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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted was filed on 07/20/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 06/22/2026 has been entered. Claims 1-16 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 03/26/2026 except for the claim objection to claim 15.
Response to Arguments
Applicant's arguments filed 06/22/2026 have been fully considered but they are not persuasive.
Applicant argues that the cited references do not teach that the stylet’s positioning and orientation is determined “relative to a predetermined bend formed in the interconnect”. Applicant argues Chopra’s reference portion 251 is not formed in a separate interconnect fiber and is not a separate interconnect fiber containing a predetermined bend.
Examiner respectfully disagrees. The claims do not recite wherein the predetermined bend is required to be formed in a “separate interconnect fiber” nor do the claims recite wherein the interconnect is an “interconnect fiber”. Rather, the claims recite “…relative to a predetermined bend formed in the interconnect”. While the claims recite “coupling the stylet to an interconnect…the interconnect includes a second optical fiber”, the interconnect is not recited to be the second optical fiber itself or an “interconnect fiber” as argued. The sensor device 258 of Chopra may therefore be considered an interconnect because it at least connects or links several components of Chopra’s system together, such as fiber 253 to fiber 280 (Fig. 3, [0049], wherein figure 3 shows the sensor device 258 forms an interconnect between one side of the system to the other side of the system). Chopra discloses in ¶ [0056], “The interrogation system 276 interrogates the shape sensor fiber 253 to determine the pose of the distal tip and the shape of the flexible catheter body 254. This sensed relative pose and shape data for the catheter body 254 is known relative to the reference portion 251 of the shape sensor fiber, which is registered to the fiduciary apparatus 260”. The pose of the catheter body 254 comprises its position and orientation. Chopra in view of Messerly teaches wherein the catheter 254 may instead be a stylet. Because Chopra’s reference portion 251 is the predetermined bend and is formed in the sensor device 258 comprising the interconnect, Chopra in view of Messerly therefore at least teaches “processing the reflected light signals to determine a positioning and an orientation of the stylet relative to a predetermined bend formed in the interconnect”.
Applicant further argues Van does not remedy the deficiency argued above. Applicant argues Van’s first optical fiber 12 serves merely as an “optical waveguide” and does not teach or suggest forming a predetermined bend in this waveguide fiber, nor does Van teach using such a bend as a reference point for determining the position and orientation of a medical instrument.
Examiner respectfully disagrees. As explained above, the claims do not recite wherein the predetermined bend is formed in an optical fiber, rather the claims recite wherein the predetermined bend is “formed in an interconnect”, and the interconnect is not recited to be an optical fiber but rather to merely include an optical fiber. Moreover, while Van discloses the first optical fiber 12 serves as an optical waveguide ([0057]), Van also discloses wherein the first and second optical fibers (12, 14) may be multi-core shape sensing optical fibers ([0069]). Chopra teaches wherein fiber Bragg gratings (FBGs) are used shape sensing of optical fibers ([0038], [0042]). Chopra modified by Van to include the first optical fiber 12 of Van would therefore result in a second optical fiber which includes one or more cores and is configured to transmit and/or receive light signals of different spectral widths (due to the FBGs). And as explained earlier above, Chopra teaches wherein the bend serves as a reference point for determining the position and orientation of the medical instrument.
Applicant argues combining Chopra with Van would not predictably result in the claimed interconnect with the predetermined bend. Applicant argues even when Van’s two-fiber architecture substituted into Chopra’s system. Chopra’s predefined reference shape 251 would logically remain in the medical instrument’s fiber (the first optical fiber), because that is where Chopra’s sensor holder 272 maintains the fiber in its predefined shape. Applicant argues neither Chopra nor Van provides any teaching or motivation to place a predetermined bend in the interconnect fiber specifically and use it as a reference point for determining the stylet’s positioning and orientation.
Examiner respectfully disagrees. Van teaches wherein both first (second) and second (first) optical fibers 12, 14 may be multi-core shape sensing optical fibers ([0069]). Van therefore teaches using two optical fibers for shape sensing, the two optical fibers being optically coupled at respective ends. Chopra teaches using a single optical fiber 253 for shape sensing (Fig. 3, [0053]). Chopra teaches wherein optical fiber 280 which connects to the interrogator is not used for shape sensing (Fig. 3, [0054]). Therefore, Chopra modified by the teachings of Van would result in substituting the single optical shape sensing fiber 253 of Chopra with the two optical shape sensing fibers 12, 14 of Van. Van teaches the two optical fibers 12, 14 are separated by a sterility barrier (Abstract, [0010]). By performing this type of substitution, the sterility barrier of Van may be placed between the medical instrument 254 (stylet) and the sensor device 258 (interconnect) of Chopra, therefore allowing repeated use of the sensor device 258 between procedures, this being one of the motivations to combine in such a manner. Having the sterility barrier be placed between the stylet and interconnect would result in the predetermined bend being formed in the interconnect (which is already taught by Chopra as explained above) and the second optical fiber (optical fiber 12 of Van). Again, the claims do not recite wherein the predetermined bend is formed in the interconnect fiber but rather just the interconnect. And even if it did recite that the predetermined bend is formed in the second optical fiber, Chopra modified by Van would result in such as explained above.
Applicant further argues claims 1 and 9 also require “receiving reflected light signals of different spectral widths of incident light signal from the first optical fiber and the second optical fiber” and one of ordinary skill would interpret that the second optical fiber must be a sensed fiber containing sensors such as FBGs. Applicant argues the combination, i.e. of Chopra and Van, does not teach or suggest receiving reflected light signals from the second optical fiber as recited in claims 1 and 9, and thus the Examiner has failed to establish prima facie obviousness for claims 1 and 9
Examiner respectfully disagrees. As explained above, the first optical fiber 12 (i.e. second optical fiber) of Van is not only an optical waveguide, but it is also a multi-core shape sensing optical fiber as disclosed by Van in ¶ [0069]. ¶ [0069] discloses both optical fibers 12, 14 of Van are sensed fibers which sense shape. Van teaches wherein fiber sensors include multiple fiber Bragg gratings ([0100]). In addition, Chopra teaches using fiber Bragg gratings to sense shape ([0038], [0042]). Therefore, Chopra modified by the teachings of Van to include a second optical fiber (optical fiber 12) which is a multi-core shape sensing optical fiber would predictably result in first and second optical fibers including FBGs for shape sensing and thus teach “receiving reflected light signals of different spectral widths of incident light signal from the first optical fiber and the second optical fiber” due to the incorporated FBGs.
Applicant further argues, in regards to claims 6 and 14, that there is no teaching or motivation to split up the continuous sensor fiber 253 into two separate sections that are coupled together, where each section includes sensors as alleged by the Examiner. Applicant argues Claim 6 explicitly requires that “each of the one or more core fibers of the first optical fiber and the second optical fiber include a plurality of sensors distributed along a length of a corresponding core fiber”. Applicant argues that because Chopra and Van teach only a single optical fiber that includes sensors (Van’s first optical fiber 12 is a passive waveguide as argued by Applicant), there’s no teaching for the above.
Examiner respectfully disagrees. Van discloses in ¶ [0069] that both first and second optical fibers 12, 14 may be multi-core shape sensing optical fibers. Van further discloses in ¶ [0100] that the fiber sensors may include multiple fiber Bragg gratings (FBGs) along their lengths. In addition, Chopra teaches using FBGs to sense shape ([0038], [0042]) and wherein the FBGs are distributed along the longitudinal length ([0040], “an array of FBG's is provided within each core”, [0042], “These data, combined with the known spacings of the FBG regions…”). Therefore, the substitution of Chopra’s single optical fiber 253 for shape sensing with Van’s two optical fibers 12, 14 for shape sensing would predictably result in “each of the one or more core fibers of the first optical fiber and the second optical fiber include a plurality of sensors distributed along a longitudinal length of a corresponding core fiber”. As explained earlier above, the motivation for such a substitution is to establish a sterility barrier between the stylet and sensor device 258 (interconnect) such that the sensor device 258 may be repeatedly used between procedures.
