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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 4, 2025 has been entered.
This action is pursuant to the claims filed on September 4, 2025. Claims 1-13 and 21 are pending. Claims 14-20 is/are canceled. An action on the merits of claims 1-13 and 21 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 . 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 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.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2: “The alloy electrode array of claim 1” should be changed to –The electrode array of claim 1” for consistency.
Appropriate correction is required.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Hastings et al. (hereinafter ‘Hastings’, U.S. PGPub. No. 2008/0161774), and further in view of Garabedian et al. (hereinafter ‘Garabedian’, U.S. PGPub. No. 2006/0129203).
In regards to independent claim 1, Hastings discloses an electrode array (distal end 14 of shaft 12 comprising a plurality of electrodes 26 in Fig. 1-3, [0038], [0044]) comprising:
a removable outer sheath ([0041]: during insertion of catheter 10 into the patient, the distal end 14 is straightened using a straightening device such as a sheath such that advancing through the distal end of the sheath causes the distal end 14 to assume the curved shape comprising the various curved sections 20, 22 and 24 as shown in Fig. 3);
an insulation layer (Figs. 7-8 shows the cross-sectional area of the distal end 14 of the shaft 12; Fig. 7 shows the portion without the electrodes and Fig. 8 shows the portion with electrodes 26; [0048]: the shaft 12 is formed from a melt-processing polymeric material such as polyether block amides, nylon, urethane, polyethylene, and other thermoplastic elastomer which reads on the insulation layer) including a plurality of orbital lumens positioned in a ring shape, the orbital lumens being separated from each other by insulation of the insulation layer, each of the orbital lumens configured to carry at least one conductive component (Fig. 7 specifically illustrates a plurality of orbital lumens each holding lead wire 28 arranged radially along the polymeric material), the outer sheath surrounding the insulation layer ([0041]: the distal end 14 formed from the polymeric material is disposed within the straightening device such as a sheath during insertion into the patient);
a central lumen surrounded by the insulation layer, the central lumen including a metal alloy of nickel and titanium (central lumen comprising shape memory wire 25 in Fig. 7, [0042]-[0043]: the wire possesses a memory causing it to return to its fixed shape after being deformed; the wire is a shape memory wire, for example a wire comprising an alloy of nickel and titanium (known commercially as NiTi or Nitinol)).
wherein placement of the outer sheath around the central lumen and the insulation layer causes the central lumen and the insulation layer to bend into a straight line for placement percutaneously over a spinal cord of a patient ([0041]: “during insertion of catheter 10 into the patient, the various curved sections 20, 22, 24 may be straightened using a sheath, stylet, or other straightening device (not shown)”; note that the claim limitation of percutaneously over a spinal cord of a patient is intended use and the catheter of Hasting is capable of being paced percutaneously over a spinal cord of a patient).
wherein the central lumen and the insulation layer being bent into a circular geometry, wherein the central lumen and the insulation layer are configured to return to the circular geometry after the outer sheath is removed for maximizing a coverage area ([0042]: “To shape curved sections 20, 22, 24, a shaping wire 25 (FIGS. 7 and 8) may be provided extending through at least a portion of shaft 12, such as one or more of curved sections 20, 22, 24. In the present invention, shaping wire 25 helps distal end 14 assume and hold the shape of curved portions 20, 22, 24, such that, when the straightening device is removed, distal end 14 returns to the curved configuration”).
Although Hasting contemplates other geometries ([0031]: “distal end 14 may have other geometries without departing from the spirit and scope of the present invention.”), it is particularly silent as to a s-shaped zig zag geometry.
