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 .
Formal Matters
Applicant’s response and amendments filed 19 December 2025 are acknowledged.
Independent claims 1, 9, and 15 are currently amended. Claims 1-20 are pending and under examination.
Response to Arguments
Applicant argues the claim objection as to the term “mil” and argues that the abbreviation is acceptable and declines to amend the claims for clarity. Accordingly, the objection is maintained for the reasons of record and the reasons set forth herein.
Regarding the rejection under 35 USC 112(b), Applicant argues that the phrase 1.5 mil or less has support in the originally filed disclosure and disagrees that the claim has more than one plausible construction under Ex Parte Miazaki because of a zero-bound. Applicant argues that as long as the physical dimensions are a tangible physical object, the requirement for claim construction is met. No amendments to resolve the rejection are made. Accordingly, the rejection is maintained for the reasons of record and the reasons set forth herein.
Regarding the rejection under 35 USC 103 over Schmidt et al., US 20180001082 (4 January 2018) in view of Eidenschink et al., US 20160096001 (7 April 2016), Applicant’s amendments to independent claims 1, 9, and 15 require additional search and consideration, for which relevant prior art has been found. Accordingly, a modified prior art rejection over all pending claims (1-20), Necessitated by Amendment, is set forth below.
Claim Objections/Rejections
Maintained and Modified – Necessitated by Amendment
Claim Objections
Claims 4, 12, and 18 remain objected to because of the following informalities: the abbreviation “mil” is used to indicate a unit of measure. The specification refers to “millimeter” which is commonly abbreviated as “mm”. The term “mil” is recited in the disclosure at ¶¶305-306. Using abbreviations in claims is acceptable, but conventionally, the full term is first used in order to promote clarity. It is recommended that Applicant recite the full term “millimeter” and then recite the abbreviation in a parenthetical for clarity. Applicant’s attention is directed to 37 CFR 1.17(a) and MPEP 608.01(m). A first recitation of the full, non-abbreviated term provides clarity. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b) - Indefiniteness
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, 12, and 18 remain 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, for the reasons of record and the reasons set forth herein.
Each of claims 4, 12, and 18 recite “wherein the expandable mesh has a wall thickness of 1.5 mil or less”. The range encompasses a lower end point of “or less” which broadly includes zero and all dimensions above zero to the upper boundary point of 1.5 millimeters. The phrase “1.5 mil or less” has support in the originally filed disclosure. However, while some non-zero lower limit may have been intended. It is not clear from the claims, as written, what the lower bound may be in order to have the expandable mesh as part of the apparatus. Technology advances to create smaller and smaller components. However, one also must be mindful not to attempt to reach through time and seek subject matter which is not yet available in the present. While the examiner recognizes the importance of giving Applicant the broadest reasonable consideration of the range, concerns regarding the metes and bounds of the range arise where the lower boundary is beyond the reach of the current state of the art or alternatively encompasses zero.
Moreover, independent claims 1, 9, and 15, upon which claims 4, 12, and 18 depend, require that the expandable mesh be sized to apply an inwardly compressive force on the implantable medical device and on the retrieval catheter. Thus, the claimed expandable mesh wall thickness needs to be functionally able to apply an inwardly compressive force on the implantable medical device and on the retrieval catheter within the recited metes and bounds of the physical size limits recited in claims 4, 12, and 18. Compare embodiments in the Specification at ¶¶305, 306 where the thickness varies based on the copolymers used (e.g. generic material that is highly flexible or “can be a Nitinol mesh”) and the number of layers (folded/double-wall construction, ¶306). Accordingly, both the structural (dimensional and compositional) requirements of the claims must be definite, along with the functional requirements.
Applicant is referred to Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (2008). A five member expanded panel of the Board held that "if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 USC 112, second paragraph, as indefinite."
Applicant is also referred to Nautilus Inc., v. Biosig Instruments, Inc., 572 U.S. 898, 908-909 (2014) in which the Court held that a claim is indefinite if the specification and prosecution history fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. The Court also held that a patent must be precise enough to afford clear notice of what is claimed thereby "appris[ing] the public of what is still open to them (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (1996)), in a manner that avoids "[a] zone of uncertainty which enterprise and experimentation may enter only at the risk of infringement claims," (citing United Carbon Co., v. Binney & Smith Co., 317 U.S. 228, 236 (1942)) (Nautilus 909). The lower boundary of the mesh wall thickness is unclear from the claims as recited.
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.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt et al., US 20180001082 (4 January 2018) (previously cited of record) in view of Eidenschink et al., US 20160096001 (7 April 2016) (previously cited of record), and further in view of Khairkhahan et al., US 20120095539 (19 April 2012).