Accordingly, the arguments are unpersuasive and thus the claims remain rejected for the same reasons as articulated in the previous Non-Final Rejection dated 03/26/2026.
Claim Objections
Claim 15 is objected to because of the following informalities:
“wherein providing the incident light comprises providing the incident light in pulses” should be corrected to:
“wherein providing the incident light signal comprises providing the incident light signal in pulses”
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 12,232,821 B2 (hereinafter “Reference Patent 1”). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Application (17/569,350)
Reference Patent 1 (US 12,232,821 B2)
1. A method for tracking a stylet, comprising:
coupling the stylet to an interconnect, wherein the stylet includes a first optical fiber and the interconnect includes a second optical fiber, each of the first optical fiber and the second optical fiber including one or more core fibers, the coupling including optically coupling a distal end of the second optical fiber to a proximal end of the first optical fiber; and
connecting the interconnect to a console, the console performing operations comprising:
providing an incident light signal to the first optical fiber and the second optical fiber;
receiving reflected light signals of different spectral widths of the incident light from the first optical fiber and the second optical fiber;
processing the reflected light signals to determine a positioning and an orientation of the stylet relative to a predetermined bend formed in the interconnect; and
generating a display of the stylet based on the reflected light signals and a determination of the positioning and orientation of the stylet relative to the predetermined bend.
1. A medical instrument system for inserting a medical instrument within a patient body, the system comprising:
the medical instrument comprising a first optical fiber having one or more core fibers;
an interconnect including a second optical fiber having one or more core fibers, the second optical fiber extending along a length of the interconnect, wherein:
a distal end of the second optical fiber is optically coupled with a proximal end of the first optical fiber, and
a predetermined bend is formed in the interconnect including the second optical fiber at a point along the length of the interconnect; and
a console optically coupled to a proximal end of the interconnect including the second optical fiber, the console including one or more processors and a non-transitory computer-readable medium having stored thereon logic, when executed by the one or more processors, causes operations including:
providing an incident light signal to the first optical fiber and the second optical fiber,
receiving reflected light signals of different spectral widths of the incident light signal from the first optical fiber and the second optical fiber,
processing the reflected light signals to determine a positioning and an orientation of the medical instrument relative to the predetermined bend,
generating a display of the medical instrument based on the reflected light signals and the determination of the positioning and the orientation of the medical instrument relative to the predetermined bend, and
causing rendering of the display of the medical instrument on a display screen.
2. The system of claim 1, wherein the medical instrument includes a stylet.
9. A non-transitory computer-readable medium having stored thereon logic that, when executed by the one or more processors, causes operations comprising:
providing an incident light signal to a first optical fiber included in a stylet and to a second optical fiber included in an interconnect, wherein each of the first optical fiber and the second optical fiber include one or more of core fibers, and wherein a distal end of the second optical fiber is optically coupled to a proximal end of the first optical fiber;
receiving reflected light signals of different spectral widths of the incident light from the first optical fiber and the second optical fiber;
processing the reflected light signals to determine a positioning and an orientation of the stylet relative to a predetermined bend formed in the interconnect; and
generating a display of the medical instrument based on the reflected light signals and the determination of the positioning and the orientation of the stylet relative to the predetermined bend.
1. A medical instrument system for inserting a medical instrument within a patient body, the system comprising:
the medical instrument comprising a first optical fiber having one or more core fibers;
an interconnect including a second optical fiber having one or more core fibers, the second optical fiber extending along a length of the interconnect, wherein:
a distal end of the second optical fiber is optically coupled with a proximal end of the first optical fiber, and
a predetermined bend is formed in the interconnect including the second optical fiber at a point along the length of the interconnect; and
a console optically coupled to a proximal end of the interconnect including the second optical fiber, the console including one or more processors and a non-transitory computer-readable medium having stored thereon logic, when executed by the one or more processors, causes operations including:
providing an incident light signal to the first optical fiber and the second optical fiber,
receiving reflected light signals of different spectral widths of the incident light signal from the first optical fiber and the second optical fiber,
processing the reflected light signals to determine a positioning and an orientation of the medical instrument relative to the predetermined bend,
generating a display of the medical instrument based on the reflected light signals and the determination of the positioning and the orientation of the medical instrument relative to the predetermined bend, and
causing rendering of the display of the medical instrument on a display screen.
2. The system of claim 1, wherein the medical instrument includes a stylet.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-9 of U.S. Patent No. 12,232,821 B2 (hereinafter “Reference Patent 1”) in view of Messerly (US20180289927).
Regarding claim 1, Reference Patent 1 teaches:
Instant Application (17/569,350)
Reference Patent 1 (US 12,232,821 B2)
1. A method for tracking a stylet, comprising:
coupling the stylet to an interconnect, wherein the stylet includes a first optical fiber and the interconnect includes a second optical fiber, each of the first optical fiber and the second optical fiber including one or more core fibers, the coupling including optically coupling a distal end of the second optical fiber to a proximal end of the first optical fiber; and
connecting the interconnect to a console, the console performing operations comprising:
providing an incident light signal to the first optical fiber and the second optical fiber;
receiving reflected light signals of different spectral widths of the incident light from the first optical fiber and the second optical fiber;
processing the reflected light signals to determine a positioning and an orientation of the stylet relative to a predetermined bend formed in the interconnect; and
generating a display of the stylet based on the reflected light signals and a determination of the positioning and orientation of the stylet relative to the predetermined bend.
1. A medical instrument system for inserting a medical instrument within a patient body, the system comprising:
the medical instrument comprising a first optical fiber having one or more core fibers;
an interconnect including a second optical fiber having one or more core fibers, the second optical fiber extending along a length of the interconnect, wherein:
a distal end of the second optical fiber is optically coupled with a proximal end of the first optical fiber, and
a predetermined bend is formed in the interconnect including the second optical fiber at a point along the length of the interconnect; and
a console optically coupled to a proximal end of the interconnect including the second optical fiber, the console including one or more processors and a non-transitory computer-readable medium having stored thereon logic, when executed by the one or more processors, causes operations including:
providing an incident light signal to the first optical fiber and the second optical fiber,
receiving reflected light signals of different spectral widths of the incident light signal from the first optical fiber and the second optical fiber,
processing the reflected light signals to determine a positioning and an orientation of the medical instrument relative to the predetermined bend,
generating a display of the medical instrument based on the reflected light signals and the determination of the positioning and the orientation of the medical instrument relative to the predetermined bend, and
causing rendering of the display of the medical instrument on a display screen.
However, claim 1 of Reference Patent 1 fails to teach wherein the medical instrument is a stylet.
