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 filed 1 April 2026 is acknowledged. Claims 4-9, 11, 12, 14, and 15 are currently amended. New claims 16-20 are added. Claims 1-20 are pending and under examination.
Applicant is advised that claims 5-13 are rejoined in light of Applicant’s amendments. However, because Applicant could have filed a preliminary amendment to remedy the multiple dependencies, the rejections over the rejoined and new amended claims are being treated as final, necessitated by amendment. See MPEP 706.07(a).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 14 April 2026 has been considered by the examiner. A signed copy is attached.
Objections/Rejections Withdrawn
The objection to claims 5-13 under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only and/or cannot depend from any other multiple dependent claim, is withdrawn in light of Applicant’s amendments.
The objection to claims 14 and 15 under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only and/or cannot depend from any other multiple dependent claim, is withdrawn in light of Applicant’s amendments.
The objection to claim 14 because of the following informalities: line 2 recites “to any of any of”, is withdrawn in light of Applicant’s amendments.
Response to Arguments
Regarding the rejections of claims 1-4 under 35 USC 102(a)(1) or 103 over Phan (US 20210085347), Applicant argues that the handle is not configured to be interchangeably operable to an atherectomy subsystem and a pulsatile intravascular lithotripsy subsystem (Response, numbered page 9). Applicant points to ¶¶14, 20, 22, 85, 91 and FIGs 1A, 2A of the specification (Remarks, numbered pp.10-13) to rebut that Phan discloses the claimed handle (Remarks, numbered p. 13). Applicant argues that “Phan does not refer to disconnecting an atherectomy subsystem from handle 22 and subsequently attaching a pulsatile intravascular lithotripsy subsystem, for example” (Remarks, numbered p. 15). Applicant argues that the claimed element requires disconnection of an atherectomy subsystem and subsequent attachment of a pulsatile intravascular lithotripsy subsystem (Remarks, numbered p. 15). Applicant argues that Pan does not contemplate any need for handle 22 to be “configured to be interchangeably operably connectable” to more than one subsystem (Remarks, numbered p. 15). Applicant refers to the prior Office Action and disagrees that a person of ordinary skill in the art would like to the different components of a subsystem of Phan as suggesting that the Phan handle is “configured to be interchangeably operably connectable” (Remarks, numbered p. 16). Applicant’s arguments have been fully considered, but they are not persuasive.
Regarding the rejection of claims 14 and 15 under 35 USC 103 over Phan (US 20210085347) in view of Grace (US 20160184570), Applicant argues that Grace does not remedy the deficiencies of Phan as discussed in regard to claims 1-4 (Remarks, numbered pp. 17-18).
Regarding new claims 16-20, Applicant argues that they are dependent on claim 1 and are allowable (Remarks, numbered p. 18).
Applicant’s attention is drawn to the fact that claims 1-4 are drawn to system claims (apparatus/device) claims. The structures claimed in claim 1 are a console and a handle. The handle as also recited functionally, as being “configured to be interchangeably operably connectable”. Applicant is reminded that the recitation of a structural element that is “configured to” is broadly interpreted as “capable of” performing a function, which is not a positive limitation, but only requires the ability to so perform. See In re Hutchison, 69 USPQ 138, 33 CCPA 879 (1946).
Additionally, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims must stand on their own. Merrill v. Yeomans, 94 US 568, 570 (1876) and In re Hiniker, 150 F.3d 1362, 1369 (Fed. Cir. 1998).
Contrary to Applicant’s arguments, there is nothing in the claims that requires an action of physically disconnecting one subsystem and the physical reconnection of a different subsystem. Moreover, the claims do not set forth any particular component of an atherectomy subsystem or a pulsatile intravascular lithotripsy subsystem such that one would know which structure of which subsystem to connect or disconnect. The “interchangeably operably connectable” language is broadly construed (as set forth of record) to encompass software and/or hardware and there are no limitations in the claims that exclude or otherwise emphasize equivalent connections to any software or hardware components of both recited subsystems. Thus, an A/B or toggle switch or alternatively a line of software code may be sufficient to effect the “interchangeably operably connectable” ability based on the language of the claims as written, as the manner by which the “interchangeably operably connectable” function is to occur is not recited in or limited by examined claims 1-4, 14, or 15. The claims have been broadly interpreted in light of the specification, as explained in detail in the Office Action mailed 8 January 2026. However, limitations from the specification are not read into the claims. The claims must stand on their own. The prior art has been applied accordingly. The rejections of record are maintained.
Objections/Rejections New, Maintained and Modified - Necessitated by AmendmentClaim Rejections - 35 USC § 102/103
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 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.
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.
Claims 1-5, 9-12 and 16 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Phan et al., US 20210085347 (25 March 2021), for the reasons of record and the reasons set forth herein.
