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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/23/2026 has been entered.
Response to Arguments
Regarding double patenting
Regarding applicant’s remarks regarding the double patenting rejection, it is noted that a complete response to a nonstatutory double patenting rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct form the reference claims or the filing of a terminal disclaimer and such a filing should not be held in abeyance (MPEP 804). Applicant’s request to hold the double patenting rejection in abeyance without such filing of a showing of the patentable distinction or a terminal disclaimer are therefore considered incomplete and are not found persuasive. The double patenting rejection is updated/maintained in view of the amendments to the claims.
Regarding 35 U.S.C. 112(b)
Examiner notes that the previously set forth 112(b) rejections of claims 8 and 13 are withdrawn in view of the amendments to the claims, however, claim 9 has not been amended and still recites “the various aspects” and is rejected for the same reasons as previously stated.
Regarding prior art
Applicant’s arguments with respect to claim 1 have been considered but are moot in view of the new grounds of rejection necessitated by amendment. Specifically new teachings from Eberle are relied upon to teach the core wire having a longitudinal notch defined in an outer surface of the core wire, the longitudinal notch extending distally from a proximal end of the core wire to a distal end of the core wire and extending parallel to a longitudinal axis of the core wire from the proximal end to the distal end. Specifically it is noted that applicant’s arguments are directed to an embodiment of Eberle which teaches a helically wound groove, however, Eberle teaches alternative embodiments of a groove formed in a core wire with respect to figs. 21A-21C and disclosure in [0281]-[0282] which explicitly disclose that the groove can extend along the length of the guidewire substantially parallel to a longitudinal axis of the guidewire 2102. Therefore applicant’s arguments regarding the teachings of Eberle with respect to the axial/helically wound groove are found to be moot in view of the new grounds of rejection.
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.
Claim 9 is 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.
Claim 9 recites the limitation “the various aspects”. There is insufficient antecedent basis for the limitation in the claims. It is therefore unclear if the various aspects is intended to be the same as the more than one aspect recited previously or if this is a different “various aspects”. For examination purposes, it has been interpreted to mean the more than one aspect, however, clarification is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ramachandran et al. (US 20140206988 A1 included in applicant’s IDS filed 01/05/2026), hereinafter Ramachandran in view of Flexman et al. (US 20180264227 A1), hereinafter Flexman in view of Eberle et al. (US 20150141854 A1), hereinafter Eberle.
Regarding claim 1,
Ramachandran teaches a catheter placement system (at least fig. 1 (100) and corresponding disclosure in at least [0021]):
Comprising a stylet (at least fig. 1 (102) and corresponding disclosure in at least [0021] which discloses the medical device 102 may include a catheter, a guidewire) including a fiber-bearing portion, the fiber-bearing portion including a core-wire ([0021] which discloses the medical device may include a guidewire. Examiner notes that the fiber-bearing portion is considered to be any portion of the guidewire, thus the guidewire itself is considered to be the fiber-bearing portion and includes a core-wire (i.e. the guide-wire)) and an optical fiber (at least fig. 1 (104/126) and corresponding disclosure in at least [0022]) secured in the core wire (see at least fig. 1), and the optical fiber (104/126) including a first plurality of optical-fiber-based strain sensors ([0023]-[0024] disclosing the use of fiber optic Bragg sensors and Bragg gratings can be used as sensing elements in the fiber optic sensors) disposed along a first longitudinal axis (at least fig. 3 (302) and corresponding disclosure in at least [0035]) of the optical fiber and a second plurality of optical-fiber-based strain sensors ([0023]-[0024] disclosing the use of fiber optic Bragg sensors and Bragg gratings can be used as sensing elements in the fiber optic sensors) disposed along a second longitudinal axis (at least fig. 3 (304) and corresponding disclosure in at least [0035]) of the optical fiber, the first longitudinal axis and the second longitudinal axis being non colinear with each other (see at least fig. 3);
A light source (at least fig. 1 (106) and corresponding disclosure in at least [0022]) operably connected to the stylet (see at least fig. 1), the light source (106) configured to produce outgoing optical signals incident on the first plurality of optical-fiber-based strain sensors and the second plurality of optical-fiber-based strain sensors (an optical source 106 may be provided as part of the interrogator 108 or as a separate unit for providing light signals to the sensing device 104);
A detector (at least fig. 1 (108) and corresponding disclosure in at least [0022]) operably connected to the stylet (see at least fig. 1), the detector (108) configured to receive return optical signals form the first plurality of optical-fiber-based strain sensors and the second plurality of optical-fiber-based strain sensors ([0022] which discloses the optical interrogator receives optical responses), wherein the return optical signals are for more than one aspect of the optical fiber in accordance with at least the first plurality of optical fiber-based strain sensors ([0035] which discloses An optical fiber may be employed to measure strain and is also sensitive to temperature. In one embodiment, three outer fiber cores 302 are disposed about a fourth central core 304. With this combination, separate measurements of strain may be obtained leading to shape (cores 302) and spatially resolved temperature (along the length) (core 304). The configuration works best if there is no axial strain present. In most scenarios, axial strain of the device 104 is negligible since the device is not stretched along its length, and therefore it is reasonable to assume that the primary influence in the central core 304 is due to temperature. Other configurations may also be employed to zero out or account for axial strain if present. For example, a second central core (not shown) with different properties from the first core may be provided such that physical strain and temperature strain may be distinguished. The second central core may be provided with different properties or different doping material to give a different refractive index and/or coefficient of expansion. These same features or differences can also be applied to the outer cores (not just central the central core or cores) where each core could have a different property such that measurement differences would permit multiple solutions to resolve axial strain, temperature values, etc);