Regarding currently amended independent claim 1, Schmidt teaches a biostimulator transport system (FIGs 1, ¶26, exemplary implantable leadless cardiac pacing device 10), comprising: a snare (FIG 2, snare 52) extending through a retrieval catheter (FIG 2, retrieval catheter 54) to capture an implantable medical device (FIG 2, implantable device 10; ¶31); and a flexible sheath (¶40, covering 60) wherein the flexible sheath (¶40, covering 60) includes an expandable mesh (¶40, mesh material, non-wovens, porous, foams, gels, sponges; ¶41 biostable polymeric material) sized to apply an inwardly compressive force on the implantable medical device (FIG 6B; ¶46 “the covering 60 may permit a loop of a snare 56 or other retrieval device, to engage the docking member 30 distal of the head portion 32 during a retrieval procedure and sufficiently tighten around the neck portion 34 such that the loop of the snare 56 will enter the recessed area 70 or hollow, and thus not slip off the docking member 30”).
Schmidt does not teach that the flexible sheath is extendable along the snare.
However, Schmidt teaches that the covering (flexible sheath) extends over at least portion of the neck portion 34 of the docking member 30 (¶40; FIGs 6A, 6B; see also ¶43).
Eidenschink teaches a delivery catheter for implanting a leadless biostimulator (Abstract). Eidenschink teaches a guide catheter sheath 211 extending distally to cause atraumatic pacemaker sheath 204 to cover catheter shaft 206, pacemaker 202, and helix 203 to protect patient tissue from the sharp edges of helix 203 during implantation (¶53). “Thus when catheter sheath 211 and its atraumatic distal end region 204 in the form of pacemaker sheath 204 are advanced distally to protect the pacemaker and helix as shown in FIGs 2C and 2D, the pacemaker 202 and helix 203 are in a protected, advanced configuration” (¶53). Eidenschink also teaches that the expandable mesh is sized to apply an inwardly compressive force on the implantable medical device (¶51).
Although Eidenschink does not teach extending the flexible sheath along the snare of a catheter retrieval device, the same principle taught by Eidenschink applies in reverse when the same type of leadless catheter device is removed, as taught by Schmidt, using a retrieval catheter. The extension of a snare would need to be protected from the snare catching on a less than optimal structure or surface, complicating the snaring process required for removal of the leadless device during retrieval.
The motivation for extending the flexible sheath over the snare is the same motivation as the extension of the flexible sheath over the helix during implantation, to protect patient tissues from contact by the retrieval device or sharp edges and insure snare placement around the optimal points of snaring of the implanted device, especially when tissue ingrowth may have occurred around parts of the implant during the tenure of implantation (see also, Schmidt ¶46).
Neither Schmidt nor Eidenschink expressly teach that the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the retrieval catheter. However, Eidenschink and Schmidt both teach that the expandable mesh is sized to apply an inwardly compressive force on the implantable medical device.
Khairkhahan teaches leadless biostimulators and delivery systems (Abstract) comprising sheath 216 that can be advanced over catheter shaft 217 to provide additional steering and support for the delivery catheter (FIGs 2A, 2D; ¶43).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Schmidt, Eidenschink, and Khairkhahan, given that they included each element claimed, although not necessarily in a single reference. Schmidt, Eidenschink, and Khairkhahan teach in the same field of art, leadless pacemaker devices. Although, Schmidt discloses the claimed base biostimulator transport system comprising a snare extending through a retrieval catheter to capture an implantable medical device and a flexible sheath wherein the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the implantable medical device, Schmidt does not teach that the flexible sheath is extendable along the snare or that the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the retrieval catheter. Eidenschink specifically addresses the problem of a guide catheter sheath extending distally to cause an atraumatic pacemaker sheath to cover a catheter shaft, pacemaker, and helix to protect patient tissue from the sharp edges of the helix during implantation (¶53). Eidenschink also expressly teaches that the expandable mesh is sized to apply an inwardly compressive force on the implantable medical device (¶51). Because Schmidt expressly includes a sheath comprising expandable mesh sized to apply an inwardly compressive force on the implantable medical device, one of ordinary skill in the art seeking to protect patient tissue from exposed structural components of the device during implantation and removal would look to Eidenschink’s extended sheath solution. Although Eidenschink does not expressly teach extending the flexible sheath along the snare of a catheter retrieval device, the same principle taught by Eidenschink applies in reverse when the same type of leadless catheter device is removed, as taught by Schmidt, using a retrieval catheter. The extension of a snare would need to be protected from the snare catching on a less than optimal structure or surface, complicating the snaring process required for removal of the leadless device during retrieval. A modified sheath can be incorporated alongside Schmidt’s base device using known assembly methods without redesigning Schmidt’s core delivery path.