In an analogous optical fiber-based medical device tracking field of endeavor, Messerly teaches such a feature (Title). Messerly teaches wherein an optical fiber (140) and a plurality of strain sensors may be included in a stylet (130) (Fig. 1A, [0036], [0039], [0048]). Messerly teaches wherein the strain sensors are fiber Bragg gratings (FBGs) ([0020], [0046-0047]). Messerly teaches wherein the stylet (130) may then be placed within a catheter (72) to enable a system (10) to guide the catheter within the vasculature of a patient ([0036]). Moreover, Messerly teaches a console (20) comprising an optical module (50) configured to provide incident light signals to the optical fiber and to receive reflected light signals (Fig. 1-2, [0035], [0048]). Messerly therefore teaches wherein a tracked medical instrument based on optical fibers may be a stylet.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Reference Patent 1 to have the tracked medical instrument be a stylet as taught by Messerly ([0036], [0046-0048]). The optically tracked stylet may be insertable into a catheter, helping guide the catheter through a patient’s vasculature to a desired location as recognized by Messerly ([0036], [0042], [0051]).
Regarding claim 2, Reference Patent 1 in view of Messerly teaches the invention as claimed above in claim 1.
However, Reference Patent 1 fails to teach the invention further comprising inserting the stylet into a catheter to guide the catheter within a vasculature of a patient.
In an analogous method for tracking a medical instrument field of endeavor, Messerly teaches such a feature. Messerly teaches inserting a stylet (130) with in a catheter (72) to be inserted into a patient (70) (Fig. 2, [0037]). Messerly teaches wherein the stylet (130) includes an optical fiber and is configured to be inserted into the catheter (72), enabling a system (10) to guide and track the catheter (72) within the vasculature of the patient to a desired destination within the body ([0022], [0036], [0041]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Reference Patent 1 to insert the stylet into a catheter to guide the catheter within a vasculature of a patient as taught by Messerly ([0022], [0036], [0041]). The optically tracked stylet being inserted into the catheter for guidance may reduce reliance on other imaging modalities such as X-ray for catheter placement, thereby reducing patient exposure to harmful x-rays as recognized by Messerly ([0024]).
Regarding claims 3-8, Reference Patent 1 in view of Messerly teaches the invention as claimed above in claim 1.
Reference Patent 1 further teaches:
Instant Application (17/569,350)
Reference Patent 1 (US 12,232,821 B2)
3. The method according to claim 1, further comprising coupling the interconnect to an ultrasound probe, the ultrasound probe in communication with the console, wherein the positioning and the orientation of the stylet is determined relative to the ultrasound probe.
4. The system of claim 1, further comprising an ultrasound probe coupled to the console, wherein the interconnect is coupled to the ultrasound probe causing the predetermined bend in the interconnect such that the positioning and the orientation of the medical instrument is determined relative to the ultrasound probe.
4. The method according to claim 3, further comprising:
receiving ultrasound imaging data from the ultrasound probe; and
rendering an ultrasound image from the ultrasound imaging data, wherein the display of the stylet is rendered as an overlay on the ultrasound image.
5. The system of claim 4, wherein the logic, when executed by the one or more processors, causes further operations including:
receiving ultrasound imaging data from the ultrasound probe, and
causing rendering of an ultrasound image from the ultrasound imaging data, wherein the display of the medical instrument is rendered as an overlay on the ultrasound image.
5. The method according to claim 1, further comprising coupling the interconnect to the patient, wherein the positioning and the orientation of the stylet is determined relative to the patient.
6. The system of claim 1, wherein the interconnect is coupled to the patient body causing the predetermined bend in the interconnect such that the positioning and the orientation of the medical instrument is determined relative to the patient body.
6. The method according to claim 1, wherein each of the one or more core fibers of the first optical fiber and the second optical fiber include a plurality of sensors distributed along a longitudinal length of a corresponding core fiber, and wherein each sensor of the plurality of sensors reflects a light signal of a different spectral width based on received incident light, and changes a characteristic of the reflected light signal for use in determining a physical state of a corresponding optical fiber.
7. The system of claim 1, wherein each of the one or more core fibers of the first optical fiber and the second optical fiber includes a plurality of sensors distributed along a longitudinal length of a corresponding core fiber and each sensor of the plurality of sensors is configured to (i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal for use in determining a physical state of a corresponding optical fiber.
7. The method according to claim 1, wherein the first optical fiber and the second optical fiber are single-core optical fibers, and wherein providing the incident light comprises providing the incident light in pulses.
8. The system of claim 1, wherein the first optical fiber and the second optical fiber are single-core optical fibers, and wherein the incident light signal is provided in pulses.
8. The method according to claim 1, wherein the first optical fiber and the second optical fiber are multi-core optical fibers, each including a plurality of core fibers.
9. The system of claim 1, wherein the first optical fiber and the second optical fiber are multi-core optical fibers, each including a plurality of core fibers.
Regarding claim 9, Reference Patent 1 teaches:
Instant Application (17/569,350)
Reference Patent 1 (US 12,232,821 B2)
9. A non-transitory computer-readable medium having stored thereon logic that, when executed by the one or more processors, causes operations comprising:
providing an incident light signal to a first optical fiber included in a stylet and to a second optical fiber included in an interconnect, wherein each of the first optical fiber and the second optical fiber include one or more of core fibers, and wherein a distal end of the second optical fiber is optically coupled to a proximal end of the first optical fiber;
receiving reflected light signals of different spectral widths of the incident light from the first optical fiber and the second optical fiber;
processing the reflected light signals to determine a positioning and an orientation of the stylet relative to a predetermined bend formed in the interconnect; and
generating a display of the medical instrument based on the reflected light signals and the determination of the positioning and the orientation of the stylet relative to the predetermined bend.
1. A medical instrument system for inserting a medical instrument within a patient body, the system comprising:
the medical instrument comprising a first optical fiber having one or more core fibers;
an interconnect including a second optical fiber having one or more core fibers, the second optical fiber extending along a length of the interconnect, wherein:
a distal end of the second optical fiber is optically coupled with a proximal end of the first optical fiber, and
a predetermined bend is formed in the interconnect including the second optical fiber at a point along the length of the interconnect; and
a console optically coupled to a proximal end of the interconnect including the second optical fiber, the console including one or more processors and
a non-transitory computer-readable medium having stored thereon logic, when executed by the one or more processors, causes operations including:
providing an incident light signal to the first optical fiber and the second optical fiber,
receiving reflected light signals of different spectral widths of the incident light signal from the first optical fiber and the second optical fiber,
processing the reflected light signals to determine a positioning and an orientation of the medical instrument relative to the predetermined bend,
generating a display of the medical instrument based on the reflected light signals and the determination of the positioning and the orientation of the medical instrument relative to the predetermined bend, and
causing rendering of the display of the medical instrument on a display screen.
However, claim 1 of Reference Patent 1 fails to teach wherein the medical instrument is a stylet.
In an analogous optical fiber-based medical device tracking field of endeavor, Messerly teaches such a feature (Title). Messerly teaches wherein an optical fiber (140) and a plurality of strain sensors may be included in a stylet (130) (Fig. 1A, [0036], [0039], [0048]). Messerly teaches wherein the strain sensors are fiber Bragg gratings (FBGs) ([0020], [0046-0047]). Messerly teaches wherein the stylet (130) may then be placed within a catheter (72) to enable a system (10) to guide the catheter within the vasculature of a patient ([0036]). Moreover, Messerly teaches a console (20) comprising an optical module (50) configured to provide incident light signals to the optical fiber and to receive reflected light signals (Fig. 1-2, [0035], [0048]). Messerly therefore teaches wherein a tracked medical instrument based on optical fibers may be a stylet.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Reference Patent 1 to have the tracked medical instrument be a stylet as taught by Messerly ([0036], [0046-0048]). The optically tracked stylet may be insertable into a catheter, helping guide the catheter through a patient’s vasculature to a desired location as recognized by Messerly ([0036], [0042], [0051]).
