DETAILED ACTION
This action is pursuant to claims filed 10/28/2025. Claims 1-5 and 7-37 are pending. Claims 1 has been amended. A final action on the merits of claims 1-5 and 7-37 is as follows.
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 .
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.
Claim(s) 1-5, 7-12, 16-19, 21-23, 25-27, and 31-37 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Lemon et al. (Hereinafter ‘Lemon’, US 2018/0169389 A1) in view of Pedroso et al. (hereinafter ‘Pedroso’, US 20220062584 A1) and in further view of Okajima (US 5554139 A).
Regarding claim 1, Lemon discloses a stylet (stylet 130 in Fig. 6A) for placing a catheter in a vasculature of a patient ([0002]: stylet for use in guiding a distal tip of a catheter to a predetermined location within the body of a patient), comprising:
an ECG sensor assembly (connector 156, conductor 135, core wire 131, and all that is contained by them form the ECG sensor assembly in Fig. 6A) including an electrode ([0095]: the distal end of the stylet 132 surrounded by conductive tubing 142 serves as an ECG sensor or electrode) extending from a proximal end (130A in Fig. 6A) to a distal end (130B in Fig. 6A) of the stylet, the proximal end configured to couple with an ECG sensor ([0065]: the connector 156, which is on the proximal end of the assembly, is configured for operable connection to an ECG sensor device);
a magnetic assembly (magnetic assembly 160 in Fig. 14) disposed along a distal tip portion of the stylet (Fig. 14 represents the distal tip portion of the stylet which is where the magnetic assembly is located), the magnetic assembly producing a magnetic field ([0002]: the magnetic assembly includes elements capable of producing a magnetic field);
a core wire (core wire 131 in Figs. 6A and 14) extending proximally away from the magnetic assembly (core wire 131 starts at distal tip as seen in Fig 14 and extends to the handle 134 as seen in Fig. 6A); and
a coil (conductive coil 194 in Fig. 14) defining a lumen (coil creates the bore of a tube as seen in Fig. 14), the coil extending along a distal portion of the stylet (coil at distal portion 130B as seen in Fig. 14), wherein:
a distal portion of the core wire is disposed within the lumen (the distal portion of the core wire 131 is surrounded by the coil as seen in Fig. 14).
the magnetic assembly comprises a plurality of magnet elements disposed within the lumen and arranged end to end within the lumen (plurality of magnets 162 disposed within lumen of coil 194 and arranged end to end as seen in Fig. 14).
Lemon further discloses methods in alternate embodiments for modifying the flexibility at the distal end of the stylet. For instance, Lemon states that in the embodiment shown in Fig. 17, the flexibility of the hypotube that forms the distal end can be modified by perforations, helical notches, or through holes to increase the flexibility ([0097]).
However, Lemon is silent to modifying the coil width of the embodiment shown in Fig. 14.
Pedroso teaches a highly-flexible kink-resistant catheter device for vascular applications that has an inner core with helical ribbon segments arranged as coils around the core ([Abstract]). Pedroso further teaches that the width of the ribbon can vary as shown in Fig. 4. Varying the widths and pitch of the coil from the proximal to the distal end allows for a high level of variability in the stiffness and can allow for better optimization of the physical capabilities ([0049]-[0050]). The variability in how the ribbon segments are cut and the amount of material in the different regions controls the stiffness changes along the catheter ([0034]). While not particularly directed towards an ECG stylet, the device of Pedroso is directed towards a device for navigating the patient vasculature, similar to the device of Lemon, and increasing the flexibility to aid in this navigation would benefit Lemon. Because Lemon discusses the potential for modifying the flexibility of the distal region of the stylet, it would be of routine skill in the art to modify the coil widths to adjust the flexibility of the tip as doing so would simply lead to the expected outcome of optimized flexibility. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the coil of Lemon with the varying widths and pitches of Pedroso such that the flexibility of the distal end of the stylet can be optimized.
