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 .
Continued Examination Under 37 CFR 1.114
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on 10/29/2025.
Response to Amendment
Amendments to the claim have been entered. Examiner acknowledges the amendments made to the claims 1, 6, 11, 15, 17 and 20. Claims 1-20 remain pending in the present application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5,7-14,16-19 is/are rejected under 35 U.S.C. 103 as being anticipated by Anderson (US Patent No 2008/0243116) in view of Demarais (US Patent No 2011/0202098) further in view of Vrba (US Patent No 20190069949).
Regarding claim 1, Anderson teaches a deployable radio-frequency (RF) ablation needle (needle electrode 72, para [0072]) for penetrating into hard and/or soft tissues of a patient, and ablating portions of the hard and/or soft tissues (electrode enters tissue for treatment, para [0072]-[0073]), the deployable RF ablation needle comprising: a proximal end, an opposite distal end, a length between the proximal end and the distal end, and a mid-longitudinal axis extending through the proximal end and the distal end, and along the length of the deployable RF ablation needle ( see fig 12 for proximal end 60, and distal end terminating at needle 72, where an axis extends throughout the length of the RF needle); an outer portion extending from at least adjacent the proximal end toward the distal end, the outer portion including an interior cavity defined by an interior first surface (sleeve 20 which is coaxially arranged around the electrode lead 12, para [0048], implying an interior surface); an intermediate portion extending from at least adjacent the proximal end toward the distal end (electrode lead 12 serves as intermediate portion, para [0048]), the intermediate including an exterior second surface and an interior cavity defined by an interior third surface (see fig 9 which shows exterior surface against sleeve 20 an interior surface around shaft 52), the intermediate portion terminating at an expandable end portion adjacent the distal end (see fig 10 which shows electrode lead 12 terminating at a distal end), the expandable end portion including at least two tines moveable between an undeployed configuration and a partially or completely deployed configuration (see fig 10 for petal or tine 22 in undeployed configuration and then fig 12 showings petals or tines 22 in a deployed configuration); and an inner portion including a body portion and a head portion (where the inner body portion is the steering shaft 52 and the head portion is electrode 64, para [0063], see also fig 7), the body portion extending from at least adjacent the proximal end to the head portion (see fig 10), and the head portion extending from the body portion to the distal end, the head portion including a tip portion configured to penetrate the hard and/or soft tissues terminating at the tip portion (a needle electrode 72 is carried on the distal end of the steering shaft 52 and thereby found on the head portion of the device and is used because penetration of the tissue is required, para [0072]), the forward-facing surface being the body portion including an exterior fourth surface (see fig 7 where shaft 52 connects to head portion 64 and contains an exterior surface); wherein portions of the intermediate portion are received within the interior cavity of the outer portion, and portions of the body portion of the inner portion are received within the interior cavity of the intermediate portion (see fig 9 for sleeve 20 surrounding intermediate portion 12 which surrounds the body shaft 52); wherein each of the at least two tines includes a first inner surface portion formed as a portion of the interior third surface (inner surface 34 of each leaf or tine 26 which folds in to be part of the interior surface of the electrical lead 12, para [0059]), and the head portion includes a rearward-facing inclined surface contactable to the first inner surface portions of the at least two tines (the petals or tines 22 of the sleeve 20 underlie the button electrode 64 when the petals 22 are in their closed configuration, para [0065]);
Anderson does not teach the explicit tine deployment technique involving that the tines are integrally formed with the intermediate portion and the head portion is moveable between a first position and a second position, with the second position being closer to the proximal end than the first position, and slidable movement of the head portion from the first position toward the second position contacts the rearward-facing inclined surface with the first inner surface portions, and slidable interaction of the rearward-facing inclined surface and the first inner surface portions expands the expandable end portion by forcing the at least two tines apart from another from the undeployed configuration toward the partially or completely deployed configuration.
