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 .
Response to Amendment
The amendment filed March 18th, 2026 has been entered. Applicant’s amendments to the Claims have overcome the claim objections and 112(b) rejections previously set forth in the Non-Final Rejection mailed December 23rd, 2025.
Response to Arguments
Applicant’s arguments, see pages 8-11, filed March 18th, 2026, with respect to the rejection(s) of claim(s) 1-4 & 9-16 under 35 U.S.C. 102 have been fully considered and are persuasive in view of the amendment and the previous interpretation of the current prior art of record. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the current prior art of record.
In response to applicant's argument that the cathode cage in Ge is not an electrode on pages 10-11, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Ge’s cathode cage is disclosed as treating tissue such that the function is the same but how it treats tissue is not structurally different. Applicant is arguing features and/or functions that are not claimed, see proceeding section, 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 cathode cage of Ge is not an “electrode” as in claims 1 & 14, that electrical current is contained within the cage/claim language to describe energy application to tissue, the polarity of the electrode, whether a ground pad is used, etc.) 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).
Applicant’s arguments, see pages 12-13, filed March 18th, 2026, with respect to the rejection(s) of claim(s) 17 under 35 U.S.C. 103 have been fully considered and are persuasive in view of the amendment and the previous interpretation of the current prior art of record. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the current prior art of record.
Applicant argues that the additional references relied upon fail to remedy the deficiencies of those used for independent claim 1 (and/or 14 & 16), the Examiner respectfully disagrees on the grounds laid out above for independent claim 1, in which the rejection for claims 1, 14 & 20 have new grounds of rejection and therefore the rejections for all dependent claims are also updated/maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 & 14-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the expanded configuration” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the claim recites “electrical current” in line 6 (second appearance) and it is unclear if this is the same electrical current or is a different electrical current in the first recitation in line 6. For examination purposes, these are the same electrical currents and the second recitation will be interpreted as “the electrical current”.
Claim 1 recites the limitation “the temperature” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the claim recites “a non-expanded configuration” in line 9 and it is unclear if this is the same non-expanded configuration as recited in line 5 or is a different non-expanded configuration. For examination purposes, these are the same non-expanded configurations and the limitation will be interpreted as “the non-expanded configuration”.
Claims 2-3, 5-13 & 21 are also rejected by virtue of their dependency on claim 1.
Claim 14 recites the limitation “the expanded configuration” in line 8. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 14, the claim recites “electrical current” in line 10 and it is unclear if this is the same electrical current or is a different electrical current recited in line 9. For examination purposes, these are the same electrical currents and the limitation will be interpreted as “the electrical current”.
Claim 14 recites the limitation “the temperature” in line 10. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 14, the claim recites “a non-expanded configuration” in line 13 and it is unclear if this is the same non-expanded configuration as recited in line 8 or is a different non-expanded configuration. For examination purposes, these are the same non-expanded configurations and the limitation will be interpreted as “the non-expanded configuration”.
Claims 15-16 are also rejected by virtue of their dependency on claim 14.
Regarding claim 17, the claim recites “electrical current” in line 13 and it is unclear if this is the same electrical current or is a different electrical current recited in line 12. For examination purposes, these are the same electrical currents and the limitation will be interpreted as “the electrical current”.
Claim 17 recites the limitation “the temperature” in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claims 18-20 are also rejected b virtue of their dependency on claim 17.
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.
Claims 1-3 & 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ge et al. (U.S. Pub. No. 20160317212, previously cited), herein referred to as “Ge” in view of Beetel et al. (U.S. Pub. No. 20120101413, previously cited), herein referred to as “Beetel”.