Regarding claim 10, Reference Patent 1 in view of Messerly teaches the invention as claimed above in claim 9.
However, Reference Patent 1 fails to teach wherein the stylet is configured for inserting into a catheter to guide the catheter within a vasculature of a patient.
In an analogous method for tracking a medical instrument field of endeavor, Messerly teaches such a feature. Messerly teaches inserting a stylet (130) with in a catheter (72) to be inserted into a patient (70) (Fig. 2, [0037]). Messerly teaches wherein the stylet (130) includes an optical fiber and is configured to be inserted into the catheter (72), enabling a system (10) to guide and track the catheter (72) within the vasculature of the patient to a desired destination within the body ([0022], [0036], [0041]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Reference Patent 1 to have the stylet be configured for insertion into a catheter to guide the catheter within a vasculature of a patient as taught by Messerly ([0022], [0036], [0041]). The optically tracked stylet being insertable into the catheter for guidance may reduce reliance on other imaging modalities such as X-ray for catheter placement, thereby reducing patient exposure to harmful x-rays as recognized by Messerly ([0024]).
Regarding claims 11-16, Reference Patent 1 in view of Messerly teaches the invention as claimed above in claim 9.
Reference Patent 1 further teaches:
Instant Application (17/569,350)
Reference Patent 1 (US 12,232,821 B2)
11. The non-transitory computer-readable medium according to claim 9, wherein the interconnect is configured to be coupled to an ultrasound probe in communication with a console, wherein the positioning and the orientation of the stylet is determined relative to the ultrasound probe.
4. The system of claim 1, further comprising an ultrasound probe coupled to the console, wherein the interconnect is coupled to the ultrasound probe causing the predetermined bend in the interconnect such that the positioning and the orientation of the medical instrument is determined relative to the ultrasound probe.
12. The non-transitory computer-readable medium according to claim 11, wherein the one or more processors causes further operations comprising:
receiving ultrasound imaging data from the ultrasound probe; and
rendering an ultrasound image from the ultrasound imaging data, wherein the display of the stylet is rendered as an overlay on the ultrasound image.
5. The system of claim 4, wherein the logic, when executed by the one or more processors, causes further operations including:
receiving ultrasound imaging data from the ultrasound probe, and
causing rendering of an ultrasound image from the ultrasound imaging data, wherein the display of the medical instrument is rendered as an overlay on the ultrasound image.
13. The non-transitory computer-readable medium according to claim 9, wherein the interconnect is configured to couple to the patient, wherein the positioning and the orientation of the stylet is determined relative to the patient.
6. The system of claim 1, wherein the interconnect is coupled to the patient body causing the predetermined bend in the interconnect such that the positioning and the orientation of the medical instrument is determined relative to the patient body.
14. The non-transitory computer-readable medium according to claim 9, wherein each of the one or more core fibers of the first optical fiber and the second optical fiber include a plurality of sensors distributed along a longitudinal length of a corresponding core fiber, and wherein each sensor of the plurality of sensors reflects a light signal of a different spectral width based on received incident light, and changes a characteristic of the reflected light signal for use in determining a physical state of a corresponding optical fiber.
7. The system of claim 1, wherein each of the one or more core fibers of the first optical fiber and the second optical fiber includes a plurality of sensors distributed along a longitudinal length of a corresponding core fiber and each sensor of the plurality of sensors is configured to (i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal for use in determining a physical state of a corresponding optical fiber.
15. The non-transitory computer-readable medium according to claim 9, wherein the first optical fiber and the second optical fiber are single-core optical fibers, and wherein providing the incident light comprises providing the incident light in pulses.
8. The system of claim 1, wherein the first optical fiber and the second optical fiber are single-core optical fibers, and wherein the incident light signal is provided in pulses.
16. The non-transitory computer-readable medium according to claim 9, wherein the first optical fiber and the second optical fiber are multi-core optical fibers, each including a plurality of core fibers.
9. The system of claim 1, wherein the first optical fiber and the second optical fiber are multi-core optical fibers, each including a plurality of core fibers.
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.
Claims 1-2, 5-6, 8-10, 13-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Chopra (US20140275997) in view of Messerly (US20180289927) and Van (US20180140170). Chopra, Messerly, and Van are cited in the IDS filed 03/26/2025.
Regarding claim 1, Chopra teaches a method for tracking a medical instrument (254) (Fig. 3, Abstract, [0002], [0049]), comprising:
coupling the medical instrument (254) to an interconnect (258), wherein the medical instrument (254) includes a first optical fiber (253), the first optical fiber (253) including one or more core fibers (Fig. 3, [0039], [0049]); and
connecting the interconnect (258) to a console (276) (Fig. 3, [0054]), the console (276) performing operations comprising:
providing an incident light signal to the first optical fiber (253) (Fig. 3, [0041], [0043], [0054], [0056]);
receiving reflected light signals of different spectral widths of the incident light signal from the first optical fiber (253) ([0054], [0040-0042], “For example, FBG's produce a reflected wavelength that is a function of the strain on the fiber and its temperature”, “measured by monitoring the wavelength shifts in each core”, wherein the reflected wavelength which is a function of strain on the fiber, each core having different strains induced therein, and monitoring wavelength shifts in each core comprises receiving reflected light signals of different spectral widths);
processing the reflected light signals to determine a positioning and an orientation of the medical instrument (254) relative to a predetermined bend (251) formed in the interconnect (258) (Fig. 3, [0053], “the reference body 262 include a sensor holder 272 configured to hold a reference portion 251 the shape sensor fiber 253 in a predefined reference shape. In this embodiment, the sensor holder 272 is a continuous winding channel that receives the shape sensor fiber 253 and maintains the fiber in a predefined shape configuration relative to the reference body 262”, [0054], “interrogation system 276 for generating, and detecting the light used to determine the current shape of the shape sensor fiber 253”, [0056], “The interrogation system 276 interrogates the shape sensor fiber 253 to determine the pose of the distal tip and the shape of the flexible catheter body 254. This sensed relative pose and shape data for the catheter body 254 is known relative to the reference portion 251 of the shape sensor fiber”, wherein the pose of the catheter 254 is its position and orientation); and
generating a display of the medical instrument (254) based on the reflected light signals and a determination of the positioning and orientation of the medical instrument (254) relative to the predetermined bend (251) ([0058], “At 326, the shape sensor information is received (in the reference frame of the shape sensor fiber 253) for processing. At 328, the pose of the distal end (or any other portion) of the shape sensor fiber 253 is determined in the image reference frame based on a registration between the image reference frame and the reference frame of the shape sensor 253. Optionally, an image from the image reference frame that corresponds to the pose of the distal end of the flexible body 254 is displayed. The image may be of the distal end of the flexible body 254 superimposed on an image from the patient model”).
However, Chopra fails to teach wherein the medical instrument is a stylet.
In an analogous optical fiber-based medical device tracking field of endeavor, Messerly teaches such a feature (Title). Messerly teaches wherein an optical fiber (140) and a plurality of strain sensors may be included in a stylet (130) (Fig. 1A, [0036], [0039], [0048]). Messerly teaches wherein the strain sensors are fiber Bragg gratings (FBGs) ([0020], [0046-0047]). Messerly teaches wherein the stylet (130) may then be placed within a catheter (72) to enable a system (10) to guide the catheter within the vasculature of a patient ([0036]). Moreover, Messerly teaches a console (20) comprising an optical module (50) configured to provide incident light signals to the optical fiber and to receive reflected light signals (Fig. 1-2, [0035], [0048]). Messerly therefore teaches wherein a tracked medical instrument based on optical fibers may be a stylet.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chopra to have the tracked medical instrument be a stylet as taught by Messerly ([0036], [0046-0048]). The optically tracked stylet may be insertable into a catheter, helping guide the catheter through a patient’s vasculature to a desired location as recognized by Messerly ([0036], [0042], [0051]).
