067) the system comprising: a scope; (Ludwin et al., Abstract, Figs. 2 - 5, Pg. 1 ¶ 0005 - 0007, 0014 and 0027, Pg. 2 ¶ 0030 - 0034, Pg. 4 ¶ 0049 - 0059, Pg. 5 ¶ 0063 - 0067) a sheath surrounding and coaxially aligned with the scope; (Ludwin et al., Figs. 2 - 4, Pg. 2 ¶ 0037 - 0039, Pg. 3 ¶ 0041 - 0046, Pg. 4 ¶ 0052 - 0054) and at least one computer-readable memory in communication with at least one processor, (Ludwin et al., Fig. 1, Pg. 2 ¶ 0036) the at least one computer readable memory having stored thereon computer-executable instructions that when executed cause the at least one processor (Ludwin et al., Fig. 1, Pg. 2 ¶ 0036) to: determine a transition position representing a position of a distal end of the scope relative to a distal end of the sheath; (Ludwin et al., Figs. 4 & 5, Pg. 1 ¶ 0027 - Pg. 2 ¶ 0030, Pg. 4 ¶ 0050 - 0052, Pg. 4 ¶ 0056 - Pg. 5 ¶ 0066) and cause a coaxial movement of the scope relative to the sheath based at least in part on the transition position and an offset. (Ludwin et al., Figs. 4 & 5, Pg. 1 ¶ 0027, Pg. 2 ¶ 0030 and 0032 - 0034, Pg. 3 ¶ 0042 - 0047, Pg. 4 ¶ 0050 - 0052, Pg. 4 ¶ 0056 - Pg. 5 ¶ 0066) Ludwin et al. fail to disclose explicitly causing an automated coaxial movement. Pertaining to analogous art, Romo et al. disclose causing an automated coaxial movement of the scope relative to the sheath. (Romo et al., Figs. 1 - 3, Pg. 1 ¶ 0007 - 0008, Pg. 3 ¶ 0035, Pg. 4 ¶ 0040 and 0043 - 0045, Pg. 5 ¶ 0049, Pg. 6 ¶ 0058 and 0065, Pg. 7 ¶ 0068 - 0071, Pg. 9 ¶ 0086 - 0087) Gordon et al. and Ludwin et al. are combinable because they are both directed towards medical probe control methods and systems that determine the location of a distal end of a probe in relation to a distal end of a sheath being used to guide the probe. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Gordon et al. with the teachings of Ludwin et al. This modification would have been prompted in order to enhance the base device of Gordon et al. with the well-known and applicable technique Ludwin et al. applied to a similar device. Causing a coaxial movement of the scope relative to the sheath based at least in part on the transition position and an offset to calibrate the endoscope, as taught by Ludwin et al., would enhance the base device of Gordon et al. by allowing for end users to utilize the determined transition position to quickly and easily achieve and maintain a desired protrusion of the distal end of the scope in relation to the distal end of the sheath and thereby provide assurance to end users that the scope is appropriately positioned during medical procedures. Furthermore, this modification would have been prompted by the teachings and suggestions of Gordon et al. that the control system may determine registrations between the catheter and captured images while a user is manipulating the catheter, that a user may insert the imaging probe by a known insertion distance and/or that the control system may provide instructions to a user to insert the imaging probe by a specified insertion distance, see at least page 11 paragraph 0085 and page 12 paragraphs 0094 - 0097 of Gordon et al. This combination could be completed according to well-known techniques in the art and would likely yield predictable results, in that the base device of Gordon et al. would cause a coaxial movement of the scope relative to the sheath based at least in part on the transition position and an offset to calibrate the endoscope so as to allow for end user to quickly and easily achieve and maintain a desired protrusion of the distal end of the scope in relation to the distal end of the sheath during medical procedures using the endoscope. In addition, Gordon et al. in view of Ludwin et al. and Romo et al. are combinable because they are all directed towards medical probe control methods and systems and, similar to Gordon et al., Romo et al. is also directed towards detecting a sheath being used to guide a probe based on image data captured by the probe. