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 .
Status of the Claims
Claims 4, 8, and 22 are cancelled. Claims 1, 3, 5-6, 9, 16, 19-21, 23, and 25-26 are currently amended. Claims 1-3, 5-7, 9-21, and 23-26 are currently pending. Claims 1-3, 5-7, 9-21, and 23-26 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/27/2026, with respect to the rejection(s) of claim(s) 1 and 19 under 103 have been fully considered and are partially persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of an alternative interpretation of Abrahamson. Examiner notes that the amendments to the independent claims, bringing the subject matter claim 4 and claim 8 into claim 1, and bringing claim 22 into claim 19 without the intervening claim 20, present claims with a scope not previously examined.
The amendments to instant specification [0041] and fig. 2B obviate the previous drawing objection. The amendments to the claims obviate the previous claim objections and 112b rejections, with the exception of the objection to “a patient” in claim 19, which is repeated below.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, contrary to the Applicant’s assertion, Seidenberger does provide motivation to add a second stylet to Salzmann, since Seidenberger [0002] notes that stylets/mandrins placed in the lumens during insertion stabilize the catheter against buckling and prevent air from penetrating into the blood vessel. Thus, Seidenberger improves upon Salzmann by preventing air from entering in either lumen since both lumens have a mandrin/stylet. Likewise, the stylet of Abrahamson improves upon Salzmann modified by Seidenberger, as previously noted, in that wire stiffener 12 is explicitly stiff enough to aid in insertion of the catheter assembly, and further allows a wider opening in the tip while still providing smooth insertion.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). See modified 103 rejections below.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the proximal section being only one structure, or only a wire portion) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Specifically, Applicant argues against the prior mapping of Abrahamson to the claimed “proximal section”. The previous interpretations of “proximal section” were different and occurred in claims which did not depend from one another. A new interpretation of Abrahamson is mapped to the “proximal section”, as described below in the modified rejections of independent claims 1 and 19. Although Applicant argues that the “finger member 31” and “flexible area 30” of Abrahamson cannot “collectively constitute the claimed ‘proximal section’”, there are no details in the current claim language which prevent the interpretation of both structures as parts of a “proximal section”.
Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19 line 10 reads “the vasculature of a patient”. This should read “the vasculature of [[a]]the patient”.
Appropriate correction 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 (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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5-6, 13-14, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Salzmann et al (US 20190246983 A1; hereafter Salzmann) in view of Seidenberger (US 20200406007 A1; hereafter Seidenberger) and further in view of Abrahamson et al (US 5382238 A; hereafter Abrahamson), or alternatively over Salzmann in view of Seidenberger, Abrahamson, and Euteneuer et al (US 20050137501 A1; hereafter Euteneuer).
Regarding claim 1, Salzmann discloses a catheter assembly, comprising:
a multi luminal catheter (catheter 10, fig. 1, [0018] catheter 10 includes an elongate catheter tube 12 that defines one or more lumens 14 extending between an open proximal end 12A and an open distal end 12B of the catheter tube), comprising:
a first extension leg (one of extension legs 18, fig. 1, [0019]) in fluid communication with a first lumen (one of lumens 14, fig. 1); and
a second extension leg (a second one of extension legs 18, fig. 1, [0019]) in fluid communication with a second lumen (one of lumens 14, fig. 1) ([0019] describes fluidic connection between each of the lumens 14 with each individual one of extension legs 18)
a primary stylet (stylet 330, fig. 8, [0051]) inserted within the first lumen ([0051] FIG. 8 shows disposal of a stylet 330 substantially within the lumen in the catheter tube 12…through a selected one of the extension legs 18), the primary stylet (330, fig. 8) including a magnetic region (magnet elements of stylet 330, noted in [0052]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to enable a medical tracking system (TLS sensor 250, fig. 8, [0052]) ([0037] tip location system = (“TLS”); [0052] The TLS sensor 250…detect[s] the magnetic field produced by the magnetic elements of the stylet 330) to track the primary stylet during advancement of the catheter along a vasculature of a patient ([0052] detection by the TLS sensor 250 of the magnetic field of the magnetic elements provides information to the clinician as to the position and orientation of the catheter distal end during its transit through the patient vasculature).
Salzmann is silent to a secondary stylet configured to inhibit buckling of the magnetic region.
Seidenberger, directed to a dual lumen catheter, teaches a catheter assembly (catheter system 10, fig. 1, [0022]), comprising: a multi luminal catheter (catheter 14, fig. 1, [0024]) comprising: a primary stylet (first mandrin 36, fig. 1, [0027]) inserted within the first lumen (introduction lumen 20, fig. 1, [0027]) ([0027] A first mandrin 36 is arranged in the introduction lumen 20), and a secondary stylet (second mandrin 42, fig. 1, [0028]) inserted into the second lumen (withdrawal lumen 22, fig. 1, [0028]) ([0028] A second mandrin 42 is also arranged in the withdrawal lumen 22.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the multi luminal catheter of Salzmann to include a secondary stylet as taught by Seidenberger since both references deal with multi luminal catheters. One would have been motivated to make the modification because, as noted by Seidenberger [0002], stylets/mandrins placed in the lumens during insertion stabilize the catheter against buckling and prevent air from penetrating into the blood vessel.
Salzmann modified by Seidenberger is silent to a secondary stylet configured to inhibit buckling of the magnetic region.