However, while Pedroso teaches varying both the width and pitch of the coil to modify the physical properties of the coil, the Lemon/Pedroso combination is silent to the width of the coil defining the pitch.
Okajima teaches a catheter including a coil layer with a greater flexibility in the distal tip for use in patient’s blood vessels ([Abstract], [Col 1, lines 7-10]). Okajima further teaches that the pitch of the coil can be changed in order to change the distribution of the rigidity of the coil. The pitch is changed in relation to the width of the coil itself. When the width is smaller, the pitch increases which allows for increased flexibility towards the tip of the catheter. Similarly, utilizing a thicker, wider coil with a smaller pitch increases the rigidity at the proximal end of the device. Varying the widths and pitches can be done in a continuous manner which gradually adjusts the flexibility along the length of the device ([Col 8, lines 26-54]). While not particularly directed towards an ECG stylet, the device of Okajima is directed towards a device for navigating the patient vasculature, similar to the device of the Lemon/Pedroso combination, and increasing the flexibility to aid in this navigation would benefit the combination. Because the Lemon/Pedroso discusses the potential for modifying the width and pitch to change the flexibility of the distal region of the stylet, it would be of routine skill in the art to modify the coil pitches in relation to the coil widths to adjust the flexibility of the tip as doing so would simply lead to the expected outcome of optimized flexibility. Additionally, the claim does not limit how the width defines the pitch coil, and it is the examiner’s assertion that if the coil has a larger width with a corresponding smaller pitch at the base and a smaller width with a corresponding larger pitch at the tip, there is a defined relationship between the pitch and the width of the coil. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pitch such that it is defined by the width of the coil such that the proximal section of the coil has a wider width and a smaller pitch and the distal section has a smaller width and larger pitch such that the flexibility is increased towards the tip of the coil as taught by Okajima.
Regarding claim 2, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, wherein the stylet is configured to be inserted within a lumen of the catheter ([0002]: the stylet is configured for use within a lumen of the catheter).
Regarding claim 3, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, wherein the stylet is configured for placement of the catheter within a superior vena cava of the patient ([0073]: one desired position to place the catheter is within the superior vena cava).
Regarding claim 4, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, wherein the electrode includes the core wire ([0095]: the distal portion of the tubing 142 forms the electrode sensor, the core wire 131 is contained within the distal portion of the tubing 142 as seen in Fig. 14).
Regarding claim 5, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, wherein the electrode includes the coil ([0095]: the distal portion of the tubing 142 forms the electrode sensor, the coil 194 is contained within the distal portion of the tubing 142 as seen in Fig. 14 and the conductive coil distal end aids in increasing the conductive surface of the ECG sensor).
Regarding claim 7, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, wherein each of the magnet elements comprises a cylindrical shape ([0074]: the magnets 162 are cylindrical shape).
Regarding claim 8, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, wherein one or more magnet elements are attached to the coil ([0094]: the conductive coil 194 is secured at the distal end with conductive epoxy 166, as seen in Fig. 14 the magnet elements 162 are also secured to the conductive epoxy 166, thus attaching the magnetic elements to the conductive coil).
Regarding claim 9, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, wherein the coil is attached to the core wire (the coil is attached to the core wire at the proximal end 194A as seen in Fig. 14).
Regarding claim 10, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, wherein the coil is electrically coupled with the core wire ([0094]: the conductive coil connects at a connection point to the core wire, this connection must be an electrical connection in order for the conductive coil to transmit signals).
Regarding claim 11, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, wherein the coil member forms a first helix (Helix shape visible at proximal end of coil in Fig. 14).
Regarding claim 12, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 11, wherein the coil member comprises a rectangular cross-sectional shape having the width and a thickness (cross section of coil clearly shows rectangular cross section with width and thickness in Fig. 14).
Regarding claim 16, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, further comprising a sheath (sheath 142 in Fig. 14) extending along the distal portion (sheath 142 clearly shown extending down distal portion in Fig. 14), the sheath covering the coil (sheath 142 surrounds coil 194 in Fig. 14).
