DETAILED ACTION
Notice of Pre-AIA or AIA Status
The amendment filed April 2, 2026, has been entered and fully considered. Claims 1-6 and 8-21 are pending. Claims 1, and 8-13 are amended. Claims 15 and 16 are withdrawn. Claim 21 is newly added.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6 and 8-14, 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Gnanashanmugam et al., (hereinafter 'Gnanashanmugam,' U.S. PGPub. No. 2013/0204068) in view of Kaplan et al., (hereinafter 'Kaplan,' U.S. Pat. No. 7,853,331) and Avitall (hereinafter ‘Avitall,’ U.S. PGPub. No. 2012/0143179).
Regarding independent claim 1 and claim 19, Gnanashanmugam (Fig. 19) discloses a catheter apparatus, comprising: an elongated shaft (150) having a proximal portion and a distal portion (Fig. 19), wherein the distal portion of the elongated shaft is configured for intravascular delivery to a body vessel of a human patient (patient's pulmonary artery PA); a therapeutic assembly (catheter 210) comprising a pre- formed shape (see helical distal section 211b of catheter 210 in Fig. 19), wherein the therapeutic assembly (210) is transformable between: a substantially straight delivery configuration ([0168], “Catheter 210 may be delivered to pulmonary artery PA in a low profile delivery configuration within sheath 150. Once positioned within the artery, the catheter may self-expand or may be expanded actively, e.g., via a pull wire or a balloon, into contact with an interior wall of the artery.”); and a treatment configuration having the pre-formed shape configured to position the therapeutic assembly in stable contact with a wall of the body vessel ([0165] “The helical distal section 211b of catheter 210 is configured to appose the vessel wall and bring electrodes 212 into close proximity to extra-vascular neural structures.”); and a mechanical decoupler (proximal section 211a) operably connected to the therapeutic assembly (210), wherein the mechanical decoupler (211a) is configured to absorb at least a portion of a force exerted on the therapeutic assembly (210) by the elongated shaft so that the therapeutic assembly maintains a generally stationary position relative to a target site when the elongated shaft moves and while the therapeutic assembly and the elongated shaft are connected via the mechanical decoupler (see Fig. 19; as broadly claimed, the proximal section 211a absorb at least a portion of a force exerted on the therapeutic assembly 210; [0168], elongated shaft 150 moves independently of proximal section 211a and therapeutic assembly 210), wherein the mechanical decoupler (211a) comprises an isolating element configured to mechanically isolate the therapeutic assembly from the elongated shaft (see length of proximal portion 211a). Gnanashanmugam (Fig. 19) discloses wherein the isolating element (211a) comprises: a first portion connected to the therapeutic assembly (210); a second portion connected to the elongated shaft (150); and a connector (length of proximal portion 211a ) extending between the first and second portions (Fig. 19).
Gnanashanmugam is silent regarding wherein the connector is configured to provide slack between the therapeutic assembly and the elongated shaft to mechanically isolate the therapeutic assembly from the elongated shaft.
However, in the same field of endeavor, Kaplan (Fig. 7) teaches a similar catheter comprising a tether (230) having a first portion connected to a therapeutic assembly (122) and a second portion connected to an elongated shaft (130), wherein the tether allows the therapeutic assembly (122) to move independently of the shaft (130) (col. 12, ll. 45-55, “The tether variation of the invention also accommodates relative motion between the device and the body (e.g., tidal motion of breathing, other muscle contractions, etc.) The tether permits the device to move relative to its intended treatment location unless the user desires and uses the tether or the sheath to pull the device back or drive it forward.” See Fig. 7 for tether 230 having ‘slack’). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the isolating element as taught by Gnanashanmugam to include wherein the connector is configured to provide slack between the therapeutic assembly and the elongated shaft to mechanically isolate the therapeutic assembly from the elongated shaft, as taught by Kaplan. By providing a tether with slack, the catheter apparatus accommodates relative motion between the device and the body and allows a user to manipulate the device (back or drive it forward), thereby improving control, efficiency, and accuracy of treatment.
