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 .
Election/Restrictions
Applicant’s election without traverse of group II in the reply filed on 9/8/2026 is acknowledged.
Claims 1-7 and 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/8/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: item 102L, 102R, and item 130. As shown in figure 4, item 102 is labeled, but not 102L and 102R. As shown in figure 6, item 130A, 130B, and 130C are labeled, but not 130. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: item 102. Item 102L and 102R are mentioned in the description, however, item 102 is not. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0038] recites “The simulated the simulated catheter 24 24”. This is grammatically incorrect. Examiner suggests replacing “The simulated the simulated catheter 24 24” in paragraph [0038] with “The simulated catheter 24”.
Appropriate correction is required.
Claim Objections
Claim 9 objected to because of the following informalities:
Line 3 recites “the distal tip”. Claim 8, which claim 9 depends on, introduces a steerable distal tip and refers to the steerable distal tip in line 9-10, 11 and line 12 of claim 8 and line 2 of claim 9. Examiner suggests replacing “the distal tip” in line 3 of claim 9 with “the steerable distal tip” to put the claim in clearer form and clearly refer to the steerable distal tip of claim 8.
Line 4 recites “the distal tip”. Claim 8, which claim 9 depends on, introduces a steerable distal tip and refers to the steerable distal tip in line 9-10, 11 and line 12 of claim 8 and line 2 of claim 9. Examiner suggests replacing “the distal tip” in line 4 of claim 9 with “the steerable distal tip” to put the claim in clearer form and clearly refer to the steerable distal tip of claim 8.
Line 6 recites “the steering signal is to steer”. Examiner suggests replacing “the steering signal is to steer” in line 6 of claim 9 with “the steering signal is configured to steer” to put the claim in clearer grammatical form.
Line 6 recites “the distal tip towards” and “of the distal tip”. Claim 8, which claim 9 depends on, introduces a steerable distal tip and refers to the steerable distal tip in line 9-10, 11 and line 12 of claim 8 and line 2 of claim 9. Examiner suggests replacing “the distal tip towards” and “of the distal tip” in line 6 of claim 9 with “the steerable distal tip towards” and “of the steerable distal tip” to put the claim in clearer form and clearly refer to the steerable distal tip of claim 8.
Claim 10 objected to because of the following informalities:
Line 2 recites “the determined proximity”. Examiner suggests replacing “the determined proximity” in line 2 with “the proximity of the steerable distal tip to the lumen wall of the lumen that is determined” to put the claim in clearer form as to which proximity “the determined proximity” refers to. See also 112 rejection below of claim 9, where if a second proximity is added to claim 8, the proximity in claim 10 would need to be specified.
Claim 11 objected to because of the following informalities:
Line 7 recites “the distal tip”. Claim 8, which claim 11 depends on, introduces a steerable distal tip and refers to the steerable distal tip in line 9-10, 11 and line 12 of claim 8. Examiner suggests replacing “the distal tip” in line 7 of claim 11 with “the steerable distal tip” to put the claim in clearer form and clearly refer to the steerable distal tip of claim 8.
Claim 12 objected to because of the following informalities:
Line 4 recites “at least one at least one”. This is grammatically incorrect. Examiner suggests replacing “at least one at least one” in line 4 of claim 12 with “at least one”.
Line 5 recites “the distal tip”. Claim 8, which claim 12 depends on, introduces a steerable distal tip and refers to the steerable distal tip in line 9-10, 11 and line 12 of claim 8. Examiner suggests replacing “the distal tip” in line 5 of claim 12 with “the steerable distal tip” to put the claim in clearer form and clearly refer to the steerable distal tip of claim 8.
Claim 16 objected to because of the following informalities:
Line 10 recites “the distal tip”. Claim 16 introduces a steerable distal tip in line 2 and refers to the steerable distal tip in 11 of claim 16. Examiner suggests replacing “the distal tip” in line 10 of claim 16 with “the steerable distal tip” to put the claim in clearer form and clearly refer to the steerable distal tip of line 2.