However, the modified combination above fails to teach wherein the interconnect includes a second optical fiber, the second optical fiber including one or more core fibers, the coupling including optically coupling a distal end of the second optical fiber to a proximal end of the first optical fiber, providing an incident light signal to the second optical fiber, and receiving reflected light signals of different spectral widths of the incident light from the second optical fiber (i.e. Chopra teaches only a single optical fiber rather than a first and second optical fiber; Chopra fails to teach wherein the first optical fiber comprises a first optical fiber and a second optical fiber).
In an analogous optical fiber-based medical device tracking field of endeavor, Van teaches such a feature. Van teaches optically coupling a first optical fiber (12) with a second optical fiber (14) for use in medical interventions (Fig. 2, [0055-0056]). Van teaches wherein one optical fiber (12) is connected to a interrogator, e.g. a console, and the other optical fiber (14) is incorporated into a flexible medical devices such as catheters, guidewires, and sheathes (i.e. stylet), which are introduced into the body of the patient, thereby serving as an optical sensor ([0057]). Van further teaches wherein the optical fibers may include one or more cores ([0020], [0056]). Van teaches optically coupling a distal end of the first optical fiber (12) (i.e. second optical fiber) to the proximal end of the second optical fiber (14) (i.e. first optical fiber) (Fig. 7, [0091], [0056], [0061]). Moreover, Van teaches providing incident light and receiving incident light to the optical fibers via an interrogator (46) (Fig. 7, [0092], [0098], wherein optically interrogating multi-core fibers for optical shape sensing implies transmitting light to and receiving reflected light from the optical fibers). Van further teaches wherein the multi-core fibers may include fiber Bragg gratings and wherein strain is measured for shape sensing ([0044], [0100], wherein FBGs produce a reflected wavelength that is a function of the strain, thereby resulting in different spectral widths of incident light signal from a multi-core fiber). Moreover, Van teaches wherein the first optical fiber (12) (i.e. second optical fiber) serves as an interconnect between the console (46) and the second optical fiber (14) (i.e. first optical fiber) included in the medical instrument (Fig. 7).
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Van therefore teaches wherein two optically coupled optical fibers may be used for medical device tracking, i.e. shape sensing.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chopra to use two optically coupled optical fibers instead of one as taught by Van (Figs. 2 & 7, [0055-0056], [0061]). Using two optical fibers instead of one allows for a sterility barrier to be provided between the optical fibers, thereby improving sterility management, and this sterility management is important for optical shape sensing, as recognized by Van (Abstract, [0004-0005], [0010]). Since Van teaches using two optically coupled optical fibers (12, 14) and using one (12) to serve as an interconnect between an optical fiber (14) of a medical instrument and a console/interrogator (46) (See figure 7), Chopra modified by the teachings of Van would predictably result in wherein the interconnect includes a second optical fiber, the second optical fiber including one or more core fibers, the coupling including optically coupling a distal end of the second optical fiber to a proximal end of the first optical fiber, providing an incident light signal to the second optical fiber, and receiving reflected light signals of different spectral widths of the incident light from the second optical fiber.
Regarding claim 2, Chopra in view of Messerly and Van teaches the invention as claimed above in claim 1.
However, Chopra fails to teach the invention further comprising inserting the stylet into a catheter to guide the catheter within a vasculature of a patient.
In an analogous method for tracking a medical instrument field of endeavor, Messerly teaches such a feature. Messerly teaches inserting a stylet (130) with in a catheter (72) to be inserted into a patient (70) (Fig. 2, [0037]). Messerly teaches wherein the stylet (130) includes an optical fiber and is configured to be inserted into the catheter (72), enabling a system (10) to guide and track the catheter (72) within the vasculature of the patient to a desired destination within the body ([0022], [0036], [0041]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chopra to insert the stylet into a catheter to guide the catheter within a vasculature of a patient as taught by Messerly ([0022], [0036], [0041]). The optically tracked stylet being inserted into the catheter for guidance may reduce reliance on other imaging modalities such as X-ray for catheter placement, thereby reducing patient exposure to harmful x-rays as recognized by Messerly ([0024]).
Regarding claim 5, Chopra in view of Messerly and Van teaches the invention as claimed above in claim 1.
Chopra teaches the invention further comprising coupling the interconnect (258) to a patient (P), wherein the positioning and the orientation of the stylet (254) is determined relative to the patient (P) (Fig. 3, [0049], “The sensor device 258 includes a fiduciary apparatus 260 and a reference body 262. The fiduciary apparatus 260 includes a surface 264 that is removably attached to the patient P using an adhesive or other chemical or mechanical fixation mechanism”, [0056], “Thus, processing the relative pose and shape information for the catheter body 254 with the registration information for the reference portion 251 of the shape sensor fiber provides the pose and shape of the catheter body 254 relative to the patient P”, and wherein Chopra modified by Messerly above results in the medical instrument/catheter to be a stylet).
Regarding claim 6, Chopra in view of Messerly and Van teaches the invention as claimed above in claim 1.
Chopra further teaches wherein each of the one or more core fibers of the first optical fiber and the second optical fiber include a plurality of sensors (FBGs) distributed along a longitudinal length of a corresponding core fiber, and wherein each sensor (FBG) of the plurality of sensors (FBGs) reflects a light signal of a different spectral width based on received incident light, and changes a characteristic of the reflected light signal for use in determining a physical state of the corresponding optical fiber ([0040-0042], wherein “an array of FBG's is provided within each core” comprises a plurality of sensors being distributed along a longitudinal length of a corresponding core fiber, “During fabrication of the FBG's, the modulations are spaced by a known distance, thereby causing reflection of a known band of wavelengths”, “FBG's produce a reflected wavelength that is a function of the strain on the fiber and its temperature”, and wherein Chopra modified by Van above results in the first optical fiber 253 to comprise a first and second optical fiber).
Regarding claim 8, Chopra in view of Messerly and Van teaches the invention as claimed above in claim 1.
Chopra further teaches wherein the first optical fiber and the second optical fiber are multi-core optical fibers, each including a plurality of core fibers ([0039], [0042], wherein Chopra modified by Van above results in the first optical fiber 253 to comprise a first and second optical fiber).