A console (at least fig. 1 (112) and corresponding disclosure in at least [0021]) operably connected to the stylet (102), the console including a memory (at least fig. 1 (116) and corresponding disclosure in at least [0021]) and a processor (at least fig. 1 (112 and/or 114) and corresponding disclosure in at least [0021])configure to:
Propagate the outgoing optical signals to the first plurality of optical-fiber based strain sensors and the second plurality of optical-fiber-based strain sensors ([0021] which discloses the optical source provides light signals to the sensing device 104);
Process optical data from the return optical signals from the first plurality of optical-fiber-based strain sensors and the second plurality of optical-fiber-based strain sensors ([0021] which discloses an optical sensing and interpretation module 115 configured to interpret optical feedback signals from a shape and/or temperature sensing device or system 104);
Map the stylet in accordance with more than one aspect of the stylet including a location of the stylet within a body of a patient ([0045] which discloses an image of the body may be registered to temperature/shape sensing space using the temperature transition point as a reference); and
A display configured to display information relating to the more than one aspect of the stylet including an image (at least fig. 2 (200) and corresponding disclosure in at least [0031]) of the optical fiber on the body of the patient (see at least fig. 2)
While Ramachandran teaches the medical device may be a catheter, Ramachandran fails to explicitly teach the catheter and stylet in combination, therefore in the embodiment in which the medical device is a stylet (i.e. guidewire), Ramachandran fails to explicitly teach a catheter including a lumen extending between a proximal end and a distal end of the catheter, the stylet removably inserted into the lumen of the catheter, the display information including an image of the catheter mapped on the body of the patient.
Flexman teaches a catheter placement system, comprising:
A catheter (at least fig. 1 (102) and corresponding disclosure in at least [0040]) including a lumen (at least fig. 1 (103) and corresponding disclosure in at least [0040]) extending between a proximal end and a distal end of the catheter;
A stylet (at least fig. 1 (108) and corresponding disclosure in at least [0040]) removably inserted into the lumen of the catheter, the stylet including a fiber bearing portion, the fiber-bearing portion including a core wire ([0040] which discloses guidewire (i.e. core wire)) and an optical fiber (at least fig. 1 (104) and corresponding disclosure in at least [0040]-[0041]) received by the core wire, and the optical fiber (104) including a first plurality of optical-fiber-based strain sensors disposed along a first longitudinal portion of the optical fiber ([0042] which discloses the fiber optics may be based on fiber optic Bragg grating sensors and [0045] which discloses Bragg grating can be used as sensing elements in fiber optical sensors);
An optical sensing module (at least fig. 1 (122) and corresponding disclosure in at least [0040]) operably connected to the stylet (see at least fig. 1), the optical sensing module configured to receive return optical signals from the plurality of optical-fiber-based strain sensors ([0040] which discloses optical sensing module 122 configured to interpret optical feedback signals from a shape sensing device or system 104)) ;
A console (at least fig. 1 (112) and corresponding disclosure in at least [0040]) operably connected to the stylet (see at least fig. 1), the console including memory (at least fig. 1 (116) and corresponding disclosure in at least [0040]) and a processor (at least fig. 1 (114 and 122) and corresponding disclosure in at least [0040]) configured to:
Process optical data from the return optical signals ([0040] which discloses the optical sensing module 122 is configured to use the optical signal feedback and any other feedback to reconstruct deformations, deflections, and other changes associated with shape sensing devices); and
Map the catheter in accordance with aspects of the stylet including a location of the stylet within a body of the patient ([0054] which discloses the over-the wire devices inserted into the measurement fixture 150 that has a known position with respect to the guidewire 108. The position of the tip of the device 102 (e.g. catheter) is computed and [0030] which discloses the shape can be detected along the fiber to known the longitudinal registration between the guidewire and the over-the-wire device. Examiner notes that any such mapping is thus in accordance with various aspects of the stylet (i.e. guidewire) including its location) ; and
A display (at least fig. 1 (118) and corresponding disclosure in at least [0047]) configured to display information relating to aspects of the stylet including an image of the catheter mapped on the body of the patient ([0047] which discloses workstation 112 includes the display 118 for viewing internal images of a subject (patient) or volume 130 and may include shape images 134 as an overlay on medical images 136 such as x-ray images [0048] which discloses the device 102 and the target node 124 are preferably visualized in an image or images 136. Examiner notes that the image of the catheter mapped on the body of the patient is considered to be information relating to the various aspects of the stylet).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ramachandran to include a catheter and removably inserting the stylet into the lumen of the catheter as taught by Flexman in order to permit a catheter to be navigated using the shape sensed guidewire (Flexman [0030]). Such a modification would provide for the guidewire of Ramachandran to be used for navigating an over-the wire catheter, thereby providing additional uses for the guidewire of Ramachandran.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ramachandran to include mapping the catheter and displaying information as taught by Flexman in order to provide additional information regarding the position of the over-the-wire device, such that a person may readily recognize the position of the entire medical device when the guidewire is in use with the catheter.