Line 11-12 recites “the detected anatomical structure”. Examiner suggests replacing “the detected anatomical structure” with “the anatomical structure” or “the anatomical structure that is detected” to put the claim in clearer form and as the anatomical structure is referred to as the anatomical structure in claims 17 and 18.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-12 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 8,
Line 11 recites “based on the determined of the steerable distal tip to the lumen wall”. It is unclear what is meant by this. For examination purposes Examiner construes “based on the determined of the steerable distal tip to the lumen wall” to be “based on the proximity of the steerable distal tip to the lumen wall”. Examiner suggests replacing “based on the determined of the steerable distal tip to the lumen wall” in line 11 of claim 8 with “based on the proximity of the steerable distal tip to the lumen wall”.
Examiner notes claims 9-12 are similarly rejected by virtue of their dependency on claim 8.
In regard to claim 9,
Line 1-2 recites “the proximity of the steerable distal tip to one or more lumen walls”. There is insufficient antecedent basis for the limitation in this claim. Claim 9 depends on claim 8. Claim 8 introduces a proximity of the steerable distal tip to a lumen wall, not the proximity of the steerable distal tip to one or more lumen walls. For examination purposes Examiner construes “the proximity” to be “a proximity”.
Line 2 recites “one or more lumen walls”. Claim 9 depends on claim 8. Claim 8 introduces a lumen wall of a lumen. It is unclear if the one or more lumen walls includes the lumen wall of claim 8 or requires one or more additional lumen walls to the lumen wall of claim 8. For examination purposes Examiner construes the one or more lumen walls to include the lumen wall of claim 8. Examiner suggests amending claim 8 to require “a proximity of the steerable distal tip to a lumen wall of a lumen or a proximity of the steerable distal tip to one or more lumen walls” and amending claim 8 and the claims dependent on claim 8 accordingly. If claim 8 is amended to require a proximity of the steerable distal tip to one or more lumen walls, the proximity in line 1 of claim 9 would not need to be amended, however “one or more lumen walls” in line 2 of claim 9 would need to be amended to state “the one or more lumen walls”.
Line 3 recites “a first lumen wall”. Line 2 recites “one or more lumen walls” and claim 8 recites “a lumen wall”. It is unclear if the first lumen wall is an additional lumen wall to the one or more lumen walls or if the first lumen wall is of the one or more lumen walls. Additionally, it is unclear if a first lumen wall refers to a wall of a first lumen or to a first wall of a lumen. For examination purposes Examiner construes a first lumen wall to be of the one or more lumen walls and to be a first wall of a lumen based on paragraph [0088] which supports the first lumen wall is a first portion of the lumen wall that is closest to the first side.
Line 4 recites “a second lumen wall”. Line 2 recites “one or more lumen walls” and claim 8 recites “a lumen wall”. It is unclear if the second lumen wall is an additional lumen wall to the one or more lumen walls or if the second lumen wall is of the one or more lumen walls. Additionally, it is unclear if a second lumen wall refers to a wall of a second lumen or to a second wall of a lumen. For examination purposes Examiner construes a second lumen wall to be of the one or more lumen walls and to be a second wall of a lumen based on paragraph [0088] which supports the second lumen wall is a portion of the lumen wall that is closest to the second side. For examination purposes Examiner construes a second lumen wall to be of the one or more lumen walls.
Line 6 recites “the steering signal is to steer the distal tip towards the second side of the distal tip”. Claim 9 depends on claim 8. Claim 8 introduces a steering signal to steer the steerable distal tip away from the lumen wall and towards a center of the lumen. The steering signal in line 6 of claim 9 appears to be a different steering signal than the steering signal of claim 8 as the steering signal is to steer the distal tip towards the second side of the distal tip. Additionally, it is unclear how the distal tip, which includes the second side, can be steered towards the second side of the distal tip. For examination purposes Examiner construes “the steering signal is to steer the distal tip towards the second side of the distal tip” to be “a steering signal is configured to steer the distal tip towards the second lumen wall”. Examiner suggests introducing and defining a second steering signal that is configured to steer the distal tip towards the second lumen wall based on the proximity of the steerable distal tip to the one or more lumen walls.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 8, 10, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ye (U.S. PG publication 20210196398).