Garabedian teaches a sheathed lead (Fig. 7 or alternatively, Fig. 12) comprising a pre-shaped two-dimensional geometry configured for stimulation and sensing of a tissue ([0006]). Specifically, Garabedian teaches a curved geometry like that of Hasting (lead 64 in Figs. 7 and 9 having a predetermined curved shape) and alternatively, a s-shaped geometry (lead 104 in Fig. 12). Given that Hasting contemplates various other geometries, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the central lumen and the insulation layer of the circular shape of Hasting into various other geometries including a s-shaped geometry as taught by Garabedian, thereby arriving at the claimed invention, as doing so is an obvious matter of design choice to one having ordinary skill in the art to stimulate and sensing a desired area of tissue ([0006]-[0007]).
In regards to claim 2, Hasting/Garabedian combination further discloses wherein the outer sheath is removable ([0041]: the straightening device such as a sheath is removed away from the distal portion 14 of the shaft 12).
In regards to claim 3, Hasting/Garabedian combination further discloses wherein the insulation layer includes a number of orbital lumen (Fig. 7 illustrates 9 orbital lumens or 9 lead wires 28).
In regards to claim 4, Hasting/Garabedian combination further discloses wherein the metal alloy of nickel and titanium is replaced with other shape memory alloys ([0042]-[0043]: the wire possesses a memory causing it to return to its fixed shape after being deformed; the wire is a shape memory wire, for example a wire comprising an alloy of nickel and titanium (known commercially as NiTi or Nitinol)).
Claim 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hastings, Garabedian and further in view of Fish et al (hereinafter ‘Fish’, U.S. PGPub. No. 2011/0004087).
In regards to independent claim 5, Hastings discloses an electrode array (distal end 14 of shaft 12 comprising a plurality of electrodes 26 in Fig. 1-3, [0038], [0044]) comprising:
a removable outer sheath ([0041]: during insertion of catheter 10 into the patient, the distal end 14 is straightened using a straightening device such as a sheath such that advancing through the distal end of the sheath causes the distal end 14 to assume the curved shape comprising the various curved sections 20, 22 and 24 as shown in Fig. 3);
an insulation layer (Figs. 7-8 shows the cross-sectional area of the distal end 14 of the shaft 12; Fig. 7 shows the portion without the electrodes and Fig. 8 shows the portion with electrodes 26; [0048]: the shaft comprises a melt-processing polymeric material such as polyether block amides, nylon, urethane, polyethylene, and other thermoplastic elastomer) including a plurality of orbital lumens positioned in a ring shape, the orbital lumens being separated from each other by insulation of the insulation layer, each of the orbital lumens configured to carry at least one conductive component (Fig. 7 specifically illustrates a plurality of orbital lumens each holding lead wire 28 arranged radially along the polymeric material), the outer sheath surrounding the insulation layer ([0041]: the distal end 14 formed from the polymeric material is disposed within the straightening device such as a sheath during insertion into the patient);
a central lumen surrounded by the insulation layer, the central lumen including a shape memory polymer (central lumen comprising shape memory wire 25 in Fig. 7, [0042]-[0043]: the wire possesses a memory causing it to return to its fixed shape after being deformed; the wire is a shape memory wire, for example a wire comprising an alloy of nickel and titanium (known commercially as NiTi or Nitinol)).
wherein placement of the outer sheath around the central lumen and the insulation layer causes the central lumen and the insulation layer to bend into a straight line for placement percutaneously over a spinal cord of a patient ([0041]: “during insertion of catheter 10 into the patient, the various curved sections 20, 22, 24 may be straightened using a sheath, stylet, or other straightening device (not shown)”; note that the claim limitation of percutaneously over a spinal cord of a patient is intended use and the catheter of Hasting is capable of being placed percutaneously over a spinal cord of a patient).
wherein the central lumen and the insulation layer being bent into a circular geometry, wherein the central lumen and the insulation layer are configured to return to the circular geometry after the outer sheath is removed for maximizing a coverage area ([0042]: “To shape curved sections 20, 22, 24, a shaping wire 25 (FIGS. 7 and 8) may be provided extending through at least a portion of shaft 12, such as one or more of curved sections 20, 22, 24. In the present invention, shaping wire 25 helps distal end 14 assume and hold the shape of curved portions 20, 22, 24, such that, when the straightening device is removed, distal end 14 returns to the curved configuration”).
