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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-10) in the reply filed on 06/30/2026 is acknowledged.
Claims 11-22 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II (claims 11-18) and Group III (claims 19-22), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/30/2026.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the cross-sectional shape" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 5 is rejected due to its dependency from claim 4.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Christian et al. (US 11229398 B2, "Christian").
Regarding claim 1, Christian teaches a medical device system (Fig. 30A; electrode system 3000) comprising: an implantable medical lead (Fig. 30A; 3000) comprising a lead body (Fig. 30A; 3002) defining a proximal end (Fig. 30A; the end moving away from the undulating, sinusoidal framework 3002) and a distal portion (Fig. 30A; the portion of 3002 with the undulating, sinusoidal shape), wherein at least a part of the distal portion of the lead body defines an undulating configuration (Fig. 30A: "The framework 3002 may comprise, for example, two shape memory (e.g., nitinol) wires forming a zig-zag or undulating or sinusoidal pattern or serpentine to create a wave frame or accordion shape"); and an introducer tool (Fig. 30A; 3006, 3010, 3012) defining a lumen (Fig. 30A; catheter 3006) configured to receive the distal portion (Fig. 30A; distal segment 3012), wherein the introducer tool (Fig. 30A; 3006, 3010, 3012) is configured to limit rotation of the distal portion within the lumen (para. (545): " The oval shape of the distal segment 3012 can be useful, for example, to resist torque and rotation.").
Regarding claim 2, Christian teaches the medical device system of claim 1 (see above), wherein the lumen (Fig. 30A; catheter 3006) has a cross- sectional shape that is at least one of rectangular, square, or elliptical (fig. 30A; see annotated figure 30A below; para. (545): "The catheter 3006 comprises a proximal segment 3010 having a generally circular cross-section and a distal segment 3012 having a generally oval cross-section.").
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Regarding claim 3, Christian teaches the medical device system of claim 2 (see above), wherein the lumen (catheter 3006) has a circular cross-sectional shape at the proximal end of the introducer tool and the at least one of rectangular, square, or elliptical cross-sectional shape at the distal portion of the introducer tool. (para. (545): "The catheter 3006 comprises a proximal segment 3010 having a generally circular cross-section and a distal segment 3012 having a generally oval cross-section.").
Regarding claim 4, Christian teaches the medical device system of claim 1 (see above), wherein the cross-sectional shape of the lumen is configured to limit rotation of the distal portion within the lumen. (para. (545): "The oval shape of the distal segment 3012 can be useful, for example, to resist torque and rotation.").
Claims 1, 4, and 10 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by McFall et al. (US 11096757 B2, "McFall").
Regarding claim 1, McFall teaches a medical device system (Fig. 2A-B) comprising: an implantable medical lead (Fig. 2A-B; Abstract: "an implantable medical lead") comprising a lead body defining a proximal end and a distal portion (para. (38): " Lead 120 may include distal portion 102 and proximal portion 104. Distal portion 102 of lead 120 may include one or more electrodes 132A-132D (collectively “electrodes”)."; Fig. 1, lead 20; Fig. 2, lead 120), wherein at least a part of the distal portion of the lead body defines an undulating configuration (Fig. 2A-B; para. (32): "Other examples of extra-cardiovascular leads including one or more defibrillation electrodes and one or more pacing and sensing electrodes 34 carried by curving, serpentine, undulating or zig-zagging distal portion of the lead body 18 that may be implemented with the techniques described herein."; para. (38): " Lead 120 may be substantially similar to lead 20 with the exception of any differences described herein."); and an introducer tool defining a lumen (introducer sheath; para. (33): "As discussed above, indicator 14 of lead 20 and a respective introducer sheath used to navigate lead 20 to the target site may be used to verify a proper orientation of lead 20 immediately prior to deployment at the substernal target site, therein improving an efficacy of system 10 that employs lead 20."; Fig. 10A; introducer sheath 650; para. (71): "Introducer sheath 650 may define lumen 656 configured to receive lead 120. Lumen 656 may extend between entry port 664 and exit port 668.) configured to receive the distal portion (Summary of invention, para. (3): "The distal portion of the implantable medical lead is configured to be inserted into the entry port of the introducer sheath and moved towards the distal portion of the introducer sheath."), wherein the introducer tool is configured to limit rotation of the distal portion within the lumen (McFall discloses the structure of claim 1. Further, McFall discloses unconstrained and constrained states based on deployment of the sheath from the introducer sheath (para. (66): “However, lead 620 may be straightened when inserted through an introducer sheath. FIG. 8C is a conceptual and schematic diagram depicting constrained state 601 in which lead 620 is straightened as lead 620 is inserted within an introducer sheath.”). Absent evidence of the contrary, the introducer sheath of McFall is configured to limit rotation of the distal portion within the lumen).
