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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/11/2026 has been entered.
Response to Amendment
The amendment filed on 5/11/2026 has been entered. Claims 1-15 are pending in the application. Claims 16-24 are cancelled.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2002/0188285 A1) in view of Pile-Spellman et al. (US 2006/0064055 A1) and further in view of Desjardins et al. (US 2013/0188855 A1).
Regarding claim 1, Brown discloses a fiber-optic enabled intravascular system (see Figs. 5a-d, par. [0038]), comprising:
a catheter (shaft 36) defining a lumen (working channel 35) extending along a central longitudinal axis (central longitudinal axis of working channel 35) (see Figs. 5a-d, par. [0041]);
an elongate medical device (fiber 20) disposed within the lumen (working channel 35) and comprising:
a shapeable portion (sleeve 22), defining a first predetermined shape at a first temperature and a second predetermined shape at a second temperature,
wherein the shapeable portion (sleeve 22) is transitionable from the first predetermined shape to the second predetermined shape in response to a change from the first temperature to the second temperature (see Figs. 5a-d, par. [0038]-[0042]); and
an optical fiber (core 25) (see Figs. 5a-d and 6a, par. [0038] and [0045]-[0046]);
a steering control system (fluid source and temperature source, see par. [0026] and [0038]-[0042]) configured to provide a fluid to the elongate medical device (fiber 20) at one of the first temperature or the second temperature to steer a distal tip of the catheter (shaft 36) towards a target location within a vasculature (see Figs. 5a-d, par. [0026] and [0038]-[0043]).
However, Brown fails to expressly state wherein the shapeable portion is transitionable from the second predetermined shape to the first predetermined shape in response to a change from the second temperature to the first temperature. Brown further fails to state the optical fiber comprising a multi-core optical fiber having a first plurality of optical fiber-based strain sensors disposed along a first longitudinal portion of the multi-core optical fiber, and a second plurality of optical fiber-based strain sensors disposed along a second longitudinal portion of the multi-core optical fiber; and a fiber optic strain sensor system communicatively coupled to the multi-core optical fiber and configured to send broadband incident light and receive reflected light signals from an optical fiber-based strain sensor of the first plurality of optical fiber-based strain sensors, the second plurality of optical fiber-based strain sensors, or both.
Pile-Spellman teaches an intravascular system (see Figs. 1a-d, par. [0025]) comprising a shapeable portion (portion of SMA wire 102 with heating coil 101), wherein the shapeable portion (portion of SMA wire 102 with heating coil 101) is transitionable from the second predetermined shape to the first predetermined shape in response to a change from the second temperature to the first temperature (see Figs. 1a-d, par. [0018], [0024], [0026], the device of Figs. 1a-d exhibits a two-way shape-memory effect in that when heated the device bends to a pre-determined bent shape and when cooled the device returns to its original essentially straight shape).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brown to include wherein the shapeable portion is transitionable from the second predetermined shape to the first predetermined shape in response to a change from the second temperature to the first temperature, as taught by Pile-Spellman, in order to allow the shapeable portion to return to its original shape when cooled which allows it to be advanced further through the vasculature (see Pile-Spellman par. [0024]).
However, modified Brown still fails to state the optical fiber comprising a multi-core optical fiber having a first plurality of optical fiber-based strain sensors disposed along a first longitudinal portion of the multi-core optical fiber, and a second plurality of optical fiber-based strain sensors disposed along a second longitudinal portion of the multi-core optical fiber; and a fiber optic strain sensor system communicatively coupled to the multi-core optical fiber and configured to send broadband incident light and receive reflected light signals from an optical fiber-based strain sensor of the first plurality of optical fiber-based strain sensors, the second plurality of optical fiber-based strain sensors, or both.