Abrahamson, directed to a catheter stiffener to aid in catheter insertion, teaches
a multi-luminal catheter (catheter assembly 10, fig. 2, col. 5 ln. 44-47)
a first extension leg (extension member 56, fig. 2, col. 8 ln. 12-16) in fluid communication with a first lumen (lumen 42, fig. 3, col. 8 ln. 12-16); and
a second extension leg (extension member 58, fig. 2, col. 8 ln. 12-16) in fluid communication with a second lumen (lumen 44, fig. 3, col. 8 ln. 12-16) (col. 8 ln. 12-16, two lumens 42 and 44 connected to hub 54 which includes pair of tubular pre-curved extension members 56 and 58 which can be clamped to control blood flow)
a secondary stylet (wire stiffener 12, fig. 1, col. 5 ln. 55-65) inserted within the second lumen (44) (see fig. 3 which shows distal tip 26 of secondary stylet/wire stiffener 12 inserted within the second lumen; see also col. 8 ln. 31-42), the secondary stylet (12) including a proximal section (flexible area 30, proximal end portion 18, handle member 22, and finger member 31; fig. 1; col. 6 ln. 43-48) defining a proximal column strength (col. 6 ln. 43-48, , flexible area 30 consists of a reduced diameter or reduced thickness portion of the wire 16 to form an area on the wire stiffener 12 which is more easily bent or flexed than the rest of the wire 16 without compromising the required tensile strength of the wire stiffener; since flexible area 30 is part of the proximal section, the proximal section defines the proximal column strength and Examiner interprets the proximal column strength to be that of the flexible area 30) and a distal section (distal tip 26, figs. 1 and 3, col. 7 ln. 1-9) defining a distal column strength (col. 6 ln. 32-34, the wire 16 of the wire stiffener 12 is an elongate member which has sufficient stiffness to assist in the insertion of the catheter assembly 10 into the patient), wherein the proximal column strength is less than the distal column strength (see col. 6 ln. 43-48, flexible area 30 is more easily bent or flexed than the rest of the wire 16; the distal column strength in the distal section is thus greater than the proximal column strength defined by the proximal section),
wherein the proximal section (30/18/22/31; fig. 1) extends proximally beyond the second extension leg (extension member 58, fig. 2, col. 8 ln. 12-16) (see fig. 2 which shows that finger member 31 of the proximal section of secondary stylet 12 extends proximally beyond the second extension leg 58; see fig. 1 and 2 and col. 6 ln. 21-25) such that the proximal section (30/18/22/31, fig. 1) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to receive a catheter insertion force applied thereto by a clinician (col. 6 ln. 21-25, “finger member 31 of the handle member 22 preferably has a pair of flat side surfaces and is circularly shaped when viewed from the side to provide the user with a member which is easy to grasp during the removal of the wire stiffener 12 from the catheter 14”) (Examiner notes that since the proximal section 30/18/22/31 may be used to remove the secondary stylet 12 by application of force from a user, then the proximal section must also be able to transfer force in the opposite direction along the length of the secondary stylet 12.),
wherein a distal section (distal tip 26, figs. 1 and 3, col. 7 ln. 1-9) of the secondary stylet (12, fig. 1) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to inhibit buckling during advancement of the catheter assembly along a vasculature of a patient (col. 6 ln. 32-34, the wire 16 of the wire stiffener 12 is an elongate member which has sufficient stiffness to assist in the insertion of the catheter assembly 10 into the patient) (col. 8 ln. 65-col. 9 ln. 3, distal tip 26 fills the transition between the distal hole 50 and the guidewire 35 (FIG. 3) to prevent the tissue or blood vessel wall snag during insertion of the catheter).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the catheter assembly of Salzmann modified by Seidenberger to have the secondary stylet be the wire stiffener taught by Abrahamson, since all three references deal with catheter assemblies inserted into a patient’s vasculature. One would have been motivated to make the modification because, as noted by Abrahamson, “wire 16 of the wire stiffener 12 is an elongate member which has sufficient stiffness to assist in the insertion of the catheter assembly 10 into the patient.” (see col. 6 ln. 32-34) and “wire stiffener 12 allows the diameter of the opening 50 on the catheter tip 46 to be greater than in prior catheters” without catching on the wall of the vessel (see col. 8 ln. 53-61), thus beneficially aiding in smooth catheter insertion and improving the versatility of the catheter by including the modified larger opening at the tip which may provide better access to the vasculature of the patient.
Examiner notes that, as modified to include the secondary stylet during insertion, the device of Salzmann modified by Abrahamson would include wherein a distal section (Abrahamson: distal tip 26, figs. 1 and 3) of the secondary stylet (Abrahamson: wire stiffener 12, fig. 1) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to inhibit buckling of the magnetic region (Salzmann: magnetic elements, [0052] magnetic elements of the stylet magnetic assembly are co-terminal with the distal end 12B of the catheter tube 12 during catheter insertion) during advancement of the catheter assembly along a vasculature of a patient (Abrahamson: col. 6 ln. 32-34, the wire 16 of the wire stiffener 12 is an elongate member which has sufficient stiffness to assist in the insertion of the catheter assembly 10 into the patient) (Abrahamson: col. 8 ln. 65-col. 9 ln. 3, distal tip 26…prevent[s] the tissue or blood vessel wall snag during insertion of the catheter).
Since the magnetic elements of Salzmann are located at the distal end of the catheter and used to track position of the catheter during insertion, and the distal section of Abrahamson is located at the distal end of the catheter to aid in catheter insertion, the combination of both the trackable and support members being at the distal end during insertion would have been obvious to one of ordinary skill in the art. Thus, the distal section 26 of the secondary stylet 12 of Abrahamson would inhibit buckling of the magnetic region of Salzmann during catheter advancement into the vasculature.
