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 .
Election/Restrictions
Claims 4, 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 9, 2026.
Information Disclosure Statement
The information disclosure statements (IDS) filed July 3, 2024 and October 18, 2024 are being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the medical instrument of claim 6 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, 7, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Leeflang et al. (US2022/313946).
Regarding claim 1, Leeflang discloses the medical device comprising: a shaft (apparatus 10, similar to apparatus 110, may be a various catheters, a sheath or other tubular device [0031]); and a braided sheath coaxial with the shaft and at least extending along the shaft between a distal end of the shaft and a proximal end of the shaft; wherein the braided sheath includes a braiding (reinforcement layer 142 comprising reinforcement members 143 and conductors 145 [0059], conductors 45 and reinforcement member 43 extend between proximal and distal ends [0049]), and wherein the braiding includes: a plurality of mechanical strands (reinforcement members 143 [0059]), and at least one conductor electrically connected and/or communicatively connected to a first electrical device positioned at or near the distal end of the shaft (wire or conductor 145 may be coupled to a plurality of sensors, actuators, electrodes, imaging elements and/or other components 148 on a distal portion 124 of apparatus 110 [0049, 0058]).
Regarding claim 2, Leeflang discloses the medical device of claim 1, further disclosing wherein the at least one conductor is a first conductor (Fig. 3A: three conductors 145, the at least one conductor is the first of the three conductors 145 [0058]), wherein the braiding includes a second conductor electrically connected and/or communicatively connected to a second electrical device (Fig. 3B: it appears there may be at least three conductors 145, Fig. 3A: one of the three conductors 145 that is not the first conductor may be the second conductor that is connected to a second electrode 148 [0049]).
Regarding claim 3, Leeflang discloses the medical device of claim 2, further disclosing wherein the first conductor is braided clockwise along the braided sheath and the second conductor is braided counterclockwise along the braided sheath (Fig. 7A: one of element 345 is braided clockwise around the apparatus 310 from left to right, the other element 345 is braided counterclockwise along the apparatus 310 from right to left).
Regarding claim 6, Leeflang discloses the medical device of claim 2, further disclosing wherein the first conductor is connected to a medical instrument, wherein the medical instrument is at least partially received by a lumen of the shaft (instrument or other elements may be passed through a primary lumen 18 [0032-0033], Fig. 1A: the first conductor 145 is connects to the instrument or other elements through other internal components within the apparatus 10 and handle 30).
Regarding claim 7, Leeflang discloses the medical device of claim 1, further disclosing wherein the at least one conductor is a coated core wire (conductors may be wire with core, having insulation layer or coating [0050]).
Regarding claim 19, Leeflang discloses a medical device (apparatus 10 may be imaging catheter [0031]) comprising: a handle (Fig. 1A: handle 30); a shaft extending from the handle, wherein the shaft includes a proximal end and a distal end (apparatus 10 is an elongated tubular member with proximal end 12 and distal end 14 [0032], distal end 12 connects to handle 30), wherein the shaft includes a working channel extending a length of the shaft (central lumen 18a); an end cap include one or more lights or cameras (distal end may comprise imaging elements, sensors and actuators [0058]); and a braided sheath coaxial with the shaft and extending along at least an exterior of the shaft between the distal end of the shaft and the proximal end of the shaft (reinforcement members 43/143 and conductors 45/145 are braided together to form reinforcement layer 142 [0059]); wherein the braided sheath includes: a plurality of mechanical strands (reinforcement members 43/143); and a first conductor configured to electrically and/or communicatively connect the handle to the one or more lights or cameras in the end cap (conductors 45/145 may be connected to sensors, actuator or imaging elements at the distal portion 124 and also connected to connectors/electronics at the proximal end [0058]).
Regarding claim 20, Leeflang discloses the medical device of claim 19, further disclosing wherein the braided sheath includes a second conductor, wherein the first conductor and the second conductor each include a termination portion positioned at a distal end of the braided sheath (multiple conductors 45/145 [0059] implies at least a second conductor, conductors 45/145 are connected to components at the distal end of apparatus 10 [0058], the point at which they are connected is the termination portion); wherein the termination portions are contained within or electrically connected to a flexible circuit (conductors 45/145 are connected to sensors, actuators, electrodes and/or other components at the distal end of apparatus 10 [0058], the portion in which the two connect is electrically connected to connectors and electronics at the proximal end of the apparatus, forming a flexible circuit [0058]).