Ramachandran further fails to explicitly teach the the core wire having a longitudinal notch defined in an outer surface of the core wire, the longitudinal notch extending distally from a proximal end of the core wire to a distal end of the core wire and extending parallel to a longitudinal axis of the core wire from the proximal end to the distal end and the optical fiber secured in the longitudinal notch of the core wire by potting and a photodetector.
Eberle, in a similar filed of endeavor involving guidewires with optical fibers, teaches
a stylet (at least fig. 21A (2100) and corresponding disclosure in at least [0281]) including a fiber-bearing portion the fiber-bearing portion including a core wire(at least fig. 21B (2118) and corresponding disclosure in at least [0281]) having a longitudinal notch (at least fig. 21B (2132) and corresponding disclosure in at least [0282]) defined in an outer surface of the core wire (2118) (see at least fig. 21A and [0281] which discloses the narrow, shallow channel or groove 2132 can be cut into the outer wall components that form the guidewire 2102), the longitudinal notch (2132) extending distally from a proximal end of the core wire to a distal end of the core wire and extending parallel to a longitudinal axis of the core wire from the proximal end to the distal end ([0282] which discloses the groove 2132 can extend along the length of the guidewire substantially parallel to a longitudinal axis of the guidewire 2102) and an optical fiber (at least fig. 21A (2104) and corresponding disclosure in at least [0281]) secured in the longitudinal notch (2132) of the core wire (2118) by potting ([0284] which discloses optical fiber 2104 can be bonded to the groove 2132 by applying a hot melt adhesive to the optical fiber 2104 prior to positioning the optical fiber 2104 in the groove 2132 and then subsequently applying heat. Examiner notes an adhesive is consistent with applicant’s specification in at least [00039] and [00051]) and the optical fiber including a first plurality of optical-fiber-based strain sensors disposed along a first longitudinal portion of the optical fiber (see at least figs. 3 and 7 (FBG 2 and FBG 3) and corresponding disclosure in at least [0117] and [0165]) and a second plurality of optical-fiber-based strain sensors disposed along a second longitudinal portion of the optical fiber (see at least figs. 3 and 7 (FBG1 and FBG4) and corresponding disclosure in at least [0117] and [0165]) ,
a light source (at least fig. 6A (604) and corresponding disclosure in at least [0137]) operably connected to the stylet (see fig. 6A), the light source (604) configured to produce outgoing optical signals incident on fbg 1 the first plurality of optical fiber-based strain sensors and a second plurality of optical fiber based strain sensors and
a photodetector (at least fig. 6A (608) and corresponding disclosure in at least [0137]) operably connected to the stylet, the photodetector (608) configured to receive return optical signals from the first plurality of optical-fiber based strain sensors and the second plurality of optical-fiber-based strain sensors (any light reflected back from the optical fiber pressure sensor can enter… and received by an optical detector 608)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ramachandran, as modified, to include a photodetector as taught by Eberle in order to receive signals from the optical fiber strain sensors accordingly. Such a modification amounts to merely a simple substitution of one known optical receiver for another yielding predictable results with respect to optical fiber sensing rendering the claim obvious MPEP 2143.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ramachandran to include a core wire having a longitudinal notch and an optical fiber secured in a longitudinal notch of the core wire as taught by Eberle in order to provide optical fiber technology into a steerable guidewire having no significant effect on the mechanical performance of the guidewire (Eberle [0088]) and allow for incorporation into very low profile catheter which can track over the present guidewires (Eberle [0088]). Eberle further recognizes the advantages and desirability of miniaturization and optical fiber and optical fiber based pressure sensor or sensors and other sensors, for incorporation into a coronary guidewire, which in turn can optionally be used for lesion assessment guiding a balloon catheter or other device for positioning and securing a stent at the desired location or for guiding other treatment techniques in [0091], where it is noted that the devices (102) may be imaging and measurement catheter (e.g. intracoronary temperature, intravascular ultrasound, fractional flow reserve (FFR) measurements), thus providing additional advantages to the device of Ramachandran and/or Ramachandran as modified by Flexman.
Regarding claim 5,
Ramachandran, as modified, teaches the elements of claim 1 as previously stated. Ramachandran, as modified, further teaches real-time calculations using the fiber-optic sensors ([0012], [0029], and [0032]), therefore, would appear to suggest the light source is configured to iteratively emit the outgoing optical signals and the photodetector is configured to iteratively receive the return optical signals, however, this feature is not explicitly disclosed by Ramachandran.
Nonetheless, Eberle teaches the light source is configured to iteratively emit the outgoing optical signals and the photodetector is configured to iteratively receive the return optical signals ([0519] which discloses data (such as FFR) can be generated at one point in a treatment procedure or at multiple times throughout a procedure. Examiner notes that such data generated at multiple times throughout the procedure means that the laser and photodetector are configured to iteratively emit optical signals and receive optical signals respectively).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ramachandran, as currently modified, to include iteratively emitting and iteratively receiving as taught by Eberle in order to perform generate strain data used for processing the strain/temperature measurements multiple times throughout the procedure.