Neither Schmidt nor Eidenschink expressly teach that the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the retrieval catheter. However, Eidenschink and Schmidt both teach that the expandable mesh is sized to apply an inwardly compressive force on the implantable medical device. Khairkhahan expressly addresses the problem by teaching that a sheath that can be advanced over the catheter shaft to provide additional steering and support for the delivery catheter (FIGs 2A, 2D; ¶43). Because the combination of Schmidt and Eidenschink provide for extending catheter sheath over the snare to protect the snare from injuring patient tissue or catching on a surface during removal, extending the sheath further to provide an inwardly compressive force on the delivery catheter to enhance steering and support for the delivery catheter during delivery and retrieval is motivated by Khairkhahan’s sheath extension solution. A person of ordinary skill in the art attempting to render Schmidt’s base biostimulator transport system more controllable, as well as safer in vivo, would look for established sheath designs to avoid creating a novel sheath system that may interfere with device delivery and catheter retrieval. Khairkhahan’s extendable catheter-covering sheath provide a sheath-based solution that can be adapted to the sheath of Schmidt modified by the snare-extended sheath covering of Eidenschink to enable better steering of the catheter device along that provides an inwardly compressive force on the implantable medical device and on the retrieval catheter.
One of ordinary skill in the art before the claimed invention could have readily envisioned substituting the fully encased delivery sheath taught by Eidenschink and the extendable steerable catheter sheath of Khairkhahan with the retrieval device of Schmidt in order to protect the snare and surrounding patient tissues during the retrieval process while also providing improved catheter steering and support for the delivery catheter during implantation and retrieval. Because the references address the same engineering problem (catheter sheath solutions for improved device performance) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a differently sized flexible sheath extendable along the snare and the catheter where the sheath is sized to apply an inwardly compressive force on the implantable medical device and on the retrieval catheter), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 2, Schmidt modified by Eidenschink and Khairkhahan teaches the biostimulator transport system of claim 1, as set forth above.
Eidenschink teaches wherein the expandable mesh includes a double-walled construction (¶¶12, 18).
Regarding claim 3, Schmidt modified by Eidenschink and Khairkhahan teaches the biostimulator transport system of claim 1, as set forth above.
Eidenschink teaches wherein a distal end of the expandable mesh is rounded (¶9 atraumatic; FIG 3K atraumatic end distal region 304). Atraumatic is broadly interpreted as being rounded, consistent with the definition in the Specification at ¶306.
Regarding claim 4, Schmidt modified by Eidenschink and Khairkhahan teaches the biostimulator transport system of claim 1, as set forth above.
Eidenschink teaches wherein the expandable mesh has a wall thickness of 1.5 mil or less (FIG 3G; ¶60, “layer 357 may have a thickness of approximately 0.0001 inch and approximately 0.005 inch”; resulting inch to mm conversions are a range of approximately 0.00254 mm and approximately 0.127 mm). The recitation of “a wall” is broadly interpreted as both singular and plural where “a layer” of the flexible sheath, which is taught in Eidenschink as comprising multiple layers. Eidenschink also teaches that the layers may be folded back on themselves such that “a wall” comprises a layer (compare FIGs 3G, 3F, and 3H of Eidenschink showing different perspectives of the doubled-over mesh, which results in an atraumatic rounded distal end and a wall layer 357 as depicted in FIG 3G). See also, Specification at ¶¶305 and 306.
Regarding claim 5, Schmidt modified by Eidenschink and Khairkhahan, teaches the biostimulator transport system of claim 1, as set forth above.
Schmidt teaches wherein the retrieval catheter (FIG 2; ¶31 retrieval catheter 54) includes a docking cap (¶31, docking member 30, head portion 32), wherein the flexible sheath (¶40, covering 60) is extendable along the retrieval catheter (¶40; FIGs 6A, 6B; see also ¶43), and wherein the expandable mesh is sized to apply an inwardly compressive force on the docking cap (FIG 2, docking member 30, head portion 32; FIG 6B; ¶46 “the covering 60 may permit a loop of a snare 56 or other retrieval device, to engage the docking member 30 distal of the head portion 32 during a retrieval procedure and sufficiently tighten around the neck portion 34 such that the loop of the snare 56 will enter the recessed area 70 or hollow, and thus not slip off the docking member 30”).
Regarding claim 6, Schmidt modified by Eidenschink and Khairkhahan, teaches the biostimulator transport system of claim 5, as set forth above.
Schmidt teaches wherein the docking cap includes a sharp distal edge (FIGs 6A-B, ¶43, recessed area 70 defined between enlarged [docking] head portion 32 and the housing 12; ¶46 The collapsible covering 60 may inhibit tissue growth or entanglement around the docking member 30, such as in the recessed area 70)”.
The recessed area 70 of Schmidt comprises an area where a pair of faces meet at the distal end of the docking cap head 32, such that it comports with the Applicant-defined meaning of “sharp distal edge” in the Specification. At ¶127, the instant Specification defines a “sharp distal edge” by way of example, staging “the sharp distal edge 550 can be located where a pair of faces meet at the distal end of the docking cap 502. One or more of the faces may be oblique to a central axis of the docking cap 502. For example, the outer wall of the docking cap 502 can be parallel to the central axis, or the outer wall can angle inward toward the distal edge to form a cutting edge with the inner wall of the docking cap 502. Similarly, the inner wall can be parallel or angled relative to the central axis. Accordingly, the sharp distal edge 550 can be formed where the faces meet, and the edge can provide a circumferential cutting blade that extends around the central axis. The edge can cut through the tissue under distal advancement forces and/or under torque transmitted through the retrieval system to the docking cap 418. Accordingly, the sharp edge can cut through tissue attached to the leadless pacemaker 402 to excise the implanted device from the patient. When the leadless pacemaker 402 is detached from the target tissue, it may be retrieved from the patient.”