Regarding claim 1, Ge discloses a surgical instrument (Abstract: a coaxial ablation probe; [0088]: Although the presently disclosed subject matter and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the presently disclosed subject matter), comprising:
an insulated shaft (sheath 3; [0036]: insulating sheath (see 3 in FIG. 2C)); and
an expandable electrode (cathode cage 1) at a distal end of the insulated shaft (see Figs. 2A-2D), wherein the expandable electrode comprises a shape memory alloy lattice ([0062]: a nitinol cathode cage; [0057]: cathode cage 1 will include a plurality of struts 12 … One example of a nickel-titanium alloy suitable for use to form struts 12 is nitinol; [0042]: cathode cage 1 includes cross-shaped support struts 28 extending laterally between struts 12 to provide structural support for cathode cage 1), and based on passing electrical current through the shape memory alloy lattice to increase the temperature of the shape memory alloy lattice above a threshold temperature ([0062]: Nitinol's shape memory results from transformation of the metal's atomic structure from a cubic crystal configuration at high temperatures (austenite) to a monoclinic crystal at low temperatures (martensite) (58, 59). These transitions are reproducible when the metal is heated to body temperature or if an electric current is passed through the wire (60); [0063]: Once probe 10 is positioned and the cathode unsheathed, the heat from physiologic temperatures, electric current from the DC generator, and liquefactive necrosis created by cathode cage 1 will allow cage 1 to return to its shape-formed geometry; wherein application of DC current to cause the transition is seen as increasing the temperature), the shape memory alloy lattice is configured to undergo a shape memory transition from a non-expanded configuration to an expanded configuration causing the expandable electrode to radially expand outward in diameter ([0063]: Once probe 10 is positioned and the cathode unsheathed, the heat from physiologic temperatures, electric current from the DC generator, and liquefactive necrosis created by cathode cage 1 will allow cage 1 to return to its shape-formed geometry. The shape-formed geometry may be any of the geometries described above for cathode cage 1. The shape-formed geometry refers to the geometry formed by cathode cage 1 through self expansion after being unsheathed. In certain embodiments, such geometry is defined at manufacturing time when struts 12 are heated held in position to form the desired geometry, and then cooled so that the geometry will be maintained).
While Ge discloses a transition upon delivery of a DC current such that the expandable electrode is capable of remaining in the non-expanded configuration while exposed from the insulated shaft and without application of electrical current (see [0062-0063]), Ge fails to explicitly disclose wherein the expandable electrode is configured to remain in the non-expanded configuration while exposed from the insulated shaft and without application of electrical current.
However, Beetel discloses wherein the expandable electrode is configured to remain in the non-expanded configuration while exposed from the insulated shaft and without application of electrical current ([0088]: the mesh structure 22 may be composed of nitinol; [0075]: FIG. 6, for example, is a side view of the distal end region 20 of the treatment device 12 in the collapsed configuration. A collapsed diameter 62 of the mesh structure 22 may be approximately equal to a diameter 61 of the elongated shaft 16; [0078]: the mesh structure 22 has elastic or super-elastic shape memory properties such that when force is removed the mesh structure elastically returns to a relaxed state … a relaxed state of the mesh structure may be a collapsed or compressed configuration). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the expandable electrode of Ge to have the non-expanded configuration, as taught by Beetel, for the purpose of the sizing and dimension of the treatment device may be configured to allow insertion with or without a guide catheter into a patient via an opening in the femoral, brachial, or radial arteries (Beetel: [0075]).
Regarding claim 2, Ge discloses wherein the shape memory alloy lattice is a pre-formed nitinol lattice ([0063]: such geometry is defined at manufacturing time when struts 12 are heated held in position to form the desired geometry, and then cooled so that the geometry will be maintained).
Regarding claim 3, Ge in view of Beetel discloses wherein the shape memory transition is reversible such that the expandable electrode returns to the non- expanded configuration upon cooling below the threshold temperature (Ge: [0063]: Once probe 10 is positioned and the cathode unsheathed, the heat from physiologic temperatures, electric current from the DC generator, and liquefactive necrosis created by cathode cage 1 will allow cage 1 to return to its shape-formed geometry. The shape-formed geometry may be any of the geometries described above for cathode cage 1. The shape-formed geometry refers to the geometry formed by cathode cage 1 through self expansion after being unsheathed. In certain embodiments, such geometry is defined at manufacturing time when struts 12 are heated held in position to form the desired geometry, and then cooled so that the geometry will be maintained; wherein this describes a process wherein upon removal of the electric current, the cage may not be in its exact shape-formed geometry; Beetel: [0075]: FIG. 6, for example, is a side view of the distal end region 20 of the treatment device 12 in the collapsed configuration. A collapsed diameter 62 of the mesh structure 22 may be approximately equal to a diameter 61 of the elongated shaft 16; [0078]: the mesh structure 22 has elastic or super-elastic shape memory properties such that when force is removed the mesh structure elastically returns to a relaxed state … a relaxed state of the mesh structure may be a collapsed or compressed configuration; wherein in this combination, Ge teaches that cooling causes a transition and Beetel teaches that the transition configuration may be a collapsed/non-expanded configuration).