Alternatively, regarding claim 1, Salzmann modified by Seidenberger and Abrahamson discloses the assembly according to claim 1, as described in the first rejection of claim 1 above, including wherein the proximal section (Abrahamson: proximal section 30/18/20/22/31 of secondary stylet/wire stiffener 12, fig. 1 and 2, col. 6 ln. 21-25) extends proximally beyond the second extension leg (Abrahamson: extension member 58, fig. 2, col. 8 ln. 12-16) (see fig. 2 which shows that finger member 31 of the proximal section 30/18/20/22/31 of secondary stylet 12 extends proximally beyond the second extension leg 58).
Salzmann modified by Seidenberger and Abrahamson is silent to wherein the proximal section is explicitly configured to receive a catheter insertion force applied thereto by a clinician.
Euteneuer, directed to a medical device with a push force limiter, teaches wherein the proximal section is configured to receive a catheter insertion force applied thereto by a clinician ([0020] a clinician may urge the distal tip forward by applying longitudinal forces to the proximal portion of the device).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the proximal section of Salzmann modified by Seidenberger and Abrahamson to be explicitly configured to receive a catheter insertion force applied by a clinician since Euteneuer also deals with inserting medical devices into the vasculature (see Euteneuer [0019]). One would have been motivated to make the modification because having the clinician push the catheter into the vasculature ensures that the clinician has an immediate feeling of how the catheter is reacting to the force and may be better able to identify blockages and appropriate levels of applied force.
Regarding claim 2, Salzmann modified by Seidenberger and Abrahamson, alternatively further modified by Euteneuer, discloses the assembly according to claim 1, as described above, including wherein the distal section (Abrahamson: distal tip 26, figs. 1 and 3) extends along the magnetic region (Salzmann: magnetic elements, [0052] magnetic elements of the stylet magnetic assembly are co-terminal with the distal end 12B of the catheter tube 12 during catheter insertion).
Note, as explained in the 103 rejection of claim 1 above, that the magnetic elements of Salzmann are located at the distal end of the catheter and used to track position of the catheter during insertion, and the distal section of Abrahamson is located at the distal end of the catheter to aid in catheter insertion. Since both noted structures are located at the distal end of the catheter, then the distal section extends along the magnetic region.
Regarding claim 3, Salzmann modified by Seidenberger and Abrahamson, or alternatively further modified by Euteneuer, discloses the assembly according to claim 1, as described above.
Either alternative rejection discloses all claim limitations except wherein the distal section defines a distal column strength greater than a column strength of the magnetic region of the primary stylet.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the column strengths of the distal section and the magnetic region such that the column strength of the distal section was greater than the column strength of the magnetic region, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 (II-A). Similarly, it would have been an obvious modification since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See MPEP 2144.05 (II-B). One would have been motivated to make the modification because the relative column strengths of the adjacent sections would determine whether the distal section of the secondary stylet or the magnetic region of the primary stylet is more rigid, thus being less flexible, and thus more easily stressed by lateral forces which the catheter tip may encounter during insertion. By having the distal section of the secondary stylet have a greater column strength, thus being less flexible and under more stress when encountering lateral forces, the more complex magnetic region of the primary stylet of Salzmann, which includes both magnet elements and sensors (Salzmann [0055] “The stylet 330, in addition to including a magnetic assembly for the magnetically-based TLS modality, includes a sensing component, i.e., an internal, intravascular ECG sensor assembly, proximate its distal end and including a portion that is co-terminal with the distal end of the catheter tip”), is protected from additional stress since the distal section of the secondary stylet bears the stress first and prevents unwanted deflection of the magnetic region of the primary stylet. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Regarding claim 5, Salzmann modified by Seidenberger and Abrahamson, or alternatively further in view of Euteneuer, discloses the assembly according to claim 1, as described above, including wherein: the proximal section (Abrahamson: proximal section 30/18/20/22/31, fig. 1) defines a proximal diameter (Abrahamson: col. 6 ln. 43-48, flexible area 30 consists of a reduced diameter or reduced thickness portion), the distal section defines a distal diameter (Abrahamson: see diameter of distal tip 26 in figs. 1 and 3, note col. 7 ln. 1-18, see Abrahamson Modified Fig-1 below), and the proximal diameter is less than the distal diameter (Abrahamson: see figs. 1 and 3; see Abrahamson Modified Fig-1 below).
PNG
media_image1.png
626
798
media_image1.png
Greyscale
Regarding claim 6, Salzmann modified by Seidenberger and Abrahamson, or alternatively further in view of Euteneuer, discloses the assembly according to claim 5, as described above, including wherein: the secondary stylet (Abrahamson: 12, fig. 1) defines a transitioning section (Abrahamson: see Abrahamson Modified Fig-1 above) extending between the proximal section and the distal section (Abrahamson: see Abrahamson Modified Fig-1 above, the noted transitioning section is located between the proximal and distal section), and the transitioning section defines a diameter between distal diameter and the proximal diameter (Abrahamson: see Abrahamson Modified Fig-1 above).
Regarding claim 13, Salzmann modified by Seidenberger and Abrahamson, or alternatively further in view of Euteneuer, discloses the assembly according to claim 1, as described above. Salzmann further discloses wherein the primary stylet (stylet 330, fig. 8) includes one or more sensors (sensing component noted in [0055]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to detect one or more electrical signals (Salzmann: [0055] stylet 330, in addition to including a magnetic assembly for the magnetically-based TLS modality, includes a sensing component, i.e., an internal, intravascular ECG sensor assembly, proximate its distal end and including a portion that is co-terminal with the distal end of the catheter tip for intravascularly sensing ECG signals).