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined teachings of Gordon et al. in view of Ludwin et al. with the teachings of Romo et al. This modification would have been prompted in order to enhance the combined base device of Gordon et al. in view of Ludwin et al. with the well-known and applicable technique Romo et al. applied to a similar device. Causing an automated coaxial movement of the scope relative to the sheath, as taught by Romo et al., would enhance the combined base device by allowing for the insertion distance of the probe to be set and/or adjusted automatically via processor-based control thereby providing end-users with more precise control over the insertion distance of the probe compared to what is achievable manually. Furthermore, this modification would have been prompted by the teachings and suggestions of Gordon et al. that a medical instrument may be manipulated by a robotic-assisted manipulator controlled by a control system, that one or both of the catheter and the imaging probe may be navigated automatically by the control system and that the proximal end of the imaging probe may include a transmission mechanism that allows for finer adjustment of the insertion distance of the imaging probe, see at least page 2 paragraphs 0024 - 0025, page 3 paragraph 0032, page 12 paragraphs 0094 - 0096 and page 13 paragraphs 0100 - 0101 of Gordon et al. Also, see MPEP § 2144.04(III). This combination could be completed according to well-known techniques in the art and would likely yield predictable results, in that the coaxial movement of the scope relative to the sheath would be automated so as to allow for the insertion distance of the probe of the combined base device to be set and/or adjusted automatically via processor-based control and thereby provide end-users with more precise control over the insertion distance of the probe compared to what is achievable through manual coaxial movement of the scope relative to the sheath. Therefore, it would have been obvious to combine Gordon et al. with Ludwin et al. to obtain the invention as specified in claim 13.
- With regards to claim 14, Gordon et al. in view of Ludwin et al. in view of Romo et al. disclose the system of claim 13, wherein the first image and a second image are captured during a change in the position of the distal end of the scope relative to the distal end of the sheath. (Gordon et al., Pg. 2 ¶ 0029, Pg. 3 ¶ 0033 - 0036, Pg. 4 ¶ 0041 - 0042, Pg. 5 ¶ 0046 - 0047, Pg. 5 ¶ 0049 - Pg. 6 ¶ 0051, Pg. 6 ¶ 0053, Pg. 7 ¶ 0058 - 0060, Pg. 8 ¶ 0067 - 0069, Pg. 9 ¶ 0071, Pg. 10 ¶ 0079 - 0082, Pg. 11 ¶ 0085 - 0086, Pg. 12 ¶ 0094 - 0096, Pg. 13 ¶ 0106, Pg. 14 ¶ 0109 [“As the imaging probe 630 is extended from the catheter 610 and/or from the sheath 620, the user and/or the control system may analyze the markers at the proximal end of the imaging probe 630 to determine the insertion distance of the imaging probe 630.”])
Claims 15 - 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. U.S. Publication No. 2024/0153113 A1 in view of Ludwin et al. U.S. Publication No. 2013/0303886 A1 in view of Romo et al. U.S. Publication No. 2023/0075251 A1 as applied to claim 13 above, and further in view of Matey et al. U.S. Patent No. 5,649,021.