Although Hasting contemplates other geometries ([0031]: “distal end 14 may have other geometries without departing from the spirit and scope of the present invention.”), it is particularly silent as to a s-shaped zig zag geometry.
Garabedian teaches a sheathed lead (Fig. 7 or alternatively, Fig. 12) comprising a pre-shaped two-dimensional geometry configured for stimulation and sensing of a tissue ([0006]). Specifically, Garabedian teaches a curved geometry like that of Hasting (lead 64 in Figs. 7 and 9) and alternatively, a s-shaped geometry (lead 104 in Fig. 12). Given that Hasting contemplates various other geometries, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the central lumen and the insulation layer of the circular shape of Hasting into various other geometries including a s-shaped geometry as taught by Garabedian, thereby arriving at the claimed invention, as doing so is an obvious matter of design choice to one having ordinary skill in the art to stimulate and sensing a desired area of tissue ([0006]-[0007]).
However, Hastings/Garabedian combination does not disclose that the shape memory polymer is a thermoset shape-memory polymer.
Fish teaches an electrode array (distal end 14 of catheter 10 in Fig. 1) similar to Hasting. Specifically, Fish discloses providing a shape wire (20 as shown in Fig. 4) that can be made out of an alloy of nickel and titanium (NiTi or Nitinol) which helps to retain its desired shape or alternatively, a plastic material which is a thermoset material to retain its desired shape ([0040]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use either an alloy of nickel or titanium or a thermoset material for providing a desired shape at a distal end of a medical catheter since the equivalence of thermoset material and nitinol for their use in the medical catheter art and the selection of any one of these known equivalents to provide a desired shape at its distal end would be within the level of ordinary skill in the art.
In regards to claim 6, Hasting/Garabedian/Fish combination further discloses wherein the insulation layer includes a number of orbital lumen (Fig. 7 illustrates 9 orbital lumens or 9 lead wires 28).
In regards to claim 7, in view of the combination in claim 5 above, although Hasting discloses the removable outer sheath, it is silent as to the material. However, Hasting discloses common materials for forming medical shaft including polymeric material such as polyether block amides, nylon, urethane, polyethylene, and other thermoplastic elastomer ([0048]). Furthermore, Fish discloses that catheter can be made of biocompatible polymeric material such as polytetrafluoroethylene (PTFE), or fluorinated ethylene-polyene copolymer (FEP) ([0031]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to form the outer sheath of Hasting with biocompatible polymeric material such as the FEP material as taught by Fish, thereby arriving at the claimed invention. Doing so involves routine skilled in the art and a predictable result would ensue.
In regards to claim 8, Hasting/Garabedian/Fish combination further discloses wherein the insulation layer comprises polyurethane ([0048]: the shaft comprises a melt-processing polymeric material such as polyether block amides, nylon, urethane, polyethylene, and other thermoplastic elastomer; note that thermoplastic polyurethane is a type of thermoplastic elastomer).
Claims 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hastings, in view of Haeusser et al. (hereinafter ‘Haeusser’, U.S. PGPub. No. 2022/040951), in view of Thakkar et al. (hereinafter ‘Thakkar’, U.S. PGPub. No. 2015/0148877), in view of Garabedian, in view of Fish, and Lafontaine et al. (U.S. Pat. No. 5,662,621) and further evidenced by Gerber et al. (hereinafter ‘Gerber’, U.S. PGPub. No. 2007/025536).