Regarding claim 14, Salzmann modified by Seidenberger and Abrahamson, or alternatively further in view of Euteneuer, discloses the assembly according to claim 13, as described above. Salzmann further discloses wherein the one or more sensors include an electrode configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to detect an ECG signal ([0055] intravascular ECG sensor assembly … for … intravascularly sensing ECG signals produced by the SA node) to enable the medical tracking system to confirm a location of the catheter within the vasculature ([0054] this third modality of the system 210 enables detection of ECG signals from the SA node in order to place the catheter distal tip in a desired location within the patient vasculature. Note that the US, TLS, and ECG modalities are seamlessly combined in the present system 210, but can be employed in concert or individually to assist in catheter placement).
Salzmann as modified is silent to the ECG sensor assembly being an electrode. However, in the same embodiment Salzmann notes the use of electrodes for gathering ECG signals. Salzmann [0058] “Together with the external baseline ECG signal received from the external ECG sensor component (i.e., the external ECG electrodes 336 placed on the patient's skin), an internal, intravascular ECG signal sensed by the internal ECG sensor component (i.e., the stylet ECG sensor assembly of the stylet 330), is received by the TLS sensor 250 positioned on the patient's chest (FIG. 8)”.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Salzmann as modified to explicitly use an electrode as the internal ECG sensor component, since Salzmann, in the same embodiment, notes that an electrode can be used as the external ECG sensor component. One would have been motivated to make the modification because using the same type of sensor for both locations would produce results of the same type which can then be easily processed together by the TLS sensor 250 to determine location.
Regarding claim 17, Salzmann modified by Seidenberger and Abrahamson, or alternatively further in view of Euteneuer, discloses the assembly according to claim 1, as described above. Salzmann further discloses wherein the primary stylet (Salzmann: stylet 330, fig. 8) includes a primary stylet attachment device (Salzmann: [0056] The stylet 330 includes a tether 334 extending from its proximal end that operably connects to the TLS sensor 25)
Salzmann as modified in either alternative applied above also discloses wherein the secondary stylet (Abrahamson: wire stiffener 12, fig. 1) includes a secondary stylet attachment device (Abrahamson: threaded cap member 20, figs. 1 and 2, col. 5 ln. 59-col. 6 ln. 9) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to selectively couple the secondary stylet (Abrahamson: 12, fig. 1) to the second extension leg (Abrahamson: 56, fig. 2) (Abrahamson: col. 6 ln. 5-7, threaded cap member 20 may be snap fit or otherwise releasably attached to the proximal portion of the catheter 14) such that longitudinal displacement of the secondary stylet (Abrahamson: 12, fig. 1) with respect to the catheter (Abrahamson: catheter assembly 10, fig. 2) is inhibited (Abrahamson: col. 6 ln. 7-9, The wire 16 is preferably molded or otherwise fixedly attached to the interior of the handle member 22.; note fig. 1, wire 16 is part of secondary stylet/wire stiffener 12).
Thus, Salzmann modified by Seidenberger and Abrahamson, or alternatively further in view of Euteneuer, discloses all of the claim limitations except for the stylet attachment device being incorporated with the primary stylet instead of the secondary stylet.
It would have been obvious to include an additional stylet attachment device associated with the primary stylet, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP 2144.04 (VI-B). One would have been motivated to make the modification because doing so would allow secure attachment of both stylets to the catheter and ensure that neither stylet slips accidentally too far into or out of the catheter during use. The modified device could still perform the function of permitting tracking of the distal end of the catheter during catheter insertion.
Regarding claim 18, Salzmann modified by Seidenberger and Abrahamson, or alternatively further in view of Euteneuer, discloses the assembly according to claim 1, as described above, including wherein the secondary stylet (Abrahamson: wire stiffener 12, fig. 1) includes a secondary stylet attachment device (Abrahamson: threaded cap member 20, figs. 1 and 2, ) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to selectively couple the secondary stylet (Abrahamson: 12, fig. 1) to the second extension leg (Abrahamson: 56, fig. 2) (Abrahamson: col. 6 ln. 5-7, threaded cap member 20 may be snap fit or otherwise releasably attached to the proximal portion of the catheter 14) such that longitudinal displacement of the secondary stylet (Abrahamson: 12, fig. 1) with respect to the catheter (Abrahamson: catheter assembly 10, fig. 2) is inhibited (Abrahamson: col. 6 ln. 7-9, The wire 16 is preferably molded or otherwise fixedly attached to the interior of the handle member 22.; note fig. 1, wire 16 is part of secondary stylet/wire stiffener 12).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Salzmann modified by Seidenberger and Abrahamson, or alternatively further in view of Euteneuer, as applied to claim 6 above, and further in view of Ferry et al (US 20040133130 A1; hereafter Ferry).
Regarding claim 7, Salzmann modified by Seidenberger and Abrahamson, or alternatively further in view of Euteneuer, discloses the assembly according to claim 6, as described above, including wherein the transitioning section defines a taper (Abrahamson: see Abrahamson Modified Fig-1 above).
Salzmann as modified is silent to the taper extending along the transitioning section.
Ferry, directed to a magnetically navigable medical guidewire, teaches wherein the transitioning section (first section 34a, fig. 3, [0019] first section 34a that widens the distal direction) defines a taper (see fig. 3 and [0019] which show/describe taper of first section 34a) extending along the transitioning section (34a, fig. 3), the taper defining: the proximal diameter at a proximal end of the transitioning section (see proximal diameter indicated between the black arrows in Ferry Modified Fig-3 below), and the distal diameter at a distal end of the transitioning section (see distal diameter indicated between the grey arrows in Ferry Modified Fig-3 below).