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.
Claims 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang in view of Kampa et al. (US2008/0251966).
Regarding claim 5, Leeflang discloses the medical device of claim 2, further disclosing the device comprising an end cap (cap [0033]), however is silent regarding whether the first conductor and the second conductor are electrically connected to the end cap. In the same field of endeavor, Kampa teaches a substantially similar medical device comprising a shaft (tubular body 10 for catheter [0061] with proximal end 40 and distal end 35), a braided sheath extending between a distal end and a proximal end of the shaft (core walls 25 with conductor wires and reinforcement layer 55 extend from proximal end 40 to distal end 35 [0061]), the braided sheath comprising a plurality of mechanical strands (reinforcement layer 55 comprises cylindrical wire braid [0063, 0079]) and a first conductor connected to a first electrical device positioned at or near the distal end of the shaft (conductor wire 85 extends to electrical devices such as electrodes at distal end 35 [0067]), and a second conductor connected to a second electrical device (conductor wires [0061] implies multiple conductor wires, in their respective core wall lumen 30 [0090], conductor wires extend to electrical devices at the distal end 35 [0067]). Kampa further teaches the first conductor and the second conductor are electrically connected to the end cap (conductors wires 85 exits the core walls lumens 30 to the end ring 310/cap to transmit an electrical current to the end ring 310 [0121], end ring 310 is also a cap [0116]). In view of Kampa, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein the first and second conductors are electrically connected to the end cap of Leeflang, as taught by Kampa, as it allows the electric current to be delivered to the distal end of the shaft for medical diagnosis and/or treatment [0121].
Regarding claim 9, Leeflang discloses the medical device of claim 1, but does not explicitly teach wherein the at least one conductor is a coaxial cable. In the same field of endeavor, Kampa teaches a substantially similar medical device comprising a shaft (tubular body 10 for catheter [0061] with proximal end 40 and distal end 35), a braided sheath extending between a distal end and a proximal end of the shaft (core walls 25 with conductor wires and reinforcement layer 55 extend from proximal end 40 to distal end 35 [0061]), the braided sheath comprising a plurality of mechanical strands (reinforcement layer 55 comprises cylindrical wire braid [0063, 0079]) and a first conductor connected to a first electrical device positioned at or near the distal end of the shaft (conductor wire 85 extends to electrical devices such as electrodes at distal end 35 [0067]). Kampa further teaches wherein the first conductor may be a coaxial cable (conductor wire 58 may be a coaxial wire [0067]). In view of Kampa, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein the conductor may be a coaxial cable, as it is well-known in the medical tubing art that conductors extending through medical catheters may be formed of various forms of conductive cabling or wires to carry an electrical current from the proximal end of the catheter to the distal of the catheter, including the coaxial cable taught by Kampa.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Leeflang in view Ackerman (US3,731,376).
Regarding claim 8, Leeflang discloses the medical device of claim 1, but does not explicitly teach wherein the at least one conductor is a stranded wire. In the same field of endeavor, Ackerman teaches a method of making a catheter, the catheter formed of a flexible core, electrically conductive electrode, and a sheath, further teaching wherein the core may be formed of solid construction or stranded wires (core may be stranded or solid construction, strands may be woven or braided together [col. 3, lines 3-10]). In view of Ackerman, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that core wire and stranded wire are suitable alternative for one another for forming a braided sheath of a catheter, and stranded wires may be preferable as provide a desirable flexibility and torque response [col. 3, lines 5-6].