Regarding claim 9, Ge discloses wherein the expanded configuration of the expandable electrode includes:
a first tapered section coupled to the insulated shaft (see portion of cage 1 coupled to sheath 3 in Figs. 2B & 2C);
a second tapered section at a distal tip (see portion of cage 1 comprising cathode tip 14 in Figs. 2B & 2C); and
a substantially cylindrical section between the first tapered section and the second tapered section (see midsection of cage 1 in Figs. 2B & 2C where a short cylindrical shape is formed in the midsection of the cage; [0037]: the shape defined by the volume surrounded by struts 12 may be any desired shape, such as a sphere, an ellipsoid).
Regarding claim 10, Ge discloses wherein the expandable electrode has a flexible tip ([0058]: Struts 12 may be formed of any suitable conductive material that has sufficient flexibility to allow expansion and contraction to achieve a desired treatment volume. Examples of suitable materials for struts 12 include metals, such as copper, gold, or platinum; metal alloys, such as nickel-titanium alloys; or conductive plastics. One example of a nickel-titanium alloy suitable for use to form struts 12 is nitinol; wherein the cage forms a flexible tip).
Regarding claim 11, Ge discloses wherein the insulated shaft comprises a conductor with insulation enabling conduction of the electrical current from a proximal end of the insulated shaft to the expandable electrode at the distal end of the insulated shaft ([0053]: DC generator 46 may be connected to each cathode strut via cathode strut wires 54; see Fig. 3; wherein wires 54 are seen as conductors comprising an insulation since electrical connections in a medical system require insulation).
Regarding claim 12, Ge discloses wherein the insulated shaft comprises a conductor and the expandable electrode is formed at the distal end of a conductor, such that the insulated shaft and the expandable electrode are formed on the conductor ([0053]: A DC generator 46 creates a DC potential across anode 2 and cathode cage 1 … DC generator 46 may be connected to each cathode strut via cathode strut wires 54; [0063]: Once probe 10 is positioned and the cathode unsheathed, the heat from physiologic temperatures, electric current from the DC generator, and liquefactive necrosis created by cathode cage 1 will allow cage 1 to return to its shape-formed geometry; see Fig. 3; wherein this connectivity is seen as the DC current being both for treatment and expansion).
Regarding claim 13, Ge discloses wherein the shape memory alloy lattice comprises:
a plurality of geometric unit cells repeated in circumferential and axial directions (see Fig. 2P where the support struts 28 & struts 12 form geometric unit cells that form a pattern around each circumference and in an axial direction of the cage 1).
Regarding claim 14, Ge discloses a surgical equipment (Abstract: a coaxial ablation probe; [0088]: Although the presently disclosed subject matter and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the presently disclosed subject matter), comprising:
an introducer (sheath 4);
a surgical instrument (probe 10) inserted into the introducer ([0037]: probe 10 is in the un-deployed state where individual struts 12 are confined by outer sheath 4), wherein the surgical instrument comprises:
an insulated shaft (sheath 3; [0036]: insulating sheath (see 3 in FIG. 2C)); and
an expandable electrode (cathode cage 1) at a distal end of the insulated shaft (see Figs. 2A-2D), wherein the expandable electrode comprises a shape memory alloy lattice ([0062]: a nitinol cathode cage; [0057]: cathode cage 1 will include a plurality of struts 12 … One example of a nickel-titanium alloy suitable for use to form struts 12 is nitinol; [0042]: cathode cage 1 includes cross-shaped support struts 28 extending laterally between struts 12 to provide structural support for cathode cage 1), and based on passing electrical current through the shape memory alloy lattice to increase the temperature of the shape memory alloy lattice above a threshold temperature ([0062]: Nitinol's shape memory results from transformation of the metal's atomic structure from a cubic crystal configuration at high temperatures (austenite) to a monoclinic crystal at low temperatures (martensite) (58, 59). These transitions are reproducible when the metal is heated to body temperature or if an electric current is passed through the wire (60); [0063]: Once probe 10 is positioned and the cathode unsheathed, the heat from physiologic temperatures, electric current from the DC generator, and liquefactive necrosis created by cathode cage 1 will allow cage 1 to return to its shape-formed geometry; wherein application of DC current to cause the transition is seen as increasing the temperature), the shape memory alloy lattice is configured to undergo a shape memory transition from a non-expanded configuration to an expanded configuration causing the expandable electrode to radially expand outward in diameter ([0063]: Once probe 10 is positioned and the cathode unsheathed, the heat from physiologic temperatures, electric current from the DC generator, and liquefactive necrosis created by cathode cage 1 will allow cage 1 to return to its shape-formed geometry. The shape-formed geometry may be any of the geometries described above for cathode cage 1. The shape-formed geometry refers to the geometry formed by cathode cage 1 through self expansion after being unsheathed. In certain embodiments, such geometry is defined at manufacturing time when struts 12 are heated held in position to form the desired geometry, and then cooled so that the geometry will be maintained; see Figs. 2A-2D).