However, the analogous RF electrode delivery system of Demarais does disclose the tines are integrally formed with the intermediate portion (Demarais, in this case the hypotube 358 can be analyzed as the intermediate portion wherein the electrode extensions 359 are integrally and directly extended from, [0088]-[0089], and fig 17) and the head portion is moveable between a first position and a second position, with the second position being closer to the proximal end than the first position, and slidable movement of the head portion from the first position toward the second position contacts the rearward-facing inclined surface with the first inner surface portions (wherein the electrode extensions 359 which are seen as the tine members are slid from a proximal position to a distal position in which the interact with tapered surface of the guide block 362 seen as the head portion. This slidable movement results in the same relative movement of the head portion being brough proximally relative to the tine members, [0091], see also figs 17A and 17B), and slidable interaction of the rearward-facing inclined surface and the first inner surface portions expands the expandable end portion by forcing the at least two tines apart from another from the undeployed configuration toward the partially or completely deployed configuration (see figures 17A and 17B as well as the disclosure of [0091] showing how the deformation electrodes 359 are deployed and positioned outwards to contact the tissue wall).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the deployable RF system taught by Anderson to include the specific deployment technique disclosed by Demarais as it is another well-known deployment technique in the art and used as an effective way to direct the electrode deformations or tines to their deployed configurations as disclosed by Demarais, [0091].
Neither Anderson nor Demarais explicitly teach during movement of the head portion between the first and second positions, the intermediate portion is axially fixed relative to the outer portion.
However, the movement of the head portion between a distal position to proximal position for tine deployment, and the movement of the tine or intermediate portion from a proximal position to a distal position resulting in the contact of the head portion for tine deployment as shown in the prior art of Demarais has the same resulting relative movement for deployment.
Furthermore, examiner understands that even though the relative movement is the same in Demarais as the present claim limitations, that Demarais does not explicitly teach that the intermediate portion is axially fixed during the movement of the head portion.
However, the analogous deployable treatment needle of Vrba does teach that the head portion of the tip 6403 is retracted proximally against the axially fixed arms 6406 herein seen as the intermediate portion which causes the deployment of the arms 6406 for treatment, see figures 64C-1 and 64C-2 as well as [0451], which results in the same movement and deployment techniques with an axially fixed intermediate portion as presently claimed.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the RF treatment needle and deployment techniques taught by Anderson and Demarais, with that of the axially fixed intermediate portion taught by Vrba as it is another known method in the art to allow for the conductive tine deployment into the treatment area as taught by Vrba, [0451].
Regarding claim 2, Anderson teaches the deployable RF ablation needle of claim 1, wherein at least portions of each of the at least two tines serve as an electrode for applying electrical current to the hard and/or soft tissues to facilitate ablation thereof (electrode 28 found on the tine 22, used for ablation treatment, para [0070]).
Regarding claim 3, Anderson teaches the deployable RF ablation needle of claim 1, wherein the rearward-facing inclined surface is at least in part frusto-conical, and the rearward-facing inclined surface serves as a wedge to force the at least two tines apart from one another (see fig 7 for head 64 in a part conical shape which separates the tines into an open position, see also para [0065]).
Regarding claim 4, Anderson teaches the deployable RF ablation needle of claim 1, wherein, when the at least two tines are in the undeployed configuration, the distal ends of a first one and a second one of at least two tines are and spaced apart from one another a first distance in a direction perpendicular to the mid-longitudinal axis, and, when the at least two tines are in the partially or completely deployed configuration, the distal ends of the first one and the second one of the at least two tines are spaced apart from one another a second distance in the direction perpendicular to the mid-longitudinal axis, the second distance being greater than the first distance (see fig 7 for head 64 in a part conical shape which separates the tines into an open position, see also para [0065], and see urging the electrical lead 12 in a distal direction relative to the sleeve 20, the petals 22/leaves 26 are moved to their open, operative configuration as shown in FIG. 2c of the drawings. Conversely, by moving the electrical lead 12 in a proximal direction relative to the sleeve 20, the petals 22/leaves 26 are moved to their closed, inoperative configuration, para [0061], see also fig 2c for open position showing a greater space and fig 2d in closed position with a smaller space).
Regarding claim 5, Anderson teaches the deployable RF ablation needle of claim 4, wherein expansion of the expandable end portion correspondingly increases an ablation zone in the hard and/or soft tissues surrounding the at least two tines with the ablation zone having a first size when the first one and the second one of the at least two tines are spaced apart the first distance, and the ablation zone having a second size when the first one and the second one of the at least two tines are spaced apart the second distance, the second size being larger than the first size.