Desjardins teaches a fiber-optic enabled intravascular system (see Figs. 1-7) comprising an elongate medical device (instrument 200 and tether 300) comprising a multi-core optical fiber (tether 300, par. [0017], [0040], [0046]) having a first plurality of optical fiber-based strain sensors (see par. [0040], [0046], at least four cores are present which each have scatterers that act as strain gauges and are spaced longitudinally along the fiber such that at least two of the scatterers can be considered the first plurality of optical fiber-based strain sensors and at least two others of the scatterers can be considered the second plurality of optical fiber-based strain sensors) disposed along a first longitudinal portion of the multi-core optical fiber (tether 300), and a second plurality of optical fiber-based strain sensors (see par. [0040], [0046], at least four cores are present which each have scatterers that act as strain gauges and are spaced longitudinally along the fiber such that at least two of the scatterers can be considered the first plurality of optical fiber-based strain sensors and at least two others of the scatterers can be considered the second plurality of optical fiber-based strain sensors) disposed along a second longitudinal portion of the multi-core optical fiber (tether 300) (see Figs. 3-4 and 6, par. [0040], [0046], at least four cores are present which each have scatterers that act as strain gauges and are spaced longitudinally along the fiber such that at least two of the scatterers can be considered the first plurality of optical fiber-based strain sensors and at least two others of the scatterers can be considered the second plurality of optical fiber-based strain sensors); and a fiber optic strain sensor system (shape determining unit 550) communicatively coupled to the multi-core optical fiber (tether 300) and configured to send broadband incident light and receive reflected light signals from an optical fiber-based strain sensor of the first plurality of optical fiber-based strain sensors (see par. [0040], [0046], at least four cores are present which each have scatterers that act as strain gauges and are spaced longitudinally along the fiber such that at least two of the scatterers can be considered the first plurality of optical fiber-based strain sensors and at least two others of the scatterers can be considered the second plurality of optical fiber-based strain sensors), the second plurality of optical fiber-based strain sensors (see par. [0040], [0046], at least four cores are present which each have scatterers that act as strain gauges and are spaced longitudinally along the fiber such that at least two of the scatterers can be considered the first plurality of optical fiber-based strain sensors and at least two others of the scatterers can be considered the second plurality of optical fiber-based strain sensors), or both (see Figs. 1-7, par. [0040], [0046], [0054]-[0055]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the fiber-optic enabled intravascular system of modified Brown to further include the optical fiber comprising a multi-core optical fiber having a first plurality of optical fiber-based strain sensors disposed along a first longitudinal portion of the multi-core optical fiber, and a second plurality of optical fiber-based strain sensors disposed along a second longitudinal portion of the multi-core optical fiber; and a fiber optic strain sensor system communicatively coupled to the multi-core optical fiber and configured to send broadband incident light and receive reflected light signals from an optical fiber-based strain sensor of the first plurality of optical fiber-based strain sensors, the second plurality of optical fiber-based strain sensors, or both, as taught by Desjardins, in order to determine the shape of the optical fiber in real-time when inserted into a patient which aids in guiding the intravascular system through the patient (see Desjardins par. [0054]-[0055], [0002]-[0003], [0007]).
Regarding claim 2, modified Brown teaches the fiber-optic enabled intravascular system according to claim 1 substantially as claimed. Brown further teaches wherein the first predetermined shape is a first angle relative to a longitudinal axis and the second predetermined shape is a second angle relative to the longitudinal axis, the second angle being greater than the first angle (see Figs. 5a-d, par. [0026] and [0038]-[0039]).
Regarding claim 3, modified Brown teaches the fiber-optic enabled intravascular system according to claim 2 substantially as claimed. Brown further teaches wherein the steering control system (fluid and temperature source, see par. [0026] and [0038]-[0042]) includes one or more of a handle (see Fig. 6a, par. [0045], handle at proximal end 28+29+30), a fluid source (see par. [0026] and [0038]- [0039]), a pump (see par. [0026]), or a temperature regulation device (see par. [0026] and [0038]-[0039], device for regulating temperature of irrigation fluid) configured to modify a temperature of the fluid (see par. [0026] and [0038]-[0042]).
Regarding claim 4, modified Brown teaches the fiber-optic enabled intravascular system according to claim 3 substantially as claimed. Brown further teaches wherein the temperature regulation device (see par. [0026] and [0038]-[0039], device for regulating temperature of irrigation fluid) includes one or more of a heat source or a cooling source (see par. [0026] and [0038]-[0042]).
Regarding claim 5, modified Brown teaches the fiber-optic enabled intravascular system according to claim 1 substantially as claimed. Brown further teaches wherein the elongate medical device (fiber 20) includes a stylet or a guidewire (see Figs. 5a-d, fiber 20 can be considered a stylet or a guidewire).
Regarding claim 6, modified Brown teaches the fiber-optic enabled intravascular system according to claim 1 substantially as claimed. Brown further teaches wherein a first portion (core 25) of the elongate medical device (fiber 20) is formed of a first material and the shapeable portion (sleeve 22) of the elongate medical device (fiber 20) is formed of a second material (see par. [0026], [0038], [0045]-[0046]), the first material including a plastic, a polymer, a metal, an alloy, or a composite (see par. [0026], [0038], [0045]-[0046], core 25 is made of metallic fibers), the second material including a metal, an alloy, a shape-memory material, a super-elastic material, or Nitinol (see par. [0026] and [0038]).
Regarding claim 7, modified Brown teaches the fiber-optic enabled intravascular system according to claim 1 substantially as claimed. Modified Brown further teaches wherein the fiber optic strain sensor system (Desjardins, shape determining unit 550) is configured to determine a shape of the elongate medical device (Brown, fiber 20) from one or more of the reflected light signals (see Desjardins par. [0054]-[0055], see previous modifications in view of Desjardins in the rejection of claim 1 above).
Regarding claim 8, modified Brown teaches the fiber-optic enabled intravascular system according to claim 7 substantially as claimed. Modified Brown further teaches wherein the shapeable portion (Brown, sleeve 22) extends annularly about a portion of the multi-core optical fiber (modified core 25 of Brown, see previous modifications in view of Desjardins in rejection of claim 1 above) (see Brown Figs. 5a-d, Brown par. [0038]).
