DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 3, 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
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.
Claim(s) 1-5, 7, 11-14, and 16, 17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helgeson et al. (US 2015/0352327) in view of Wang et al. (US 10,799,672).
Regarding claim 1, Helgeson et al. (henceforth Helgeson) discloses an elongate medical device (10), comprising: a deflectable shaft section (12) comprising a central shaft member section comprising a central shaft member material (paragraph [0026]); two pull-wire lumens (87, 88) disposed within the central shaft member section, diametrically opposed to one another on opposite sides of the deflectable shaft section, and aligned with a deflection plane (across the minor axis of the central lumen); two pull wires (48, 49), wherein each of the two pull wires is disposed in a respective one of the two pull-wire lumens (Figure 4), and wherein the two pull wires are actuatable to induce a cross-sectional bending of the deflectable shaft section (paragraph [0049]); a handle (17) operable to actuate the two pull wires to induce a cross-sectional bending of the deflectable shaft section (paragraph [0027] & [0037]); and a lumen liner (86, Figure 4) extending within the central shaft member section and comprising a lumen liner material (e.g., polymer forming liner), wherein the lumen liner surrounds and defines a lumen (Figure 4), wherein the lumen liner is configured to cause the deflectable shaft section to have an out-of-plane bending stiffness that is greater than an in-plane bending stiffness of the deflectable shaft section, wherein the out-of-plane stiffness is oriented to resist bending induced deflection of the deflectable shaft section perpendicular to the deflection plane to provide planarity control of the deflectable shaft section during the cross-sectional bending of the deflectable shaft section (as depicted in Figure 4, lumen 40 is of oval or elliptical cross-section; for this reason, the lumen provides the greatest resistance to bending in the direction perpendicular to the major axis or along the plane that contains the long, or major axis, of the cross-section). Helgeson fails to explicitly disclose the liner stiffer than the shaft material.
Wang et al. (henceforth Wang) teaches (Figures 2-3) a catheter liner member (hypotube 26 is a liner for shaft 20), defines a lumen (within 26; figure 3) and has a continuous circumferential liner surface (it’s a single extrusion which is cylindrical; Col. 7, lines 62-64; Col. 8, lines 13-16), wherein the entire lumen liner is made of a material that is stiffer than the shaft material (Col. 8, line 48-Col. 9, line 16; see also Col. 5, line 66-Col. 6, line 11 which discloses that the stiffness of the hypotube increases the pushability and torqueability of the catheter body).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the liner member of Helgeson to comprise the stiffening hypotube of Wang so as to allow for a device which flexes a desired amount during a procedure to provide better torqueability and pushability which contributes to easier navigability of the catheter body as taught by Wang (Col. 6, lines 9-11).
Regarding claim 2, Helgeson further discloses (Figure 4) two pull-wire lumens (87, 88) within the deflectable shaft section and disposed diametrically opposed to one another on opposite sides of the first lumen (Figure 4); and two pull wires (48, 49) via which the handle is drivingly coupled with the deflectable shaft section, wherein each of the two pull wires is disposed in a respective one of the two pull-wire lumens, and wherein the two pull wires are actuatable to induce the cross-sectional bending of the deflectable shaft section (paragraph [0034]).
Regarding claims 3 and 4, Helgeson further discloses wherein the first area is joined to the second area (as set forth above, the claim does not require the first and second area to be separate and distinct in size or shape; as such, one portion of the oval-shaped lumen may be considered the first area, and a second portion may be considered the second area; they are joined as they are formed as a single lumen cross-section; as per claim 4, these areas may overlap; see annotated figure below).
Regarding claim 5, Helgeson further discloses wherein the first lumen (40) is further defined by a third area connecting the first area to the second area (see annotated figure below).
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Regarding claim 7, Helgeson further discloses wherein the third area is smaller than each of the first area and second area (the claimed areas may be arbitrarily determined and therefore a section of the lumen, connecting the first and second portions as claimed may be smaller than either of the other two).
Regarding claim 11, Helgeson further discloses wherein the first lumen (40) is symmetrical (Figure 4, it’s oval-shaped).
Regarding claim 12, Helgeson further discloses wherein the first lumen (40) is asymmetrical (it is noted that no frame of reference or plane of symmetry is claimed; it is understood that any shape may be considered asymmetrical if an offset plane is being referenced regarding the symmetry).
Regarding claim 13, Helgeson/Wang further teach wherein the liner member comprises a heat setting material (e.g., polyimide as per Col. 5, lines 28-42) and the shaft material comprises a reflowable polymer (Col. 6, the table sets forth the use of polyethylene, a known reflowable polymer, for the intermediate section; also Col. 7, line 62-Col. 8, line 16 of Wang teaches the use of known reflowable polymers for the hypotube such as polyurethane). It would have been obvious to one of ordinary skill in the art at the time of filing to form the shaft and liner sections from the claimed materials as Samson teaches that such materials are known in the art for forming catheters and liner members for insertion into a patient during a procedure. The cited materials provide for sufficient rigidity while also allowing for a desired flexibility to aid in navigating to a target site.