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang in view of Cajamarca et al. (US2015/0119859),
Regarding claim 10, Leeflang discloses the medical device of claim 1, but fails to disclose the device further comprising a polyimide wrap layer that covers the braided sheath and extends coaxially with the braided sheath. In the same field of endeavor, Cajamarca teaches a substantially similar medical device comprising a shaft (catheter 4 comprising shaft 10 [0032]), a braided sheath extending between a distal end and a proximal end of the shaft (shaft is comprised of suitable braided polyimide tube [0036]), the braided sheath comprising a plurality of mechanical strands (braid is generally a ribbon or woven pattern of stainless-steel wire [0036]). Cajamarca further teaches device comprising a polyimide wrap layer that covers the braided sheath and extends coaxially with the braided sheath (Fig. 4: outer layer 104 and 106 covers the braided polyimide tube 100; first outer layer 104 may be a polyimide layer [0039]; second outer layer 106 may be various materials, including polyimide [0040]). In view of Cajamarca, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the polyimide wrap layer of Cajamarca, covering the braided sheath of Leeflang, as it is known in the catheter art to improve flexibility and a smooth finish to the surface of the catheter [0040].
Regarding claim 11, Leeflang, modified by Cajamarca, discloses the medical device of claim 10. Cajamarca further teaches wherein the polyimide wrap layer includes a first layer and a second layer (Fig. 4: first outer layer 104, second outer layer 106).
Regarding claim 12, Leeflang, modified by Cajamarca, discloses the medical device of claim 11. Cajamarca further discloses wherein the first layer is a continuous ground plane (Fig. 4: first outer layer 104 is formed of a polyimide [0039], which the material is capable as a ground plane).
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang in view of Cajamarca and Bremer (US4,753,223).
Regarding claim 13, Leeflang, modified by Cajamarca, discloses the medical device of claim 12, but fails to disclose wherein the second layer includes one or more conductors. In the same field of endeavor, Bremer teaches substantially similar medical device comprising a shaft (Fig. 1 & 2: medical probe device 10 is a tubular multi-layered shaft [col. 3, lines 14-16]), a braided sheath coaxial with the shaft and at least extending along the shaft between a distal end of the shaft and a proximal end of the shaft (plurality of conductors 17 spirally wound [col. 3, lines 17-20]), wherein the shaft includes a braiding, and wherein the braiding includes a plurality of mechanical strands and at least one conductor (Fig 1: plurality of conductors 17 spirally wound [col. 3, lines 17-20], some of which acting as mechanical strands). Bremer further teaches a wrap layer that covers the braided sheath (Fig. 1 & 2: rigid ring 18 and insulating material 14 comprises the wrap layer that covers the plurality of conductors 17 [col. 3, lines 28-34]), the wrap layer comprising a first layer (insulating material 14) and a second layer (rigid ring 18), wherein the second layer comprises one or more conductors (Fig. 1 & 2: rigid rings 18 comprises biometal wire 20 [col. 3, line 35], which act as conductors). In view of Bremer, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the biometal wires in the second layer of Leeflang, modified by Cajamarca, as it is known in the art that the biometal wires through the second layer can be heated to assist in the flexibility of the shaft [col. 4, lines 28-40].
Regarding claim 15, Leeflang, modified by Cajamarca and Bremer, discloses the medical device of claim 13. Bremer further teaches wherein the one or more conductors are impedance-controlled conductors (biometal wires comprises resistance/impedance of 3ohms [col. 4, lines 28-31], therefore an impedance-controlled conductor).
Allowable Subject Matter
Claims 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 14 recites the limitation requiring that the second layer of the polyimide wrap layer includes an exterior surface and an interior surface, wherein the one or more conductors of the second layer are disposed on one of the exterior surface and the interior surface, and a ground layer of the second layer is disposed on the other of the exterior surface and the interior surface. The prior arts referenced in this Office Action does teach the second layer of the polyimide wrap layer comprising a conductor, however the art fails to teach wherein the conductor is disposed on one of the exterior surface and the interior surface of the second layer of the polyimide wrap layer, and a ground layer of the second layer is disposed on the other of the exterior surface and the interior surface. Bremer appears to teach wherein the conductor is within the second layer and not located on either surface of the layer. While various prior arts cited in the PTO-892 show some of the limitations required for claim 14, individually or in lesser combinations, the prior art fails to teach this feature of including the placement of the conductor and a ground layer relative to the second layer of the polyimide wrap layer. Further, there is no reason, teaching or suggesting provided with any prior art of record to modify the polyimide wrap layer, to include wherein the conductor is on one surface of the second layer and a ground layer is on the other surface of the second layer. For the reasons stated above, claim 14 has been indicated as containing allowable subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See referenced cited in PTO-892.
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/LI-TING SONG/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
04/24/26
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