Gnanashanmugam in view of Kaplan are silent regarding wherein the mechanical decoupler is positioned at and extends from a distal end of the elongated shaft.
However, in the same field of endeavor, Avitall (Figs. 1 and 5) teaches a similar mechanical decoupler (guidewire 26) that is positioned at and extends from a distal end of an elongated shaft (deflectable transdermal sheath 28; [0048], “The guidewire may be attached to or drawn through the distal end of a deflectable transdermal sheath, a fragment of which is shown at 28”). This configuration both stabilizes the therapeutic assembly (154) and provides that the therapeutic assembly (154) is held securely in place against the wall of the targeted tissue ([0056]-[0057]), thereby increasing control and accuracy of treatment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the mechanical decoupler as taught by Gnanashanmugam in view of Kaplan to include wherein the mechanical decoupler is positioned at and extends from a distal end of the elongated shaft, as taught by Avitall, in order to stabilize and securely position the therapeutic assembly as desired, thereby increasing control and accuracy of treatment. Further, this attachment configuration would have merely comprised a simple substitution of one well known attachment configuration for another (i.e., guidewire may be attached to or drawn through the distal end of a deflectable transdermal sheath), MPEP 2143(B)(I).
Regarding claim 2, Gnanashanmugam (Fig. 19) discloses wherein the therapeutic assembly (210) comprises a pre-formed helical member defined by a single wire electrode ([0168], “Catheter 210 may be delivered to pulmonary artery PA in a low profile delivery configuration within sheath 150. Once positioned within the artery, the catheter may self-expand or may be expanded actively, e.g., via a pull wire or a balloon, into contact with an interior wall of the artery.”).
Regarding claim 3, Gnanashanmugam (Fig. 19) discloses a plurality of energy delivery elements (212) carried by the therapeutic assembly (210).
Regarding claim 4, Gnanashanmugam (Fig. 19) discloses wherein the mechanical decoupler (211a) further comprises at least one of a flexible shaft, a fixation member, a corrugated shaft, a telescoping shaft, an expandable anchor, an isolating element, a lead screw, or an inner sheath (see length of proximal portion 211a which meets the limitation of at least an isolating element as proximal portion 211a isolates elongated shaft 150 from therapeutic assembly 210).
Regarding claim 5, Gnanashanmugam (Fig. 19) discloses wherein the distal portion of the elongated shaft and the therapeutic assembly are sized and configured for intravascular delivery into the pulmonary artery (see Fig. 19 for pulmonary artery ‘PA’).
Regarding claim 6, Gnanashanmugam (Fig. 19) discloses wherein the distal portion of the elongated shaft (150) and the therapeutic assembly (210) are sized and configured for intravascular delivery into the renal artery (as broadly claimed, the apparatus is capable of being delivered into the renal artery). A recitation of intended use of the claimed invention must result in a structural different 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.