While Ge discloses a transition upon delivery of a DC current such that the expandable electrode is capable of remaining in the non-expanded configuration while exposed from the insulated shaft and without application of electrical current (see [0062-0063]), Ge fails to explicitly disclose wherein the expandable electrode is configured to remain in the non-expanded configuration while exposed from the insulated shaft and without application of electrical current.
However, Beetel discloses wherein the expandable electrode is configured to remain in the non-expanded configuration while exposed from the insulated shaft and without application of electrical current ([0088]: the mesh structure 22 may be composed of nitinol; [0075]: FIG. 6, for example, is a side view of the distal end region 20 of the treatment device 12 in the collapsed configuration. A collapsed diameter 62 of the mesh structure 22 may be approximately equal to a diameter 61 of the elongated shaft 16; [0078]: the mesh structure 22 has elastic or super-elastic shape memory properties such that when force is removed the mesh structure elastically returns to a relaxed state … a relaxed state of the mesh structure may be a collapsed or compressed configuration). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the expandable electrode of Ge to have the non-expanded configuration, as taught by Beetel, for the purpose of the sizing and dimension of the treatment device may be configured to allow insertion with or without a guide catheter into a patient via an opening in the femoral, brachial, or radial arteries (Beetel: [0075]).
Regarding claim 15, Ge discloses wherein:
the surgical instrument is configured to be selectively translatable relative to the introducer between a proximal retracted position in which the expandable electrode is housed within the introducer to a distal extended position in which the expandable electrode is exposed from the introducer to permit the expandable electrode to radially expand from the non-expanded configuration to the expanded configuration ([0056]: Unsheathing cathode cage 1 may include sliding sheath 4 axially away from apex 14 of probe 10 to allow struts 12 to expand to their pre-treatment diameter; see Fig. 2A-2D).
Regarding claim 16, Ge discloses further comprising:
a power source (DC generator 46) coupled to the surgical instrument to provide the electrical current to the expandable electrode ([0053]: A DC generator 46 creates a DC potential across anode 2 and cathode cage 1 … DC generator 46 may be connected to each cathode strut via cathode strut wires 54; [0063]: Once probe 10 is positioned and the cathode unsheathed, the heat from physiologic temperatures, electric current from the DC generator, and liquefactive necrosis created by cathode cage 1 will allow cage 1 to return to its shape-formed geometry).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ge in view of Beetel as applied to claim 1 above, and further in view of Lee et all (U.S. Pub. No. 20200253659, cited in IDS), herein referred to as “Lee”.
Regarding claim 5, Ge in view of Beetel fails to disclose wherein the expandable electrode has a length of about 100 mm.
However, Lee discloses wherein the expandable electrode has a length of about 100 mm ([0042]: the basket is of sufficient length (e.g. 5-15 cm, 8-10 cm)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the length of the expandable electrode of Ge in view of Beetel to be 100 mm, as taught by Lee, for the purpose of allowing ablation in the treatment region without moving or repositioning the device during treatment delivery (Lee: [0042]).
Additionally, 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 expandable electrode to have a length of about 100 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Ge would not operate differently with the claimed diameter since Ge discloses in [0036] that “The dimensions and operational size range of probe 10 can be scaled according to a particular application” such that Ge’s disclosure details that the size may be changed.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ge in view of Beetel as applied to claim 1 above, and further in view of Waldstreicher et al. (U.S. Pub. No. 20210146126, previously cited), herein referred to as “Waldstreicher”.
Regarding claim 6, Ge in view of Beetel fails to disclose wherein the expanded configuration of the expandable electrode has an outer diameter of about 1.65 mm.