Schmidt also teaches that “collapsible covering 60 is provided around docking member 30 to inhibit tissue growth or entanglement around docking member 30, such as in the recessed area 70, and /or preclude blood coagulation or embolization around the neck portion 34, such as in the recessed area 70, while implanted in a patient which may otherwise obstruct the recessed area and thus inhibit the loop of the snare 56 from being sufficiently tightened around the docking member 30” (¶46). This collapsible covering taught by Schmidt protects these docking member (cap and neck) faces (including faces oblique to a centra axis of the docking member and docking cap) meeting the definition of “sharp distal edges” as defined by the instant specification. Eidenschink also teaches structures meeting the definition of “sharp distal edge” at FIGs 4D-E, attachment feature 424 and key 432.
Regarding claim 7, Schmidt modified by Eidenschink and Khairkhahan, teaches the biostimulator transport system of claim 1, as set forth above.
Schmidt teaches the system further comprising a rigid sheath (FIG 2, retrieval catheter 54).
Eidenschink teaches the system further comprising a rigid sheath (FIGs 2C-D, ¶53, guide catheter sheath 211) extendable along the flexible sheath to press the flexible sheath against the implantable medical device (¶¶51, 53).
Regarding claim 8, Schmidt modified by Eidenschink and Khairkhahan, teaches the biostimulator transport system of claim 1, as set forth above.
Eidenschink teaches the system further comprising a protective sheath disposable about the rigid sheath and the flexible sheath (FIGs 2C-D; ¶53, guide catheter sheath 211 is extended distally to cause atraumatic pacemaker sheath 204 to cover catheter shaft 206).
Regarding independent claim 9, Schmidt, teaches a retrieval system (FIGs 1, ¶26, exemplary implantable leadless cardiac pacing device 10), comprising:
a snare (FIG 2, snare 52) extending through a retrieval catheter to capture an implantable medical device (FIG 2, implantable device 10; ¶31); and
a flexible sheath (¶40, covering 60), wherein the flexible sheath (¶40, covering 60) includes an expandable mesh (¶40, mesh material, non-wovens, porous, foams, gels, sponges; ¶41 biostable polymeric material) sized to apply an inwardly compressive force on the implantable medical device (FIG 6B; ¶46 “the covering 60 may permit a loop of a snare 56 or other retrieval device, to engage the docking member 30 distal of the head portion 32 during a retrieval procedure and sufficiently tighten around the neck portion 34 such that the loop of the snare 56 will enter the recessed area 70 or hollow, and thus not slip off the docking member 30”).
Schmidt does not teach that the flexible sheath is extendable along the snare.
However, Schmidt teaches that the covering (flexible sheath) extends over at least portion of the neck portion 34 of the docking member 30 (¶40; FIGs 6A, 6B; see also ¶43).
Eidenschink teaches a delivery catheter for implanting a leadless biostimulator (Abstract). Eidenschink teaches a guide catheter sheath 211 extending distally to cause atraumatic pacemaker sheath 204 to cover catheter shaft 206, pacemaker 202, and helix 203 to protect patient tissue from the sharp edges of helix 203 during implantation (¶53). “Thus when catheter sheath 211 and its atraumatic distal end region 204 in the form of pacemaker sheath 204 are advanced distally to protect the pacemaker and helix as shown in FIGs 2C and 2D, the pacemaker 202 and helix 203 are in a protected, advanced configuration” (¶53). Eidenschink also teaches that the expandable mesh is sized to apply an inwardly compressive force on the implantable medical device (¶51).
Although Eidenschink does not teach extending the flexible sheath along the snare of a catheter retrieval device, the same principle taught by Eidenschink applies in reverse when the same type of leadless catheter device is removed, as taught by Schmidt, using a retrieval catheter. The extension of a snare would need to be protected from the snare catching on a less than optimal structure or surface, complicating the snaring process required for removal of the leadless device during retrieval.
The motivation for extending the flexible sheath over the snare is the same motivation as the extension of the flexible sheath over the helix during implantation, to protect patient tissues from contact by the retrieval device or sharp edges and insure snare placement around the optimal points of snaring of the implanted device, especially when tissue ingrowth may have occurred around parts of the implant during the tenure of implantation (see also, Schmidt ¶46).
Neither Schmidt nor Eidenschink expressly teach that the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the retrieval catheter. However, Eidenschink and Schmidt both teach that the expandable mesh is sized to apply an inwardly compressive force on the implantable medical device.