Regarding independent claim 8 and claim 17, Gnanashanmugam (Figs. 19 and 25) discloses a method for neuromodulation, comprising: positioning a therapeutic assembly (210) of a catheter at a treatment site proximate to a vessel of a patient (Fig. 19), wherein the catheter comprises: an elongated shaft (150) having a proximal portion and a distal portion (Fig. 19), wherein the distal portion of the elongated shaft is configured for intravascular delivery to the vessel (pulmonary artery ‘PA’); the therapeutic assembly (210), wherein the therapeutic assembly (210) comprises: a support structure (210) configured for intravascular delivery to the vessel; and a plurality of energy delivery elements (electrodes 212) carried by the support structure (Fig. 19); and a mechanical decoupler (proximal section 211a) operably connected to the therapeutic assembly (210), wherein the mechanical decoupler (211a) is configured to absorb at least a portion of a force exerted on the therapeutic assembly (210) by the elongated shaft so that the therapeutic assembly (210) maintains a generally stationary position relative to the treatment site when the elongated shaft moves and while the therapeutic assembly and the elongated shaft are connected via the mechanical decoupler (see Fig. 19; as broadly claimed, the proximal section 211a absorb at least a portion of a force exerted on the therapeutic assembly 210; [0168], elongated shaft 150 moves independently of proximal section 211a and therapeutic assembly 210), wherein the mechanical decoupler (211a) comprises an isolating element configured to mechanically isolate the therapeutic assembly from the elongated shaft (see length of proximal portion 211a); deploying the support structure such from a generally straight configuration to a helical or spiral configuration ([0168], “Catheter 210 may be delivered to pulmonary artery PA in a low profile delivery configuration within sheath 150. Once positioned within the artery, the catheter may self-expand or may be expanded actively, e.g., via a pull wire or a balloon, into contact with an interior wall of the artery.”; see [0165] “The helical distal section 211b of catheter 210 is configured to appose the vessel wall and bring electrodes 212 into close proximity to extra-vascular neural structures.”); and activating the energy delivery elements to modulate nerves proximate the wall of the vessel ([0164]-[0168], electrodes 212 deliver a pulsed electric field across a wall of the vasculature). Gnanashanmugam (Fig. 19) further discloses wherein the isolating element (211a) comprises: a first portion connected to the therapeutic assembly (210); a second portion connected to the elongated shaft (150); and a connector (length of proximal portion 211a ) extending between the first and second portions (Figs. 19).
Gnanashanmugam is silent regarding wherein the connector is configured to provide slack between the therapeutic assembly and the elongated shaft to mechanically isolate the therapeutic assembly from the elongated shaft.
However, in the same field of endeavor, Kaplan (Fig. 7) teaches a similar catheter comprising a tether (230) having a first portion connected to a therapeutic assembly (122) and a second portion connected to an elongated shaft (130), wherein the tether allows the therapeutic assembly (122) to move independently of the shaft (130) (col. 12, ll. 45-55, “The tether variation of the invention also accommodates relative motion between the device and the body (e.g., tidal motion of breathing, other muscle contractions, etc.) The tether permits the device to move relative to its intended treatment location unless the user desires and uses the tether or the sheath to pull the device back or drive it forward.” See Fig. 7 for tether 230 having ‘slack’). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the isolating element as taught by Gnanashanmugam to include wherein the connector is configured to provide slack between the therapeutic assembly and the elongated shaft to mechanically isolate the therapeutic assembly from the elongated shaft, as taught by Kaplan. By providing a tether with slack, the catheter apparatus accommodates relative motion between the device and the body and allows a user to manipulate the device (back or drive it forward), thereby improving control, efficiency, and accuracy of treatment.
Gnanashanmugam in view of Kaplan are silent regarding wherein the mechanical decoupler is positioned at and extends from a distal end of the elongated shaft.
However, in the same field of endeavor, Avitall (Figs. 1 and 5) teaches a similar mechanical decoupler (guidewire 26) that is positioned at and extends from a distal end of an elongated shaft (deflectable transdermal sheath 28; [0048], “The guidewire may be attached to or drawn through the distal end of a deflectable transdermal sheath, a fragment of which is shown at 28”). This configuration both stabilizes the therapeutic assembly (154) and provides that the therapeutic assembly (154) is held securely in place against the wall of the targeted tissue ([0056]-[0057]), thereby increasing control and accuracy of treatment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the mechanical decoupler as taught by Gnanashanmugam in view of Kaplan to include wherein the mechanical decoupler is positioned at and extends from a distal end of the elongated shaft, as taught by Avitall, in order to stabilize and securely position the therapeutic assembly as desired, thereby increasing control and accuracy of treatment. Further, this attachment configuration would have merely comprised a simple substitution of one well known attachment configuration for another (i.e., guidewire may be attached to or drawn through the distal end of a deflectable transdermal sheath), MPEP 2143(B)(I).