Anderson teaches that urging the electrical lead 12 in a distal direction relative to the sleeve 20, the petals 22/leaves 26 are moved to their open, operative configuration as shown in FIG. 2c of the drawings. Conversely, by moving the electrical lead 12 in a proximal direction relative to the sleeve 20, the petals 22/leaves 26 are moved to their closed, inoperative configuration, para [0061], see also fig 2c for open position showing a greater space and fig 2d in closed position with a smaller space. Anderson also states the electrodes 28 and 64 are used to affect the ablation treatment at the site of the patient's body, para [0070], and therefore if the petals or tines are opened larger the electrodes would then have a larger ablation zone according to Anderson.
Regarding claim 7, Anderson teaches the deployable RF ablation needle of claim 5, wherein at least portions of each of the at least two tines serve as an electrode for applying electrical current to the hard and/or soft tissues to facilitate ablation thereof (electrode 28 found on the tine 22, used for ablation treatment, para [0070]).
Regarding claim 8, Anderson teaches the deployable RF ablation needle of claim 1, wherein the head portion includes a forward-facing surface terminating at the tip portion, the forward-facing surface being configured to facilitate penetration of the deployable RF ablation needle into the hard and/or soft tissues (a needle electrode 72 is carried on the distal end of the steering shaft 52 and thereby found on the head portion of the device and is used because penetration of the tissue is required, para [0072]).
Regarding claim 9, Anderson teaches the deployable RF ablation needle of claim 8, wherein, when the at least two tines are in the undeployed configuration, portions of the at least two tines are tucked behind portions of the head portion in the direction of insertion (the petals or tines 22 of the sleeve 20 underlie the head electrode 64 when the petals 22 are in their closed configuration, para [0065]).
Regarding claim 10, Anderson teaches the deployable RF ablation needle of claim 9, wherein each of the at least two tines include a second inner surface angled to correspond to the rearward- facing inclined surface to facilitate contact therebetween when the at least two tines are in the undeployed configuration (see fig 5, which shows the distal end 58 which contains edges for contact between an inner angled surface of the tine 22, see also para [0063]).
Regarding claim 11, Anderson teaches a deployable radio-frequency (RF) ablation needle (needle electrode 72, para [0072]) for penetrating into hard and/or soft tissues of a patient, and ablating portions of the hard and/or soft tissues (electrode enters tissue for treatment, para [0072]-[0073]), the deployable RF ablation needle comprising: a proximal end, an opposite distal end, a length between the proximal end and the distal end, and a mid-longitudinal axis extending through the proximal end and the distal end, and along the length of the deployable RF ablation needle (see fig 12 for proximal end 60, and distal end terminating at needle 72, where an axis extends throughout the length of the RF needle); an outer portion extending from at least adjacent the proximal end toward the distal end; an intermediate portion extending from at least adjacent the proximal end toward the distal end, a portion of the intermediate portion being received in the outer portion (sleeve or outer portion 20 which is coaxially arranged around the electrode lead or intermediate portion 12, para [0048]), the intermediate portion terminating at an expandable end portion adjacent the distal end (see fig 10 which shows electrode lead 12 terminating at a distal end), the expandable end portion including at least four tines (plurality of petals or tines 22, four are defined in the disclosure, para [0049]) moveable between an undeployed configuration and a partially or completely deployed configuration (see fig 10 for petal or tine 22 in undeployed configuration and then fig 12 showings petals or tines 22 in a deployed configuration), each of the at least four tines including a first inner surface; and an inner portion including a body portion and a head portion (where the inner body portion is the steering shaft 52 and the head portion is electrode 64, para [0063], see also fig 7), the body portion extending from at least adjacent the proximal end to the head portion (see fig 10), and the head portion extending from the body portion to the distal end, a portion of the body portion of the inner portion being received in the intermediate portion (see fig 9 for sleeve 20 surrounding intermediate portion 12 which surrounds the body shaft 52), and the head portion including a tip portion, a forward-facing inclined surface, and a rearward-facing inclined surface, the forward-facing inclined surface terminating at the tip portion, and the tip portion and the forward-facing inclined surface being configured to penetrate the hard and/or soft tissues (a needle electrode 72 is carried on the distal end of the steering shaft 52 and thereby found on the head portion of the device and is used because penetration of the tissue is required, para [0072]); and wherein, when the at least four tines are in the undeployed configuration, the distal ends of a first one and a second one of at least four tines are opposite from and spaced apart from one another a first distance in a direction perpendicular to the mid-longitudinal axis, and, when the at least four tines are in the partially or completely deployed configuration, the distal ends of the first one and the second one of the at least four tines are opposite from and spaced apart from one another a second distance in the direction perpendicular to the mid- longitudinal axis, the second distance being greater than the first distance (urging the electrical lead 12 in a distal direction relative to the sleeve 20, the petals 22/leaves 26 are moved to their open, operative configuration as shown in FIG. 2c of the drawings. Conversely, by moving the electrical lead 12 in a proximal direction relative to the sleeve 20, the petals 22/leaves 26 are moved to their closed, inoperative configuration, para [0061]).