Regarding claim 4, McFall teaches the medical device system of claim 1 (see rejection above), wherein the cross-sectional shape of the lumen is configured to limit rotation of the distal portion within the lumen (para. (77) discloses the introducer sheath and lumen's ability to orient the lead to the target cite, and an alignment window between the introducer sheath and the lead: "In some examples, an introducer sheath may include a window through which an indicator of a lead may be aligned to verify that a distal portion of a lead is properly oriented at/adjacent a target site… Introducer sheath 750 may be substantially similar to introducer sheath 650 with the exception of any differences described herein… Introducer sheath 750 may be configured such that, when introducer sheath 750 is inserted to the predetermined depth within an adult patient and lead 120 is inserted into introducer sheath 750 and patient 8 such that indicator 114 is aligned with alignment window 752, distal portion 102 of lead 120 may be properly longitudinally and radially orientated at the target site for, e.g., 95% of patients. Including alignment window 752 within introducer sheath 750 may improve an ability of a clinician to longitudinally and radially orient distal portion 102 of lead 120 at target site 670 within patient 8."); Since the structure of the sheath and lumen are disclosed, absent evidence of the contrary, the cross-sectional shape of the lumen (sheath) of McFall would be able to limit rotation of the lead within the lumen).
Regarding claim 10, McFall teaches the medical device system of claim 1 (see rejection above), wherein an implantable medical lead further comprises: a first defibrillation electrode (defibrillation electrode 132A) and a second defibrillation electrode (defibrillation electrode 132B) disposed along the undulating configuration (Fig. 2A; lead 120 with curved section 110A), the first and second defibrillation electrodes configured to deliver anti-tachyarrhythmia shocks (defibrillation implies shocks; para. (22): "In some examples, two leads are used. IMD 12 may be configured to deliver high-energy cardioversion or defibrillation pulses to a patient's heart 18 when a ventricular tachyarrhythmias, e.g., ventricular tachycardia (VT) or ventricular fibrillation (VF), is detected. Cardioversion shocks are typically delivered in synchrony with a detected R-wave when fibrillation detection criteria are met. Defibrillation shocks are typically delivered when fibrillation criteria are met, and the R-wave cannot be discerned from signals sensed by IMD 12."); and a pace electrode configured to deliver a pacing pulse that generates an electric field proximate to the pace electrode (para. (31): " Lead 20 may also include one or more pace/sense electrodes 34A, 34B (individually or collectively, “pace/sense electrode(s) 34”) located on the distal portion of lead 20. Electrodes 34 are referred to herein as pace/sense electrodes because they are generally configured for use in delivery of pacing pulses and/or sensing of cardiac electrical signals.; para. (39): "Electrodes 132 may be similar to defibrillation electrodes 32 and/or pace/sense electrodes 34. For example, electrodes 132A, 132B may be substantially similar to defibrillation electrodes 32, and electrodes 132C, 132D may be substantially similar to pace/sense electrodes 34."; The electrodes 132A-D can be configured to be either defibrillation electrodes or sensing/pacing electrodes.).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over McFall et al. (US 11096757 B2, "McFall"). in view of Christian et al. (US 11229398 B2, "Christian").
Regarding claim 5, McFall teaches wherein the introducer tool is configured to straighten the undulating (Fig. 2A-2C; para. (48); curved section 110") configuration of the distal portion upon insertion of the distal portion within the lumen (Fig. 2A-2C; para. (48):" Lead 120 may be configured to be straightened when received by an introducer sheath. FIG. 2C is a conceptual and schematic diagram depicting constrained state 101 in which lead 120 is straightened as lead 120 is inserted within an introducer sheath. As depicted, curved sections 110 may be relatively straight when in constrained state 101. An amount of deformation that takes place when transitioning between constrained 101 and unconstrained states 100 may be predetermined, such that an eventual shape that will be defined by lead 120 in unconstrained state 100 may be accurately predicted based on the relative longitudinal and radial orientation of lead 120 in constrained state 101 immediately prior to deployment."; the sheath is considered to be the lumen), wherein the cross-sectional shape of the lumen is configured to allow the distal portion to at least partially expand to undulate in a particular rotational direction within the lumen thereby limiting rotational movement of the distal portion (para. (48); the transition between constrained and unconstrained states and the amount of deformation is defined by the lead. The introducer sheath is what straightens the lead, and the shape of the sheath is what constrains the lead. Absent evidence of the contrary, the cross-sectional shape of the lumen (sheath) of McFall is configured to able to allow expansion of the undulating portion in a particular direction by limiting rotation). However, McFall does not expressly disclose wherein a first width of the lumen is smaller than a second width of the distal portion of the lead body.
Christian, in the same field of endeavor of implantable leads, discloses an undulating lead framework for implantation in the heart. Christian discloses the medical device system of claim 4 (see 102 rejection above). Christian further discloses wherein a first width of the lumen is smaller than a second width of the distal portion of the lead body (Fig. 30A; See annotated figure below where the width between arrows labeled 1 and 2 (distal portion) is wider than the width between the proximal portion of the lumen with arrows labeled 3 and 4.).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of McFall to include a first width of the lumen that is smaller than a distal portion of the lead body, as disclosed by Christian. One of ordinary skill would recognize that the lead and lumen configuration of Christian are useful in deploying electrodes through vasculature. One would further recognize that the catheter and lead system of Christian would improve deployment in that it would the structure would better conform to vasculature and limit rotation of the electrodes. For these benefits, it would have been obvious to implement the lead and lumen configuration of Christian in the undulating lead system of McFall.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Christian et al. (US 11229398 B2, "Christian") in view of Harris et al. (US 20050049663 A1, "Harris").