Regarding claim 14, Helgeson/Wang teach the claimed invention as set forth above for claim 1, and Wang further teaches, as set forth above for claim 13, wherein the monolithic lumen liner member comprises PEEK (Col. 7, lines 65-67 of Wang). Wang further teaches wherein the shaft section material comprises a polyether block amide (Col. 9, lines 34-41 disclose the claimed polymer for outer jacket 20).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the outer member of Helgeson to be formed from a polyether block amide as such a polymer is known in the art and results in a device with desirable mechanical properties for steerable catheter devices as taught by Wang.
Regarding claim 16, Helgeson further discloses wherein at least one of the first area and the second area has a circular shape (e.g., each side of lumen 40 forms a semi-circle; the claims fail to require the entire conformation to be circular; see annotated figure above).
Regarding claim 17, Helgeson further discloses wherein at least one of the first area and the second area has a non-circular shape (e.g., a portion of each area may be considered to comprise at least part of the flattened central portion of the lumen thereby comprising at least a portion that is non-circular; see annotated figure above).
Regarding claim 20, Helgeson further discloses wherein the deflectable shaft section has a deflectable shaft section central axis along which the deflectable shaft section extends; and the deflectable shaft section has an in-plane bending stiffness centroidal axis that intersects the deflectable shaft section central axis (the lumen of Helgeson provides for an in-plane bending stiffness in a direction perpendicular to the major axis of the lumen; this axis is considered to intersect with a shaft section central axis as claimed).
Claim(s) 6, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helgeson in view of Wang, and further in view of Chesnin et al. (US 2009/0247868).
Regarding claims 6 and 18, Helgeson/Wang teach the claimed invention substantially as set forth above for claim 1, but fail to teach the third area as narrower than the first and second areas (e.g., a peanut shape).
Chesnin et al. (henceforth Chesnin) teaches (Figure 4), a catheter lumen formed from two areas and a connected to a narrowed third area therebetween that substantially forms a peanut shape as claimed (it is noted that the install application, in paragraph [0044], discloses that a peanut shape may be an hourglass or dumbbell shape while still meeting such a definition).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the oval-shaped lumen of Helgeson to comprise the configuration taught by Chesnin as such a conformation is known from the art and allows for the simultaneous use of three separate lumen during a procedure for guiding additional elements and fluid therethrough.
Regarding claim 19, Chesnin further teaches adjacent embodiments of circular and “peanut-shaped” lumen (e.g., Figures 3 and 4; paragraph [0032] states that the central lumen 303 may be circular or formed in other shapes that efficiently utilize the internal space of the catheter).
It would have been obvious to one of ordinary skill in the art at the time of filing to combine the circular lumen configuration with the peanut-shaped configuration since Chesnin teaches that any desired shape would be suitable for the intended purpose as long as said shape efficiently utilizes the internal space of the catheter and since it has been held that combining embodiments in a single prior art reference does not require a leap of inventiveness (see e.g., BOSTON SCIENTIFIC V CORDIS CORP, No. 08-1073 (Fed. Cir. 2009)).
Claim(s) 8 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helgeson in view of Wang, and further in view of Carlin et al. (US 2007/0219441).
Regarding claim 8, Helgeson/Wang teach the claimed invention substantially as set forth above for claim 1, but do not explicitly disclose a flexible circuit within the first lumen and coupled with a waist portion of the liner to hold it in position.
Carlin et al. (henceforth Carlin) teaches a catheter having an integrated sensor (29) embodied as a flexible circuit (e.g., Figures 3-5) which is mounted within a catheter lumen (e.g., paragraphs [0048]-[0050)) to maintain the circuit in position within the lumen (paragraph [0048] discloses that the circuit remains within the lumen).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the catheter device of Helgeson/Wang to comprise a flexible circuit mounted and secured within the first lumen so as to provide for the catheter to measure physical parameters while in use and to maintain the location of the sensor within the catheter via attachment means as taught by Carlin. It would have been obvious to attach the flexible circuit to any portion of the inner lumen including the waist area if desired.
Regarding claim 15, Helgeson/Wang fail to explicitly disclose the circuit as contributing to the planarity control of the shaft section during bending.
Carlin further teaches the flexible circuit disposed in a lumen and aligned with an elongated axis of the liner (to extend therethrough) to contribute to the planarity control of the deflectable shaft section during the cross-sectional bending of the deflectable shaft section (the incorporation of a flexible circuit within the lumen will have some effect on the bending profile of the catheter shaft due to its material properties and location within the lumen; this will “contribute” to the control of the deflection of the shaft as claimed).
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helgeson in view of Wang, and further in view of Leeflang et al. (US 2014/0323964).
Regarding claims 9 and 10, Helgeson/Wang teach the claimed invention substantially as set forth above for claim 1, but do not explicitly disclose the liner member having an inner layer and outer layer which comprises a reflowable material.
Leeflang teaches a steerable catheter comprising an inner liner (e.g., 40a) which is formed from multiple layers and wherein one or more of the layers may include a reflowable material (e.g., paragraphs [0046] and [0048] disclose the liner may be formed from multiple layers and further teaches the use of reflowable polymers as an example of a layer material.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the liner member of Helgeson/Wang to comprise multiple layers wherein an outer layer is formed from are flowable material so as to create the liner member with the desired material properties (e.g., by adding reinforcement or the like as disclosed by Leeflang) before being assembled into the final catheter shaft.
Conclusion
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783