Khairkhanan teaches leadless biostimulators and delivery systems (Abstract) comprising sheath 216 that can be advanced over catheter shaft 217 to provide additional steering and support for the delivery catheter (FIGs 2A, 2D; ¶43).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Schmidt, Eidenschink, and Khairkhanan, given that they included each element claimed, although not necessarily in a single reference. Schmidt, Eidenschink, and Khairkhanan teach in the same field of art, leadless pacemaker devices. Although, Schmidt discloses the claimed base biostimulator transport system comprising a snare extending through a retrieval catheter to capture an implantable medical device and a flexible sheath wherein the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the implantable medical device, Schmidt does not teach that the flexible sheath is extendable along the snare or that the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the retrieval catheter. Eidenschink specifically addresses the problem of a guide catheter sheath extending distally to cause an atraumatic pacemaker sheath to cover a catheter shaft, pacemaker, and helix to protect patient tissue from the sharp edges of the helix during implantation (¶53). Eidenschink also expressly teaches that the expandable mesh is sized to apply an inwardly compressive force on the implantable medical device (¶51). Because Schmidt expressly includes a sheath comprising expandable mesh sized to apply an inwardly compressive force on the implantable medical device, one of ordinary skill in the art seeking to protect patient tissue from exposed structural components of the device during implantation and removal would look to Eidenschink’s extended sheath solution. Although Eidenschink does not expressly teach extending the flexible sheath along the snare of a catheter retrieval device, the same principle taught by Eidenschink applies in reverse when the same type of leadless catheter device is removed, as taught by Schmidt, using a retrieval catheter. The extension of a snare would need to be protected from the snare catching on a less than optimal structure or surface, complicating the snaring process required for removal of the leadless device during retrieval. A modified sheath can be incorporated alongside Schmidt’s base device using known assembly methods without redesigning Schmidt’s core delivery path.
Neither Schmidt nor Eidenschink expressly teach that the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the retrieval catheter. However, Eidenschink and Schmidt both teach that the expandable mesh is sized to apply an inwardly compressive force on the implantable medical device. Khairkhanan expressly addresses the problem by teaching that a sheath that can be advanced over the catheter shaft to provide additional steering and support for the delivery catheter (FIGs 2A, 2D; ¶43). Because the combination of Schmidt and Eidenschink provide for extending catheter sheath over the snare to protect the snare from injuring patient tissue or catching on a surface during removal, extending the sheath further to provide an inwardly compressive force on the delivery catheter to enhance steering and support for the delivery catheter during delivery and retrieval is motivated by Khairkhanan’s sheath extension solution. A person of ordinary skill in the art attempting to render Schmidt’s base biostimulator transport system more controllable, as well as safer in vivo, would look for established sheath designs to avoid creating a novel sheath system that may interfere with device delivery and catheter retrieval. Khairkhanan’s extendable catheter-covering sheath provide a sheath-based solution that can be adapted to the sheath of Schmidt modified by the snare-extended sheath covering of Eidenschink to enable better steering of the catheter device along that provides an inwardly compressive force on the implantable medical device and on the retrieval catheter.
One of ordinary skill in the art before the claimed invention could have readily envisioned substituting the fully encased delivery sheath taught by Eidenschink and the extendable steerable catheter sheath of Kharikhanan with the retrieval device of Schmidt in order to protect the snare and surrounding patient tissues during the retrieval process while also providing improved catheter steering and support for the delivery catheter during implantation and retrieval. Because the references address the same engineering problem (catheter sheath solutions for improved device performance) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a differently sized flexible sheath extendable along the snare and the catheter where the sheath is sized to apply an inwardly compressive force on the implantable medical device and on the retrieval catheter), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 10, Schmidt modified by Eidenschink and Khairkhahan, teaches the retrieval system of claim 9, as set forth above.
Eidenschink teaches wherein the expandable mesh includes a double-walled construction (¶¶12, 18).
Regarding claim 11, Schmidt modified by Eidenschink and Khairkhahan, teaches the retrieval system of claim 9, as set forth above.
Eidenschink teaches wherein a distal end of the expandable mesh is rounded (¶9 atraumatic; FIG 3K atraumatic end distal region 304). Atraumatic is broadly interpreted as being rounded, consistent with the definition in the instant Specification at ¶306.
Regarding claim 12, Schmidt modified by Eidenschink and Khairkhahan, teaches the retrieval system of claim 9, as set forth above.
Eidenschink teaches wherein the expandable mesh has a wall thickness of 1.5 mil or less (FIG 3G; ¶60, “layer 357 may have a thickness of approximately 0.0001 inch and approximately 0.005 inch”; resulting inch to mm conversions are a range of approximately 0.00254 mm and approximately 0.127 mm). The recitation of “a wall” is broadly interpreted as both singular and plural where “a layer” of the flexible sheath, which is taught in Eidenschink as comprising multiple layers. Eidenschink also teaches that the layers may be folded back on themselves such that “a wall” comprises a layer (compare FIGs 3G, 3F, and 3H of Eidenschink showing different perspectives of the doubled-over mesh, which results in an atraumatic rounded distal end and a wall layer 357 as depicted in FIG 3G). See also, Specification at ¶¶305 and 306.