However, Waldstreicher discloses wherein the expanded configuration of the expandable electrode has an outer diameter of about 1.65 mm ([0535]: the energy delivery body 108 has … a maximum diameter of approximately 1.5 mm). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the diameter of the expanded configuration of Ge in view of Beetel to be about 1.65 mm, as taught by Waldstreicher, for the purpose of the size enabling access to 5th and 6th generation subsegments of the respiratory tract (Waldstreicher: [0535]).
Additionally, 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 expanded configuration of the expandable electrode to have an outer diameter of about 1.65 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Ge would not operate differently with the claimed diameter since Ge discloses in [0036] that “The dimensions and operational size range of probe 10 can be scaled according to a particular application” such that Ge’s disclosure details that the outer diameter may comprise the claimed diameter.
Regarding claim 7, Ge in view of Beetel fails to disclose wherein the non-expanded configuration of the expandable electrode has an outer diameter of about a 22 gauge needle.
However, Waldstreicher discloses wherein the non-expanded configuration of the expandable electrode has an outer diameter of about a 22 gauge needle ([0535]: the energy delivery body 108 has …a maximum diameter of approximately 0.5 or 1.0 mm; wherein a 22 gauge needle as a diameter of 0.71 mm such that if the maximum outer diameter is 0.5-1.0 mm the unexpanded diameter is about 0.71 mm). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the diameter of the non-expanded configuration of Ge in view of Beetel to be an outer diameter of a 22 gauge needle, as taught by Waldstreicher, for the purpose of the size enabling access to 6th and 7th generation subsegments of the respiratory tract (Waldstreicher: [0535]).
Additionally, 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 non-expanded configuration of the expandable electrode to have an outer diameter of about a 22 gauge needle since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Ge would not operate differently with the claimed diameter since Ge discloses in [0036] that “the compact coaxial ablation probe design will be contained within a catheter having an inner diameter from about 0.3 mm to about 3.0 cm” such that Ge’s disclosure details that the outer diameter may comprise the claimed diameter.
Regarding claim 8, Ge in view of Beetel fails to disclose wherein the expanded configuration of the expandable electrode has an outer diameter of about a 16 gauge needle.
However, Waldstreicher discloses wherein the expanded configuration of the expandable electrode has an outer diameter of about a 16 gauge needle ([0535]: the energy delivery body 108 has … a maximum diameter of approximately 1.5 mm; wherein a 16 gauge needle as a diameter of 1.65 mm). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the diameter of the expanded configuration of Ge in view of Beetel to be an outer diameter of a 16 gauge needle, as taught by Waldstreicher, for the purpose of the size enabling access to 5th and 6th generation subsegments of the respiratory tract (Waldstreicher: [0535]).
Additionally, 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 expanded configuration of the expandable electrode to have an outer diameter of about a 16 gauge needle since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Ge would not operate differently with the claimed diameter since Ge discloses in [0036] that “The dimensions and operational size range of probe 10 can be scaled according to a particular application” such that Ge’s disclosure details that the outer diameter may comprise the claimed diameter.
Claims 17-18 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ge in view of Beetel and Truckai et al. (U.S. Pat. No. 7070597, previously cited), herein referred to as “Truckai”.