Regarding claim 17, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, wherein the core wire includes a first thickness (thickness of wire 131 at proximal region in Fig. 14, [claim 4]: the core wire has a first diameter) extending along a proximal portion of the core wire and a second thickness (second thickness at distal end of wire 131 in Fig 14, [claim 4]: the core wire has a second diameter) extending along a distal portion of the core wire, wherein the second thickness is less than the first thickness (the second thickness is clearly smaller than the first thickness of wire 131 in Fig 14, [claim 4]: the second diameter is less than the first diameter).
Regarding claim 18, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 17, wherein the core wire includes a taper extending between the first thickness the second thickness (There is a clear taper between the first and second thicknesses in wire 131 in Fig. 14, [claim 5]: the transition from the first diameter to the second diameter is tapered).
Regarding claim 19, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 17, wherein the distal portion of the core wire is round (distal portion of wire 131 is round like the rest of the wire in Fig. 14, [claim 4]: the distal portion of the core wire has a diameter which only round objects have).
Regarding claim 21, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, further comprising a distal tip member (distal tip member 166 in Fig. 14) coupled with the coil ([0094]: distal tip 166 couples to coil 194).
Regarding claim 22, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 21, wherein the distal tip member is formed of an electrically conductive material ([0094]: distal tip member is made from a conductive epoxy).
Regarding claim 23, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 22, wherein the distal tip member is electrically coupled with the coil ([0094]: the conductive epoxy 166 is coupled to the conductive coil to increase the conductive surface area).
Regarding claim 25, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 24, wherein the distal tip member is electrically coupled with the core wire ([0094]: the distal tip member 166 couples to the coil 194 which couples to the core wire 131, thus the core wire is electrically coupled with the distal tip member).
Regarding claim 26, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, further comprising a handle (handle 164 in Fig. 6A) attached to the core wire at a proximal end of the core wire (handle 134 at proximal end of wire 131 in Fig. 6A).
Regarding claim 27, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, further comprising a tether (tether 135 in Fig. 6A) coupled with the core wire at the proximal end of the core wire (at the proximal end of the core wire 131 in Fig. 6A, the wire couples to the handle 134 which in turn couples to the tether 135), wherein the tether comprises an electrical conductor forming a portion of the electrode ([0065]: the tether comprises a plurality of electrically conductive wires connected to components disposed in the distal segment 132 of the stylet 130, the distal segment which forms part of the sensing electrode).
Regarding claim 31, the Lemon/Pedroso/Okajima combination discloses an intravascular catheter assembly (catheter assembly 110 in Fig. 4A), comprising:
a catheter (catheter 112 in Fig. 4A) comprising a lumen (lumen 114 in Fig. 4A); and
the stylet according to claim 1 disposed within the lumen of the catheter (the stylet 130 enters the catheter at port 122 as seen in Fig. 4A).
Regarding claim 32, the Lemon/Pedroso/Okajima combination discloses the catheter assembly of claim 31, wherein the catheter is configured for placement of a tip of the catheter within superior vena cava of a patient ([0073]: one desired position to place the catheter is within the superior vena cava).
Regarding claim 33, the Lemon/Pedroso/Okajima combination discloses the catheter assembly of claim 31, wherein a distal end of the catheter and a distal end of the stylet are substantially co-terminal ([0081]: the distal end of the stylet containing the magnetic assembly is co-terminal with the distal end of the catheter).
Regarding claim 34, the Lemon/Pedroso/Okajima combination discloses the catheter assembly of claim 31, further comprising a preformed curve along a distal portion of the catheter assembly ([0042]: the distal segment of the catheter assembly can have a pre-shaped curve).
Regarding claim 35, the Lemon/Pedroso/Okajima combination discloses the catheter assembly of claim 34, wherein the preformed curve is defined by a preform curve of the stylet ([0042]: the stylet may be configured to retain a curve which the distal segment of the catheter assembly is pre-shaped to match).