Regarding claim 13, Schmidt modified by Eidenschink and Khairkhahan, teaches the retrieval system of claim 9, as set forth above.
Schmidt teaches wherein the retrieval catheter (FIG 2; ¶31 retrieval catheter 54) includes a docking cap (¶31, docking member 30, head portion 32), wherein the flexible sheath (¶40, covering 60) is extendable along the retrieval catheter (¶40; FIGs 6A, 6B; see also ¶43), and wherein the expandable mesh is sized to apply an inwardly compressive force on the docking cap (FIG 2, docking member 30, head portion 32; FIG 6B; ¶46 “the covering 60 may permit a loop of a snare 56 or other retrieval device, to engage the docking member 30 distal of the head portion 32 during a retrieval procedure and sufficiently tighten around the neck portion 34 such that the loop of the snare 56 will enter the recessed area 70 or hollow, and thus not slip off the docking member 30”).
Regarding claim 14, Schmidt modified by Eidenschink and Khairkhahan, teaches the retrieval system of claim 13, as set forth above.
Schmidt teaches wherein the docking cap includes a sharp distal edge (FIGs 6A-B, ¶43, recessed area 70 defined between enlarged [docking] head portion 32 and the housing 12; ¶46 The collapsible covering 60 may inhibit tissue growth or entanglement around the docking member 30, such as in the recessed area 70)”.
The recessed area 70 of Schmidt comprises an area where a pair of faces meet at the distal end of the docking cap head 32, such that it comports with the Applicant-defined meaning of “sharp distal edge” in the Specification. At ¶127, the instant Specification defines a “sharp distal edge” by way of example, staging “the sharp distal edge 550 can be located where a pair of faces meet at the distal end of the docking cap 502. One or more of the faces may be oblique to a central axis of the docking cap 502. For example, the outer wall of the docking cap 502 can be parallel to the central axis, or the outer wall can angle inward toward the distal edge to form a cutting edge with the inner wall of the docking cap 502. Similarly, the inner wall can be parallel or angled relative to the central axis. Accordingly, the sharp distal edge 550 can be formed where the faces meet, and the edge can provide a circumferential cutting blade that extends around the central axis. The edge can cut through the tissue under distal advancement forces and/or under torque transmitted through the retrieval system to the docking cap 418. Accordingly, the sharp edge can cut through tissue attached to the leadless pacemaker 402 to excise the implanted device from the patient. When the leadless pacemaker 402 is detached from the target tissue, it may be retrieved from the patient.”
Schmidt also teaches that “collapsible covering 60 is provided around docking member 30 to inhibit tissue growth or entanglement around docking member 30, such as in the recessed area 70, and /or preclude blood coagulation or embolization around the neck portion 34, such as in the recessed area 70, while implanted in a patient which may otherwise obstruct the recessed area and thus inhibit the loop of the snare 56 from being sufficiently tightened around the docking member 30” (¶46). This collapsible covering taught by Schmidt protects these docking member (cap and neck) faces (including faces oblique to a centra axis of the docking member and docking cap) meeting the definition of “sharp distal edges” as defined by the instant specification. Eidenschink also teaches structures meeting the definition of “sharp distal edge” at FIGs 4D-E, attachment feature 424 and key 432.
Regarding independent claim 15, Schmidt, teaches a delivery system (FIGs 1, ¶26, exemplary implantable leadless cardiac pacing device 10), comprising: a snare (FIG 2, snare 52) extending through a retrieval catheter to capture an implantable medical device (FIG 2, implantable device 10; ¶31); and
a flexible sheath (¶40, covering 60) extendable along the snare, wherein the flexible sheath (¶40, covering 60) includes an expandable mesh (¶40, mesh material, non-wovens, porous, foams, gels, sponges; ¶41 biostable polymeric material) sized to apply an inwardly compressive force on the implantable medical device (FIG 6B; ¶46 “the covering 60 may permit a loop of a snare 56 or other retrieval device, to engage the docking member 30 distal of the head portion 32 during a retrieval procedure and sufficiently tighten around the neck portion 34 such that the loop of the snare 56 will enter the recessed area 70 or hollow, and thus not slip off the docking member 30”).
Schmidt does not teach that the flexible sheath is extendable along the snare.
However, Schmidt teaches that the covering (flexible sheath) extends over at least portion of the neck portion 34 of the docking member 30 (¶40; FIGs 6A, 6B; see also ¶43).