Regarding claim 9, Chopra teaches a non-transitory computer-readable medium having stored thereon logic that, when executed by the one or more processors ([0078], “Processor readable storage device examples include an electronic circuit…”), causes operations comprising:
providing an incident light signal to a first optical fiber (253) included in a medical instrument (254), wherein the first optical fiber (253) includes one or more of core fibers (Fig. 3, [0041], [0043], [0054], [0056]);
receiving reflected light signals of different spectral widths of the incident light signal from the first optical fiber (253) ([0054], [0040-0042], “For example, FBG's produce a reflected wavelength that is a function of the strain on the fiber and its temperature”, “measured by monitoring the wavelength shifts in each core”, wherein the reflected wavelength which is a function of strain on the fiber, each core having different strains induced therein, and monitoring wavelength shifts in each core comprises receiving reflected light signals of different spectral widths);
processing the reflected light signals to determine a positioning and an orientation of the medical instrument (254) relative to a predetermined bend (251) formed in an interconnect (258) (Fig. 3, [0053], “the reference body 262 include a sensor holder 272 configured to hold a reference portion 251 the shape sensor fiber 253 in a predefined reference shape. In this embodiment, the sensor holder 272 is a continuous winding channel that receives the shape sensor fiber 253 and maintains the fiber in a predefined shape configuration relative to the reference body 262”, [0054], “interrogation system 276 for generating, and detecting the light used to determine the current shape of the shape sensor fiber 253”, [0056], “The interrogation system 276 interrogates the shape sensor fiber 253 to determine the pose of the distal tip and the shape of the flexible catheter body 254. This sensed relative pose and shape data for the catheter body 254 is known relative to the reference portion 251 of the shape sensor fiber”, wherein the pose of the catheter 254 is its position and orientation); and
generating a display of the medical instrument (254) based on the reflected light signals and the determination of the positioning and the orientation of the medical instrument (254) relative to the predetermined bend (251) ([0058], “At 326, the shape sensor information is received (in the reference frame of the shape sensor fiber 253) for processing. At 328, the pose of the distal end (or any other portion) of the shape sensor fiber 253 is determined in the image reference frame based on a registration between the image reference frame and the reference frame of the shape sensor 253. Optionally, an image from the image reference frame that corresponds to the pose of the distal end of the flexible body 254 is displayed. The image may be of the distal end of the flexible body 254 superimposed on an image from the patient model”).
However, Chopra fails to teach wherein the medical instrument is a stylet.
In an analogous optical fiber-based medical device tracking field of endeavor, Messerly teaches such a feature (Title). Messerly teaches wherein an optical fiber (140) and a plurality of strain sensors may be included in a stylet (130) (Fig. 1A, [0036], [0039], [0048]). Messerly teaches wherein the strain sensors are fiber Bragg gratings (FBGs) ([0020], [0046-0047]). Messerly teaches wherein the stylet (130) may then be placed within a catheter (72) to enable a system (10) to guide the catheter within the vasculature of a patient ([0036]). Moreover, Messerly teaches a console (20) comprising an optical module (50) configured to provide incident light signals to the optical fiber and to receive reflected light signals (Fig. 1-2, [0035], [0048]). Messerly therefore teaches wherein a tracked medical instrument based on optical fibers may be a stylet.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chopra to have the tracked medical instrument be a stylet as taught by Messerly ([0036], [0046-0048]). The optically tracked stylet may be insertable into a catheter, helping guide the catheter through a patient’s vasculature to a desired location as recognized by Messerly ([0036], [0042], [0051]).
However, the modified combination above fails to teach providing an incident light signal to a second optical fiber included in the interconnect, wherein the second optical fiber includes one or more core fibers, and wherein a distal end of the second optical fiber is optically coupled to a proximal end of the first optical fiber; and receiving reflected light signals of different spectral widths of the incident light from the second optical fiber (i.e. Chopra teaches only a single optical fiber rather than a first and second optical fiber; Chopra fails to teach wherein the first optical fiber comprises a first optical fiber and a second optical fiber).
In an analogous optical fiber-based medical device tracking field of endeavor, Van teaches such a feature. Van teaches optically coupling a first optical fiber (12) with a second optical fiber (14) for use in medical interventions (Fig. 2, [0055-0056]). Van teaches wherein one optical fiber (12) is connected to a interrogator, e.g. a console, and the other optical fiber (14) is incorporated into a flexible medical devices such as catheters, guidewires, and sheathes (i.e. stylet), which are introduced into the body of the patient, thereby serving as an optical sensor ([0057]). Van further teaches wherein the optical fibers may include one or more cores ([0020], [0056]). Van teaches optically coupling a distal end of the first optical fiber (12) (i.e. second optical fiber) to the proximal end of the second optical fiber (14) (i.e. first optical fiber) (Fig. 7, [0091], [0056], [0061]). Moreover, Van teaches providing incident light and receiving incident light to the optical fibers via an interrogator (46) (Fig. 7, [0092], [0098], wherein optically interrogating multi-core fibers for optical shape sensing implies transmitting light to and receiving reflected light from the optical fibers). Van further teaches wherein the multi-core fibers may include fiber Bragg gratings and wherein strain is measured for shape sensing ([0044], [0100], wherein FBGs produce a reflected wavelength that is a function of the strain, thereby resulting in different spectral widths of incident light signal from a multi-core fiber). Moreover, Van teaches wherein the first optical fiber (12) (i.e. second optical fiber) serves as an interconnect between the console (46) and the second optical fiber (14) (i.e. first optical fiber) included in the medical instrument (Fig. 7).
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Van therefore teaches wherein two optically coupled optical fibers may be used for medical device tracking, i.e. shape sensing.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chopra to use two optically coupled optical fibers instead of one as taught by Van (Figs. 2 & 7, [0055-0056], [0061]). Using two optical fibers instead of one allows for a sterility barrier to be provided between the optical fibers, thereby improving sterility management, and this sterility management is important for optical shape sensing, as recognized by Van (Abstract, [0004-0005], [0010]). Since Van teaches using two optically coupled optical fibers (12, 14) and using one (12) to serve as an interconnect between an optical fiber (14) of a medical instrument and a console/interrogator (46) (See figure 7), Chopra modified by the teachings of Van would predictably result in providing an incident light signal to a second optical fiber included in the interconnect, wherein the second optical fiber includes one or more core fibers, and wherein a distal end of the second optical fiber is optically coupled to a proximal end of the first optical fiber; and receiving reflected light signals of different spectral widths of the incident light from the second optical fiber.
Regarding claim 10, Chopra in view of Messerly and Van teaches the invention as claimed above.
However, Chopra fails to teach wherein the stylet is configured for inserting into a catheter to guide the catheter within a vasculature of a patient.
In an analogous method for tracking a medical instrument field of endeavor, Messerly teaches such a feature. Messerly teaches inserting a stylet (130) with in a catheter (72) to be inserted into a patient (70) (Fig. 2, [0037]). Messerly teaches wherein the stylet (130) includes an optical fiber and is configured to be inserted into the catheter (72), enabling a system (10) to guide and track the catheter (72) within the vasculature of the patient to a desired destination within the body ([0022], [0036], [0041]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chopra to have the stylet be configured for insertion into a catheter to guide the catheter within a vasculature of a patient as taught by Messerly ([0022], [0036], [0041]). The optically tracked stylet being insertable into the catheter for guidance may reduce reliance on other imaging modalities such as X-ray for catheter placement, thereby reducing patient exposure to harmful x-rays as recognized by Messerly ([0024]).
Regarding claim 13, Chopra in view of Messerly and Van teaches the invention as claimed above in claim 9.
Chopra further teaches wherein the interconnect (258) is configured to couple to a patient (P), wherein the positioning and the orientation of the stylet (254) is determined relative to the patient (P) (Fig. 3, [0049], “The sensor device 258 includes a fiduciary apparatus 260 and a reference body 262. The fiduciary apparatus 260 includes a surface 264 that is removably attached to the patient P using an adhesive or other chemical or mechanical fixation mechanism”, [0056], “Thus, processing the relative pose and shape information for the catheter body 254 with the registration information for the reference portion 251 of the shape sensor fiber provides the pose and shape of the catheter body 254 relative to the patient P”, and wherein Chopra modified by Messerly above results in the medical instrument/catheter to be a stylet).
Regarding claim 14, Chopra in view of Messerly and Van teaches the invention as claimed above in claim 9.