Regarding claim 17, Ge discloses a method of ablating tissue in a patient with a surgical instrument (Abstract: a coaxial ablation probe and method and system for real time monitoring of ablation progress for percutaneous ablation), comprising:
inserting the surgical instrument (sheath 3) into the introducer (sheath 4) ([0055]: In step 102, probe 10 is inserted into the patient centered on the target identified in step 100. Probe 10 may have any of the configurations described herein. Probe 10 may be inserted into the tissue to be treated, for example, into the patient's liver or other organ; [0056]: In step 104, cathode cage 1 is unsheathed to a desired diameter; wherein step 102 is seen as also comprising inserting the surgical instrument into the introducer since the cage is unsheathed following insertion into the body), wherein the surgical instrument comprises an insulated shaft (sheath 3; [0036]: insulating sheath (see 3 in FIG. 2C)) and an expandable electrode (cathode cage 1) at a distal end of the insulated shaft (see Figs. 2A-2D), wherein the expandable electrode comprises a shape memory alloy lattice ([0062]: a nitinol cathode cage; [0057]: cathode cage 1 will include a plurality of struts 12 … One example of a nickel-titanium alloy suitable for use to form struts 12 is nitinol; [0042]: cathode cage 1 includes cross-shaped support struts 28 extending laterally between struts 12 to provide structural support for cathode cage 1);
exposing the expandable electrode relative to the introducer causing the expandable electrode to protrude out from the introducer ([0056]: In step 104, cathode cage 1 is unsheathed to a desired diameter. Unsheathing cathode cage 1 may include sliding sheath 4 axially away from apex 14 of probe 10 to allow struts 12 to expand to their pre-treatment diameter);
applying electrical current to pass through the shape memory alloy lattice of the expandable electrode to increase the temperature of the shape memory alloy lattice above a threshold temperature ([0062]: Nitinol's shape memory results from transformation of the metal's atomic structure from a cubic crystal configuration at high temperatures (austenite) to a monoclinic crystal at low temperatures (martensite) (58, 59). These transitions are reproducible when the metal is heated to body temperature or if an electric current is passed through the wire (60); [0063]: Once probe 10 is positioned and the cathode unsheathed, the heat from physiologic temperatures, electric current from the DC generator, and liquefactive necrosis created by cathode cage 1 will allow cage 1 to return to its shape-formed geometry; wherein application of DC current to cause the transition is seen as increasing the temperature) and to cause the shape memory alloy lattice to undergo a shape memory transition from a non-expanded configuration to an expanded configuration so that the expandable electrode radially expands outward in diameter ([0056]: In step 106, a DC bias is applied to probe 10. The DC bias is applied between anode 2 and cathode cage 1; [0063]: Once probe 10 is positioned and the cathode unsheathed, the heat from physiologic temperatures, electric current from the DC generator, and liquefactive necrosis created by cathode cage 1 will allow cage 1 to return to its shape-formed geometry. The shape-formed geometry may be any of the geometries described above for cathode cage 1. The shape-formed geometry refers to the geometry formed by cathode cage 1 through self expansion after being unsheathed. In certain embodiments, such geometry is defined at manufacturing time when struts 12 are heated held in position to form the desired geometry, and then cooled so that the geometry will be maintained); and
contacting the tissue with at least a portion of the expandable electrode exposed from the introducer while in the expanded configuration ([0056]: The DC bias causes an electrochemical reaction (described above) in the treatment volume, as defined by volume enclosed within the cathode cage struts 12, which ablates tissue within the treatment volume with minimal effect on tissue outside of the treatment volume).
But Ge fails to disclose:
inserting a trocar needle through an introducer and into the patient allowing the introducer to be positioned adjacent to a target area;
removing the trocar needle from the introducer.
However, Truckai discloses inserting a trocar needle through an introducer and into the patient allowing the introducer to be positioned adjacent to a target area (Col. 8, lines 49-55: any overlying tissue such as an abdominal wall can be is penetrated by any suitable means such as a trocar that leaves a cannula (not shown) in place. Ultimately, the working end 122 of the energy delivery member or body 120 is placed in a desired relationship to the targeted tissue tt in a predetermined location);
removing the trocar needle from the introducer ((Col. 8, lines 49-55: any overlying tissue such as an abdominal wall can be is penetrated by any suitable means such as a trocar that leaves a cannula (not shown) in place. Ultimately, the working end 122 of the energy delivery member or body 120 is placed in a desired relationship to the targeted tissue tt in a predetermined location)).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Ge to include the steps of Truckai for the purpose of enabling the surgical instrument to be placed in a desired relationship to the targeted tissue in a predetermined location (Truckai: Col. 8, lines 52-55).
While Ge discloses a transition upon delivery of a DC current such that the expandable electrode is capable of remaining in a non-expanded configuration while exposed from the introducer and without application of electrical current, Ge fails to explicitly disclose wherein the expandable electrode is configured to remain in a non-expanded configuration while exposed from the introducer and without application of electrical current.