In regards to independent claim 9 and claims 10-13, Hasting discloses a method comprising:
adapting biocompatible shape-memory alloy-based wire to an electrode array, whereby said wire are within a central lumen of the array ([0042]-[0043] & [0045]-[0048]: catheter 10 comprises shape memory wire at a distal end 14 of a catheter shaft 12 as shown in Fig. 7), the electrode comprising an insulation layer (Figs. 7-8 shows the cross-sectional area of the distal end 14 of the shaft 12; Fig. 7 shows the portion without the electrodes and Fig. 8 shows the portion with electrodes 26; [0048]: the shaft comprises a melt-processing polymeric material such as polyether block amides, nylon, urethane, polyethylene, and other thermoplastic elastomer) including a plurality of orbital lumens positioned in a ring shape, the orbital lumens being separated from each other by insulation of the insulation layer, each of the orbital lumens configured to carry at least one conductive component (Fig. 7 specifically illustrates a plurality of orbital lumens each holding lead wire 28 arranged radially along the polymeric material);
inserting the adapted electrode array in a minimally invasive fashion into a part of a human body ([0041]: during insertion of catheter 10 into the vasculature, straightening device can be used);
transforming the adapted electrode array electrode shape maximize a coverage area of the part of the human body ([0042]-[0043]: the wire 25 causes the distal end 14 to retain a desired shape).
However, Hasting does not disclose the method step of inserting the adapted electrode array is for positioning over a spinal cord of a human body.
Haeusser teaches generally an electrophysiology mapping catheter similar to Hasting can also be adapted and configured for use in other applications including a patient’s spinal cord or other nerves ([0205]: “The various systems, devices, components and methods described and disclosed herein may also be adapted and configured for use in electrophysiological mapping applications other than those involving the interior of a patient's heart, more about which is said below. These alternative applications can include internal or external EP mapping and diagnosis of a patient's epicardium or other portions of the patient's heart, a patient's spinal cord or other nerves, or a patient's brain or portions thereof.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to the method step of Hasting so that the device is used in a method of mapping and treating other location including a patient’s spinal cord as taught by Haeusser, the use of the same medical device on other parts of the patient’s body for sensing and/or treatment, where needed, involves only routine skill in the art and a predictable result of sensing and treating of the patient’s spinal cord would ensue.
However, Hasting/Haeusser combination does not disclose inserting the adapted electrode array in a minimally invasive fashion through a needle over a spinal cord of a human body.
Thakkar teaches that a catheter may be percutaneously inserted via a hypodermic needle into a region adjacent to a target area ([0004], [0076]). The concept of percutaneously inserting a catheter similar to Hasting/Haeusser combination via a hypodermic needle and advancing through a vasculature or directly on the target area of treatment is well-established in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method step of Hasting/Haeusser combination and incorporate the step of inserting the adapted electrode array in a minimally invasive fashion through a needle as taught by Thakkar, thereby position the adapted electrode array over the spinal cord, as doing so is a well-known minimally invasive technique for advancing and positioning a medical treatment device along a target tissue area.
However, Hasting/Haeusser/Thakkar combination does not disclose the step of transforming the adapted electrode array electrode shape to a s-shaped zig zag geometry.
Garabedian teaches a sheathed lead (Fig. 7 or alternatively, Fig. 12) comprising a pre-shaped two-dimensional geometry configured for stimulation and sensing of a tissue ([0006]). Specifically, Garabedian teaches a curved geometry like that of Hasting (lead 64 in Figs. 7 and 9) and alternatively, a s-shaped geometry (lead 104 in Fig. 12). Given that Hasting contemplates various other geometries, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the central lumen and the insulation layer of the circular shape of Hasting into various other geometries including a s-shaped geometry as taught by Garabedian, thereby arriving at the claimed invention, as doing so is an obvious matter of design choice to one having ordinary skill in the art to stimulate and sensing a desired area of tissue ([0006]-[0007]).
However, Hasting/Haeusser/Thakkar/Garabedian combination does not disclose providing a plurality of shape-memory alloy-based wires.
Fish teaches an electrode array (distal end 14 of catheter 10 in Fig. 1) similar to Hasting. Specifically, Fish discloses providing a shape wire (20 as shown in Fig. 4) that can be made out of an alloy of nickel and titanium (NiTi or Nitinol) and the use of more than one shape wire to predispose the distal region 14 into a desired shape ([0041]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the single alloy of nickel and titanium alloy Hasting and provide multiple alloy of nickel and titanium as taught by Fish for providing a desired shape at a distal end of a medical catheter.