Regarding claim 6,
Ramachandran further teaches wherein the first plurality of optical-fiber-based strain sensors is included on a first channel of the optical fiber and the second plurality of optical-fiber-based strain sensors is included on a second channel of the optical fiber ([0035] which discloses An optical fiber may be employed to measure strain and is also sensitive to temperature. In one embodiment, three outer fiber cores 302 are disposed about a fourth central core 304. With this combination, separate measurements of strain may be obtained leading to shape (cores 302) and spatially resolved temperature (along the length) (core 304))
Regarding claim 7,
Ramachandran, as modified, teaches wherein the first plurality of optical-fiber-based strain sensors and the second plurality of optical-fiber-based strain sensors include fiber Bragg gratings (Flexman [0023]-[0025] which discloses FBG sensors for measuring temperature and strain. See also [0035] disclosing the optical fiber shape/temperature sensing device)
Regarding claim 8,
Ramachandran, as modified, further teaches wherein the one or more aspect of the stylet further include a two-dimensional shape, a three-dimensional shape, a position or orientation within the body of the patient, a pressure, and a temperature of the stylet ([0035] which discloses a shape/temperature sensing device 104 is illustratively shown with a cross-sectional view. An optical fiber may be employed to measure strain and is also sensitive to temperature. In one embodiment, three outer fiber cores 302 are disposed about a fourth central core 304. With this combination, separate measurements of strain may be obtained leading to shape (cores 302) and spatially resolved temperature (along the length) (core 304), [0037] which discloses with the configuration of four cores (302, 304), strains from temperature can be easily distinguished from geometrical strains. The strains in cores 302 may be employed to resolve temperature regions along the fibers as the geometry indicated by the cores 302 will provide positional information relative to the information collected from the central core 304 and [0020] which discloses the strain measurements are employed to determine device shape and determine specific locations along the device having temperature gradients).
Regarding claim 9,
Ramachandran, as modified, further teaches wherein the various aspects of the stylet include the location of the stylet within the body of the patient and a temperature of the stylet ([0035] which discloses a shape/temperature sensing device 104 is illustratively shown with a cross-sectional view. An optical fiber may be employed to measure strain and is also sensitive to temperature. In one embodiment, three outer fiber cores 302 are disposed about a fourth central core 304. With this combination, separate measurements of strain may be obtained leading to shape (cores 302) and spatially resolved temperature (along the length) (core 304), [0037] which discloses With the configuration of four cores (302, 304), strains from temperature can be easily distinguished from geometrical strains. The strains in cores 302 may be employed to resolve temperature regions along the fibers as the geometry indicated by the cores 302 will provide positional information relative to the information collected from the central core 304 and [0020] which discloses The strain measurements are employed to determine device shape and determine specific locations along the device having temperature gradients).
Regarding claim 10,
Ramachandran, as modified, further teaches wherein differences in the temperature of the stylet along a length of the stylet enable the catheter placement system to determine when a point along the length of the stylet has entered the body of the patient ([0025] which discloses from the multitude of measured positions, the total three-dimensional form is determined and temperature differences can be determined and [0042] which discloses In block 402, strain data is collected from a fiber optic strain sensing device disposed within at least two different temperature regions. The sensing device may include a first portion having a first temperature and a second portion having a second temperature, and the first portion is internal to a body, and the second portion is external to the body. In this instance, the transition point includes a point of entry in the body)
Regarding claim 11,
Flexman, as modified, further teaches wherein the differences in the temperature of the stylet along the length of the stylet enable the catheter placement system to display a location of the insertion site on the display ([0042] which discloses In block 402, strain data is collected from a fiber optic strain sensing device disposed within at least two different temperature regions. The sensing device may include a first portion having a first temperature and a second portion having a second temperature, and the first portion is internal to a body, and the second portion is external to the body. In this instance, the transition point includes a point of entry in the body. See at least fig. 2),
Regarding claim 12,
Ramachandran, as modified, teaches the elements of claim 1 as previously stated. Ramachandran, as modified, further teaches wherein a distal end of the stylet is aligned with a distal end of the catheter the catheter for indicating a location of the catheter within the body of the patient (Flexman [0052] which discloses alignment of the guidewire 108 and device 102 (e.g., catheter) includes aligning a distal tip of the guidewire 108 with the device 102 to measure the length of the over-the-wire device 102).
Regarding claim 13,
Ramachandran, as modified, further teaches wherein the information relating to the various aspects of the stylet assists a user of the catheter placement system in guiding the stylet and the catheter to a desired location within the body of the patient for placement of the catheter (See at least fig. 2 of Ramachandran and [0012] which discloses . This information can be employed to calculate a length of the instrument within the body as the device is inserted and manipulated further within the body in a real-time fashion. Examiner notes that such information and display thereof necessarily assists a user of the catheter placement system in guiding the medical device (i.e. the stylet and catheter in the modified system))
Claims 2 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ramachandran, Flexman, and Eberle as applied to claim 1 above, and further in view of Powers et al. (US 20120046562 A1), hereinafter Powers.
Regarding claim 2,
Ramachandran, as modified, teaches the elements of claim 1 as previously stated. Ramachandran, as modified, fails to explicitly teach wherein the stylet includes a catheter connector and a console connector respectively configured to connect to a Luer connector of the catheter.