Regarding claim 9, modified Brown teaches the fiber-optic enabled intravascular system according to claim 7 substantially as claimed. Modified Brown further teaches wherein the shapeable portion (Brown, sleeve 22) is disposed distally of a distal tip of the multi-core optical fiber (modified core 25 of Brown, see previous modifications in view of Desjardins in rejection of claim 1 above) (see Brown Fig. 6a, Brown par. [0044]).
Regarding claim 10, modified Brown teaches the fiber-optic enabled intravascular system according to claim 1 substantially as claimed. Brown further teaches wherein the shapeable portion (sleeve 22) defines a third predetermined shape at a third temperature, wherein the third temperature is between the first temperature and the second temperature (see par. [0025]-[0026] and [0038]- [0042], the fluid can be controlled to temperatures between the first and second temperature and the shape of the sleeve 22 is dependent upon the temperature of the fluid).
Regarding claim 11, modified Brown teaches the fiber-optic enabled intravascular system according to claim 1 substantially as claimed. Brown further teaches wherein the first predetermined shape is a linear shape and the second predetermined shape is a non-linear shape (see Figs. 5a-d, par. [0026] and [0038]-[0039]).
Regarding claim 12, modified Brown teaches the fiber-optic enabled intravascular system according to claim 1 substantially as claimed. Brown further teaches wherein the first predetermined shape is a non-linear shape and the second predetermined shape is a linear shape (see Figs. 5a-d, par. [0026] and [0038]-[0039]).
Regarding claim 13, modified Brown teaches the fiber-optic enabled intravascular system according to claim 10 substantially as claimed. Brown further teaches wherein the first predetermined shape is a linear shape and the second predetermined shape is a curved shape where an axis of a distal tip of the elongate medical device (fiber 20) extends at a first angle relative to the central longitudinal axis (central longitudinal axis of working channel 35), and the third predetermined shape is a curved shape where the axis of the distal tip of the elongate medical device (fiber 20) extends at a second angle relative to the central longitudinal axis (central longitudinal axis of working channel 35), wherein the second angle is less than the first angle (see Figs. 5a-d, par. [0025]-[0026] and [0038]-[0042], the fluid can be controlled to temperatures between the first and second temperature and the shape of the sleeve 22 is dependent upon the temperature of the fluid such that the sleeve 22 can be straight at a first/coldest temperature, slightly curved at a third/intermediate temperature, and more curved at a second/highest temperature).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2002/0188285 A1) in view of Pile-Spellman et al. (US 2006/0064055 A1) and further in view of Desjardins et al. (US 2013/0188855 A1), as applied to claim 2 above, and further in view of Beri (US 2014/0378945 A1).
Regarding claim 14, modified Brown teaches the fiber-optic enabled intravascular system according to claim 2 substantially as claimed. However, modified Brown fails to state wherein the elongate medical device further includes a first lumen, and wherein the steering control system is in fluid communication with the first lumen and configured to modify a temperature of the fluid within the first lumen.
Beri teaches a system (see Figs. 1 and 3) wherein the elongate medical device (catheter shaft/body 104) further includes a first lumen (one of lumens 124), and wherein the steering control system (fluid heating and cooling device) is in fluid communication with the first lumen (one of lumens 124) and configured to modify a temperature of the fluid within the first lumen (one of lumens 124) (see Figs. 1 and 3, par. [0037] and [0039]-[0041]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the fiber-optic enabled intravascular system of modified Brown to include wherein the elongate medical device further includes a first lumen, and wherein the steering control system is in fluid communication with the first lumen and configured to modify a temperature of the fluid within the first lumen, as taught by Beri, in order to allow fluid to circulate directly within the elongate medical device in a closed loop rather than in the lumen of the catheter so as the fluid would not be required to be absorbed by the patient (see Beri par. [0039]-[0040] and Brown par. [0026] and [0039]).
Regarding claim 15, modified Brown teaches the fiber-optic enabled intravascular system according to claim 14 substantially as claimed. However, modified Brown fails to state wherein the elongate medical device further includes a second lumen, and wherein the steering control system is configured to modify the temperature of the fluid within the first lumen independently of the temperature of the fluid within the second lumen.
Beri teaches a system (see Figs. 1 and 3) wherein the elongate medical device (catheter shaft/body 104) further includes a second lumen (other of lumens 124), and wherein the steering control system (fluid heating and cooling device) is configured to modify the temperature of the fluid within the first lumen (one of lumens 124) independently of the temperature of the fluid within the second lumen (other of lumens 124) (see Figs. 1 and 3, par. [0037] and [0039]-[0041]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the fiber-optic enabled intravascular system of modified Brown to include wherein the elongate medical device further includes a second lumen, and wherein the steering control system is configured to modify the temperature of the fluid within the first lumen independently of the temperature of the fluid within the second lumen, as taught by Beri, in order to allow fluid to circulate directly within the elongate medical device in a closed loop rather than in the lumen of the catheter so as the fluid would not be required to be absorbed by the patient (see Beri par. [0039]-[0040] and Brown par. [0026] and [0039]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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