Anderson does not teach the explicit tine deployment technique involving the tines integrally formed with the intermediate portion and the head portion is moveable between a first position and a second position, with the second position being closer to the proximal end than the first position, and slidable movement of the head portion from the first position toward the second position contacts the rearward-facing inclined surface with the first inner surface portions, and slidable interaction of the rearward-facing inclined surface and the first inner surface portions expands the expandable end portion by forcing the at least two tines apart from another from the undeployed configuration toward the partially or completely deployed configuration
However, the analogous RF electrode delivery system of Demarais does disclose the tines integrally formed with the intermediate portion (Demarais, in this case the hypotube 358 can be analyzed as the intermediate portion wherein the electrode extensions 359 are integrally and directly extended from, [0088]-[0089], and fig 17) and the head portion is moveable between a first position and a second position, with the second position being closer to the proximal end than the first position, and slidable movement of the head portion from the first position toward the second position contacts the rearward-facing inclined surface with the first inner surface portions (wherein the electrode extensions 359 which are seen as the tine members are slid from a proximal position to a distal position in which the interact with tapered surface of the guide block 362 seen as the head portion. This slidable movement results in the same relative movement of the head portion being brough proximally relative to the tine members, [0091], see also figs 17A and 17B), and slidable interaction of the rearward-facing inclined surface and the first inner surface portions expands the expandable end portion by forcing the at least two tines apart from another from the undeployed configuration toward the partially or completely deployed configuration (see figures 17A and 17B as well as the disclosure of [0091] showing how the deformation electrodes 359 are deployed and positioned outwards to contact the tissue wall).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the deployable RF system taught by Anderson to include the specific deployment technique disclosed by Demarais as it is another well-known deployment technique in the art and used as an effective way to direct the electrode deformations or tines to their deployed configurations as disclosed by Demarais, [0091].
Neither Anderson nor Demarais explicitly teach during movement of the head portion between the first and second positions, the intermediate portion is axially fixed relative to the outer portion.
However, the movement of the head portion between a distal position to proximal position for tine deployment, and the movement of the tine or intermediate portion from a proximal position to a distal position resulting in the contact of the head portion for tine deployment as shown in the prior art of Demarais has the same resulting relative movement for deployment.
Furthermore, examiner understands that even though the relative movement is the same in Demarais as the present claim limitations, that Demarais does not explicitly teach that the intermediate portion is axially fixed during the movement of the head portion.
However, the analogous deployable treatment needle of Vrba does teach that the head portion of the tip 6403 is retracted proximally against the axially fixed arms 6406 herein seen as the intermediate portion which causes the deployment of the arms 6406 for treatment, see figures 64C-1 and 64C-2 as well as [0451], which results in the same movement and deployment techniques with an axially fixed intermediate portion as presently claimed.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the RF treatment needle and deployment techniques taught by Anderson and Demarais, with that of the axially fixed intermediate portion taught by Vrba as it is another known method in the art to allow for the conductive tine deployment into the treatment area as taught by Vrba, [0451].
Regarding claim 12, Anderson teaches the deployable RF ablation needle of claim 11, wherein at least portions of each of the at least four tines serve as an electrode for applying electrical current to the hard and/or soft tissues to facilitate ablation thereof (electrode 28 found on the tine 22, used for ablation treatment, para [0070]).
Regarding claim 13, Anderson teaches the deployable RF ablation needle of claim 11, wherein the rearward-facing inclined surface is at least in part frusto-conical, and the rearward-facing inclined surface serves as a wedge to force the at least four tines apart from one another (see fig 7 for head 64 in a part conical shape which separates the tines into an open position, see also para [0065]).
Regarding claim 14, Anderson teaches the deployable RF ablation needle of claim 11, wherein expansion of the expandable end portion correspondingly increases an ablation zone in the hard and/or soft tissues surrounding the at least four tines with the ablation zone having a first size when the first one and the second one of the at least four tines are spaced apart the first distance, and the ablation zone having a second size when the first one and the second one of the at least four tines are spaced apart the second distance, the second size being larger than the first size.