- With regards to claim 15, Gordon et al. in view of Ludwin et al. in view of Romo et al. disclose the system of claim 13, wherein the determining the transition position comprises: processing the first image based on a color of the sheath; (Gordon et al., Pg. 4 ¶ 0041 - 0042, Pg. 6 ¶ 0053 - 0055, Pg. 7 ¶ 0059 and 0063, Pg. 8 ¶ 0067 - 0069, Pg. 9 ¶ 0072, Pg. 10 ¶ 0083 [“sheath 620 may include one or more identification features 615. An appearance of the identification feature(s) 615 may be detected by the imaging device 635. For example, a shape of the identification feature(s) 615, a location of the identification feature(s) 615, and/or any other component regarding how the identification feature(s) looks may be identified in the imaging data captured by the imaging device 635” and “a greater contrast may be shown between the identification feature and the sheath 620 and/or a difference in color between the identification feature and the sheath 620 may be more defined”]) determining that a processed portion of the first image satisfies a threshold condition; (Gordon et al., Abstract, Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0029, Pg. 4 ¶ 0041 - 0042, Pg. 6 ¶ 0053 - 0055, Pg. 7 ¶ 0059 and 0063, Pg. 8 ¶ 0067 - 0069, Pg. 9 ¶ 0072, Pg. 10 ¶ 0083, Pg. 12 ¶ 0092 - 0093) and in response to the determination that the processed portion satisfies the threshold condition, determining that a sheath is detected. (Gordon et al., Abstract, Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0029, Pg. 4 ¶ 0041 - 0042, Pg. 6 ¶ 0053 - 0055, Pg. 7 ¶ 0059 and 0063, Pg. 8 ¶ 0067 - 0069, Pg. 9 ¶ 0072, Pg. 10 ¶ 0083, Pg. 12 ¶ 0092 - 0093) Gordon et al. fail to disclose explicitly filtering the image based on a color; and determining that a filtered portion satisfies a threshold condition. Pertaining to analogous art, Matey et al. disclose wherein the determining the transition position comprises: filtering the first image based on a color of the sheath; (Matey et al., Abstract, Figs. 1 - 5, Col. 2 Lines 1 - 29, Col. 2 Line 61 - Col. 3 Line 14, Col. 3 Line 60 - Col. 4 Line 54, Col. 5 Line 63 - Col. 6 Line 29, Col. 7 Lines 26 - 51, Col. 7 Line 66 - Col. 8 Line 11, Col. 14 Lines 37 - 53) determining that a filtered portion of the first image satisfies a threshold condition; (Matey et al., Abstract, Col. 3 Lines 20 - 40, Col. 3 Line 60 - Col. 4 Line 54, Col. 5 Lines 22 - 26, Col. 5 Line 60 - Col. 6 Line 29, Col. 6 Lines 60 - 67, Col. 7 Line 66 - Col. 8 Line 46, Col. 8 Line 59 - Col. 9 Line 20, Col. 14 Lines 32 - 53) and in response to the determination that the filtered portion satisfies the threshold condition, determining that a sheath is detected. (Matey et al., Abstract, Col. 1 Line 65 - Col. 2 Line 29, Col. 2 Line 61 - Col. 3 Line 14, Col. 4 Lines 14 - 34, Col. 6 Lines 1 - 29 and 60 - 67) Gordon et al. in view of Ludwin et al. in view of Romo et al. and Matey et al. are combinable because they are all directed towards medical probe control methods and systems and, similar to Gordon et al. and Romo et al., Matey et al. is also directed towards detecting a sheath being used to guide a probe based on image data captured by the probe. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined teachings of Gordon et al. in view of Ludwin et al. in view of Romo et al. with the teachings of Matey et al. This modification would have been prompted in order to substitute the sheath detection technique of Gordon et al. for the color-based sheath detection method of Matey et al. The color-based sheath detection method could be substituted in place of the sheath detection technique of Gordon et al. using well-known techniques in the art and would likely yield predictable results, in that, in the combination, the color-based sheath detection method of Matey et al. would be utilized to detect the sheath in the image data. Furthermore, this modification would have been prompted by the teachings and suggestions of Gordon et al. that the sheath may include one or more identification features with detectable appearances, such as a shape or color, see at least page 6 paragraphs 0053 and 0055, page 7 paragraphs 0059 and 0063, page 8 paragraph 0066, page 9 paragraphs 0072 and 0075 and page 10 paragraphs 0079 - 0083 of Gordon et al. This combination could be completed according to well-known techniques in the art and would likely yield predictable results, in that the combined base device would utilize the color-based sheath detection method of Matey et al. to detect the sheath in captured image data. Therefore, it would have been obvious to combine Gordon et al. in view of Ludwin et al. in view of Romo et al. with Matey et al. to obtain the invention as specified in claim 15.
