DETAILED ACTION
The following is a Non-Final Office Action on the merits.
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/28/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 9/28/2026.
Applicant’s amendments are sufficient to overcome the claim objections set forth in the previous office action.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-8, 10, 12-15, 17, 23-28 & 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over McClurken et al. (2005/0015085, previously cited).
Concerning claim 1, as illustrated in at least Figs. 22-28, McClurken et al. disclose an ablation catheter (electrosurgical device 5c; [0218]), comprising:
an elongate body having a fluid lumen extending therethrough (fluid 24 is communicated down a lumen of electrical insulator 90; [0162], [0181], [0187]); and
a distal electrode assembly coupled to the elongate body (tip portion 45; [0218]) and comprising:
an insert electrode having a non-circular cross-sectional shape with at least three vertices (electrode 25 comprises non-circular shank portion 64 with at least three vertices in Fig. 27; [0219-0221], [0234]); and
an outer electrode at least partially surrounding the insert electrode, wherein the outer electrode is fixedly and electrically coupled to the insert electrode and positioned at or adjacent to a distal end surface of a tip of the elongate body (shaft 17 is made of conductive metal and electrically and fixedly connected to shank portion 64; [0162], [0221], [0245]), and
wherein spaces between the at least three vertices of the insert electrode and an inner surface of the outer electrode define fluid passages in fluid communication with the fluid lumen (electrode 25 comprises at least recesses 64 which provides an elongated fluid flow channel for the distribution of fluid 24 with inner surface of shank 17; [0227-0228]).
McClurken et al. fail to disclose a proximal end of the outer electrode is coupled to a distal end of the elongate body in the embodiment of Figs. 22-28 since the outer electrode (17) extends to the proximal end of the ablation catheter. However, in the embodiment of Fig. 9-14, McClurken et al. disclose an outer electrode (82) partially surrounding an insert electrode (25) and coupled to a distal end of an elongate body (90), the outer electrode (82) being coupled to a conductive shaft (17) for providing power to the electrode assembly (82, 25) ([0179]). McClurken et al. further teach that the outer electrode (82) and conductive shaft (17) can be formed separately or as a unitary piece ([0179]). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the embodiment of Figs. 22-28 of McClurken et al. such that the outer electrode and conductive shaft are separate structural pieces and a proximal end of the outer electrode is coupled to a distal end of the elongate body, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. See also In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Concerning claim 2, McClurken et al. disclose the insert electrode (25) protrudes distally an exposed length (39 & 57) beyond the distal end surface of the tip of the catheter (5a) (Fig. 20-22).
Concerning claim 3, McClurken et al. fail to disclose the exposed length of the insert electrode is about 0.5 mm to about 1 mm. However, McClurken et al. disclose the exposed length (39 & 57) of the insert electrode (25) is within a range of 3-16 mm since the length of 57 can be between 1-8 mm and the length of 39 can be between 2 mm – 8 mm, and thus the smallest length can be 3 mm ([0222-0226]). McClurken et al. also teach that the electrodes surface area which comprises an exposed length, affects tissue treatment when it is either too large or too small. Applicant appears to have placed no criticality on the claimed range (see pp. [0157] indicating various exposed lengths). It would have been obvious to one having ordinary skill in the art at the time of the invention was effectively filed to modify the invention of McClurken et al. such that the exposed length of the insert electrode is about 0.5 mm to about 1 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Concerning claim 4, McClurken et al. fail to specifically disclose a ratio between the exposed length of the insert electrode and a diameter of the elongate body of the catheter is about 1:8 to about 1:4. 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 invention of McClurken et al. such that a ratio between the exposed length of the insert electrode and a diameter of the elongate body of the catheter is about 1:8 to about 1:4 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 modified embodiment of McClurken et al. would not operate differently with the claimed ratio and the device would function appropriately having the claimed ratio. Further, Applicant places no criticality on the range claimed, indicating simply that the ratio “may” be within the claimed ranges (specification pp. [0158]).