Eidenschink teaches a delivery catheter for implanting a leadless biostimulator (Abstract). Eidenschink teaches a guide catheter sheath 211 extending distally to cause atraumatic pacemaker sheath 204 to cover catheter shaft 206, pacemaker 202, and helix 203 to protect patient tissue from the sharp edges of helix 203 during implantation (¶53). “Thus when catheter sheath 211 and its atraumatic distal end region 204 in the form of pacemaker sheath 204 are advanced distally to protect the pacemaker and helix as shown in FIGs 2C and 2D, the pacemaker 202 and helix 203 are in a protected, advanced configuration” (¶53). Eidenschink also teaches that the expandable mesh is sized to apply an inwardly compressive force on the implantable medical device (¶51).
Although Eidenschink does not teach extending the flexible sheath along the snare of a catheter retrieval device, the same principle taught by Eidenschink applies in reverse when the same type of leadless catheter device is removed, as taught by Schmidt, using a retrieval catheter. The extension of a snare would need to be protected from the snare catching on a less than optimal structure or surface, complicating the snaring process required for removal of the leadless device during retrieval.
The motivation for extending the flexible sheath over the snare is the same motivation as the extension of the flexible sheath over the helix during implantation, to protect patient tissues from contact by the retrieval device or sharp edges and insure snare placement around the optimal points of snaring of the implanted device, especially when tissue ingrowth may have occurred around parts of the implant during the tenure of implantation (see also, Schmidt ¶46).
Neither Schmidt nor Eidenschink expressly teach that the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the retrieval catheter. However, Eidenschink and Schmidt both teach that the expandable mesh is sized to apply an inwardly compressive force on the implantable medical device.
Khairkhanan teaches leadless biostimulators and delivery systems (Abstract) comprising sheath 216 that can be advanced over catheter shaft 217 to provide additional steering and support for the delivery catheter (FIGs 2A, 2D; ¶43).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Schmidt, Eidenschink, and Khairkhanan, given that they included each element claimed, although not necessarily in a single reference. Schmidt, Eidenschink, and Khairkhanan teach in the same field of art, leadless pacemaker devices. Although, Schmidt discloses the claimed base biostimulator transport system comprising a snare extending through a retrieval catheter to capture an implantable medical device and a flexible sheath wherein the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the implantable medical device, Schmidt does not teach that the flexible sheath is extendable along the snare or that the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the retrieval catheter. Eidenschink specifically addresses the problem of a guide catheter sheath extending distally to cause an atraumatic pacemaker sheath to cover a catheter shaft, pacemaker, and helix to protect patient tissue from the sharp edges of the helix during implantation (¶53). Eidenschink also expressly teaches that the expandable mesh is sized to apply an inwardly compressive force on the implantable medical device (¶51). Because Schmidt expressly includes a sheath comprising expandable mesh sized to apply an inwardly compressive force on the implantable medical device, one of ordinary skill in the art seeking to protect patient tissue from exposed structural components of the device during implantation and removal would look to Eidenschink’s extended sheath solution. Although Eidenschink does not expressly teach extending the flexible sheath along the snare of a catheter retrieval device, the same principle taught by Eidenschink applies in reverse when the same type of leadless catheter device is removed, as taught by Schmidt, using a retrieval catheter. The extension of a snare would need to be protected from the snare catching on a less than optimal structure or surface, complicating the snaring process required for removal of the leadless device during retrieval. A modified sheath can be incorporated alongside Schmidt’s base device using known assembly methods without redesigning Schmidt’s core delivery path.
Neither Schmidt nor Eidenschink expressly teach that the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the retrieval catheter. However, Eidenschink and Schmidt both teach that the expandable mesh is sized to apply an inwardly compressive force on the implantable medical device. Khairkhanan expressly addresses the problem by teaching that a sheath that can be advanced over the catheter shaft to provide additional steering and support for the delivery catheter (FIGs 2A, 2D; ¶43). Because the combination of Schmidt and Eidenschink provide for extending catheter sheath over the snare to protect the snare from injuring patient tissue or catching on a surface during removal, extending the sheath further to provide an inwardly compressive force on the delivery catheter to enhance steering and support for the delivery catheter during delivery and retrieval is motivated by Khairkhanan’s sheath extension solution. A person of ordinary skill in the art attempting to render Schmidt’s base biostimulator transport system more controllable, as well as safer in vivo, would look for established sheath designs to avoid creating a novel sheath system that may interfere with device delivery and catheter retrieval. Khairkhanan’s extendable catheter-covering sheath provide a sheath-based solution that can be adapted to the sheath of Schmidt modified by the snare-extended sheath covering of Eidenschink to enable better steering of the catheter device along that provides an inwardly compressive force on the implantable medical device and on the retrieval catheter.
One of ordinary skill in the art before the claimed invention could have readily envisioned substituting the fully encased delivery sheath taught by Eidenschink and the extendable steerable catheter sheath of Kharikhanan with the retrieval device of Schmidt in order to protect the snare and surrounding patient tissues during the retrieval process while also providing improved catheter steering and support for the delivery catheter during implantation and retrieval. Because the references address the same engineering problem (catheter sheath solutions for improved device performance) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a differently sized flexible sheath extendable along the snare and the catheter where the sheath is sized to apply an inwardly compressive force on the implantable medical device and on the retrieval catheter), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 16, Schmidt modified by Eidenschink and Khairkhahan teaches the delivery system of claim 15, as set forth above.
