DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 10/14/2025 has been entered. Claims 1-15 are pending in the application. Claims 16-24 are cancelled.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown (US 2002/0188285 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 including a shapeable portion (sleeve 22), defining a first predetermined shape at a first temperature and a second predetermined shape at a second temperature, the shapeable portion (sleeve 22) transitionable between the first predetermined shape and the second predetermined shape in response to a change between the first temperature and the second temperature (see Figs. 5a-d, par. [0038]-[0042]); and
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]).
Regarding claim 2, Brown discloses the fiber-optic enabled intravascular system according to claim 1, 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, Brown discloses the fiber-optic enabled intravascular system according to claim 2, 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, Brown discloses the fiber-optic enabled intravascular system according to claim 3, 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, Brown discloses the fiber-optic enabled intravascular system according to claim 1, 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, Brown discloses the fiber-optic enabled intravascular system according to claim 1, 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 10, Brown discloses the fiber-optic enabled intravascular system according to claim 1, 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, Brown discloses the fiber-optic enabled intravascular system according to claim 1, 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, Brown discloses the fiber-optic enabled intravascular system according to claim 1, 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, Brown discloses the fiber-optic enabled intravascular system according to claim 10, 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).
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.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2002/0188285 A1), as applied to claim 1 above, in view of Ding et al. (US 2020/0188036 A1).
Regarding claim 7, Brown discloses the fiber-optic enabled intravascular system according to claim 1, wherein the elongate medical device (fiber 20) further includes an optical fiber (core 25) extending longitudinally (see Figs. 5a-d and 6a, par. [0038] and [0045]-[0046]).
However, Brown fails to state wherein the optical fiber is communicatively coupled to a fiber optic strain sensor system configured to determine a shape of the elongate medical device.
Ding teaches a fiber-optic enabled system (see Figs. 1 and 3-5) wherein the optical fiber (optical fibers 124+126+128) is communicatively coupled to a fiber optic strain sensor system (sensor 122) configured to determine a shape of the elongate medical device (sleeve 308) (see Figs. 1 and 3-5, par. [0044] and [0073]-[0074]).
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 Brown to include that the optical fiber is communicatively coupled to a fiber optic strain sensor system configured to determine a shape of the elongate medical device, as taught by Ding, in order to model the shape and curvature of the elongate medical device for the user (see Ding par. [0073]-[0074]).
Regarding claim 8, modified Brown teaches the fiber-optic enabled intravascular system according to claim 7 substantially as claimed. Brown further teaches wherein the shapeable portion (sleeve 22) extends annularly about a portion of the optical fiber (core 25) (see Figs. 5a-d, par. [0038]).
Regarding claim 9, modified Brown teaches the fiber-optic enabled intravascular system according to claim 7 substantially as claimed. Brown further teaches wherein the shapeable portion (sleeve 22) is disposed distally of a distal tip of the optical fiber (core 25) (see Fig. 6a, par. [0044]).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2002/0188285 A1), as applied to claim 2 above, in view of Beri (US 2014/0378945 A1).
Regarding claim 14, Brown discloses the fiber-optic enabled intravascular system according to claim 2. However, 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 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 filed 10/14/2025 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues that Brown fails to disclose the limitations "an elongate medical device…including a shapeable portion, defining a first predetermined shape at a first temperature and a second predetermined shape at a second temperature, the shapeable portion transitionable between the first predetermined shape and the second predetermined shape in response to a change between the first temperature and the second temperature". This argument is not persuasive. Brown discloses an elongate medical device (fiber 20) including a shapeable portion (sleeve 22) which transitions between a first/straight shape (see Fig. 5a) and a second/"centering half helix" shape (see Fig. 5b) when the temperature of the sleeve 22 changes between a first/lower temperature and a second/higher temperature (see Brown Figs. 5a-5b, par. [0038]-[0042]). It appears (based on the Remarks, bottom of page 6 through top of page 7) that Applicant believes this claim language (in particular the term "between") requires what is known as a two-way shape memory effect, where the shapeable portion is a first shape at a first temperature, then changes to a second shape at a second temperature, and reverts back to the first shape when changed back to the first temperature. In other words, a two-way shape memory effect requires the material to repeatably remember two distinct shapes at two distinct temperatures and be able to change back and forth between the shapes as the temperatures are changed back and forth. However, it is the Examiner's position that the broadest reasonable interpretation of the claim language, including the term "between" as used in the claim, does not require such a two-way shape memory effect. The Specification further does not appear to provide a special definition of the term "between" or any other term recited in the claim that would require the claim to be interpreted as requiring a two-way shape memory effect for the shapeable portion. On the contrary, the claim language only requires the shapeable portion to have a one-way shape memory effect. For a one-way shape memory effect, the material must exist at a first shape at a first temperature (as is the case in Brown's straight shape at a first/lower temperature regarding Fig. 5a), then change to a second shape at a second temperature (as is the case in Brown's "centering half helix" shape at a second/higher temperature regarding Fig. 5b), but not necessarily revert back to the first shape if reverted back to the first temperature. Thus, Brown discloses each and every limitation of claim 1 as currently recited.
Should Applicant amend the claim to require that the shapeable portion exhibits a two-way shape memory effect, the Examiner notes that this concept appears to be well known in the art. See, for example, Stice (US 4,984,581 A), Mcfann et al. (US 6,371,928 B1), and Baum et al. (US 6,258,118 B1) which each appear to teach intravascular systems comprising two-way shape memory devices.
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.
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