Concerning claim 5, McClurken et al. fail to disclose a ratio between the exposed length of the insert electrode and a maximum transverse dimension of the insert electrode is configured to promote a substantially symmetric electrical field about a longitudinal axis of the elongate body. However, as McClurken et al. disclose various diameters and lengths (which affect exposed length and maximum transverse dimension) for the insert electrode ([0223-0226]), it would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of McClurken et al. such that a ratio between the exposed length of the insert electrode and a maximum transverse dimension of the insert electrode is configured to promote a substantially symmetric electrical field about a longitudinal axis of the elongate body is(are) of whatever desired relative size(s), since a modification would have involved a mere change in the proportions of components. A change in proportion is generally recognized as being within the level of ordinary skill in the art. In re Reese, 129 USPQ 402.
Concerning claim 6, McClurken et al. disclose a distal end surface (53) of the outer electrode (17) is substantially flush with the distal end surface (90) of the tip of the catheter (17, 90) ([0218], [0245]; Fig. 20-22 & 34).
Concerning claim 7, the modified invention of McClurken et al. disclose the outer electrode (18) comprises a circular cross-sectional shape (Fig. 9-14 & 20-22).
Concerning claim 8, the modified invention of McClurken et al. disclose the outer electrode (18) surrounds a proximal portion (46) of the insert electrode (25) disposed within a lumen in the tip (distal end) of the elongate body (90) ([0221-0222]; Fig. 20-22).
Concerning claim 10, McClurken et al. disclose wherein each of the at least three vertices forms an interference fit with a corresponding portion of the outer electrode (17) ([0221], [0232-0234]; Fig. 25-28).
Concerning claim 12, McClurken et al. disclose vertices of the insert electrode (25) are spaced at substantially equal angular intervals around a central longitudinal axis of the insert electrode (25) (Fig. 25-28).
Concerning claim 13¸ McClurken et al. disclose the insert electrode (25) further comprises arcuate sidewalls extending between adjacent vertices, and wherein each fluid passage (64) is formed between one of the arcuate sidewalls and an the inner surface of the outer electrode (17) ([0221], [0232-0234]; Fig. 25-28).
Concerning claim 14, McClurken et al. disclose the insert electrode (25) comprises a triangular cross-section ([0241-0242]; Fig. 33-34).
Concerning claim 15, McClurken et al. disclose the fluid passages comprise three discrete fluid passages, wherein the insert electrode (25) is configured to divide fluid (24) from the fluid lumen (23) into three discrete fluid passages ([0221], [0232-0234]; Fig. 25-28).
Concerning claim 17, McClurken et al. disclose the vertices of the insert electrode (25) converge to form a rounded distal apex (39) configured to contact tissue (Fig. 20-22).
Concerning claim 23, as illustrated in at least Figs. 22-28, McClurken et al. disclose an ablation catheter (electrosurgical device 5c; [0218]), comprising:
an elongate body having a fluid lumen extending therethrough (fluid 24 is communicated down a lumen of electrical insulator 90; [0162], [0181], [0187]); and
a distal electrode assembly (tip portion 45; [0218]) and comprising:
an insert electrode (electrode 25 comprises non-circular shank portion 64 with at least three vertices in Fig. 27; [0219-0221], [0234]); and
an outer electrode positioned around and fixedly coupled to the insert electrode (shaft 17 is made of conductive metal and electrically and fixedly connected to shank portion 64; [0162], [0221], [0245]),
wherein the insert electrode engages an inner surface of the outer electrode at a plurality of discrete contact regions spaced around a longitudinal axis of the distal electrode assembly, and wherein interstitial spaces formed between the plurality of discrete contact regions are configured to receive fluid from the fluid lumen (electrode 25 comprises at least recesses 64 which provides an elongated fluid flow channel for the distribution of fluid 24 with the inner surface of shank 17; [0227-0228]).