Regarding claims 6 and 7, Christian teaches the medical device system of claim 1 (see 102 rejection above), further comprising a dilator tool (dilator 4834). However, Christian does not expressly teach where a dilator tool is configured to be received within the lumen, or wherein a dilator tool is configured to change the cross-sectional shape of the lumen upon insertion of the dilator tool within the lumen.
Harris, concerned with the common problem of introducing a stimulation lead through lumen, discloses a sheath and dilator. Harris discloses a dilator tool (dilator 18) configured to be received within a lumen (sheath 20; para. [0030]: " In practice, sheath 20 fits over dilator 18 to form the stimulation lead introducer.") and configured to aid in inserting the introducer tool (para. [0030]: “lead introducer”) into a patient (the dilator aids the introducer in introducing the stimulation lead into the patient by widening the path.)(claim 6). Harris further discloses wherein the introducer tool comprises a flexible material (para. [0030]: " Like dilator 18, sheath 20 may be made of extruded or molded material. The material may include a substantially deformable material, such as polyethylene. The deformable properties of the material allow sheath 20 to be formed to fit the anatomy of a patient more accurately."; Furthermore, the material must be flexible so that it fits the patient anatomy.), wherein the dilator tool is configured to change the cross-sectional shape of the lumen upon insertion of the dilator tool within the lumen (abstract: "The dilator fits within the sheath and serves to widen a path through the epidural region for the introduction of a stimulation lead."; para. [0053]: "…to widen a path surrounding guidewire 16 so a stimulation lead can fit through the path. Sheath 20 serves to maintain the path, which may be oblong, that dilator 18 widens.")(claim 7).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Christian to include the introducer tool of Harris. One of ordinary skill in the art would recognize that the dilator of Harris would be useful in enlarging the catheter of Christian. This would have been an obvious improvement since the dilator, with its deformable properties, would improve conformity to patient anatomy, which would make it easier to introduce a lead into a patient. Therefore, incorporating a dilator modification into the catheter of Christian would have been an obvious improvement to the device of Christian.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Christian et al. (US 11229398 B2, "Christian"), Harris et al. (US 20050049663 A1, "Harris"), and Lurie et al. (US 6277107 B1, "Lurie").
Regarding claim 8, Christian, in combination with Harris, discloses the medical device of claim 7 (see 103 rejection above). However, neither Christian nor Harris expressly discloses wherein the introducer tool is configured to resume its shape after the introducer tool is inserted within the patient and the dilator tool is removed from the lumen.
Lurie, in the same field of endeavor of introducing electrical leads, discloses a dilator and introducer. Lurie discloses wherein an introducer tool (Detailed description, para. (21): “guiding introducer”) is configured to resume its shape after the introducer tool is inserted within the patient and the dilator tool is removed from the lumen. (Detailed description, para. (21): " When the dilator is removed from the lumen of the coronary sinus guiding introducer, the coronary sinus guiding introducer returns to its predetermined shape.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Christian to include the introducer tool that resumes its shape after removal of the dilator, as disclosed by Lurie. One of ordinary skill in the art would recognize that an introducer that changes shape and reforms before and after removal of a dilator would have been advantageous to include in the system of Christian since the guiding introducer permits precise placement and precision for introduction of medical devices. Therefore, it would have been an obvious improvement to modify the device of Christian to include the introducer of Lurie.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Christian et al. (US 11229398 B2, "Christian") in view of Boggs et al. (US 20170340891 A1, “Boggs”).
Regarding claim 9, Christian teaches the medical device system of claim 1 (see 102 rejection above). However, Christian does not expressly teach wherein the introducer tool comprises a radiopaque marker configured to indicate a rotational orientation of the introducer tool within a patient (the radiopaque marker of Christian is disclosed in a separate embodiment in Fig. 28D, and is not taught as being a part of the introducer tool).
Boggs, in the same field of endeavor of devices for introducing electrodes, discloses an introducing device. Boggs discloses wherein an introducer tool comprises a radiopaque marker configured to indicate a rotational orientation of the introducer tool within a patient (para. [0222]: “Modifications to the existing introducer system and/or lead through the addition of radiopaque markers can simplify the lead placement procedure, reduce risk for the patient, and improve reliability of lead placement, allowing visualization of lead placement and avoiding improper or premature deployment of the self-anchoring lead.).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Christian to include the radiopaque marker on an introducer, as disclosed by Boggs. One of ordinary skill in the art would recognize that a radiopaque marker can simplify lead placement and improves reliability while reducing patient risk. Therefore, since Boggs discloses modifying an introducer tool to include a radiopaque marker, it would have been obvious to do the same and include a marker to improve the device of Christian.
Conclusion
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/O.L.M./Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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