- With regards to claim 16, Gordon et al. in view of Ludwin et al. in view of Romo et al. in view of Matey et al. disclose the system of claim 15. Gordon et al. fail to disclose explicitly wherein the determining the transition position comprises: generating a binary image based on the filtered portion. Pertaining to analogous art, Matey et al. disclose wherein the determining the transition position comprises: generating a binary image based on the filtered portion. (Matey et al., Col. 7 Lines 26 - 56, Col. 14 Lines 15 - 53)
- With regards to claim 17, Gordon et al. in view of Ludwin et al. in view of Romo et al. in view of Matey et al. disclose the system of claim 15. Gordon et al. fail to disclose explicitly wherein the determining that the filtered portion of the first image satisfies the threshold condition comprises: masking the filtered portion with an inverse shape mask. Pertaining to analogous art, Matey et al. disclose wherein the determining that the filtered portion of the first image satisfies the threshold condition comprises: masking the filtered portion with an inverse shape mask. (Matey et al., Col. 3 Lines 15 - 40, Col. 7 Line 26 - Col. 8 Line 11, Col. 14 Lines 23 - 53 [“A mask is generated from the H plane which isolates the hue(s) of interest. The mask is applied to the L plane, blanking out all regions which do not correspond to the hue(s) of interest.”])
- With regards to claim 18, Gordon et al. in view of Ludwin et al. in view of Romo et al. in view of Matey et al. disclose the system of claim 17. Gordon et al. fail to disclose explicitly wherein the determining that the filtered portion of the first image satisfies the threshold condition comprises: applying the inverse shape mask to the filtered portion to generate a masked image; and counting pixels in each quadrant of the masked image. Pertaining to analogous art, Matey et al. disclose wherein the determining that the filtered portion of the first image satisfies the threshold condition comprises: applying the inverse shape mask to the filtered portion to generate a masked image; (Matey et al., Col. 3 Lines 15 - 40, Col. 7 Line 26 - Col. 8 Line 11, Col. 14 Lines 23 - 53 [“A mask is generated from the H plane which isolates the hue(s) of interest. The mask is applied to the L plane, blanking out all regions which do not correspond to the hue(s) of interest. A threshold operator is applied to the L plane, so that only pixels which have the correct hue and a brightness above the threshold remain. An erosion operator is then applied to the L plane, essentially eliminating one pixel from each set of contiguous pixels having the correct hue and brightness. This eliminates all single pixels from the solution set. Only objects larger than one pixel remain. Similarly, if the object is large, then objects smaller than a threshold number of pixels (N) in size may be deleted from the solution set by repeating the erosion step N times. The remaining pixels are identified as the marker 22”]) and counting pixels in each quadrant of the masked image. (Matey et al., Col. 3 Lines 15 - 40, Col. 4 Lines 50 - 54, Col. 5 Line 63 - Col. 6 Line 29, Col. 6 Lines 60 - 67, Col. 7 Line 26 - Col. 8 Line 11, Col. 14 Lines 23 - 53 [“A mask is generated from the H plane which isolates the hue(s) of interest. The mask is applied to the L plane, blanking out all regions which do not correspond to the hue(s) of interest. A threshold operator is applied to the L plane, so that only pixels which have the correct hue and a brightness above the threshold remain… Similarly, if the object is large, then objects smaller than a threshold number of pixels (N) in size may be deleted from the solution set by repeating the erosion step N times. The remaining pixels are identified as the marker 22.” Matey et al. delete sets of contiguous pixels that are smaller than a threshold number of pixels in the masked image and detect sets of contiguous pixels that are larger than the threshold number of pixels in the masked image as being the marker, thus Matey et al. disclose counting pixels in the entirety, i.e., in each quadrant, of the masked image.])
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. U.S. Publication No. 2024/0153113 A1 in view of Ludwin et al. U.S. Publication No. 2013/0303886 A1 in view of Romo et al. U.S. Publication No. 2023/0075251 A1 in view of Matey et al. U.S. Patent No. 5,649,021 as applied to claim 15 above, and further in view of Li et al. U.S. Publication No. 2024/0346670 A1.