Regarding claim 9, Gnanashanmugam (Fig. 19) discloses wherein the support structure (210) defines a central lumen configured to receive a control member therethrough ([0191]; [0192], “With the guidewire G and the guide catheter GC positioned in the right pulmonary artery RPA, a catheter 302 of an apparatus 300 may be advanced over the guidewire G and through the guide catheter GC into position within the artery.” As broadly claimed, support structure 210 would necessarily define a central lumen such that support structure 210 may be advanced over guidewire G and through the guide catheter GC into position within the artery. Also see [0198]), and wherein one of the support structure (210) or the control member comprises a pre-formed helical or spiral shape (see helical distal section 211b of catheter 210 in Fig. 19) and the other of the support structure or the control member (guidewire G in Figs. 25A-B) comprises a substantially straight shape (guidewire G comprises a substantially straight shape).
Regarding claim 10-13, Gnanashanmugam in view of Kaplan and Avitall teach all of the limitations of the method according to claim 8. Gnanashanmugam further discloses a method wherein the pulmonary vessel comprises a main pulmonary artery of the patient ([0078], [0081], and [0164]): the steps include positioning the therapeutic assembly at a treatment site ([0078], [0081] and [0164]), and the wall includes a wall of the pulmonary vessel such that activating the plurality of energy delivery elements in order to modulate the nerves proximate the wall of the pulmonary vessel ([0078], and [0164]), and repeating at different treatment sites wherein the treatment sites comprise a variety of different locations including the pulmonary trunk, the left pulmonary artery, and the right pulmonary artery ([0078], [0081] and [0164]), and wherein the order of treatment of the different sites can be rearranged ([0191]; Figs. 25A-25H).
Regarding claim 14, Gnanashanmugam (Figs. 19 and 25) discloses wherein positioning the therapeutic assembly (210) further includes: positioning a first shaft (guide catheter GC) within the vessel ([0192]); positioning a second shaft (catheter 302) within the vessel distal to the first shaft ([0192]), wherein the second shaft is slidably positioned within the first shaft, and wherein the therapeutic assembly is carried by a distal portion of the second shaft (Figs. 25A-25B).
Regarding claim 18, Gnanashanmugam in view of Kaplan and Avitall teach all of the limitations of the method according to claim 8, but are silent regarding further comprising releasing a connection between the therapeutic element and the elongated shaft using a locking mechanism operably connected to the isolating member.
However, in the same field of endeavor, Kaplan (Fig. 7) teaches a similar catheter comprising an isolating member (tether 230) having a first portion connected to a therapeutic assembly (122) and a second portion connected to an elongated shaft (130), wherein the tether allows the therapeutic assembly (122) to move independently of the shaft (130) (col. 12, ll. 45-55). Kaplan further teaches the use of locking members to “hold the devices together once an operator has fixed an appropriate spatial relationship between the entities” (col. 5, ll. 37-40). Further, a lock may be implemented to limit the position of the treatment catheter and avoid the need for repeated user manipulation or stabilizing the position of devices (col. 5, ll. 40-47). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method as taught by Gnanashanmugam in view of Kaplan and Avitall to include releasing a connection between the therapeutic element and the elongated shaft using a locking mechanism operably connected to the isolating member, as taught by Kaplan, in order to hold the devices together once an operator has fixed an appropriate spatial relationship between the entities and further release said position once complete, thereby improving ease of use and overall control and accuracy.
Regarding claim 20, Gnanashanmugam in view of Kaplan and Avitall teach all of the limitations of the catheter according to claim 1, but are silent regarding further comprising a locking mechanism operably connected to the isolating member, wherein the locking mechanism is configured to enable a user to release a connection between the therapeutic element and the elongated shaft.