McClurken et al. fail to disclose a proximal end of the outer electrode is coupled to a distal end of the elongate body in the embodiment of Figs. 22-28 since the outer electrode (17) extends to the proximal end of the ablation catheter. However, in the embodiment of Fig. 9-14, McClurken et al. disclose an outer electrode (82) partially surrounding an insert electrode (25) and coupled to a distal end of an elongate body (90), the outer electrode (82) being coupled to a conductive shaft (17) for providing power to the electrode assembly (82, 25) ([0179]). McClurken et al. further teach that the outer electrode (82) and conductive shaft (17) can be formed separately or as a unitary piece ([0179], [0218]). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the embodiment of Figs. 22-28 of McClurken et al. such that the outer electrode and conductive shaft are separate structural pieces and a proximal end of the outer electrode is coupled to a distal end of the elongate body as taught by McClurken et al. in the embodiments of Fig. 9-14, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. See also In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Claim 24 is rejected upon the same rationale as applied to claim 2.
Claim 25 is rejected upon the same rationale as applied to claim 4.
Claim 26 is rejected upon the same rationale as applied to claim 6.
Claim 27 is rejected upon the same rationale as applied to claim 8.
Claim 28 is rejected upon the same rationale as applied to claim 13.
Claim 30 is rejected upon the same rationale as applied to claim 17.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over McClurken et al. (2005/0015085, previously cited), as applied to claim 1, in further view of Wang et al. (2009/0163912, previously cited).
Concerning claim 9, while McClurken et al. disclose the elongate body (50) having a tip having a lumen (Fig. 22-28), McClurken et al. fail to specifically disclose a tip body, wherein the lumen in the tip of the elongate body is a lumen in the tip body. However, Wang et al. disclose an ablation catheter comprising an elongate body (14) and a tip body (16) that forms a part of the tip electrode assembly. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of McClurken et al. to further comprise a tip body, wherein the lumen in the tip of the elongate body is a lumen in the tip body in order to provide the benefit of multiple members that connect or fit together to form the electrode assembly that are then attached to the elongate body as taught by Wang et al. ([0023], [0028]; Fig. 1)
Claim(s) 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over McClurken et al. (2005/0015085, previously cited), as applied to claim 1, in further view of Carmel et al. (2015/0196350, previously cited).
Concerning claim 18, McClurken et al. fail to disclose a proximal electrode coupled to the elongate body proximal of the distal electrode assembly. However, Carmel et al. disclose an ablation catheter comprising an elongate body and a distal electrode assembly comprising an electrode (1) and two proximal electrodes (2 and/or 3) coupled to the elongate body proximal of the distal electrode assembly (1). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of McClurken et al. to further comprise a proximal electrode coupled to the elongate body proximal of the distal electrode assembly in order to provide the benefit of altering energy distribution advantageously as taught by Carmel et al. ([0035], [0096-0097]; Fig. 1-4D)
Concerning claim 19, Carmel et al. further disclose a collective surface area of exposed portions of the distal assembly is less than a surface area of an exposed portion of the proximal electrode (2 and/or 3) ([0097]; Fig. 3).
Concerning claim 20, Carmel et al. further disclose the proximal electrode (2 and/or 3) is a first proximal electrode (2) and the ablation catheter further comprises a second proximal electrode (3) coupled to the elongate body proximal of the first proximal electrode (2) ([0096-0097]; Fig. 1-4D).
Concerning claim 21, Carmel et al. further disclose the first (2) and second (3) proximal electrodes are ring electrodes (Fig. 4A-D).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over McClurken et al. (2005/0015085, previously cited), as applied to claim 1, in further view of Datta (2007/0156131).
Concerning claim 32, McClurken et al. disclose connection to a power source via at least conductive shaft (17) that extends towards the proximal end of the device, and thus McClurken et al. fail to disclose a high voltage cable coupled to a proximal end of the insert electrode. However, Datta et al. disclose an ablation catheter comprising a distal electrode assembly (36) comprising an insert electrode (118) that electrically connects to a power source via a high voltage cable (40) coupled to a proximal end of the insert electrode (118). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of McClurken et al. such that power source connection is via a high voltage cable coupled to a proximal end of the insert electrode in place of the conductive shaft in order to provide the benefit of more flexible connection that allows movement as the catheter is manipulated as taught by Datta et al. ([0039], [0040], [0050]; Fig. 3A) and since the high voltage cable taught by Datta et al. provides the same benefit as the conductive shaft of McClurken et al. to connect the insert electrode to a power source.