- With regards to claim 19, Gordon et al. in view of Ludwin et al. in view of Romo et al. in view of Matey et al. disclose the system of claim 15. Gordon et al. fail to disclose explicitly wherein the determining that the filtered portion of the first image satisfies the threshold condition comprises: masking the filtered portion with a segmentation mask generated using a trained neural network. Pertaining to analogous art, Li et al. disclose wherein the determining that the filtered portion of the first image satisfies the threshold condition comprises: masking the filtered portion with a segmentation mask generated using a trained neural network. (Li et al., Abstract, Pg. 3 ¶ 0028 - 0030, Pg. 4 ¶ 0035 - 0039, Pg. 5 ¶ 0048 and 0050, Pg. 6 ¶ 0055, Pg. 6 ¶ 0062 - Pg. 7 ¶ 0064) Gordon et al. in view of Ludwin et al. in view of Romo et al. in view of Matey et al. and Li et al. are combinable because they are all directed towards medical probe control methods and systems and, similar to Gordon et al., Romo et al. and Matey et al., Li et al. is also directed towards detecting a sheath/catheter being used to guide a probe based on image data. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined teachings of Gordon et al. in view of Ludwin et al. in view of Romo et al. in view of Matey et al. with the teachings of Li et al. This modification would have been prompted in order to substitute the mask and/or template of Matey et al. for the segmentation mask generated using a trained neural network of Li et al. The segmentation mask generated using a trained neural network of Li et al. could be substituted in place of the mask and/or template of Matey et al. using well-known techniques in the art and would likely yield predictable results, in that, in the combination, the segmentation mask of Li et al. would be utilized to identify the sheath/catheter in the image data. Furthermore, this modification would have been prompted by the teachings and suggestions of Matey et al. that a variety of different methods may be utilized to identify the sheath in the image data, see at least column 7 line 66 - column 9 line 20 and column 14 lines 15 - 53 of Matey et al. This combination could be completed according to well-known techniques in the art and would likely yield predictable results, in that the combined base device would utilize a segmentation mask generated using a trained neural network to identify the sheath/catheter in the image data. Therefore, it would have been obvious to combine Gordon et al. in view of Ludwin et al. in view of Romo et al. in view of Matey et al. with Li et al. to obtain the invention as specified in claim 19.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. U.S. Publication No. 2024/0153113 A1 in view of Ludwin et al. U.S. Publication No. 2013/0303886 A1 in view of Matey et al. U.S. Patent No. 5,649,021.
- With regards to claim 20, Gordon et al. disclose a method for determining a protrusion of a scope relative to a sheath (Gordon et al., Pg. 2 ¶ 0029, Pg. 3 ¶ 0033 - 0034, Pg. 4 ¶ 0041 - 0042, Pg. 6 ¶ 0051 - 0055, Pg. 7 ¶ 0058 - 0059 and 0063, Pg. 8 ¶ 0066 - 0068, Pg. 10 ¶ 0079 - 0080) that surrounds and is coaxially aligned with the scope, (Gordon et al., Figs. 3 & 5A - 9F, Pg. 2 ¶ 0028 - 0029, Pg. 5 ¶ 0047, Pg. 5 ¶ 0050 - Pg. 6 ¶ 0053, Pg. 8 ¶ 0066 - 0068, Pg. 11 ¶ 0089 - 0091) the method comprising: capturing one or more images with a camera proximate a distal end of the scope; (Gordon et al., Abstract, Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0025, Pg. 2 ¶ 0028 - Pg. 3 ¶ 0031, Pg. 3 ¶ 0034 - 0035, Pg. 5 ¶ 0046 - Pg. 6 ¶ 0053) processing the one or more images based on a visual property of the sheath to generate a processed portion; (Gordon et al., Pg. 4 ¶ 0041 - 0042, Pg. 6 ¶ 0053 - 0055, Pg. 7 ¶ 0059 and 0063, Pg. 8 ¶ 0067 - 0069, Pg. 9 ¶ 0072, Pg. 10 ¶ 0083 [“sheath 620 may include one or more identification features 615. An appearance of the identification feature(s) 615 may be