Anderson teaches that urging the electrical lead 12 in a distal direction relative to the sleeve 20, the petals 22/leaves 26 are moved to their open, operative configuration as shown in FIG. 2c of the drawings. Conversely, by moving the electrical lead 12 in a proximal direction relative to the sleeve 20, the petals 22/leaves 26 are moved to their closed, inoperative configuration, para [0061], see also fig 2c for open position showing a greater space and fig 2d in closed position with a smaller space. Anderson also states the electrodes 28 and 64 are used to affect the ablation treatment at the site of the patient's body, para [0070], and therefore if the petals or tines are opened larger the electrodes would then have a larger ablation zone according to Anderson.
Regarding claim 16, Anderson teaches the deployable RF ablation needle of claim 14, wherein at least portions of each of the at least four tines serve as an electrode for applying electrical current to the hard and/or soft tissues to facilitate ablation thereof (electrode 28 found on the tine 22, used for ablation treatment, para [0070]).
Regarding claim 17, Anderson teaches a deployable radio-frequency (RF) ablation needle (needle electrode 72, para [0072]) for penetrating into hard and/or soft tissues of a patient, and ablating portions of the hard and/or soft tissues (electrode enters tissue for treatment, para [0072]-[0073]), the deployable RF ablation needle comprising: a proximal end, an opposite distal end, a length between the proximal end and the distal end, and a mid-longitudinal axis extending through the proximal end and the distal end, and along the length of the deployable RF ablation needle (see fig 12 for proximal end 60, and distal end terminating at needle 72, where an axis extends throughout the length of the RF needle); an outer portion extending from at least adjacent the proximal end toward the distal end; an intermediate portion extending from at least adjacent the proximal end toward the distal end, a portion of the intermediate portion being received in the outer portion (sleeve or outer portion 20 which is coaxially arranged around the electrode lead or intermediate portion 12, para [0048]), the intermediate portion terminating at an expandable end portion adjacent the distal end (see fig 10 which shows electrode lead 12 terminating at a distal end), the expandable end portion including at least four tines (plurality of petals or tines 22, four are defined in the disclosure, para [0049]) moveable between an undeployed configuration and a partially or completely deployed configuration (see fig 10 for petal or tine 22 in undeployed configuration and then fig 12 showings petals or tines 22 in a deployed configuration), each of the at least four tines including a first inner surface portion; and an inner portion including a body portion and a head portion (where the inner body portion is the steering shaft 52 and the head portion is electrode 64, para [0063], see also fig 7), the body portion extending from at least adjacent the proximal end to the head portion (see fig 10), and the head portion extending from the body portion to the distal end, a portion of the body portion of the inner portion being received in the intermediate portion (see fig 9 for sleeve 20 surrounding intermediate portion 12 which surrounds the body shaft 52), and the head portion including a tip portion, a forward-facing inclined surface, and a rearward-facing inclined surface, the forward-facing inclined surface terminating at the tip portion, and the tip portion and the forward-facing inclined surface being configured to penetrate the hard and/or soft tissues (a needle electrode 72 is carried on the distal end of the steering shaft 52 and thereby found on the head portion of the device and is used because penetration of the tissue is required, para [0072]); and wherein expansion of the at least four tines of the expandable end portion correspondingly increases an ablation zone in the hard and/or soft tissues surrounding the at least four tines with the ablation zone having a first size when the expandable end portion is in the undeployed configuration, and the ablation zone having a second size when the expandable end portion is in the partially or completely deployed configuration, the second size being larger than the first size (urging the electrical lead 12 in a distal direction relative to the sleeve 20, the petals 22/leaves 26 are moved to their open, operative configuration as shown in FIG. 2c of the drawings. Conversely, by moving the electrical lead 12 in a proximal direction relative to the sleeve 20, the petals 22/leaves 26 are moved to their closed, inoperative configuration, para [0061]).