Claim(s) 1-10, 12-15, 17, 23-28 & 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulier et al. (5,897,553, previously cited) in view of Wang et al. (2009/0163912, previously cited) and McClurken et al. (2005/0015085, previously cited).
Concerning claim 1, as illustrated in at least Figs. 1-5, Mulier et al. disclose an ablation catheter (fluid-assisted electrocautery device 10; Col. 3, ll. 34-41), comprising:
an elongate body having a fluid lumen extending therethrough (electrical insulator 30 comprises fluid lumen; Col. 4, ll. 8-13); and
a distal electrode assembly coupled to the elongate body (electrode/tip 14; Col. 3, ll. 34-41) and comprising:
an insert electrode having a non-circular cross-sectional shape (plug electrode 18 may be non-spherical; Col. 6, ll. 28-40); and
an outer electrode at least partially surrounding the insert electrode, wherein the outer electrode is fixedly and electrically coupled to the insert electrode and positioned at or adjacent to a distal end surface of a tip of the elongate body (hollow cylindrical metal tube 16 surrounds and is fixedly and electrically coupled to plug electrode 18 at the catheter tip; Col. 6, ll. 28-40), and
wherein spaces between the insert electrode and an inner surface of the outer electrode define fluid passages in fluid communication with the fluid lumen (plug electrode 18 would be retained in tube 16 at the distal end 28 of tube 16 so that fluid can pass from interior 26 of tube 16 and around the plug to expelled from the distal end 28; Col. 6, ll. 28-40).
Mulier et al. fail to specifically disclose the non-circular cross-sectional shape to have at least three vertices. However, Wang et al. disclose an ablation catheter (12) comprising a distal electrode assembly (10) comprising an insert electrode (18) having a non-circular cross-sectional shape (28) with at least three vertices contacting an inner surface of an outer member (16). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Mulier et al. such that the insert electrode has a non-circular cross-sectional shape with at least three vertices contacting the inner surface of the outer electrode in order to provide the benefit of fluid flow that exits out of passageways and flows substantially parallel to the body of the electrode therein improving or optimizing the irrigation of the electrode as taught by Wang et al. ([0008-0009], [0022], [0025], [0032]; Fig. 1-4F)
Mulier et al. disclose the proximal end of the outer electrode to extend proximally to connect with a power source, and thus Mulier et al in view of Wang et al. fail to disclose a proximal end of the outer electrode is coupled to a distal end of the elongate body. However, McClurken et al. disclose an ablation catheter embodiment comprising a distal electrode assembly (45) comprising an insert electrode (25) surrounded by an outer electrode (82), where a proximal end of the outer electrode (82) is coupled to a distal end of an elongate body (90) (Figs. 9-14) and an ablation catheter embodiment comprising a distal electrode assembly (45) comprising an insert electrode (25) surrounded by an outer electrode (17), where a proximal end of the outer electrode (17) extends proximally to connect with a power source (Fig. 22-28). McClurken et al. further teach that the outer electrode (82) and conductive shaft (17) can be formed separately or as a unitary piece. ([0179], [02187]) It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Mulier et al. in view of Wang such that the outer electrode and conductive shaft are separate structural pieces and a proximal end of the outer electrode is coupled to a distal end of the elongate body as taught by McClurken et al., since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. See also In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Concerning claim 2, Mulier et al. disclose the insert electrode (18) protrudes distally an exposed length beyond the distal end surface of the tip of the catheter (Fig. 3-5).
Concerning claim 3, Mulier et al. in view of Wang et al. and McClurken et al. fail to specifically disclose the exposed length of the insert electrode to be within a range of 0.5 mm to 1 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify invention of Mulier et al. in view of Wang et al. and McClurken et al. such that the exposed length of the insert electrode is within a range of 0.5 mm to 1 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 Mulier et al. in view of Wang et al. and McClurken et al. would not operate differently with the claimed ratio and the device would function appropriately having the claimed ratio. Further, Applicant appears to have placed no criticality on the claimed range (see pp. [0157] indicating various exposed lengths).