Powers, in a similar field of endeavor involving medical device placement, teaches a stylet (at least fig. 2 (130) and corresponding disclosure in at least [0026]) includes a catheter connector (Examiner notes that the Luer connector 74C operably connects to a portion of the stylet which is considered a catheter connector in its broadest reasonable interpretation) and a console connector (at least fig. 2 (50) and corresponding disclosure in at least [0026]) respectively configured to connect to a Luer connecter (at least fig. 12 (74C) and corresponding disclosure in at least [0017]) of the catheter and a port (at least fig. 1 (52) and corresponding disclosure in at least [0019] of the console (see at last figs. 1 and 2).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ramachandran, as currently modified, to include a catheter connector and a console connector as taught by Powers in order to provide attachment to suitable medical devices (Powers [0017]). Such a modification would ensure the appropriate connections are made between the stylet and the catheter and the stylet and console, such that data acquired by the stylet regarding the nature of the catheter are delivered to the console accordingly.
Regarding claim 14,
Ramachandran, as modified, teaches the elements of claim 1 as previously stated. Ramachandran further teaches further comprising an ultrasound probe ([0027] which discloses imaging system may be employed externally to the subject and may be employed for collecting and processing pre-operative images and [0028] which discloses the imaging system may include an ultrasonic system for collecting and processing images would necessarily comprise and ultrasound probe. Ramachandran, as modified, fails to explicitly teach further the ultrasound probe is configured for ultrasound-based visualization of a blood vessel of the patient in preparation for insertion of the catheter into the blood vessel.
Powers, in a similar field of endeavor involving medical device placement, teaches an ultrasound probe (at least fig. 2 (40) and corresponding disclosure in at least [0021]) configured for ultrasound based visualization of a blood vessel in a patient in preparation for insertion of the catheter into the blood vessel ([0021] which discloses ultra-sound visualization of a vessel, such as a vein in preparation for insertion of a catheter 72 in preparation for insertion of into the blood vessel).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ramachandran, as modified, to include an ultrasound probe configured for ultrasound based visualization of a blood vessel as taught by Powers in order to assist in reducing complications typically associated with introducing a catheter (Powers [0021]). Such a modification would allow for assistance when inserting the catheter into tissue such as the blood vessel accordingly.
Regarding claim 15,
Ramachandran, as modified, further teaches wherein the ultrasound probe provides an ultrasound modality for the insertion of the catheter into the blood vessel (Powers [0021] which discloses such visualization gives real-time ultrasound guidance for introducing the catheter into the vasculature of the patient), and the stylet in the catheter provides an optical modality for guiding placement of the catheter within the body of the patient (Examiner notes that the stylet of Ramachandran and/or Ramachandran, as modified, by provides an optical modality (i.e. optical fiber based strain sensing) for guiding placement of the catheter within the body of the patient which is considered an intended use and further Ramachandran teaches guiding placement of the catheter within the body).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ramachandran, Flexman, Eberle, and Powers as applied to claim 2 above, and further in view of Cox et al. (US 20090234328 A1), hereinafter Cox.
Regarding claim 3,
Ramachandran, as modified, teaches the elements of claim 2 as previously stated. Ramachandran, as currently modified, fails to explicitly teach a tether between the catheter connector and the console connector.
Nonetheless, Powers further teaches a tether (at least fig. 2 (134) and corresponding disclosure in at least [0026]) between the catheter connector and the console connector (50) (see at least fig. 2)
Ramachandran, as modified, fails to explicitly teach a handle with the tether to assist with manipulation of the stylet by a user.
Nonetheless, Cox in a similar field of endeavor involving medical device placement, teaches a handle (at least fig. 11 (136) and corresponding disclosure in at least [0072]) with the tether (at least fig. 11 (134) and corresponding disclosure in at least [0072]) to assist with manipulation of the stylet by a user ([0074] which discloses the handle is provided to enable insertion/removal of the stylet and assist in navigating the catheter distal portion through the vasculature of the patient).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified been obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of Ramachandran, as currently modified, to include the handle as taught by Cox in order to allow for manipulation of the stylet accordingly. Such a modification amounts to merely a combination of prior art elements according to known techniques yielding predictable results with respect to stylet manipulation rendering the claim obvious (MPEP 2143).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ramachandran, Flexman, and Eberle as applied to claim 1 above, and further in view of Larkin et al. (US 20070156019 A1), hereinafter Larkin.
Regarding claim 4,
Ramachandran, as modified, teaches the elements of claim 1 as previously stated. Ramachandran, as modified, fails to explicitly teach wherein the light source is a tunable swept laser.
Larkin, in a similar field of endeavor involving optical fibers and medical devices teaches a light source (at least fig. 4 (410) and corresponding disclosure at least [0055]) is a tunable swept laser ([0055] which discloses The optical source 410 used in OFDR interrogation system may be a tunable laser and provides high-coherence light that can be swept over a broad band of wavelengths), the laser (410) and a photodetector (at least fig. 4 (420) and corresponding disclosure in at least [0055]) disposed in an optical module (at least fig. 4 (260) and corresponding disclosure in at least [0051])
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ramchandran, as currently modified, to include a tunable swept laser and the laser and photodetector in an optical module as taught by Lark in order to provide an interrogation/detection system which provides high coherence light that can be swept over a broad band of wavelengths (Larkin [0055]). Such a modification would allow for a reflection spectrum of each grating to be separated from the others using the data acquired in a single scan of the core (Larkin [0055]) which would allow for enhanced detection of signals from each of the gratings.
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.
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Claims 1-3 and 6-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12140487 in view of Ramachandran and Flexman.
