DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to claims 1-6 and 10-23 have been considered but the arguments do not apply to the combination of the references being used in the new grounds of rejection set forth above. The applicant asserts that the prior art rejections do not teach or suggest the features as now amended into the amended claims; therefore, the examiner has applied a new combination of prior art to reject the claims and address the arguments necessitated by such amendment.
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.
Claim(s) 1-6, 10-17, 19-20 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Reddy (US 2009/0259272 A1) in view of Williams (US 5,246,014 A) and Schmidt (US 2020/0338345 A1)
Regarding claim 1, Reddy discloses a lead distal tip for a pacemaker lead (e.g. Fig 2a/b; Fig 6; [0021]-[0024]), comprising a lead distal tip body having a first end and a second end, opposite the first end (e.g. [0021]-[0022]; [0044]; Fig 2/3:34); a linear member disposed at the first end (e.g. [0036]; Fig 6:304 it is detailed that the end of Fig 2 can be the embodiment shown as Fig 6); a helical member surrounding the linear member (e.g. [0036]; Fig 6:302 it is detailed that the end of Fig 2 can be the embodiment shown as Fig 6); a ring electrode disposed on the lead distal tip body (e.g. [0022]; [0029]-[0031]; Fig 2/3:40); and a lead body extending from the second end (e.g. [0021]-[0022]; [0044]; Fig 2/3:24), the outer diameter of the lead body is less than an outer diameter of the lead distal tip body (e.g. Fig 3 the lead body 24 has an outer diameter less than the outer diameter of the lead distal tip body 40).
Reddy is silent regarding wherein the lead body has an outer diameter of 2 French or less and the lead body is positioned at a side of the lead distal tip body in a side view of the lead distal tip.
However, Williams discloses an implantable lead system for cardiac tissue wherein the lead body has an outer diameter of 2 French or less (e.g. col 4 lines 25-34 and col 11 lines 34-39).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Reddy to incorporate the teachings of Williams wherein the lead body has an outer diameter of 2 French or less for the purpose of utilizing a desirable design of a smaller size lead (e.g. Williams col 4 lines 25-34).
Furthermore, Schmidt discloses electrodes for electrical stimulation to treat tissue wherein the lead body is positioned at a side of the lead distal tip body in a side view of the lead distal tip (e.g. Figs 19 and 20:106 [0064]; [0104]-[0106]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify they system of Reddy to incorporate the teachings of Schmidt to substitute the current position of the lead body to have the lead body is positioned at a side of the lead distal tip body in a side view of the lead distal tip for the purpose of utilizing another known configuration of a lead that includes one or more electrodes to be positioned near the desired tissue (e.g. Schmidt [0064]; [0072]).
Regarding claim 2, modified Reddy discloses wherein the lead distal tip body includes an engagement feature configured to engage with a delivery tool, the lead body is positioned to not interfere with the engagement feature of the lead distal tip body (e.g. Reddy [0030] Fig 3:54 Schmidt Figs 19 and 20:106 [0064]; [0104]-[0106]).
Regarding claim 3, modified Reddy discloses wherein the engagement feature includes a socket formed at the second end of the lead distal tip body (e.g. Reddy [0030] Fig 3:56).
Regarding claim 4, modified Reddy discloses wherein the socket is configured to receive a stylet of the delivery tool (e.g. Reddy [0030] Fig 3:46 ).
Regarding claims 5 and 6, modified Reddy is silent regarding wherein the engagement feature includes a plurality of depressions/projections on an outer surface of the lead distal tip body.
However, the instant specification details in [0032] “The engagement feature can be any suitable engagement feature selected based on the ability to engage the corresponding engagement feature… The engagement feature 306 can alternatively be, for example, projections, notches, recesses, a combination of projections…” Therefore, this appears to merely be a design choice to make a change in shape in order for the engagement and one of ordinary skill in the art would utilize the desired engagement feature such as a plurality of depressions/projections in order to safely engage the catheter and the lead. See MPEP 2144.04 In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 10, Reddy discloses a pacemaker lead and delivery system (e.g. Fig 1:10 [0020]-[0021]), comprising: a lead distal tip including (e.g. Fig 2a/b; Fig 6; [0021]-[0024]): a lead distal tip body having a first end and a second end, opposite the first end (e.g. [0021]-[0022]; [0044]; Fig 2/3:34); a linear member disposed at the first end (e.g. [0036]; Fig 6:304 it is detailed that the end of Fig 2 can be the embodiment shown as Fig 6); a helical member surrounding the linear member (e.g. [0036]; Fig 6:302 it is detailed that the end of Fig 2 can be the embodiment shown as Fig 6); a ring electrode disposed on the lead distal tip body (e.g. [0022]; [0029]-[0031]; Fig 2/3:40); and a lead body extending from the second end (e.g. [0021]-[0022]; [0044]; Fig 2/3:24); a tip engagement feature on the lead distal tip body (e.g.[0043]-[0044]); and a lead delivery catheter including (e.g. [0037] Fig 7:72): a rigid body segment (e.g. [0037] Fig 7:72); and a delivery catheter engagement feature configured to engage the tip engagement feature (e.g. [0043]-[0044] Fig 7:74).