Concerning claim 4, Mulier et al. in view of Wang et al. fail to specifically disclose a ratio between the exposed length of the insert electrode and a diameter of the elongate body of the catheter is about 1:8 to about 1:4. 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 invention of Mulier et al. in view of Wang et al. and McClurken such that a ratio between the exposed length of the insert electrode and a diameter of the elongate body of the catheter is about 1:8 to about 1:4 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 Mulier et al. in view of Wang et al. and McClurken would not operate differently with the claimed ratio and the device would function appropriately having the claimed ratio. Further, Applicant places no criticality on the range claimed, indicating simply that the ratio “may” be within the claimed ranges (specification pp. [0158]).
Concerning claim 5, Mulier et al. in view of Wang et al. and McClurken fail to disclose a ratio between the exposed length of the insert electrode and a maximum transverse dimension of the insert electrode is configured to promote a substantially symmetric electrical field about a longitudinal axis of the elongate body. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Mulier et al. in view of Wang et al. and McClurken such that a ratio between the exposed length of the insert electrode and a maximum transverse dimension of the insert electrode is configured to promote a substantially symmetric electrical field about a longitudinal axis of the elongate body is(are) of whatever desired relative size(s), since a modification would have involved a mere change in the proportions of components. A change in proportion is generally recognized as being within the level of ordinary skill in the art. In re Reese, 129 USPQ 402.
Concerning claim 6, Mulier et al. disclose a distal end surface (28) of the outer electrode (16) is substantially flush with the distal end surface of the tip of the catheter (Fig. 5).
Concerning claim 7, Mulier et al. disclose the outer electrode (16) comprises a circular cross-sectional shape (Fig. 1-5).
Concerning claim 8, Mulier et al. disclose the outer electrode (16) surrounds a proximal portion of the insert electrode (18) disposed within a lumen in the tip of the elongate body (30) (Fig. 3-5).
Concerning claim 9, Mulier et al. disclose a tip body (38), wherein the lumen in the tip of the elongate body (30) is a lumen (40) in the tip body (38) (Col. 6, ll. 13-22; Fig. 5).
Concerning claim 10, Mulier et al. teach the insert electrode (18) forms an interference fit with a corresponding portion of the outer electrode (16) (Col. 3, ll. 59-67; Fig. 3-5) and Wang et al. further disclose each vertex forms an interference fit with a corresponding portion of the outer member (102) ([0028]; Fig. 3-4F). Thus, the modified invention of Mulier et al. in view of Wang and McClurken teach each vertex forms an interference fit with a corresponding portion of the outer electrode.
Concerning claim 12, Wang et al. further disclose vertices of the insert electrode (18) are spaced at substantially equal angular intervals around a central longitudinal axis of the insert electrode (18) (Fig. 3-4F).
Concerning claim 13¸Wang et al. further disclose the insert electrode (18) further comprises arcuate sidewalls (30) extending between adjacent vertices, and wherein each fluid passage (38) is formed between one of the arcuate sidewalls (30) and an the outer member (16) ([0022]; Fig. 4E). Thus, the modified invention of Mulier et al. in view of Wang and McClurken teach the fluid passages formed between the arcuate sidewalls and an inner surface of the outer electrode.
Concerning claim 14, Wang et al. further disclose the insert electrode (18) comprises a triangular cross-section ([0022]; Fig. 4E).
Concerning claim 15, Mulier et al. disclose the insert electrode (18) divides fluid from the fluid lumen (23) into fluid passages (Col. 6, ll. 28-39; Fig. 3-5) and Wang et al. disclose the insert electrode (18) to have three vertices and forming three discrete passages (38) (Fig. 4E). Thus, the modified invention of Mulier et al. in view of Wang and McClurken teach the insert electrode divides fluid into three discrete fluid passages.
Concerning claim 17, Wang et al. further disclose the vertices of the insert electrode (18) converge to form a rounded distal apex (32) configured to contact tissue ([0022]; Fig. 1).