Regarding claim 36, the Lemon/Pedroso/Okajima combination discloses the catheter assembly of claim 31, wherein the coil of the stylet is entirely disposed within the lumen of the catheter (as seen in Fig. 4A, the entire distal end of the stylet, which includes the coil, is disposed within the lumen of the catheter assembly).
Regarding claim 37, the Lemon/Pedroso/Okajima combination discloses the catheter assembly of claim 31, wherein a sheath of the stylet is entirely disposed within the lumen of the catheter (as seen in Fig. 4A, the core wire assembly of the stylet, which includes the sheath, is disposed within the lumen of the catheter assembly).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over the Lemon/Pedroso/Okajima combination as applied to claim 11/1 and described above, in view of Schwager (US 5,706,826 A).
Regarding claim 13, the Lemon/Pedroso/Okajima combination discloses the invention substantially in claim 11/1 and described above. Lemon further discloses a single coil member forming a helix shape.
However, the Lemon/Pedroso/Okajima combination does not disclose a second coil member.
Schwager teaches a guide wire with a distal end helical coil, very similar to that of the Lemon/Pedroso/Okajima combination, for positioning catheters through blood vessels. Schwager further teaches a coil assembly with a first coil member and a second coil member that both form helices around the wire core (see first coil member 5 and second coil member 8 wrapped around the core wire 16 in Fig. 1). Utilizing multiple coils allows for different flexibilities and connecting them end to end allows for uninterrupted flexibility from the first coil to the second coil (Col 3, lines 3-21). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the two coils of Schwager with the coil member of the Lemon/Pedroso/Okajima combination to allow for varying degrees of flexibility in the tip of the stylet, thus arriving at the claimed invention.
Regarding claim 14, the Lemon/Pedroso/Okajima/Schwager combination further teaches that the first and second coil cross each other such that the distal portion of the first coil is surrounded by the proximal portion of the second coil to create a strong engagement between each other (Col 3, lines 29-60).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over the Lemon/Pedroso/Okajima combination as applied to claim 1 and described above, in view of Brown et al. (hereinafter ‘Brown’, US 20180304043 A1).
Regarding claim 15, the Lemon/Pedroso/Okajima combination discloses the invention substantially in claim 1 and described above. Lemon further discloses a coil that creates a lumen within which the core wire is disposed.
However, the combination does not disclose the coil being a braded or woven structure.
Brown teaches a magnetic stylet with a core element with a distal region within which a core element, magnetic element, and a closure element are disposed ([Abstract]). Brown further teaches the stylet having a coil that runs the length of the stylet forming a lumen that houses the core wire and a magnetic assembly that terminates at the distal tip (coil 55, core wire 60, magnetic assembly 70 in Fig. 5). The coil element can take the form of a braid in order to reinforce the stylet and provide a desired level of flexibility or rigidity ([0060]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the braided structure of Brown with the coil of Lemon/Pedroso/Okajima combination in order to impart better reinforcing properties and achieve the desired flexibility or rigidity, thus arriving at the claimed invention.
Claims 20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over the Lemon/Pedroso/Okajima combination as applied to claims 1 and 17/1 and described above.
Regarding claim 20, the Lemon/Pedroso/Okajima combination discloses the invention substantially in claim 17/1 and described above.
However, the current embodiment used for the above rejection does not disclose the core wire extending along the magnet assembly.
It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to continue the core wire adjacent to the magnets, since applicant has not disclosed that continuing the core wire solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the coil connection of the embodiment in Fig. 14. In fact, applicant even states in paragraph [0064] of the instant application that extending the core wire in this manner simply provides an alternate embodiment in which the coil does not need to electrically couple to the core wire. Additionally, Lemon teaches an alternate embodiment in which a smaller, distal portion 190 of the core wire extends adjacent to the magnets to connect the body of the core wire to the distal tip as seen in Fig. 21. Although called a separate entity in the disclosure of Lemon, it forms a continuous connection between the distal tip and the core wire and can thus be interpreted as a single conductive unit. This allows the main body of the core wire to form an electrical connection with the distal tip ([0093]). It would be of routine skill in the art for one skilled in the art to form a continuous connection between the core wire and the distal tip adjacent to the magnets disposed within the coil lumen as taught by Fig. 21 of Lemon.