Regarding instant claim 1,
Reference claim 1 recites
A catheter placement system (Reference claim 1 “a console of a medical device placement system”) comprising:
A catheter including a lumen extending between a proximal end and a distal end of the catheter (Reference claim 1 “a catheter…. At least one lumen extending between at least a proximal end and a distal end of the elongate catheter tube”)
A stylet removably inserted into the lumen of the catheter (Reference claim 1 “a stylet removably inserted into the at least one lumen of the catheter”), the stylet including a fiber-bearing portion, the fiber bearing portion including a core wire (Reference claim 1 “the fiber bearing portion of the stylet includes a core wire”), the fiber-bearing portion including a core-wire having a longitudinal notch defined in an outer surface of the core wire, the longitudinal notch extending distally from a proximal end of the core wire to a distal end of the core wire and extending parallel to a longitudinal axis of the core wire from the proximal end to the distal end ((Reference claim 1“the optical fiber secured in a longitudinal notch of the core wire” Examiner notes that a longitudinal notch is understood to be defined in an outer surface of the core wire and extends parallel to a longitudinal axis of the core wire from the proximal end to the distal end. This is further evidenced by applicant’s arguments see REMARKS filed 03/23/2026 pg. 7) and an optical fiber (Reference claim 1 “the fiber-bearing portion of the stylet includes a core wires and the optical fiber”) secured in a longitudinal notch of the core wire (Reference claim 1“the optical fiber secured in a longitudinal notch of the core wire”), and the optical fiber including a first plurality of optical-fiber-based strain sensors disposed along a first longitudinal portion of the optical fiber and second plurality of optical-fiber-based strain sensors disposed along a second longitudinal portion of the optical fiber (Reference claim 1 “a first plurality of optical fiber-based strain sensors disposed along a first longitudinal portion of the optical fiber and a second plurality of optical fiber-based strain sensors disposed along a second longitudinal portion of the optical fiber”)
A light source operably connected to the stylet, the light source configured to produce outgoing optical signals incident on the first plurality of optical-fiber-based strain sensors and the second plurality of optical-fiber-based strain sensors (Reference claim 1 “the first plurality of optical fiber-based strain sensors and the second plurality of optical fiber-based strain sensors configured to receive incoming optical signals from an operably connected light source”)
A photodetector operably connected to the stylet, the photodetector configured to receive return optical signals from the first plurality of optical-fiber-based strain sensors and the second plurality of optical-fiber-based strain sensors (Reference claim 1 “the first plurality of optical fiber-based strain sensors and the second plurality of optical fiber-based strain sensors configured to…return outgoing optical signals to an operably connected photodetector”), wherein the return optical signals are for more than one aspect of the optical fiber in accordance with at least the first plurality of optical fiber-based strain sensors and the second plurality of optical fiber-based strain sensors (“return outgoing optical signals to an operably connected photodetector for more than one aspect of the optical fiber in accordance with at least the first plurality of optical fiber-based strain sensors and the second plurality of optical fiber-based strain sensors”)
A console (Reference claim 1 “a console of a medical device placement system”) operably connected to the stylet:
Reference claim 1 fails to explicitly recite the first plurality of optical-fiber-based strain sensors disposed along a first longitudinal axis of the optical fiber and a second plurality of optical-fiber-based strain sensors disposed along a second longitudinal axis of the optical fiber, the first longitudinal axis and the second longitudinal axis being non colinear with each other, the console including memory and a processor configured to:
Propagate the outgoing optical signals to the first plurality of optical fiber-based strain sensors;
Process optical data form the return optical signals from the first plurality of optical-fiber-based strain sensors and the second plurality of optical fiber-based strain sensors; and
Map the catheter in accordance with the more than one aspect of the stylet including a location of the stylet within a body of a patient; and
A display configured to display information relating to the more than one aspect of the stylet including an image of the catheter mapped on the body of the patient
Ramachandran, in a similar field of endeavor involving catheter guidance, Ramachandran teaches a catheter placement system (at least fig. 1 (100) and corresponding disclosure in at least [0021]):
Comprising a stylet (at least fig. 1 (102) and corresponding disclosure in at least [0021] which discloses the medical device 102 may include a catheter, a guidewire) including a fiber-bearing portion, the fiber-bearing portion including a core-wire ([0021] which discloses the medical device may include a guidewire. Examiner notes that the fiber-bearing portion is considered to be any portion of the guidewire, thus the guidewire itself is considered to be the fiber-bearing portion and includes a core-wire (i.e. the guide-wire)) and an optical fiber (at least fig. 1 (104/126) and corresponding disclosure in at least [0022]) secured in the core wire (see at least fig. 1), and the optical fiber (104/126) including a first plurality of optical-fiber-based strain sensors ([0023]-[0024] disclosing the use of fiber optic Bragg sensors and Bragg gratings can be used as sensing elements in the fiber optic sensors) disposed along a first longitudinal axis (at least fig. 3 (302) and corresponding disclosure in at least [0035]) of the optical fiber and a second plurality of optical-fiber-based strain sensors ([0023]-[0024] disclosing the use of fiber optic Bragg sensors and Bragg gratings can be used as sensing elements in the fiber optic sensors) disposed along a second longitudinal axis (at least fig. 3 (304) and corresponding disclosure in at least [0035]) of the optical fiber, the first longitudinal axis and the second longitudinal axis being non colinear with each other (see at least fig. 3);
A light source (at least fig. 1 (106) and corresponding disclosure in at least [0022]) operably connected to the stylet (see at least fig. 1), the light source (106) configured to produce outgoing optical signals incident on the first plurality of optical-fiber-based strain sensors and the second plurality of optical-fiber-based strain sensors (an optical source 106 may be provided as part of the interrogator 108 or as a separate unit for providing light signals to the sensing device 104);