Concerning claim 23, as illustrated in at least Figs. 1-5, Mulier et al. disclose an ablation catheter (fluid-assisted electrocautery device 10; Col. 3, ll. 34-41), comprising:
an elongate body having a fluid lumen extending therethrough (electrical insulator 30 comprises fluid lumen; Col. 4, ll. 8-13); and
a distal electrode assembly (electrode/tip 14; Col. 3, ll. 34-41) and comprising:
an insert electrode having a non-circular cross-sectional shape (plug electrode 18 may be non-spherical; Col. 6, ll. 28-40); and
an outer electrode positioned around the insert electrode (hollow cylindrical metal tube 16 surrounds and is fixedly and electrically coupled to plug electrode 18 at the catheter tip; Col. 6, ll. 28-40),
wherein the insert electrode engages an inner surface of the outer electrode at a contact region spaced around a longitudinal axis of the distal electrode assembly, and wherein interstitial spaces formed between the discrete contact regions are configured to receive fluid from the fluid lumen (plug electrode 18 would be retained in tube 16 at the distal end 28 of tube 16 so that fluid can pass from interior 26 of tube 16 and around the plug to expelled from the distal end 28; Col. 6, ll. 28-40]).
Mulier et al. fail to disclose wherein the insert electrode engages the inner surface of the outer electrode at a plurality of discrete contact regions spaced around the longitudinal axis, wherein the fluid receiving interstitial spaces are formed between the discrete contact regions. However, Wang et al. disclose an ablation catheter (12) comprising a distal electrode assembly (10) comprising an insert electrode (18) having a non-circular cross-sectional shape (28) with at least three vertices that engage an inner surface of an outer member (18) at a plurality of discrete contact regions spaced around the longitudinal axis. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Mulier et al. such that the insert electrode has a non-circular cross-sectional shape wherein the insert electrode engages the inner surface of the outer electrode at a plurality of discrete contact regions spaced around the longitudinal axis in order to provide the benefit of fluid flow that exits out of passageways and flows substantially parallel to the body of the electrode therein improving or optimizing the irrigation of the electrode as taught by Wang et al. ([0008-0009], [0022], [0025], [0032]; Fig. 1-4F) The modified invention of Mulier et al. in view of Wang et al. teaches the fluid receiving interstitial spaces are formed between the discrete contact regions.
Mulier et al. disclose the proximal end of the outer electrode to extend proximally to connect with a power source, and thus Mulier et al in view of Wang et al. fail to disclose a proximal end of the outer electrode is coupled to a distal end of the elongate body. However, McClurken et al. disclose an ablation catheter embodiment comprising a distal electrode assembly (45) comprising an insert electrode (25) surrounded by an outer electrode (82), where a proximal end of the outer electrode (82) is coupled to a distal end of an elongate body (90) (Figs. 9-14) and an ablation catheter embodiment comprising a distal electrode assembly (45) comprising an insert electrode (25) surrounded by an outer electrode (17), where a proximal end of the outer electrode (17) extends proximally to connect with a power source (Fig. 22-28). McClurken et al. further teach that the outer electrode (82) and conductive shaft (17) can be formed separately or as a unitary piece. ([0179], [02187]) It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Mulier et al. in view of Wang such that the outer electrode and conductive shaft are separate structural pieces and a proximal end of the outer electrode is coupled to a distal end of the elongate body as taught by McClurken et al., since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. See also In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Claim 24 is rejected upon the same rationale as applied to claim 2.
Claim 25 is rejected upon the same rationale as applied to claim 4.
Claim 26 is rejected upon the same rationale as applied to claim 6.
Claim 27 is rejected upon the same rationale as applied to claim 8.
Claim 28 is rejected upon the same rationale as applied to claim 13.
Claim 30 is rejected upon the same rationale as applied to claim 17.
Claim(s) 16, 29 & 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulier et al. (5,897,553, previously cited) in view of Wang et al. (2009/0163912, previously cited) and McClurken et al. (2005/0015085, previously cited), as applied to claims 1 & 23, and evidenced by Datta et al. (2007/0156131).