Anderson does not teach the explicit tine deployment technique involving the tines integrally formed with the intermediate portion and the head portion is moveable between a first position and a second position, with the second position being closer to the proximal end than the first position, and slidable movement of the head portion from the first position toward the second position contacts the rearward-facing inclined surface with the first inner surface portions, and slidable interaction of the rearward-facing inclined surface and the first inner surface portions expands the expandable end portion by forcing the at least two tines apart from another from the undeployed configuration toward the partially or completely deployed configuration
However, the analogous RF electrode delivery system of Demarais does disclose the tines integrally formed with the intermediate portion (Demarais, in this case the hypotube 358 can be analyzed as the intermediate portion wherein the electrode extensions 359 are integrally and directly extended from, [0088]-[0089], and fig 17) and the head portion is moveable between a first position and a second position, with the second position being closer to the proximal end than the first position, and slidable movement of the head portion from the first position toward the second position contacts the rearward-facing inclined surface with the first inner surface portions (wherein the electrode extensions 359 which are seen as the tine members are slid from a proximal position to a distal position in which the interact with tapered surface of the guide block 362 seen as the head portion. This slidable movement results in the same relative movement of the head portion being brough proximally relative to the tine members, [0091], see also figs 17A and 17B), and slidable interaction of the rearward-facing inclined surface and the first inner surface portions expands the expandable end portion by forcing the at least two tines apart from another from the undeployed configuration toward the partially or completely deployed configuration (see figures 17A and 17B as well as the disclosure of [0091] showing how the deformation electrodes 359 are deployed and positioned outwards to contact the tissue wall).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the deployable RF system taught by Anderson to include the specific deployment technique disclosed by Demarais as it is another well-known deployment technique in the art and used as an effective way to direct the electrode deformations or tines to their deployed configurations as disclosed by Demarais, [0091].
Neither Anderson nor Demarais explicitly teach during movement of the head portion between the first and second positions, the intermediate portion is axially fixed relative to the outer portion.
However, the movement of the head portion between a distal position to proximal position for tine deployment, and the movement of the tine or intermediate portion from a proximal position to a distal position resulting in the contact of the head portion for tine deployment as shown in the prior art of Demarais has the same resulting relative movement for deployment.
Furthermore, examiner understands that even though the relative movement is the same in Demarais as the present claim limitations, that Demarais does not explicitly teach that the intermediate portion is axially fixed during the movement of the head portion.
However, the analogous deployable treatment needle of Vrba does teach that the head portion of the tip 6403 is retracted proximally against the axially fixed arms 6406 herein seen as the intermediate portion which causes the deployment of the arms 6406 for treatment, see figures 64C-1 and 64C-2 as well as [0451], which results in the same movement and deployment techniques with an axially fixed intermediate portion as presently claimed.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the RF treatment needle and deployment techniques taught by Anderson and Demarais, with that of the axially fixed intermediate portion taught by Vrba as it is another known method in the art to allow for the conductive tine deployment into the treatment area as taught by Vrba, [0451].
Regarding claim 18, Anderson teaches the deployable RF ablation needle of claim 17, wherein at least portions of each of the at least four tines serve as an electrode for applying electrical current to the hard and/or soft tissues to facilitate ablation thereof (electrode 28 found on the tine 22, used for ablation treatment, para [0070]).
Regarding claim 19, Anderson teaches the deployable RF ablation needle of claim 17, wherein the rearward-facing inclined surface is at least in part frusto-conical, and the rearward-facing inclined surface serves as a wedge to force the at least four tines apart from one another (see fig 7 for head 64 in a part conical shape which separates the tines into an open position, see also para [0065]).
Claim(s) 6, 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US Patent No 2008/0243116) in view of Demarais (US Patent No 2011/0202098) further in view of Vrba (US Patent No 20190069949) further in view of Ko (US Patent No 20190343576).
Regarding claim 6, Anderson, Demarais and Vrba teach the deployable RF ablation needle of claim 5, wherein each of the at least two tines include a proximal first end and a distal second end (see Anderson fig 2c), the intermediate portion to facilitate movement of the at least two tines between the undeployed configuration and the partially or completely deployed configuration (Anderson, see fig 10 for petal or tine 22 in undeployed configuration and then fig 12 showings petals or tines 22 in a deployed configuration).
Anderson, Demarais and Vrba do not teach wherein the tines are configured to pivot radially about scored pivot regions at or adjacent the proximal first ends and relative to via the proximal end.
However, the analogous bipolar surgical ablation instrument disclosed by Ko does teach tines configured to pivot radially about scored pivot regions at or adjacent the proximal first ends connected via the proximal end (see Ko, fig 2 which depicts a plurality of conductive arms 102 which all contain individual scored hinge members 115 which allow for the proximal side of the arms 102 to radially pivot about the working end of the device 100, see also [0025]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to connect the tines pivotally with a scored hinge member to the body disclosed by the previous combination as it is taught by Ko to be a method of rotatability and movability of a device component (para [0025]) and well known to one skilled in the art.