A detector (at least fig. 1 (108) and corresponding disclosure in at least [0022]) operably connected to the stylet (see at least fig. 1), the detector (108) configured to receive return optical signals form the first plurality of optical-fiber-based strain sensors and the second plurality of optical-fiber-based strain sensors ([0022] which discloses the optical interrogator receives optical responses), wherein the return optical signals are for more than one aspect of the optical fiber in accordance with at least the first plurality of optical fiber-based strain sensors ([0035] which discloses An optical fiber may be employed to measure strain and is also sensitive to temperature. In one embodiment, three outer fiber cores 302 are disposed about a fourth central core 304. With this combination, separate measurements of strain may be obtained leading to shape (cores 302) and spatially resolved temperature (along the length) (core 304). The configuration works best if there is no axial strain present. In most scenarios, axial strain of the device 104 is negligible since the device is not stretched along its length, and therefore it is reasonable to assume that the primary influence in the central core 304 is due to temperature. Other configurations may also be employed to zero out or account for axial strain if present. For example, a second central core (not shown) with different properties from the first core may be provided such that physical strain and temperature strain may be distinguished. The second central core may be provided with different properties or different doping material to give a different refractive index and/or coefficient of expansion. These same features or differences can also be applied to the outer cores (not just central the central core or cores) where each core could have a different property such that measurement differences would permit multiple solutions to resolve axial strain, temperature values, etc);
A console (at least fig. 1 (112) and corresponding disclosure in at least [0021]) operably connected to the stylet (102), the console including a memory (at least fig. 1 (116) and corresponding disclosure in at least [0021]) and a processor (at least fig. 1 (112 and/or 114) and corresponding disclosure in at least [0021])configure to:
Propagate the outgoing optical signals to the first plurality of optical-fiber based strain sensors and the second plurality of optical-fiber-based strain sensors ([0021] which discloses the optical source provides light signals to the sensing device 104);
Process optical data from the return optical signals from the first plurality of optical-fiber-based strain sensors and the second plurality of optical-fiber-based strain sensors ([0021] which discloses an optical sensing and interpretation module 115 configured to interpret optical feedback signals from a shape and/or temperature sensing device or system 104);
Map the stylet in accordance with more than one aspect of the stylet including a location of the stylet within a body of a patient ([0045] which discloses an image of the body may be registered to temperature/shape sensing space using the temperature transition point as a reference); and
A display configured to display information relating to the more than one aspect of the stylet including an image (at least fig. 2 (200) and corresponding disclosure in at least [0031]) of the optical fiber on the body of the patient (see at least fig. 2)
It would have been obvious to a person having ordinary skill in the art before effective filing date to have modified reference claim 1 to include a first plurality of optical-fiber-based strain sensors, and second plurality of optical fiber-based strain sensors, console and display as taught by Ramachandran in order to provide guidance to a user of the catheter system of Reference claim 1. Such a modification would allow for calculating a length of the instrument within the body as the device is inserted and manipulated further within the body in a real-time fashion.
Modified reference claim 1 fails to explicitly teach the display information including an image of the catheter on the body of the patient.
Nonetheless, Flexman teaches a display (at least fig. 1 (118) and corresponding disclosure in at least [0047]) configured to display information relating to aspects of the stylet including an image of the catheter mapped on the body of the patient ([0047] which discloses workstation 112 includes the display 118 for viewing internal images of a subject (patient) or volume 130 and may include shape images 134 as an overlay on medical images 136 such as x-ray images [0048] which discloses the device 102 and the target node 124 are preferably visualized in an image or images 136. Examiner notes that the image of the catheter mapped on the body of the patient is considered to be information relating to the various aspects of the stylet).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ramachandran to include mapping the catheter and displaying information as taught by Flexman in order to provide additional information regarding the position of the over-the-wire device, such that a person may readily recognize the position of the entire medical device when the guidewire is in use with the catheter.
Regarding instant claim 2,
Reference claim 1 further recites wherein the stylet includes a catheter connector and a console connector respectively configured to connect to a Luer connecter of the catheter and a port of the console (Reference claim 1 “the stylet comprising: a system connector configured to operably connect with a console of a medical device placement system; a catheter connector configured to operably connect with at least one Luer connector of the catheter assembly, a fiber-bearing portion of the stylet extending distally from the catheter connector to a distal end of the stylet”);
Regarding instant claim 3,
Reference claim 1 further recites the stylet further including a tether between the catheter connector and the console connector (Reference claim 1 “a tether between the system connector and the catheter connector”); and
A handle with the tether to assist with manipulation of the stylet by a user (Reference claim 1 “a handle with the tether to assist with manipulation of the stylet by a user”)
Regarding instant claim 6,
Ramachandran, as applied to instant claim 1 above, further teaches wherein the first plurality of optical-fiber-based strain sensors is included on a first channel of the optical fiber and the second plurality of optical-fiber-based strain sensors is included on a second channel of the optical fiber ([0035] which discloses An optical fiber may be employed to measure strain and is also sensitive to temperature. In one embodiment, three outer fiber cores 302 are disposed about a fourth central core 304. With this combination, separate measurements of strain may be obtained leading to shape (cores 302) and spatially resolved temperature (along the length) (core 304))
Regarding instant claim 7,
Reference claim 1, as currently modified, fails to explicitly teach wherein the first plurality of fiber-based strain sensors and the second plurality of optical-fiber-based strain sensors include fiber Bragg gratings, nonetheless, Ramachandran further teaches wherein optical-fiber-based strain sensors are fiber Bragg gratings.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Reference claim 1, as currently modified, to include fiber Bragg gratings as taught by Ramachandran in order to provide shape sensing capabilities. Furthermore, such a modification amounts to merely a simple substitution of one known optical fiber based strain sensor for another yielding predictable results with respect to optical fiber sensing rendering the claim obvious (MPEP 2143).