PNG
media_image2.png
144
306
media_image2.png
Greyscale
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Salzmann as modified to include the transitioning section defining a taper which transitions between the proximal diameter and the distal diameter since Ferry also deals with navigating the vasculature of a patient. One would have been motivated to make the modification because including the transitioning section with a taper between diameters reduces the risk of debris getting caught along the stylet or any portion of the lumen getting caught on an edge of the stylet during advancement through a tortuous portion of the vasculature.
Claim(s) 9-11, 19-21, and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Salzmann modified by Seidenberger and Abrahamson and further in view of Euteneuer.
Regarding claim 9, Salzmann modified by Seidenberger and Abrahamson or alternatively further modified by Euteneuer discloses the assembly according to claim 1, as described above.
Either alternative combination is silent to the proximal column strength defining an insertion force limit.
Euteneuer, directed to a medical device with a push force limiter, further teaches wherein the proximal column strength (column strength of intermediate portion 20 noted in [0023]) defines an insertion force limit for the catheter ([0030] push force limiting intermediate portion 20 buckles at a specific predetermined force, thereby preventing additional force from being transmitted to the tip), when the catheter insertion force is applied to the secondary stylet (device 10 is interpreted to be a core wire for use with other medical devices as optionally noted in [0022], fig. 1, [0022] device 10 may comprise a core wire (for use alone or with a variety of other medical devices), guidewire, catheter (e.g., therapeutic, diagnostic, or guide catheter), endoscopic device, laproscopic device, an embolic protection device, or any other suitable device.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the proximal section of Salzmann modified by Seidenberger and Abrahamson to buckle as taught, since Euteneuer also deals with inserting medical devices into the vasculature (see Euteneuer [0019]). Additionally, [0023] of Euteneuer notes that the intermediate portion 20 has a decreased column strength of increased flexibility than that of the distal end 21 of the device 10, and Abrahamson col. 6 ln. 43-48 describes flexible area 30 consists of a reduced diameter or reduced thickness portion of the wire 16 to form an area on the wire stiffener 12 which is more easily bent or flexed than the rest of the wire 16. One would have been motivated to make the modification because, as noted by Euteneuer [0030], this design “prevent[s] additional force from being transmitted to the tip”. This modification thus prevents too much force from being transmitted through the distal tip into delicate regions of the vasculature and may reduce trauma during catheter insertion.
Regarding claim 10, Salzmann modified by Seidenberger, Abrahamson, and Euteneuer discloses the assembly according to claim 9, as described above, including wherein the proximal section (Euteneuer: intermediate portion 20, figs. 1 and 2, [0030]) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to buckle when the catheter insertion force exceeds the insertion force limit (Euteneuer: [0030] push force limiting intermediate portion 20 buckles at a specific predetermined force, thereby preventing additional force from being transmitted to the tip).
Regarding claim 11, Salzmann modified by Seidenberger, Abrahamson, and Euteneuer discloses the assembly according to claim 9, as described above, including wherein the insertion force limit is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to prevent buckling of the magnetic region (Salzmann: magnetic elements, [0052] magnetic elements of the stylet magnetic assembly are co-terminal with the distal end 12B of the catheter tube 12 during catheter insertion) (Euteneuer: [0030] push force limiting intermediate portion 20 buckles at a specific predetermined force, thereby preventing additional force from being transmitted to the tip).
Examiner notes that since the intermediate portion 20 of Euteneuer buckling prevents the distal tip 18 (see figs. 1 and 2) of Euteneuer from buckling, and the magnetic region of Salzmann is coterminal with the distal tip of the catheter during insertion, then the modified device would meet the functional limitation since the insertion force limit would cause the proximal section/intermediate section 20 of Euteneuer to buckle and thus prevent the distal end from buckling as shown in fig. 2 of Euteneuer.
Regarding claim 19, Salzmann discloses a method for placing a catheter within a vasculature of a patient, comprising:
providing a catheter assembly, comprising:
a multi-luminal catheter (catheter 10, fig. 1, [0018] catheter 10 includes an elongate catheter tube 12 that defines one or more lumens 14 extending between an open proximal end 12A and an open distal end 12B of the catheter tube) having a first extension leg (one of extension legs 18, fig. 1, [0019]) in fluid communication with a first lumen (one of lumens 14, fig. 1) and a second extension leg (a second one of extension legs 18, fig. 1, [0019]) in fluid communication with a second lumen (one of lumens 14, fig. 1) ([0019] describes fluidic connection between each of the lumens 14 with each individual one of extension legs 18)
a primary stylet (stylet 330, fig. 8, [0051]) inserted within the first lumen ([0051] FIG. 8 shows disposal of a stylet 330 substantially within the lumen in the catheter tube 12…through a selected one of the extension legs 18), (330, fig. 8) including a magnetic region (magnet elements of stylet 330, noted in [0052]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to enable a medical tracking system (TLS sensor 250, fig. 8, [0052]) ([0037] tip location system = (“TLS”); [0052] The TLS sensor 250…detect[s] the magnetic field produced by the magnetic elements of the stylet 330) to track the primary stylet during advancement of the catheter along the vasculature of a patient ([0052] detection by the TLS sensor 250 of the magnetic field of the magnetic elements provides information to the clinician as to the position and orientation of the catheter distal end during its transit through the patient vasculature).
Salzmann is silent to a secondary stylet.