Chopra further teaches wherein each of the one or more core fibers of the first optical fiber and the second optical fiber include a plurality of sensors (FBGs) distributed along a longitudinal length of a corresponding core fiber, and wherein each sensor (FBG) of the plurality of sensors (FBGs) reflects a light signal of a different spectral width based on received incident light, and changes a characteristic of the reflected light signal for use in determining a physical state of the corresponding optical fiber ([0040-0042], wherein “an array of FBG's is provided within each core” comprises a plurality of sensors being distributed along a longitudinal length of a corresponding core fiber, “During fabrication of the FBG's, the modulations are spaced by a known distance, thereby causing reflection of a known band of wavelengths”, “FBG's produce a reflected wavelength that is a function of the strain on the fiber and its temperature”, and wherein Chopra modified by Van above results in the first optical fiber 253 to comprise a first and second optical fiber).
Regarding claim 16, Chopra in view of Messerly and Van teaches the invention as claimed above in claim 9.
Chopra further teaches wherein the first optical fiber and the second optical fiber are multi-core optical fibers, each including a plurality of core fibers ([0039], [0042], wherein Chopra modified by Van above results in the first optical fiber 253 to comprise a first and second optical fiber).
Claims 3-4 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Chopra (US20140275997) in view of Messerly (US20180289927) and Van (US20180140170) as applied to claims 1 and 9 respectively above, and further in view of Cole (US20170290563). Cole is cited in the IDS filed 03/26/2025.
Regarding claim 3, Chopra in view of Messerly and Van teaches the invention as claimed above in claim 1.
However, Chopra fails to teach the invention further comprising coupling the interconnect to an ultrasound probe, the ultrasound probe in communication with the console, wherein the positioning and the orientation of the stylet is determined relative to the ultrasound probe.
In an analogous medical instrument including an optical fiber field of endeavor, Cole teaches such a feature. Cole teaches a shape sensing device or system (104) including one or more optical fibers (126) (Fig. 1, [0034-0035], wherein the shape sensing device 104 comprises an interconnect). Cole teaches the shape sensing device (104) may be included in a catheter, guidewire, or other medical component ([0035], wherein a catheter comprises a medical instrument). Cole teaches the shape sensing device (104) may be a catheter that is used with an ultrasound probe (102) (Fig. 1, [0034], [0048]). Cole teaches the shape sensing device (104), optical fibers (126), and the ultrasound probe (102) are connected to a workstation (112) (Fig. 1, [0033-0035], “System 100 may include a workstation or console 112 from which a procedure is supervised and/or managed”, wherein the workstation 112 comprises a console and figure 1 shows both the shape sensing device 104 and the ultrasound probe 102 connected to the workstation/console 112). Moreover, Cole teaches the medical device (102) comprising an ultrasound probe (102) has an attachment piece (106) including a fiber carrying template or pathway (105) with distinctive geometry (Fig. 1, [0034], [0048]). Cole teaches the fiber (126) takes a predefined path/shape (107) around the probe (102) via a template (105) of an attachment piece (106) on the ultrasound probe (102) (Fig. 1, [0034-0035], [0045], [0048], wherein the fiber taking a predefined path/shape around the probe comprises a predetermined bend in the interconnect). Cole therefore teaches an interconnect comprising an optical fiber (126) coupled to an ultrasound probe (102) such that it causes a predetermined bend (107) in the interconnect (126). Cole teaches a registration module (130) is configured to register the optical fiber (126) or shape sensing device (104) to the template (105, 106) attached to the ultrasound probe (102) ([0042]). Cole teaches an axis defining an origin position and orientation can be defined relative to the shape template (105, 126) ([0045]). Cole teaches the fiber (126) is tracked relative to the probe (102) for optimal registration ([0043]). Cole illustrates in figure 6 an example of a predefined bend/shape/path a fiber (502) may take while coupled to an ultrasound probe (500) (Fig. 6, [0054]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chopra to further couple the interconnect comprising an optical fiber to an ultrasound probe such that the predetermined bend is formed and the position/orientation of the medical instrument is determined relative to the ultrasound probe as taught by Cole (Figs. 1 & 6, [0033-0035], [0042-0043], [0045], [0048], [0054]). Cole teaches ultrasound imaging is often used for interventional cardiac and vascular procedures ([0021]), and by integrating the fiber with the ultrasound probe, the ultrasound probe may be tracked as recognized by Cole ([0026]). Moreover, by tracking both the device (stylet) and the ultrasound transducer/probe, the interventional devices can be registered to an ultrasound image space without secondary imaging modalities or tracking methods, further enabling for advanced functions of the devices and for interpretation of ultrasound imaging including automatic image slice selection as further recognized by Cole ([0028]).
Regarding claim 4, Chopra in view of Messerly, Van, and Cole teaches the invention as claimed above in claim 3.
However, Chopra fails to teach the invention further comprising: receiving ultrasound imaging data from the ultrasound probe; and rendering an ultrasound image from the ultrasound imaging data, wherein the display of the stylet is rendered as an overlay on the ultrasound image.
In an analogous medical instrument including an optical fiber field of endeavor, Cole teaches such a feature. Cole teaches a shape sensing device or system (104) including one or more optical fibers (126) (Fig. 1, [0034-0035]). Cole teaches the shape sensing device (104) may be included in a catheter, guidewire, or other medical component ([0035], wherein the shape sensing device (104) included in a catheter comprises a medical instrument). Cole teaches the shape sensing device (104) may be a catheter that is used with an ultrasound probe (102) (Fig. 1, [0034], [0048]). Cole teaches an image (134) of the shape sensing device (104) can be displayed on a display device (118) ([0041]). Cole teaches the image (134) is an ultrasound image captured by the ultrasound probe (102) ([0041]). Cole teaches the image (134) of the shape sensing system (104) may be an overlay or other rendering registered with the shape sensing device (104) on the display (118) ([0041]). Moreover, Cole teaches interventional devices can be registered to the ultrasound image space, enabling image overlay of advanced information such as device position ([0028]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chopra to display an ultrasound image of the shape sensed device (medical instrument, i.e. stylet) on a display and to render the device as an overlay on the ultrasound image as taught by Cole ([0028], [0041]). Cole teaches the image of the device may be included as an overlay or other rendering registered with the device ([0041]). Moreover, Cole teaches overlaying information such as device position on the ultrasound image ([0028]). Modifying Chopra in view of Messerly, whom teaches a stylet, with the teachings of Cole would predictably result in overlaying the position and/or rendering of the stylet on the ultrasound image received from the ultrasound probe.
Regarding claim 11, Chopra in view of Messerly and Van teaches the invention as claimed above in claim 9.
However, Chopra fails to teach wherein the interconnect is configured to be coupled to an ultrasound probe in communication with a console, wherein the positioning and the orientation of the stylet is determined relative to the ultrasound probe.