However, in the same field of endeavor, Kaplan (Fig. 7) teaches a similar catheter comprising an isolating member (tether 230) having a first portion connected to a therapeutic assembly (122) and a second portion connected to an elongated shaft (130), wherein the tether allows the therapeutic assembly (122) to move independently of the shaft (130) (col. 12, ll. 45-55). Kaplan further teaches the use of locking members to “hold the devices together once an operator has fixed an appropriate spatial relationship between the entities” (col. 5, ll. 37-40). Further, a lock may be implemented to limit the position of the treatment catheter and avoid the need for repeated user manipulation or stabilizing the position of devices (col. 5, ll. 40-47). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the catheter apparatus as taught by Gnanashanmugam in view of Kaplan and Avitall to include a locking mechanism operably connected to the isolating member, wherein the locking mechanism is configured to enable a user to release a connection between the therapeutic element and the elongated shaft, as taught by Kaplan, in order to hold the devices together once an operator has fixed an appropriate spatial relationship between the entities, thereby minimizing the need for revision and improving control and accuracy.
Regarding claim 21, Gnanashanmugam in view of Avitall and Kaplan teach all of the limitations of the catheter apparatus according to claim 1. In view of the prior modification of Gnanashanmugam in view of Kaplan in view of Avitall, Avitall teaches wherein the mechanical decoupler is located entirely between a proximal end of the elongated shaft and the therapeutic assembly (Fig. 1; [0048]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6 and 8-21 have been considered but are moot because the amendment has necessitated a new ground of rejection.
Applicant’s argument that Gnanashanmugam fails to teach all of the limitations of amended claim 1 is acknowledged. However, it is the Examiner’s position that Kaplan in view of Avitall cure any perceived deficiencies.
Applicant has argued (pp.4-5), “Gnanashanmugam, however, fails to disclose or suggest that the sheath 150 and the catheter 210 are connected via the proximal section 211 of the catheter 210. . . . Indeed, a person of ordinary skill in the art would understand that the catheter 210 merely passes through the sheath 150 and is not mechanically connected to the sheath 150. For example, Gnanashanmugam describes that the "[c]atheter 210 may be delivered to pulmonary artery PA in a low profile delivery configuration within sheath 150. Once positioned within the artery, the catheter may self-expand or may be expanded actively . . .into contact with an interior wall of the artery."4 Gnanashanmugam further describes that "expandable helical electrodes may comprise shape-memory properties that facilitate self-expansion, e.g., after passage through sheath 150.” As broadly claimed, it is the Examiner’s position that all of the components of Gnanashanmugam are “connected.” As can be seen in Figure 19, all of the components extend through one another, and are associated and related in some respect, thereby meeting the limitations of the claim.
Applicant further asserts “Gnanashanmugam also fails to disclose or suggest that the proximal section 211 a of the catheter 210 ‘comprises an isolating element configured to mechanically isolate the therapeutic assembly from the elongated shaft,’ as recited in claim 1.” This assertion is not found persuasive. As broadly claimed, Figure 19 illustrates wherein the mechanical decoupler (211a) comprises an isolating element configured to mechanically isolate the therapeutic assembly from the elongated shaft (see length of proximal portion 211a).
Lastly, Applicant states “Gnanashanmugam fails to disclose or suggest that the proximal section 211 a of the catheter 210 is a "mechanical decoupler [] positioned at and extend[ing] from a distal end of the elongated shaft," as recited in amended claim 1. As illustrated in FIG. 19 of Gnanashanmugam, the proximal section 211 a of the catheter 210 is positioned proximal to the sheath 150 and the catheter 210 extends through the sheath 150. Thus, a person of ordinary skill in the art would not have understood the proximal section 211 a of the catheter 210 to have been "positioned at and extending from a distal end of the" sheath 150.” Applicant is directed to the new rejection set forth above which address this amendment.
No further arguments have been set forth regarding the independent claims.
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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/C.A.D./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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