Seidenberger, directed to a dual lumen catheter, teaches a catheter assembly (catheter system 10, fig. 1, [0022]), comprising: a multi luminal catheter (catheter 14, fig. 1, [0024]) comprising: a primary stylet (first mandrin 36, fig. 1, [0027]) inserted within the first lumen (introduction lumen 20, fig. 1, [0027]) ([0027] A first mandrin 36 is arranged in the introduction lumen 20), and a secondary stylet (second mandrin 42, fig. 1, [0028]) inserted into the second lumen (withdrawal lumen 22, fig. 1, [0028]) ([0028] A second mandrin 42 is also arranged in the withdrawal lumen 22.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the multi luminal catheter of Salzmann to include a secondary stylet as taught by Seidenberger since both references deal with multi luminal catheters. One would have been motivated to make the modification because, as noted by Seidenberger [0002], stylets/mandrins placed in the lumens during insertion stabilize the catheter against buckling and prevent air from penetrating into the blood vessel.
Salzmann modified by Seidenberger is silent to a secondary stylet with a distal column strength greater than a proximal column strength.
Abrahamson, directed to a catheter stiffener to aid in catheter insertion, teaches
a multi-luminal catheter (catheter assembly 10, fig. 2, col. 5 ln. 44-47)
a first extension leg (extension member 58, fig. 2, col. 8 ln. 12-16) in fluid communication with a first lumen (lumen 42, fig. 3, col. 8 ln. 12-16); and
a second extension leg (extension member 56, fig. 2, col. 8 ln. 12-16) in fluid communication with a second lumen (lumen 44, fig. 3, col. 8 ln. 12-16) (col. 8 ln. 12-16, two lumens 42 and 44 connected to hub 54 which includes pair of tubular pre-curved extension members 56 and 58 which can be clamped to control blood flow)
a secondary stylet (wire stiffener 12, fig. 1, col. 5 ln. 55-65) inserted within the second lumen (44) (see fig. 3 which shows distal tip 26 of secondary stylet/wire stiffener 12 inserted within the second lumen; see also col. 8 ln. 31-42),
the secondary stylet (12) including a proximal section (flexible area 30, proximal end portion 18, handle member 22, and finger member 31; fig. 1; col. 6 ln. 43-48) extending proximally beyond the second extension leg (56) (see fig. 2 which shows finger member 31, part of proximal section of wire stiffener 12, extending proximally of second extension leg 56) and a distal section (distal tip 26, figs. 1 and 3, col. 7 ln. 1-9) defining a distal column strength (col. 6 ln. 32-34, the wire 16 of the wire stiffener 12 is an elongate member which has sufficient stiffness to assist in the insertion of the catheter assembly 10 into the patient), wherein the proximal section defines a proximal column strength (col. 6 ln. 43-48, , flexible area 30 consists of a reduced diameter or reduced thickness portion of the wire 16 to form an area on the wire stiffener 12 which is more easily bent or flexed than the rest of the wire 16 without compromising the required tensile strength of the wire stiffener; since flexible area 30 is part of the proximal section, the proximal section defines the proximal column strength and Examiner interprets the proximal column strength to be that of the flexible area 30) less than the distal column strength (see col. 6 ln. 43-48, flexible area 30 is more easily bent or flexed than the rest of the wire 16; the distal column strength in the distal section is thus greater than the proximal column strength defined by the proximal section).
Examiner notes that Salzmann and Abrahamson are technically silent to applying an insertion force to the proximal section to advance the catheter along the vasculature, however both disclose advancing the catheter along the vasculature, and it would be necessary to apply a force to the proximal section in order to advance the catheter into the vasculature.
Euteneuer, in the art of catheter insertion, teaches applying an insertion force to a proximal section ([0020] a clinician may urge the distal tip forward by applying longitudinal forces to the proximal portion of the device) to advance a device (device 10 is interpreted to be a core wire for use with other medical devices as optionally noted in [0022], see fig. 1) along a vasculature ([0019] Using this method, virtually any target site in the patient's vascular system may be accessed).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the method of inserting of Salzmann modified by Seidenberger and Abrahamson to explicitly include applying an insertion force to the proximal section to advance the catheter of Salzmann along the vasculature, as taught by Euteneuer, since all references deal with medical device insertion into the vasculature. One would have been motivated to make the modification because, as previously noted, Salzmann and Abrahamson both disclose advancing a catheter through a patient’s vasculature, which would require some kind of force on the proximal end of the device.
Regarding claim 20, Salzmann modified by Seidenberger, Abrahamson, and Euteneuer discloses the method according to claim 19, as described above.
Salzmann modified by Seidenberger, Abrahamson, and Euteneuer discloses all claim limitations except for wherein the distal column strength greater is greater than a column strength of the magnetic region of the primary stylet.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the column strengths of the distal section and the magnetic region such that the column strength of the distal section was greater than the column strength of the magnetic region, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 (II-A). Similarly, it would have been an obvious modification since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See MPEP 2144.05 (II-B). One would have been motivated to make the modification because the relative column strengths of the adjacent sections would determine whether the distal section of the secondary stylet or the magnetic region of the primary stylet is more rigid, thus being less flexible, and thus more easily stressed by lateral forces which the catheter tip may encounter during insertion. By having the distal section of the secondary stylet have a greater column strength, thus being less flexible and under more stress when encountering lateral forces, the more complex magnetic region of the primary stylet of Salzmann, which includes both magnet elements and sensors (Salzmann [0055] “The stylet 330, in addition to including a magnetic assembly for the magnetically-based TLS modality, includes a sensing component, i.e., an internal, intravascular ECG sensor assembly, proximate its distal end and including a portion that is co-terminal with the distal end of the catheter tip”), is protected from additional stress since the distal section of the secondary stylet bears the stress first and prevents unwanted deflection of the magnetic region of the primary stylet. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation
Regarding claim 21, Salzmann modified by Seidenberger, Abrahamson, and Euteneuer discloses the method according to claim 20, as described above, including wherein providing the catheter assembly includes: inserting the primary stylet (Salzmann: stylet 330, fig. 8) into the first lumen (Salzmann: [0051] FIG. 8 shows disposal of a stylet 330 substantially within the lumen in the catheter tube 12…through a selected one of the extension legs 18; [0019] each extension leg 18 connects to a lumen 14); and inserting the secondary stylet (Abrahamson: wire stiffener 12, fig. 1) into the second lumen (Abrahamson: see fig. 3 which shows distal tip 26 of secondary stylet/wire stiffener 12 inserted within the second lumen; see also col. 8 ln. 31-42) such that the distal section (Abrahamson: distal tip 26 of secondary stylet/wire stiffener 12, see fig. 3) is disposed adjacent the magnetic region (Salzmann: see fig. 8 and [0051]).