detected by the imaging device 635. For example, a shape of the identification feature(s) 615, a location of the identification feature(s) 615, and/or any other component regarding how the identification feature(s) looks may be identified in the imaging data captured by the imaging device 635” and “a greater contrast may be shown between the identification feature and the sheath 620 and/or a difference in color between the identification feature and the sheath 620 may be more defined”]) determining that the processed portion satisfies a threshold; (Gordon et al., Abstract, Pg. 1 ¶ 0005 - 0006, Pg. 2 ¶ 0029, Pg. 4 ¶ 0041 - 0042, Pg. 6 ¶ 0053 - 0055, Pg. 7 ¶ 0059 and 0063, Pg. 8 ¶ 0067 - 0069, Pg. 9 ¶ 0072, Pg. 10 ¶ 0083, Pg. 12 ¶ 0092 - 0093) determining a transition position of the scope relative to the sheath based at least in part on the determination that the processed portion satisfies the threshold; (Gordon et al., Pg. 2 ¶ 0029, Pg. 3 ¶ 0033 - 0034, Pg. 4 ¶ 0041 - 0043, Pg. 5 ¶ 0050 - Pg. 6 ¶ 0055, Pg. 7 ¶ 0058 - 0059 and 0063, Pg. 8 ¶ 0066 - 0068, Pg. 10 ¶ 0079 - 0084) and determining a target protrusion. (Gordon et al., Pg. 11 ¶ 0085 - 0086, Pg. 12 ¶ 0092 - 0096, Pg. 13 ¶ 0099, 0103 and 0106) Gordon et al. fail to disclose explicitly calibrating a protrusion of a scope relative to a sheath; filtering the one or more images based on a visual property to generate a filtered portion; determining that the filtered portion satisfies a threshold; determining a position based at least in part on the determination that the filtered portion satisfies the threshold; and determining a target protrusion based at least in part on the transition position. Pertaining to analogous art, Ludwin et al. disclose a method for calibrating a protrusion of a scope (Ludwin et al., Abstract, Figs. 1 - 5, Pg. 1 ¶ 0027 - Pg. 2 ¶ 0031, Pg. 2 ¶ 0036, Pg. 4 ¶ 0056 - Pg. 5 ¶ 0067) relative to a sheath that surrounds and is coaxially aligned with the scope, (Ludwin et al., Figs. 2 - 4, Pg. 2 ¶ 0037 - 0039, Pg. 3 ¶ 0041 - 0046, Pg. 4 ¶ 0052 - 0054) the method comprising: determining a transition position of the scope relative to the sheath; (Ludwin et al., Figs. 4 & 5, Pg. 1 ¶ 0027 - Pg. 2 ¶ 0030, Pg. 4 ¶ 0056 - Pg. 5 ¶ 0066) and determining a target protrusion based at least in part on the transition position. (Ludwin et al., Figs. 4 & 5, Pg. 1 ¶ 0027 - Pg. 2 ¶ 0030, Pg. 4 ¶ 0056 - Pg. 5 ¶ 0066) Ludwin et al. fail to disclose explicitly filtering the one or more images based on a visual property to generate a filtered portion; determining that the filtered portion satisfies a threshold; and determining a position based at least in part on the determination that the filtered portion satisfies the threshold. Pertaining to analogous art, Matey et al. disclose filtering the one or more images based on a visual property of the sheath to generate a filtered portion; (Matey et al., Abstract, Figs. 1 - 5, Col. 2 Lines 1 - 29, Col. 2 Line 61 - Col. 3 Line 14, Col. 3 Line 60 - Col. 4 Line 54, Col. 5 Line 63 - Col. 6 Line 29, Col. 7 Lines 26 - 51, Col. 7 Line 66 - Col. 8 Line 11, Col. 14 Lines 37 - 53) determining that the filtered portion satisfies a threshold; (Matey et al., Abstract, Col. 3 Lines 20 - 40, Col. 3 Line 60 - Col. 4 Line 54, Col. 5 Lines 22 - 26, Col. 5 Line 60 - Col. 6 Line 29, Col. 6 Lines 60 - 67, Col. 7 Line 66 - Col. 8 Line 46, Col. 8 Line 59 - Col. 9 Line 20, Col. 14 Lines 32 - 53) and determining a position based at least in part on the determination that the filtered portion satisfies the threshold. (Matey et al., Abstract, Col. 3 Lines 20 - 40, Col. 3 Line 60 - Col. 4 Line 54, Col. 5 Lines 22 - 26, Col. 5 Line 60 - Col. 6 Line 29, Col. 6 Lines 60 - 67, Col. 7 Line 66 - Col. 8 Line 46, Col. 8 Line 59 - Col. 9 Line 20, Col. 14 Lines 32 - 53, Col. 15 Lines 5 - 13) Gordon et al. and Ludwin et al. are combinable because they are both directed towards medical probe control methods and systems that determine the location of a distal end of a probe in relation to a distal end of a sheath being used to guide the probe. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Gordon et al. with the teachings of Ludwin et al. This modification would have been prompted in order to enhance the base device of Gordon et al. with the well-known and applicable technique Ludwin et al. applied to a similar device. Determining a target protrusion based at least in part on the transition position to calibrate a protrusion of the scope relative to the sheath, as taught by Ludwin et al., would enhance the base device of Gordon et al. by allowing for end users to utilize the determined transition position to quickly and easily achieve and maintain a desired protrusion of the distal end of the scope in relation to the distal end of the sheath and thereby provide assurance to end users that the scope is appropriately positioned during medical procedures. Furthermore, this modification would have been prompted by the teachings and suggestions of Gordon et al. that the control system may determine registrations between the catheter and captured images while a user is manipulating the catheter, that a user may insert the imaging probe by a known insertion distance and/or that the control system may provide instructions to a user to insert the imaging probe by a specified insertion distance, see at least page 11 paragraph 0085 and page 12 paragraphs 0094 - 0097 of Gordon et al. This combination could be completed according to well-known techniques in the art and would likely yield predictable results, in that the base device of Gordon et al. would determine a target protrusion based at least in part on the transition position to calibrate a protrusion of the scope relative to the sheath so as to allow for end user to quickly and easily achieve and maintain a desired protrusion of the distal end of the scope in relation to the distal end of the sheath during medical procedures. In addition, Gordon et al. in view of Ludwin et al. and Matey et al. are combinable because they are all directed towards medical probe control methods and systems and, similar to Gordon et al., Matey et al. is also directed towards detecting a sheath being used to guide a probe based on image data captured by the probe. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined teachings of Gordon et al. in view of Ludwin et al. with the teachings of Matey et al. This modification would have been prompted in order to substitute the sheath detection technique of Gordon et al. for the color-based sheath detection method of Matey et al. The color-based sheath detection method could be substituted in place of the sheath detection technique of Gordon et al. using well-known techniques in the art and would likely yield predictable results, in that, in the combination, the color-based sheath detection method of Matey et al. would be utilized to detect the sheath in the image data. Furthermore, this modification would have been prompted by the teachings and suggestions of Gordon et al. that the sheath may include one or more identification features with detectable appearances, such as a shape or color, see at least page 6 paragraphs 0053 and 0055, page 7 paragraphs 0059 and 0063, page 8 paragraph 0066, page 9 paragraphs 0072 and 0075 and page 10 paragraphs 0079 - 0083 of Gordon et al. This combination could be completed according to well-known techniques in the art and would likely yield predictable results, in that the combined base device would utilize the color-based sheath detection method of Matey et al. to detect the sheath in captured image data. Therefore, it would have been obvious to combine Gordon et al. in view of Ludwin et al. with Matey et al. to obtain the invention as specified in claim 20.
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.
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/ERIC RUSH/Primary Examiner, Art Unit 2677
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