Regarding claim 24, the Lemon/Pedroso/Okajima combination discloses the stylet of claim 1, wherein the core wire extends distally beyond the magnetic assembly (distal portion of the core wire 190B extends distally beyond the magnets into the distal tip as seen in Fig. 21 of Lemon).
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over the Lemon/Pedroso/Okajima combination as applied to claim 12/11/1 and described above, in view of Zhou et al. (Hereinafter ‘Zhou’, US 8377035 B2).
Regarding claim 28, the Lemon/Pedroso/Okajima combination discloses the invention substantially in claim 12/11/1 and described above. The Lemon/Pedroso/Okajima combination further discloses a coil having a width as seen in the cross section of the coil in Fig. 14.
However, the Lemon/Pedroso/Okajima combination is silent to the width of the coil.
Zhou teaches a device shaft that utilizes a braid reinforcement layer that creates a lumen for the core wire (lumen 18 in Fig. 2) and allows for improved kink resistance and torque performance for use in medical devices such as guide catheters, which the Lemon/Pedroso/Okajima combination is ([Abstract]). More specifically, Zhou teaches a braid layer consisting of rectangular coils as seen in Fig. 5A. The coils in this layer each have their own width and thickness. Zhou further teaches that the individual coil widths can range from 0.25mm up to 7mm (Col 7, lines 28-38). This range overlaps significantly with the claimed range, thus Zhou teaches the claimed range of 0.01mm up to 1mm. See MPEP 2131.03. Combining the coil widths of Zhou would be a simple combination with the Lemon/Pedroso/Okajima combination that would yield the expected result of improved kink and torque resistance. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the coil width of Zhou with the coil of the Lemon/Pedroso/Okajima combination in order to provide improved kink and torque resistance, thus arriving at the claimed invention.
Regarding claim 29, the Lemon/Pedroso/Okajima /Zhou combination further teaches the claimed thickness of 0.01mm up to 1mm since Zhou teaches the thickness of the coils to be 0.2mm up to 6mm (Col 7, lines 28-38) which overlaps substantially with the claimed range. See MPEP 2131.03.
Claims 30 is rejected under 35 U.S.C. 103 as being unpatentable over the Lemon/Pedroso/Okajima combination as applied to claim 11/1 and described above, in view of Shireman et al. (Hereinafter ‘Shireman’, US 8,222,566 B2).
Regarding claim 30, the Lemon/Pedroso/Okajima combination discloses the invention substantially in claim 11/1 and described above. The Lemon/Pedroso/Okajima combination further discloses having a pitch that creates a lumen that encloses the core wire.
However, the Lemon/Pedroso/Okajima combination is silent to the pitch of the coil.
Shireman teaches a guidewire for use in navigation and treatment within a patient that has a flexible distal end, like the Lemon/Pedroso/Okajima combination. Shireman further teaches the guide wire having a core wire 16 wrapped by a coil 80 at its distal end (see Fig. 1). The pitch of the coil 80 may be tightly wrapped so that each turn touches the succeeding turn or the pitch may be set such that coil 80 is wrapped in an open fashion. In some embodiments, the coil can have a pitch of up to about 0.04 inches, in some embodiments a pitch of up to about 0.02 inches, and in some embodiments, a pitch in the range of about 0.001 to about 0.004 inches (Col 16, lines 21-37). The pitch going from touching up to 0.04 inches, which is approximately 1 mm, teaches the range of 0.01mm to 10mm since touching to 0.04in falls substantially within the claimed range. See MPEP 2131.03. Shireman teaches that changing the pitch changes the flexibility, so setting the desired pitch is important based on the flexibility in the desired application (Col 16, lines 21-37). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the pitch of Shireman with the coil of the Lemon/Pedroso/Okajima combination in order to arrive at the desired flexibility and the claimed invention.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5 and 7-37 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571)272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794
Prosecution Insights