Note, as explained in the 103 rejection of claim 19 above, that the magnetic elements of Salzmann are located at the distal end of the catheter and used to track position of the catheter during insertion, and the distal section of Abrahamson is located at the distal end of the catheter to aid in catheter insertion. Since both noted structures are located at the distal end of the catheter, the distal section 26 of the secondary stylet 12 of Abrahamson would be adjacent to the magnetic region of Salzmann.
Regarding claim 23, Salzmann modified by Seidenberger, Abrahamson, and Euteneuer discloses the method according to claim 20, as described above.
Salzmann as currently modified is silent to wherein: the proximal column strength defines an insertion force limit for the catheter, and the proximal section is configured to buckle when the insertion force exceeds the insertion force limit.
Euteneuer, directed to a medical device with a push force limiter, further teaches wherein the proximal column strength (column strength of intermediate portion 20 noted in [0023]) defines an insertion force limit for the catheter ([0030] push force limiting intermediate portion 20 buckles at a specific predetermined force, thereby preventing additional force from being transmitted to the tip), and the proximal section (intermediate portion 20, figs. 1 and 2, [0030]) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to buckle when the catheter insertion force exceeds the insertion force limit ([0030] push force limiting intermediate portion 20 buckles at a specific predetermined force, thereby preventing additional force from being transmitted to the tip).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the proximal section of Salzmann modified by Seidenberger and Abrahamson to buckle as taught, since Euteneuer also deals with inserting medical devices into the vasculature (see Euteneuer [0019]). Additionally, [0023] of Euteneuer notes that the intermediate portion 20 has a decreased column strength of increased flexibility than that of the distal end 21 of the device 10, and Abrahamson col. 6 ln. 43-48 describes flexible area 30 consists of a reduced diameter or reduced thickness portion of the wire 16 to form an area on the wire stiffener 12 which is more easily bent or flexed than the rest of the wire 16. One would have been motivated to make the modification because, as noted by Euteneuer [0030], this design “prevent[s] additional force from being transmitted to the tip”. This modification thus prevents too much force from being transmitted through the distal tip into delicate regions of the vasculature and may reduce trauma during catheter insertion.
Regarding claim 24, Salzmann modified by Seidenberger, Abrahamson, and Euteneuer discloses the method according to claim 23, as described above, including wherein the insertion force limit is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to prevent buckling of the magnetic region (Salzmann: magnetic elements, [0052] magnetic elements of the stylet magnetic assembly are co-terminal with the distal end 12B of the catheter tube 12 during catheter insertion) (Euteneuer: [0030] push force limiting intermediate portion 20 buckles at a specific predetermined force, thereby preventing additional force from being transmitted to the tip).
Examiner notes that since the intermediate portion 20 of Euteneuer buckling prevents the distal tip 18 (see figs. 1 and 2) of Euteneuer from buckling, and the magnetic region of Salzmann is coterminal with the distal tip of the catheter during insertion, then the modified device would meet the functional limitation since the insertion force limit would cause the proximal.
Regarding claim 25, Salzmann modified by Seidenberger, Abrahamson, and Euteneuer discloses the method according to claim 19, as described above. Salzmann further discloses wherein the primary stylet (Salzmann: stylet 330, fig. 8) includes a primary stylet attachment device (Salzmann: [0056] The stylet 330 includes a tether 334 extending from its proximal end that operably connects to the TLS sensor 25)
Salzmann modified by Seidenberger, Abrahamson, and Euteneuer as applied above further discloses comprising coupling a secondary stylet attachment device (Abrahamson: threaded cap member 20, figs. 1 and 2, col. 5 ln. 59-col. 6 ln. 9) between the secondary stylet (Abrahamson: wire stiffener 12, fig. 1) and the second extension leg (Abrahamson: 56, fig. 2) (Abrahamson: col. 6 ln. 5-7, threaded cap member 20 may be snap fit or otherwise releasably attached to the proximal portion of the catheter 14) of the catheter to inhibit longitudinal displacement of the primary stylet with respect to the catheter (Abrahamson: col. 6 ln. 7-9, The wire 16 is preferably molded or otherwise fixedly attached to the interior of the handle member 22.; note fig. 1, wire 16 is part of secondary stylet/wire stiffener 12).
Thus, Salzmann modified by Seidenberger, Abrahamson, and Euteneuer discloses all of the claim limitations except for the stylet attachment device being incorporated with the primary stylet instead of the secondary stylet.
It would have been obvious to include an additional stylet attachment device associated with the primary stylet, and modify the method to include a step of attaching the primary stylet to the first extension leg, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP 2144.04 (VI-B). One would have been motivated to make the modification because doing so would allow secure attachment of both stylets to the catheter and ensure that neither stylet slips accidentally too far into or out of the catheter during use. The modified device and method could still perform the function of permitting tracking of the distal end of the catheter during catheter insertion.