Regarding instant claim 8,
Ramachandran as applied to claim 1 above further teaches wherein the various aspects of the stylet include the location of the stylet within the body of the patient and at least another aspect of the stylet selected from a two-dimensional shape, a three-dimensional shape, a position or orientation within the body of the patient, a pressure, and a temperature of the stylet ([0035] which discloses a shape/temperature sensing device 104 is illustratively shown with a cross-sectional view. An optical fiber may be employed to measure strain and is also sensitive to temperature. In one embodiment, three outer fiber cores 302 are disposed about a fourth central core 304. With this combination, separate measurements of strain may be obtained leading to shape (cores 302) and spatially resolved temperature (along the length) (core 304), [0037] which discloses With the configuration of four cores (302, 304), strains from temperature can be easily distinguished from geometrical strains. The strains in cores 302 may be employed to resolve temperature regions along the fibers as the geometry indicated by the cores 302 will provide positional information relative to the information collected from the central core 304 and [0020] which discloses The strain measurements are employed to determine device shape and determine specific locations along the device having temperature gradients).
Regarding instant claim 9,
Ramachandran, as applied to claim 1 above further teaches wherein the various aspects of the stylet include the location of the stylet within the body of the patient ([0035] which discloses a shape/temperature sensing device 104 is illustratively shown with a cross-sectional view. An optical fiber may be employed to measure strain and is also sensitive to temperature. In one embodiment, three outer fiber cores 302 are disposed about a fourth central core 304. With this combination, separate measurements of strain may be obtained leading to shape (cores 302) and spatially resolved temperature (along the length) (core 304), [0037] which discloses With the configuration of four cores (302, 304), strains from temperature can be easily distinguished from geometrical strains. The strains in cores 302 may be employed to resolve temperature regions along the fibers as the geometry indicated by the cores 302 will provide positional information relative to the information collected from the central core 304 and [0020] which discloses The strain measurements are employed to determine device shape and determine specific locations along the device having temperature gradients).
Regarding instant claim 10,
Ramachandran, as applied to claim 1 above, further teaches wherein differences in the temperature of the stylet along a length of the stylet enable the catheter placement system to determine when a point along the length of the stylet has entered the body of the patient ([0025] which discloses from the multitude of measured positions, the total three-dimensional form is determined and temperature differences can be determined and [0042] which discloses In block 402, strain data is collected from a fiber optic strain sensing device disposed within at least two different temperature regions. The sensing device may include a first portion having a first temperature and a second portion having a second temperature, and the first portion is internal to a body, and the second portion is external to the body. In this instance, the transition point includes a point of entry in the body)
Regarding instant claim 11,
Ramachandran, as applied to claim 10 above, further teaches wherein the differences in the temperature of the stylet along the length of the stylet enable the catheter placement system to display a location of the insertion site on the display ([0042] which discloses In block 402, strain data is collected from a fiber optic strain sensing device disposed within at least two different temperature regions. The sensing device may include a first portion having a first temperature and a second portion having a second temperature, and the first portion is internal to a body, and the second portion is external to the body. In this instance, the transition point includes a point of entry in the body. See at least fig. 2),
Regarding instant claim 12,
Reference claim 1 recites the elements of instant claim 1 as previously stated. Reference claim 1, as currently modified, fails to recite wherein a distal end of the stylet is aligned with a distal end of the catheter for indicating a location of the catheter within the body of the patient.
Nonetheless, Flexman further teaches wherein a distal end of the stylet is aligned with a distal end of the catheter for indicating a location of the catheter within the body of the patient ([0052] which discloses alignment of the guidewire 108 and device 102 (e.g., catheter) includes aligning a distal tip of the guidewire 108 with the device 102 to measure the length of the over-the-wire device 102).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Reference claim 1, as currently modified, to include aligning a distal end of the stylet with a distal end of the catheter as taught by Flexman in order to measure the length of the over-the-wire device 102 (i.e. catheter) (Flexman [0052])
Regarding instant claim 13,
Ramachandran, as applied to claim 1 above, further teaches wherein the information relating to the one or more aspects of the stylet assists a user of the catheter placement system in guiding a stylet and the catheter to a desired location within the body of the patient for placement of the catheter
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Caron (US 20160128583 A1) teaches In alternative embodiments (not illustrated) the grooves in the guidewire run straight along the length of the guidewire
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/BROOKE LYN KLEIN/ Primary Examiner, Art Unit 3797
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