In an analogous medical instrument including an optical fiber field of endeavor, Cole teaches such a feature. Cole teaches a shape sensing device or system (104) including one or more optical fibers (126) (Fig. 1, [0034-0035], wherein the shape sensing device 104 comprises an interconnect). Cole teaches the shape sensing device (104) may be included in a catheter, guidewire, or other medical component ([0035], wherein a catheter comprises a medical instrument). Cole teaches the shape sensing device (104) may be a catheter that is used with an ultrasound probe (102) (Fig. 1, [0034], [0048]). Cole teaches the shape sensing device (104), optical fibers (126), and the ultrasound probe (102) are connected to a workstation (112) (Fig. 1, [0033-0035], “System 100 may include a workstation or console 112 from which a procedure is supervised and/or managed”, wherein the workstation 112 comprises a console and figure 1 shows both the shape sensing device 104 and the ultrasound probe 102 connected to the workstation/console 112). Moreover, Cole teaches the medical device (102) comprising an ultrasound probe (102) has an attachment piece (106) including a fiber carrying template or pathway (105) with distinctive geometry (Fig. 1, [0034], [0048]). Cole teaches the fiber (126) takes a predefined path/shape (107) around the probe (102) via a template (105) of an attachment piece (106) on the ultrasound probe (102) (Fig. 1, [0034-0035], [0045], [0048], wherein the fiber taking a predefined path/shape around the probe comprises a predetermined bend in the interconnect). Cole therefore teaches an interconnect comprising an optical fiber (126) coupled to an ultrasound probe (102) such that it causes a predetermined bend (107) in the interconnect (126). Cole teaches a registration module (130) is configured to register the optical fiber (126) or shape sensing device (104) to the template (105, 106) attached to the ultrasound probe (102) ([0042]). Cole teaches an axis defining an origin position and orientation can be defined relative to the shape template (105, 126) ([0045]). Cole teaches the fiber (126) is tracked relative to the probe (102) for optimal registration ([0043]). Cole illustrates in figure 6 an example of a predefined bend/shape/path a fiber (502) may take while coupled to an ultrasound probe (500) (Fig. 6, [0054]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chopra to further couple the interconnect comprising an optical fiber to an ultrasound probe such that the predetermined bend is formed and the position/orientation of the medical instrument is determined relative to the ultrasound probe as taught by Cole (Figs. 1 & 6, [0033-0035], [0042-0043], [0045], [0048], [0054]). Cole teaches ultrasound imaging is often used for interventional cardiac and vascular procedures ([0021]), and by integrating the fiber with the ultrasound probe, the ultrasound probe may be tracked as recognized by Cole ([0026]). Moreover, by tracking both the device (stylet) and the ultrasound transducer/probe, the interventional devices can be registered to an ultrasound image space without secondary imaging modalities or tracking methods, further enabling for advanced functions of the devices and for interpretation of ultrasound imaging including automatic image slice selection as further recognized by Cole ([0028]).
Regarding claim 12, Chopra in view of Messerly, Van, and Cole teaches the invention as claimed above in claim 11.
However, Chopra fails to teach wherein the one or more processors causes further operations comprising: receiving ultrasound imaging data from the ultrasound probe; and rendering an ultrasound image from the ultrasound imaging data, wherein the display of the stylet is rendered as an overlay on the ultrasound image.
In an analogous medical instrument including an optical fiber field of endeavor, Cole teaches such a feature. Cole teaches a shape sensing device or system (104) including one or more optical fibers (126) (Fig. 1, [0034-0035]). Cole teaches the shape sensing device (104) may be included in a catheter, guidewire, or other medical component ([0035], wherein the shape sensing device (104) included in a catheter comprises a medical instrument). Cole teaches the shape sensing device (104) may be a catheter that is used with an ultrasound probe (102) (Fig. 1, [0034], [0048]). Cole teaches an image (134) of the shape sensing device (104) can be displayed on a display device (118) ([0041]). Cole teaches the image (134) is an ultrasound image captured by the ultrasound probe (102) ([0041]). Cole teaches the image (134) of the shape sensing system (104) may be an overlay or other rendering registered with the shape sensing device (104) on the display (118) ([0041]). Moreover, Cole teaches interventional devices can be registered to the ultrasound image space, enabling image overlay of advanced information such as device position ([0028]). Cole further teaches wherein the methods described herein may be performed or executed by hardware including a processor and memory ([0030-0031]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chopra to have the processor cause receiving ultrasound imaging data and displaying an ultrasound image of the shape sensed device (medical instrument, i.e. stylet) on a display and to render the device as an overlay on the ultrasound image as taught by Cole ([0028], [0030-0031], [0041]). Cole teaches the image of the device may be included as an overlay or other rendering registered with the device ([0041]). Moreover, Cole teaches overlaying information such as device position on the ultrasound image ([0028]). Modifying Chopra in view of Messerly, whom teaches a stylet, with the teachings of Cole would predictably result in overlaying the position and/or rendering of the stylet on the ultrasound image received from the ultrasound probe.
Claims 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Chopra (US20140275997) in view of Messerly (US20180289927) and Van (US20180140170) as applied to claims 1 and 9 respectively above, and further in view of Younge (US20120321243). Younge is cited in the IDS filed 03/26/2025.
Regarding claim 7, Chopra in view of Messerly and Van teaches the invention as claimed above in claim 1.
However, Chopra fails to teach wherein the first optical fiber and the second optical fiber are single-core optical fibers, and wherein providing the incident light signal comprises providing the incident light signal in pulses.
In an analogous medical instrument including an optical fiber field of endeavor, Younge teaches such a feature. Younge teaches a method of addressing twist or rotation of an elongate instrument using an optical fiber Bragg grating to determine positions of sections along the length of the elongate instrument (Fig. 20, [0096]). Younge teaches the implementation of an optical fiber Bragg grating system for determining the position of the instrument may be comprised of single-core optical fibers, multi-core optical fibers, or a combination of the two (Fig. 20, [0096]). Younge teaches pulses of light may be propagated down an optical fiber (12) to a number of fiber gratings, each pulse from a pulsed light source (52) resulting in a number of return pulses (Fig. 30B, [0104]). Younge teaches this allows for measurements of twist to be made ([0104]). Younge teaches by measuring twist, more accurate estimates of position or shape of an elongate instrument using optical fibers may be made ([0095]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chopra to use single-core optical fibers and to pulse light down said optical fibers as taught by Younge ([0095-0096], [0104]). A single-core optical fiber may similarly be used to determine position of an instrument as recognized by Younge ([0096]), and pulsing light down an optical fiber may be used to extract and measure twist, leading to a more accurate measurement of position and/or shape as further recognized by Younge ([0095], [0104]). Modifying Chopra with Younge would predictably result in both first and second optical fibers being single-cored and having incident light be pulsed therein.
Regarding claim 15, Chopra in view of Messerly and Van teaches the invention as claimed above in claim 9.
However, Chopra fails to teach wherein the first optical fiber and the second optical fiber are single-core optical fibers, and wherein providing the incident light comprises providing the incident light in pulses.
In an analogous medical instrument including an optical fiber field of endeavor, Younge teaches such a feature. Younge teaches a method of addressing twist or rotation of an elongate instrument using an optical fiber Bragg grating to determine positions of sections along the length of the elongate instrument (Fig. 20, [0096]). Younge teaches the implementation of an optical fiber Bragg grating system for determining the position of the instrument may be comprised of single-core optical fibers, multi-core optical fibers, or a combination of the two (Fig. 20, [0096]). Younge teaches pulses of light may be propagated down an optical fiber (12) to a number of fiber gratings, each pulse from a pulsed light source (52) resulting in a number of return pulses (Fig. 30B, [0104]). Younge teaches this allows for measurements of twist to be made ([0104]). Younge teaches by measuring twist, more accurate estimates of position or shape of an elongate instrument using optical fibers may be made ([0095]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chopra to use single-core optical fibers and to pulse light down said optical fibers as taught by Younge ([0095-0096], [0104]). A single-core optical fiber may similarly be used to determine position of an instrument as recognized by Younge ([0096]), and pulsing light down an optical fiber may be used to extract and measure twist, leading to a more accurate measurement of position and/or shape as further recognized by Younge ([0095], [0104]). Modifying Chopra with Younge would predictably result in both first and second optical fibers being single-cored and having incident light be pulsed therein.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TOMMY T LY/ Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/ Supervisory Patent Examiner, Art Unit 3795
07/28/26
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