Regarding claim 26, Salzmann modified by Seidenberger, Abrahamson, and Euteneuer discloses the method according to claim 19, as described above, including further comprising coupling a secondary stylet attachment device (Abrahamson: threaded cap member 20, figs. 1 and 2, col. 5 ln. 59-col. 6 ln. 9) between the secondary stylet (Abrahamson: wire stiffener 12, fig. 1) and the second extension leg (Abrahamson: 56, fig. 2) (Abrahamson: col. 6 ln. 5-7, threaded cap member 20 may be snap fit or otherwise releasably attached to the proximal portion of the catheter 14) of the catheter to inhibit longitudinal displacement of the primary stylet with respect to the catheter (Abrahamson: col. 6 ln. 7-9, The wire 16 is preferably molded or otherwise fixedly attached to the interior of the handle member 22.; note fig. 1, wire 16 is part of secondary stylet/wire stiffener 12).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Salzmann modified by Seidenberger and Abrahamson, or alternatively further in view of Euteneuer, as applied to claim 1 above, and further in view of Lemon et al (US 20180169389 A1; hereafter Lemon).
Regarding claim 12, Salzmann ad modified in either alternative discloses the assembly according to claim 1, as described above.
Salzmann as modified is silent to a sheath along the magnetic region.
Lemon, directed to a catheter assembly including EDG sensor and magnetic assemblies, teaches wherein: the primary stylet (stylet 30, fig. 2, [0047]) includes a sheath (sleeve 42, fig. 3d, [0053]) extending along the magnetic region (stylet distal segment 32, fig. 3d, [0053]), and the magnetic region (32) includes one or more magnets (magnets 60, fig. 3d, [0053]) disposed within the sheath (42) (see fig. 3d which shows that the magnets 60 are disposed within the sheath/sleeve 42).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the magnetic region of the primary stylet of Salzmann as modified to include a sheath and the magnets disposed within the sheath as taught by Lemon because Lemon also deals with a similar catheter assembly having two extension legs (see fig. 1 and [0038] The hub 16 permits fluid communication between extension tubing 18 and 20 and the lumen(s) 14 of the catheter 12.). One would have been motivated to make the modification because having a sheath extending over the magnets would help to keep the magnets in place and the construction of the distal tip of the primary stylet of Lemon would prevent movement of the magnets along the longitudinal direction, ensuring that the magnets remain co-terminal with the end of the catheter and ensuring proper location tracking of the catheter tip.
Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being obvious over Salzmann modified by Seidenberger and Abrahamson, or alternatively further in view of Euteneuer as applied to claim 1 above, and further in view of Sowards et al (US 20210275256 A1; hereafter Sowards).
Examiner notes that although the applied reference has a common applicant with the instant application, the limitations of claim 15 are not found in the US provisional application to which priority is claimed, and thus the limitations of claim 15 have a priority date of 01/18/2023.
Regarding claim 15, Salzmann modified by Seidenberger and Abrahamson, or alternatively further in view of Euteneuer, discloses the assembly according to claim 1, as described above.
Either alternative modification is silent to wherein the primary stylet includes an optical fiber extending therealong, the optical fiber configured to enable shape sensing of the primary stylet by the medical tracking system.
Sowards, directed to catheter advancement, teaches wherein a primary stylet (stylet 130, fig. 2, [0065]) includes an optical fiber (multi-core optical fiber 135, fig. 5, [0066] multi-core optical fiber 135 included within the stylet 130) extending therealong (see fig. 5 and [0066]), the optical fiber (135, fig. 5) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to enable shape sensing of the primary stylet by the medical tracking system ([0065] from variations (shifts) in the wavelength of the reflected light from the sensors positioned on each core fiber within the multi-core optical fiber 135…shape sensing analytic logic 192 within the console 110 (see FIG. 1) may determine the physical state of the stylet 130 (e.g., shape, orientation, etc.))
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the primary stylet of Salzmann as modified to further include an optical fiber which permits shape sensing to determine the physical state of the stylet as taught by Sowards, since Sowards also deals with catheter insertion. One would have been motivated to make the modification because, as noted by [0065] of Sowards, shape sensing can determine the shape and orientation of the stylet. This information would help the clinician to effectively track and position the stylet, and therefore the catheter, appropriately within the vasculature.
Regarding claim 16, Salzmann modified by Seidenberger and Abrahamson, or alternatively further in view of Euteneuer, discloses the assembly according to claim 1, as described above.
Salzmann as modified is silent to wherein the primary stylet includes at least one of one or more sensor configured to detect one or more electrical signals or an optical fiber configured to enable shape sensing of the primary stylet by the medical tracking system.
Sowards, directed to catheter advancement, teaches wherein a stylet (stylet 130, fig. 2, [0065]) includes an optical fiber (multi-core optical fiber 135, fig. 5, [0066] multi-core optical fiber 135 included within the stylet 130) extending therealong (see fig. 5 and [0066]), the optical fiber (135, fig. 5) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to enable shape sensing of the primary stylet by the medical tracking system ([0065] from variations (shifts) in the wavelength of the reflected light from the sensors positioned on each core fiber within the multi-core optical fiber 135…shape sensing analytic logic 192 within the console 110 (see FIG. 1) may determine the physical state of the stylet 130 (e.g., shape, orientation, etc.))
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the primary stylet of Salzmann as modified to further include an optical fiber which permits shape sensing to determine the physical state of the stylet as taught by Sowards, since Sowards also deals with catheter insertion. One would have been motivated to make the modification because, as noted by [0065] of Sowards, shape sensing can determine the shape and orientation of the stylet. This information would help the clinician to effectively track and position the stylet, and therefore the catheter, appropriately within the vasculature.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 06/12/2026
Prosecution Insights