However, Hasting/Haeusser/Thakkar/Garabedian/Fish combination does not disclose the biocompatible memory alloy-based material can change shape via heat.
Lafontaine teaches providing a material formed from nitinol wires (col. 7, ln. 54-55) that are embedded in a polymeric material (col. 5, ln. 64-66: elastomeric material of the core 24) together provide more ductile or stiff state as needed (col. 7, ln. 37-39). Specifically, Lafontaine teaches that the nitinol can change shape via heat, light or the use of chemicals (col. 7, ln. 59-65). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the biocompatible shape-memory alloy-based material wires of Hasting/Haeusser/Thakkar/Garabedian/Fish combination such that it is configured to change shape via various sources including heat as taught by Lafontaine, as doing so allows for more precise and accurate actuation of shape transformation even after the catheter extends distally from the outer sheath.
Furthermore, as evidenced by Gerber, the use of heat from human body temperature and/or external heat source such as UV light, heated liquid and so forth to activate the shape memory material is known in the art (Figs. 3B, 4B 8 discloses a shape memory polymer portion 20 which changes the shape from linear to coiled arrangement; [0088]: heating the shape memory polymer to a particular temperature causes change in shape of the shape memory polymer portion 20 including human body temperature or external heat source, thus meeting claims 12-13).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hastings, Garabedian, and Fish as applied to claim 5 and further in view of Shandas et al. (hereinafter ‘Shandas’, U.S. PGPub. No. 2015/0299359).
In regards to claim 21, Hasting/Garabedian/Fish combination discloses the invention substantially as claimed in claim 5 and discussed above.
However, Hasting/Garabedian/Fish combination does not disclose the thermoset shape-memory polymer comprises, in weight percent based on the total weight of the thermoset shape-memory polymer: 89.2% Tert-butyl acrylate (tBA); 10% poly(ethylene glycol)m dimethacrylate (PEGDMA); and 0.2% photoinitiator 2,2-dimethoxy-2-phenylacetophenone.
Shandas teaches a formulation of shape memory polymer (SMP) teaches a shape memory polymer composition comprising tert-butyl acrylate (tBA) comprising from about 60 wt% to about 90 wt%, less than 20 wt% of nBA, and iBA from about 0% to 10% ([0064]-[0074]). This formulation provides the desired stress and strain level initiated by temperature ([0049]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the shape memory material of Hasting/Garabedian/Fish combination with the composition of Shandas, to tailor the temperature of activation, the time of activation, the rate of activation, and the mechanical stiffness can be varied based upon application requirements ([0046]).
Response to Arguments
Applicant’s Remarks filed on February 6, 2026 is fully acknowledged.
Applicant’s arguments with respect to claim(s) 1, 5 and 9 have been considered. Applicant argues that Hasting does not disclose pre-bending the catheter in a zigzag shape or s-shape to cover a spinal cord. This argument is persuasive and the rejections have been withdrawn. Upon further consideration, a new ground of rejection is made in view of Garabedian et al. (U.S. PGPub. No. 2006/0129203) teaches a sheathed lead (Fig. 7 or alternatively, Fig. 12) comprising a pre-shaped two-dimensional geometry configured for stimulation and sensing of a tissue ([0006]). Specifically, Garabedian teaches a curved geometry like that of Hasting (lead 64 in Figs. 7 and 9) and alternatively, a s-shaped geometry (lead 104 in Fig. 12). Given that Hasting contemplates various other geometries, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the central lumen and the insulation layer of the circular shape of Hasting into various other geometries including a s-shaped geometry as taught by Garabedian, thereby arriving at the claimed invention, as doing so is an obvious matter of design choice to one having ordinary skill in the art to stimulate and sensing a desired area of tissue ([0006]-[0007]).
Conclusion
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 3/24/2026