Eidenschink teaches wherein the expandable mesh includes a double-walled construction (¶¶12, 18).
Regarding claim 17, Schmidt modified by Eidenschink and Khairkhahan, teaches the delivery system of claim 15, as set forth above.
Eidenschink teaches wherein a distal end of the expandable mesh is rounded (¶9 atraumatic; FIG 3K atraumatic end distal region 304). Atraumatic is broadly interpreted as being rounded, consistent with the definition in the Specification at ¶306.
Regarding claim 18, Schmidt modified by Eidenschink and Khairkhahan, teaches the delivery system of claim 15, as set forth above.
Eidenschink teaches wherein the expandable mesh has a wall thickness of 1.5 mil or less (FIG 3G; ¶60, “layer 357 may have a thickness of approximately 0.0001 inch and approximately 0.005 inch”; resulting inch to mm conversions are a range of approximately 0.00254 mm and approximately 0.127 mm). The recitation of “a wall” is broadly interpreted as both singular and plural where “a layer” of the flexible sheath, which is taught in Eidenschink as comprising multiple layers. Eidenschink also teaches that the layers may be folded back on themselves such that “a wall” comprises a layer (compare FIGs 3G, 3F, and 3H of Eidenschink showing different perspectives of the doubled-over mesh, which results in an atraumatic rounded distal end and a wall layer 357 as depicted in FIG 3G). See also, Specification at ¶¶305 and 306.
Regarding claim 19, Schmidt modified by Eidenschink and Khairkhahan, teaches the delivery system of claim 15, as set forth above.
Schmidt teaches wherein the retrieval catheter (FIG 2; ¶31 retrieval catheter 54) includes a docking cap (Schmidt: ¶31, docking member 30, head portion 32), wherein the flexible sheath (¶40, covering 60) is extendable along the retrieval catheter (¶40; FIGs 6A, 6B; see also ¶43), and wherein the expandable mesh is sized to apply an inwardly compressive force on the docking cap (FIG 2, docking member 30, head portion 32; FIG 6B; ¶46 “the covering 60 may permit a loop of a snare 56 or other retrieval device, to engage the docking member 30 distal of the head portion 32 during a retrieval procedure and sufficiently tighten around the neck portion 34 such that the loop of the snare 56 will enter the recessed area 70 or hollow, and thus not slip off the docking member 30”).
Regarding claim 20, Schmidt modified by Eidenschink and Khairkhahan, as set forth above, teaches the delivery system of claim 19, as set forth above.
Schmidt teaches wherein the docking cap includes a sharp distal edge (FIGs 6A-B, ¶43, recessed area 70 defined between enlarged [docking] head portion 32 and the housing 12; ¶46 The collapsible covering 60 may inhibit tissue growth or entanglement around the docking member 30, such as in the recessed area 70)”.
The recessed area 70 of Schmidt comprises an area where a pair of faces meet at the distal end of the docking cap head 32, such that it comports with the Applicant-defined meaning of “sharp distal edge” in the Specification. At ¶127, the instant Specification defines a “sharp distal edge” by way of example, staging “the sharp distal edge 550 can be located where a pair of faces meet at the distal end of the docking cap 502. One or more of the faces may be oblique to a central axis of the docking cap 502. For example, the outer wall of the docking cap 502 can be parallel to the central axis, or the outer wall can angle inward toward the distal edge to form a cutting edge with the inner wall of the docking cap 502. Similarly, the inner wall can be parallel or angled relative to the central axis. Accordingly, the sharp distal edge 550 can be formed where the faces meet, and the edge can provide a circumferential cutting blade that extends around the central axis. The edge can cut through the tissue under distal advancement forces and/or under torque transmitted through the retrieval system to the docking cap 418. Accordingly, the sharp edge can cut through tissue attached to the leadless pacemaker 402 to excise the implanted device from the patient. When the leadless pacemaker 402 is detached from the target tissue, it may be retrieved from the patient.”
Schmidt also teaches that “collapsible covering 60 is provided around docking member 30 to inhibit tissue growth or entanglement around docking member 30, such as in the recessed area 70, and /or preclude blood coagulation or embolization around the neck portion 34, such as in the recessed area 70, while implanted in a patient which may otherwise obstruct the recessed area and thus inhibit the loop of the snare 56 from being sufficiently tightened around the docking member 30” (¶46). This collapsible covering taught by Schmidt protects these docking member (cap and neck) faces (including faces oblique to a centra axis of the docking member and docking cap) meeting the definition of “sharp distal edges” as defined by the instant specification. Eidenschink also teaches structures meeting the definition of “sharp distal edge” (FIGs 4D-E, attachment feature 424 and key 432).
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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