In regard to claim 8,
Ye discloses a catheter navigation system (figure 3, item 340, position sensor described in at least paragraph [0082]-[0083], and control system described in at least paragraph [0087], [0101], and [0124] collectively form the catheter navigation system) comprising:
a catheter (figure 3, item 340; paragraph [0073]) comprising a steerable distal tip (figure 3, item 342; paragraph [0074]-[0076], and [0083]) including a proximity sensor (position sensor described in at least paragraph [0082]-[0083] and [0087]); and
a catheter controller (control system described in at least paragraph [0087], [0101], and [0124]; see also paragraph [0065]), coupled to the catheter (paragraph [0087], [0101], and [0124]), comprising:
a processor (paragraph [0087], [0101], [0124], and [0065]); and
memory (paragraph [0087], [0101], [0124], and [0065]) storing instructions that, when executed by the processor, cause the catheter controller to perform operations (paragraph [0087] and [0101]) comprising:
receiving, from the catheter, a proximity signal generated by the proximity sensor (paragraph [0087] and [0101]);
based on the proximity signal, determining a proximity of the steerable distal tip to a lumen wall of a lumen (paragraph [0038], [0087] and [0101]); and
based on the determined of the steerable distal tip to the lumen wall, generating a steering signal to steer the steerable distal tip away from the lumen wall and towards a center of the lumen (paragraph [0006], [0038], [0101]; paragraph [0088]: wherein item 340 can be controlled automatically).
In regard to claim 10,
Ye discloses the catheter navigation system of claim 8, wherein the operations further comprise, based on the determined proximity, identifying the center of the lumen (paragraph [0006] and [0101]).
In regard to claim 16,
Ye discloses a catheter navigation system (figure 3, item 340, position sensor described in at least paragraph [0082]-[0083], and control system described in at least paragraph [0087], [0101], and [0124] collectively form the catheter navigation system) comprising:
a catheter (figure 3, item 340; paragraph [0073]) comprising a steerable distal tip (figure 3, item 342; paragraph [0074]-[0076], and [0083]) including a proximity sensor position sensor described in at least paragraph [0082]-[0083] and [0087]); and
a catheter controller (control system described in at least paragraph [0087], [0101], and [0124]; see also paragraph [0065]), coupled to the catheter (paragraph [0087], [0101], and [0124]), comprising:
a processor (paragraph [0087], [0101], [0124], and [0065]); and
memory (paragraph [0087], [0101], [0124], and [0065]) storing instructions that, when executed by the processor, cause the catheter controller to perform operations (paragraph [0087] and [0101]) comprising:
receiving, from the catheter, a proximity signal generated by the proximity sensor (paragraph [0087] and [0101]);
based on the proximity signal, detecting an anatomical structure in proximity to the distal tip (paragraph [0038], [0087] and [0101]); and
generating a steering signal to steer the steerable distal tip away from the detected anatomical structure (paragraph [0006], [0101]; paragraph [0088]: wherein item 340 can be controlled automatically).
In regard to claim 17,
Ye discloses the catheter navigation system of claim 16, wherein the anatomical structure is a lumen wall (paragraph [0038], [0087] and [0101]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ye (U.S. PG publication 20210196398) further in view of Viola (U.S. PG publication 20100268030).
In regard to claim 9,
Ye discloses the catheter navigation system of claim 8.
Ye is silent as to wherein determining the proximity of the steerable distal tip to one or more lumen walls comprises: determining a first distance of a first side of the distal tip to a first lumen wall; and determining a second distance of a second side of the distal tip to a second lumen wall, wherein the second distance is greater than the first distance; and wherein the steering signal is to steer the distal tip towards the second side of the distal tip.