Reddy is silent regarding wherein the lead body has an outer diameter of 2 French or less and the lead body is positioned at a side of the lead distal tip body in a side view of the lead distal tip.
However, Williams discloses an implantable lead system for cardiac tissue wherein the lead body has an outer diameter of 2 French or less (e.g. col 4 lines 25-34 and col 11 lines 34-39).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Reddy to incorporate the teachings of Williams wherein the lead body has an outer diameter of 2 French or less for the purpose of utilizing a desirable design of a smaller size lead (e.g. Williams col 4 lines 25-34).
Furthermore, Schmidt discloses electrodes for electrical stimulation to treat tissue wherein the lead body is positioned at a side of the lead distal tip body in a side view of the lead distal tip (e.g. Figs 19 and 20:106 [0064]; [0104]-[0106]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify they system of Reddy to incorporate the teachings of Schmidt to substitute the current position of the lead body to have the lead body is positioned at a side of the lead distal tip body in a side view of the lead distal tip for the purpose of utilizing another known configuration of a lead that includes one or more electrodes to be positioned near the desired tissue (e.g. Schmidt [0064]; [0072]).
Regarding claim 11, modified Reddy discloses wherein the tip engagement feature includes a socket (e.g. Reddy [0030] Fig 3:56) and the delivery catheter engagement feature includes a stylet (e.g. Reddy [0030] Fig 3:46).
Regarding claim 12, modified Reddy discloses wherein at least one of the linear member and the helical member are extendable and retractable (e.g. [0026]; [0036]), and wherein the stylet is configured to extend or retract said at least one of the linear member and the helical member (e.g. [0026]; [0036]; [0044]).
Regarding claims 13 and 14, modified Reddy is silent regarding wherein the delivery catheter engagement feature includes recesses/projections in an inner surface of a distal end of the lead delivery catheter, and the tip engagement feature includes projections/recesses on an outer surface of the lead distal tip body.
However, the instant specification details in [0032] “The engagement feature can be any suitable engagement feature selected based on the ability to engage the corresponding engagement feature… The engagement feature 306 can alternatively be, for example, projections, notches, recesses, a combination of projections…” Therefore, this appears to merely be a design choice to make a change in shape in order for the engagement and one of ordinary skill in the art would utilize the desired engagement feature such as a plurality of depressions/projections in order to safely engage the catheter and the lead. See MPEP 2144.04 In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 15, modified Reddy discloses wherein a distal end of the delivery catheter is configured to be deflected such that the delivery catheter engagement feature interfaces with the tip engagement feature (e.g. Reddy [0042]-[0043]).
Regarding claim 16, modified Reddy discloses further comprising grasping lines extending from the distal end of the delivery catheter, the grasping lines configured to deflect the distal end of the delivery catheter when tension is applied to the grasping lines (e.g. Reddy [0037]; [0042]-[0043]).
Regarding claim 17, Reddy discloses a method of implanting a pacemaker lead in a subject (e.g. [0037] claim 25), comprising: engaging tip engagement features of a lead distal tip with delivery catheter engagement features of a delivery catheter (e.g. [0003]; [0037]; [0040]-[0041]); directing the lead distal tip to a target location while the tip engagement features and the delivery catheter engagement features are engaged (e.g. [0040]-[0041]); attaching the lead distal tip to heart tissue of the subject at the target location (e.g. [0041]); and disengaging the tip engagement features from the delivery catheter engagement features after the lead distal tip is attached to the heart tissue (e.g. [0041]), wherein the lead distal tip further includes: a lead distal tip body having a first end and a second end, opposite the first end (e.g. [0021]-[0022]; [0044]; Fig 2/3:34); a linear member disposed at the first end (e.g. [0036]; Fig 6:304 it is detailed that the end of Fig 2 can be the embodiment shown as Fig 6); a helical member surrounding the linear member (e.g. [0036]; Fig 6:302 it is detailed that the end of Fig 2 can be the embodiment shown as Fig 6); a ring electrode disposed on the lead distal tip body (e.g. [0022]; [0029]-[0031]; Fig 2/3:40); and a lead body extending from the second end (e.g. [0021]-[0022]; [0044]; Fig 2/3:24 ).
Reddy is silent regarding wherein the lead body has an outer diameter of 2 French or less and the lead body is positioned at a side of the lead distal tip body in a side view of the lead distal tip.