Concerning claims 16, 29 & 31, Wang et al. further disclose the fluid flow to be parallel fluid flow through each of the fluid passages (38) formed by the inner surface of the outer member (16) and outer surface of an insert electrode (18) of the distal electrode assembly (18) and parallel to the distal insert electrode (18) ([0022], [0025]). Further, Datta teaches an ablation catheter comprising fluid passages (112) configured to provide laminar or near laminar fluid flow through each of the fluid passages (112) since the fluid passages (112) are angled to direct the flow of fluid in a direction generally parallel to the outer surface an insert electrode (104) such that there can be more uniform cooling of the outer surface. Since Wang et al. teach the flow of fluid to be parallel to the electrode (18), and Datta teach laminar flow to be when the flow of fluid in a direction generally parallel to the outer surface an insert electrode (104) such that there can be more uniform cooling of the outer surface, the modified invention of Mulier et al. in view of Wang and McClurken teach the distal electrode assembly configured to provide laminar or near laminar fluid flow through each of the fluid passages and are configured to promote the laminar or near laminar fluid flow.
Claim(s) 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulier et al. (5,897,553, previously cited) in view of Wang et al. (2009/0163912, previously cited) and McClurken et al. (2005/0015085, previously cited), as applied to claim 1, in further view of Carmel et al. (2015/0196350, previously cited).
Concerning claim 18, Mulier et al. in view of Wang et al. and McClurken et al. fail to disclose a proximal electrode coupled to the elongate body proximal of the distal electrode assembly. However, Carmel et al. disclose an ablation catheter comprising an elongate body and a distal electrode assembly comprising an electrode (1) and two proximal electrodes (2 and/or 3) coupled to the elongate body proximal of the distal electrode assembly (1). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Mulier et al. in view of Wang et al. and McClurken et al. to further comprise a proximal electrode coupled to the elongate body proximal of the distal electrode assembly in order to provide the benefit of altering energy distribution advantageously as taught by Carmel et al. ([0035], [0096-0097]; Fig. 1-4D)
Concerning claim 19, Carmel et al. further disclose a collective surface area of exposed portions of the distal assembly is less than a surface area of an exposed portion of the proximal electrode (2 and/or 3) ([0097]; Fig. 3).
Concerning claim 20, Carmel et al. further disclose the proximal electrode (2 and/or 3) is a first proximal electrode (2) and the ablation catheter further comprises a second proximal electrode (3) coupled to the elongate body proximal of the first proximal electrode (2) ([0096-0097]; Fig. 1-4D).
Concerning claim 21, Carmel et al. further disclose the first (2) and second (3) proximal electrodes are ring electrodes (Fig. 4A-D).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulier et al. (5,897,553, previously cited) in view of Wang et al. (2009/0163912, previously cited) and McClurken et al. (2005/0015085, previously cited), as applied to claim 1, in further view of Datta (2007/0156131).
Concerning claim 32, Mulier et al. disclose connection to a power source via conductive shaft (16) (Col. 4, ll. 14-19), and thus Mulier et al. in view of Wang et al. and McClurken et al. fail to disclose a high voltage cable coupled to a proximal end of the insert electrode. However, Datta et al. disclose an ablation catheter comprising a distal electrode assembly (36) comprising an insert electrode (118) that electrically connects to a power source via a high voltage cable (40) coupled to a proximal end of the insert electrode (118). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Mulier et al. in view of Wang et al. and McClurken et al. such that power source connection is via a high voltage cable coupled to a proximal end of the insert electrode in place of the conductive shaft in order to provide the benefit of more flexible connection that allows movement as the catheter is manipulated as taught by Datta et al. ([0039], [0040], [0050]; Fig. 3A) and since the high voltage cable taught by Datta et al. provides the same benefit as the conductive shaft of McClurken et al. to connect the insert electrode to a power source.
Response to Arguments
Applicant’s arguments filed 9/28/2026 are moot in view of the new ground(s) of rejection.
The Examiner suggests claiming the structure show in Fig. 7 to overcome the prior art rejections of record.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