However, Beetel discloses wherein the expandable electrode is configured to remain in a non-expanded configuration while exposed from the introducer and without application of electrical current ([0088]: the mesh structure 22 may be composed of nitinol; [0075]: FIG. 6, for example, is a side view of the distal end region 20 of the treatment device 12 in the collapsed configuration. A collapsed diameter 62 of the mesh structure 22 may be approximately equal to a diameter 61 of the elongated shaft 16; [0078]: the mesh structure 22 has elastic or super-elastic shape memory properties such that when force is removed the mesh structure elastically returns to a relaxed state … a relaxed state of the mesh structure may be a collapsed or compressed configuration). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the expandable electrode of Ge in view of Truckai to have the non-expanded configuration, as taught by Beetel, for the purpose of the sizing and dimension of the treatment device may be configured to allow insertion with or without a guide catheter into a patient via an opening in the femoral, brachial, or radial arteries (Beetel: [0075]).
Regarding claim 18, Ge discloses wherein the expandable electrode receives the electrical current and generates heat, and wherein based on contacting the tissue with the portion of the expandable electrode exposed from the introducer while in the expanded configuration results in forming a lesion circumferentially along a body of the expandable electrode ([0056]: In step 106, a DC bias is applied to probe 10. The DC bias is applied between anode 2 and cathode cage 1. The DC bias causes an electrochemical reaction (described above) in the treatment volume, as defined by volume enclosed within the cathode cage struts 12, which ablates tissue within the treatment volume with minimal effect on tissue outside of the treatment volume; [0037]: When outer sheath 4 is moved axially away from probe tip 14, struts 12 expand radially outwardly to form, in one embodiment, a generally spherical shape. In another embodiment, the shape defined by the volume surrounded by struts 12 may be any desired shape, such as a sphere, an ellipsoid).
Regarding claim 19, Ge in view of Truckai fails to disclose:
detecting a temperature of the expandable electrode with a thermistor; and
based on the temperature being above a threshold, discontinuing application of the electrical current to the shape memory alloy lattice.
However, Beetel discloses detecting a temperature of the expandable electrode with a thermistor ([0067]: one or more sensors (not shown), such as one or more temperature (e.g., thermocouple, thermistor, etc.), impedance, pressure, optical, flow, chemical or other sensors, may be located proximate to or within the energy delivery element 24; [0127]: As previously discussed, energy delivery may be controlled and monitored via data collected with one or more sensors, such as temperature sensors (e.g., thermocouples, thermistors, etc.); [0148]: The operating parameters monitored in accordance with the algorithm may include, for example, temperature, time, impedance, power, flow velocity, volumetric flow rate, blood pressure, heart rate, etc); and
based on the temperature being above a threshold, discontinuing application of the electrical current to the shape memory alloy lattice ([0148]: Discrete values in temperature may be used to trigger changes in power or energy delivery. For example, high values in temperature (e.g., 85.degree. C.) could indicate increased risk of thrombosis, etc., in which case the algorithm may decrease or stop the power and energy delivery).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Ge in view of Truckai to include the steps of Beetel for the purpose of prevent undesirable thermal effects to target or non-target tissue (Beetel: [0148]).
Regarding claim 20, Ge discloses further comprising:
after said contacting, discontinuing application of the electrical current to the shape memory alloy lattice to cause the shape memory alloy lattice to transition from the expanded configuration to the non-expanded configuration ([0056]: Enlarging the cage or withdrawing the probe may include adjusting actuators 18 to return each strut 12 to the minimum of the adjustment range defined by each actuator 18, sheathing cathode cage 1 to decrease the diameter of cathode cage 1 to its insertion diameter and then withdrawing probe 10 through the same tract used for insertion).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ge in view of Beetel as applied to claim 1 above, and further in view of Soden et al. (U.S. Pub. No. 20250160920, earliest effective filing date), herein referred to as “Soden”.
Regarding claim 21, Ge in view of Beetel fails to disclose wherein the expandable electrode comprises a monolithic shape memory alloy lattice laser-cut from a single conductor.
However, Soden discloses wherein the expandable electrode comprises a monolithic shape memory alloy lattice laser-cut from a single conductor ([0185]: The body 200 has a laser cut tube construction 201 between couplers 202 and 203. In its preferable implementation this entire body acts as an electrode, the electrode itself being the expanding body). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the expandable electrode of Ge in view of Beetel to comprise a monolithic shape memory alloy lattice laser-cut from a single conductor, as taught by Soden for the purpose that laser tube cutting is a convenient way to provide an electrode as an expanding body (Soden: [0185]).
Applicant is reminded that if the device is being claimed then this is seen as a product by process and therefore if the same structure is found the process to obtain that structure is negligible. See MPEP §2173.05(p) & §2113.
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.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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