Viola teaches wherein determining the proximity of the steerable distal tip (figure 10, item 205) to one or more lumen walls (see figure 9-12) comprises: determining a first distance of a first side of the distal tip to a first lumen wall (see 112 rejection above for claim interpretation; paragraph [0027] and [0034]-[0039]); and determining a second distance of a second side of the distal tip to a second lumen wall (see 112 rejection above for claim interpretation; paragraph [0027] and [0034]-[0039]), wherein the second distance is greater than the first distance (paragraph [0027] and [0034]-[0039]); and wherein the steering signal is to steer the distal tip towards the second side of the distal tip (paragraph [0037]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Ye to replace the proximity sensor of Ye with proximity sensor 212, 214, 216, 218 of Viola and to modify the catheter controller accordingly, and to include wherein determining the proximity of the steerable distal tip to one or more lumen walls comprises: determining a first distance of a first side of the distal tip to a first lumen wall; and determining a second distance of a second side of the distal tip to a second lumen wall, wherein the second distance is greater than the first distance; and wherein the steering signal is to steer the distal tip towards the second side of the distal tip, as taught by Viola, for the purpose of better enabling use in a tortuous path by sensing position of the distal tip relative to a lumen wall and automatically centering the distal tip (paragraph [0003], [0008], and [0037] of Viola).
Claims 11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ye (U.S. PG publication 20210196398) further in view of Soper (U.S. PG publication 20050182295).
In regard to claim 11,
Ye discloses the catheter navigation system of claim 8, wherein the steering signal is a first steering signal (paragraph [0101]), and the operations further comprise: based on an anatomy model of the patient (paragraph [0070]), identifying a lumen as providing a pathway to a navigation target in the anatomy model (paragraph [0070]); and generating a second steering signal to steer the distal tip into the lumen (paragraph [0070]).
Ye is silent as to and the operations further comprise: based on the proximity signal, identifying a bifurcation of a first lumen and a second lumen of a patient. Ye is therefore also silent as to based on an anatomy model of the patient, identifying the first lumen as providing a pathway to a navigation target in the anatomy model; and generating a second steering signal to steer the distal tip into the first lumen.
Soper teaches based on the proximity signal, identifying a bifurcation of a first lumen and a second lumen of a patient (paragraph [0088]), and identifying the first lumen as providing a pathway to a navigation target in the anatomy model (paragraph [0088]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Ye to include the operations further comprise: based on the proximity signal, identifying a bifurcation of a first lumen and a second lumen of a patient, as taught by Soper, therefore resulting in based on an anatomy model of the patient, identifying the first lumen as providing a pathway to a navigation target in the anatomy model; and generating a second steering signal to steer the distal tip into the first lumen for the purpose of ensuring the position is actually at a bifurcation before steering and updating a model accordingly (paragraph [0088] of Soper).
In regard to claim 18,
Ye discloses the catheter navigation system of claim 16.
Ye is silent as to wherein the anatomical structure is tissue dividing two lumens at a junction.
Soper teaches wherein the anatomical structure is tissue dividing two lumens at a junction (paragraph [0088).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Ye to include wherein the anatomical structure is tissue dividing two lumens at a junction, as taught by Soper, for the purpose of ensuring correct positioning to enable navigation down a desired branch (paragraph [0088] of Soper).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ye (U.S. PG publication 20210196398) further in view of Paul (U.S. PG publication 20110270046).
In regard to claim 12,
Ye discloses the catheter navigation system of claim 8.
Ye is silent as to wherein the proximity sensor comprises: a proximity emitter; and at least one at least one proximity receiver positioned at least partially around a circumference of the distal tip.
Paul teaches wherein the proximity sensor (paragraph [0003], [0016]-[0017], [0019], [0059], [0061]-[0062], [0075]) comprises: a proximity emitter (paragraph [0016]-[0017], [0019], [0062]); and at least one at least one proximity receiver (paragraph [0016]-[0017], [0019], [0062]) positioned at least partially around a circumference of the distal tip (paragraph [0016]-[0017], [0019], [0062]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Ye to substitute the proximity sensor of Paul in place of the proximity sensor of Ye, as taught by Paul, because the substitution is a simple substitution that would yield the same predictable result of proximity/orientation detection (paragraph [0082]-[0083] and [0087] of Ye and paragraph [0059], [0061] and [0003] of Paul). Furthermore Ye discloses modifications can be made (paragraph [0174] of Ye).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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