Regarding claim 15, the combination teaches the deployable RF ablation needle of claim 14, wherein each of the at least four tines include a proximal first end and a distal second end (see Anderson fig 2c), the proximal first ends being configured to pivot radially about scored pivot regions at or adjacent the proximal first ends connected via the proximal end (see Ko, fig 2 which depicts a plurality of conductive arms 102 which all contain individual scored hinge members 115 which allow for the proximal side of the arms 102 to radially pivot about the working end of the device 100, see also [0025]) and relative to remaining portions of the intermediate portion to facilitate movement of the at least four tines between the undeployed configuration and the partially or completely deployed configuration (Anderson, see fig 10 for petal or tine 22 in undeployed configuration and then fig 12 showings petals or tines 22 in a deployed configuration).
Regarding claim 20, the combination teaches the deployable RF ablation needle of claim 17, wherein each of the at least four tines include a proximal first end and a distal second end (see Anderson fig 2c), the proximal first ends being configured to pivot radially about scored pivot regions at or adjacent the proximal first ends connected via the proximal end (see Ko, fig 2 which depicts a plurality of conductive arms 102 which all contain individual scored hinge members 115 which allow for the proximal side of the arms 102 to radially pivot about the working end of the device 100, see also [0025]) and relative to remaining portions of the intermediate portion to facilitate movement of the at least four tines between the undeployed configuration and the partially or completely deployed configuration (Anderson, see fig 10 for petal or tine 22 in undeployed configuration and then fig 12 showings petals or tines 22 in a deployed configuration).
Response to Arguments
Applicant’s arguments filed 09/29/2025 with respect to independent claim(s) 1, 11 and 17 as well as dependent claims 6, 15 and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In regards to the arguments presented for the independent claims 1, 11 and 17, that the prior art of record as is does not contain the amended limitation of “during movement of the head portion between the first and second positions, the intermediate portion is axially fixed relative to the outer portion,” has been considered and is partially persuasive. The examiner would like to reemphasize the fact that Demarais does include and disclose the tine deployment in the same structural way under the same relative movement as the present invention as seen in the disclosure of Demarais paragraph [0091] in which the RF electrode deformation extensions 359 deform outwardly as they come in contact with the guide block 362 or head piece of the system. Whether the head piece is moved more proximal, or the intermediate portion is moved more distal, the relative movement of both motions is the same. However, examiner understands that even though the relative movement is the same in Demarais as the present claim limitations, that Demarais does not explicitly teach that the intermediate portion is axially fixed during the movement of the head portion. Therefore, after further search and consideration, which was necessitated by the amended claim language, it has been found that the new analogous prior art of record of Vrba does teach that the head portion of the tip 6403 is retracted proximally against the axially fixed arms 6406 herein seen as the intermediate portion which causes the deployment of the arms 6406 for treatment, see figures 64C-1 and 64C-2 as well as [0451], which results in the same movement and deployment techniques with an axially fixed intermediate portion as presently claimed. Therefore, the amended independent claims 1, 11 and 17 remain rejected under the new prior art of record rejection of Anderson in view of Demarais further in view of Vrba set forth in the present office action.
In regards to the dependent claims 6, 15 and 20, the examiner agrees that the previous prior art of record did not explicitly teach the amended claim language that tines are configured to pivot radially about scored pivot regions. However, after further search and consideration, as necessitated by the amended claim language it has been found that the new prior art of record Ko does teach tines configured to pivot radially about scored pivot regions at or adjacent the proximal first ends connected via the proximal end (see Ko, fig 2 which depicts a plurality of conductive arms 102 which all contain individual scored hinge members 115 which allow for the proximal side of the arms 102 to radially pivot about the working end of the device 100, see also [0025]). Therefore, as the new prior art of record teaches all the amended claim limitations, the dependent claims 6, 15 and 20 remain rejected under the new prior art of record rejection of Anderson in view of Demarais further in view of Vrba further in view of Ko set forth in the present office action.
All other claims as being dependent on claims 1, 11, and 17 also remain rejected under the new prior art of record rejection set forth of Anderson in view of Demarais further in view of Vrba.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794