However, Williams discloses an implantable lead system for cardiac tissue wherein the lead body has an outer diameter of 2 French or less (e.g. col 4 lines 25-34 and col 11 lines 34-39).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Reddy to incorporate the teachings of Williams wherein the lead body has an outer diameter of 2 French or less for the purpose of utilizing a desirable design of a smaller size lead (e.g. Williams col 4 lines 25-34).
Furthermore, Schmidt discloses electrodes for electrical stimulation to treat tissue wherein the lead body is positioned at a side of the lead distal tip body in a side view of the lead distal tip (e.g. Figs 19 and 20:106 [0064]; [0104]-[0106]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify they system of Reddy to incorporate the teachings of Schmidt to substitute the current position of the lead body to have the lead body is positioned at a side of the lead distal tip body in a side view of the lead distal tip for the purpose of utilizing another known configuration of a lead that includes one or more electrodes to be positioned near the desired tissue (e.g. Schmidt [0064]; [0072]).
Regarding claim 19, modified Reddy discloses wherein attaching the lead distal tip to the heart tissue of the subject includes extending one or more of the linear member and the helical member into the heart tissue (e.g. Reddy [0023]; [0026]).
Regarding claim 20, Reddy discloses a lead distal tip for a pacemaker lead (e.g. Fig 2a/b; Fig 6; [0021]-[0024]), comprising a lead distal tip body having a first end and a second end, opposite the first end (e.g. [0021]-[0022]; [0044]; Fig 2/3:34); a core disposed at the first end (e.g. [0036]; Fig 6:304 it is detailed that the end of Fig 2 can be the embodiment shown as Fig 6); a helical member surrounding the core (e.g. [0036]; Fig 6:302 it is detailed that the end of Fig 2 can be the embodiment shown as Fig 6); and a lead body extending from the second end (e.g. [0021]-[0022]; [0044]; Fig 2/3:24 ),
Reddy is silent regarding wherein the lead body has an outer diameter of 2 French or less and the lead body is positioned at a side of the lead distal tip body in a side view of the lead distal tip.
However, Williams discloses an implantable lead system for cardiac tissue wherein the lead body has an outer diameter of 2 French or less (e.g. col 4 lines 25-34 and col 11 lines 34-39).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Reddy to incorporate the teachings of Williams wherein the lead body has an outer diameter of 2 French or less for the purpose of utilizing a desirable design of a smaller size lead (e.g. Williams col 4 lines 25-34).
Furthermore, Schmidt discloses electrodes for electrical stimulation to treat tissue wherein the lead body is positioned at a side of the lead distal tip body in a side view of the lead distal tip (e.g. Figs 19 and 20:106 [0064]; [0104]-[0106]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify they system of Reddy to incorporate the teachings of Schmidt to substitute the current position of the lead body to have the lead body is positioned at a side of the lead distal tip body in a side view of the lead distal tip for the purpose of utilizing another known configuration of a lead that includes one or more electrodes to be positioned near the desired tissue (e.g. Schmidt [0064]; [0072]).
Regarding claim 22, modified Reddy discloses wherein the engagement feature is spaced away from the lead body in the side view (e.g. Reddy [0030] Fig 3:54 Schmidt Figs 19 and 20:106 [0064]; [0104]-[0106]).
Regarding claim 23, modified Reddy discloses wherein the engagement feature is positioned at the side of the lead distal tip body in the side view (e.g. Reddy [0030] Fig 3:54 Schmidt Figs 19 and 20:106 [0064]; [0104]-[0106]).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Reddy in view of Williams and Schmidt as applied to claim 17 above, and further in view of Smits (US 2003/0199938 A1)
Regarding claim 18, modified Reddy is silent regarding wherein the target location is interventricular septum (IVS) or interatrial septum (IAS) of the subject.
However, Smits discloses precise cardiac lead placement wherein the target location is interventricular septum (IVS) or interatrial septum (IAS) of the subject (e.g. abstract [0004]; [0007]-[0011]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified method of Reddy to incorporate the teachings of Smits wherein the target location is interventricular septum (IVS) or interatrial septum (IAS) of the subject for the purpose of utilizing a known target for cardiac pacing.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Reddy in view of Williams and Schmidt as applied to claim 1 above, and further in view of Michels (US 2004/0215307 A1)
Regarding claim 21, modified Reddy is silent regarding wherein the lead distal tip body has a length ranging from approximately 5 millimeters to approximately 16 millimeters.
However, Michels discloses medical lead designs for lead placement through tissue wherein the lead distal tip body has a length ranging from approximately 5 millimeters to approximately 16 millimeters (e.g. [0007]-[0009]; [0031] Fig 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified system of Reddy to incorporate the teachings of Michels wherein the lead distal tip body has a length ranging from approximately 5 millimeters to approximately 16 millimeters for the purpose of utilizing a known length of the lead distal tip body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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Jessandra Hough March 1, 2026
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796