Regarding claim 1, Phan teaches a system comprising:
a console (FIG 1A, voltage pulse generator, 28); and
a handle (FIG 1A, handle 22; ¶50),
wherein the handle is configured to be interchangeably operably connectable to: an atherectomy subsystem, and a pulsatile intravascular lithotripsy subsystem (¶50, handle 22 includes an entry port for receiving the guidewire 20 and an electrical connection port 24 is also located on the proximal end 22 to provide an electrical connection between the distal shockwave generator 16 and an external high pulsed high voltage source 28, such as the IVL generator in FIG 1A).
Phan teaches in the field of minimally invasive surgical tools comprising catheters for treating occlusions in blood vessels including balloons, and pulse shock wave generators for intravascular lithotripsy.
Phan does not use the same terminology as the current claims.
However, given the broadest reasonable interpretation standard, as informed by the Specification, the system components taught by Phan meet the definitions of the claimed components and are configured to interact with “subsystems” of the recited tools/procedures.
Because Phan includes system components comprising a console and a handle, wherein the handle is configured to interact with the subsystem components of multiple systems involved in treating vascular occlusions, including electrical components, fluidic systems, pulsed shock waves, guidewires, catheters, and balloons, a person of ordinary skill in the art, seeking to provide common connectivity to common tools used in a variety of related vascular occlusion treatment systems would reasonably consult Phan’s catheter and multi-component system, including the standardized modular interface used by Phan in handle 22 (same location and port connectivity for multiple internal and external tools) using known assembly methods without redesigning Phan’s core delivery path.
Because Phan addresses the same engineering problem (common connectivity mechanism for multiple related subsystems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (providing common connectors for related subsystems), 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.
It is also noted that one of ordinary skill in the art would be reasonably apprised that an atherectomy subsystem and a pulsatile intravascular lithotripsy subsystem are not required components of the claims. Rather, the claims require that the handle be configured to be “interchangeably operably connectable” to a subsystem within the definition of those tools, as broadly interpreted below, in light of the Specification. The definitional basis for the claim interpretation is set forth below.
A “console” is interpreted under the broadest reasonable interpretation standard. The Specification at 11 discloses that a console comprises a housing or multiple housings, a console unit may be employed in connection with providing potential energy to atherectomy subsystem 160, and a second console unit may be employed in connection with providing
potential energy to pulsatile intravascular lithotripsy subsystem 150. “Console unit 120 includes potential source 121 for generating or providing energy for transmission to handle 111 comprising switch 141 via a potential regulator 122 for modulating transmitted potential energy.”
The phrase “operably connectable” is interpreted under the broadest reasonable interpretation standard. The Specification at page 17 states that connector 113 is used to provide an interface, e.g., a standard or uniform or modular interface, between rotational assembly 161 and output of handle 111. At page 27, the specification discloses proximal connector 151 comprises an interface for releasably operably connecting to an interface of handle 111 with identical shape and/or connections and/or interlocking elements. Specification at page 56 discloses that connector and handle interfaces may comprise operable connections (e.g., high pressure fluid connections), electrical connectors, other interlock mechanisms, etc., and such aspects may be identical between an atherectomy connector of an atherectomy subsystem and a proximal connector of a pulsatile intravascular lithotripsy subsystem. Page 6 of the Specification discloses that [b]y "interchangeably operably connectable," it is meant, for example, that embodiments of handles of the invention comprise a single interface that is configured such that the same handle interface can be connected to either atherectomy subsystem or a pulsatile intravascular lithotripsy subsystem. The specification at p. 6-7 discloses that the handle interface may comprise one or more structural elements, such as a shape or depth or other volumetric features, connector elements, such as a pneumatic connector, including, for example, an O-ring and/or seating for an O-ring, alignment elements, keying elements, electrical connections, or the like, where the arrangement and shape of such elements of the interface are such that they align with corresponding elements of each of the atherectomy subsystem and pulsatile intravascular lithotripsy subsystem. Accordingly the phrase “operably connectable” is broadly interpreted as a standard or uniform modular interface with identical shape and/or connections and/or interlocking elements and may comprise high pressure fluid connections, electrical connectors, other interlocking mechanisms as described.
The phrase “atherectomy subsystem” is interpreted under the broadest reasonable interpretation standard. The Specification at page 5 states that FIG 2B provides a schematic diagram of aspects of an atherectomy subsystem and a pulsatile intravascular subsystem with combined tools. Specification at page 3 states that the atherectomy subsystem comprises a lateral transmission assembly configured to propagate rotational energy from a rotational assembly to an atherectomy tool and comprises sensors to sense one or more of current, rotational position, speed, acceleration, temperature, linear position, torque, pressure or flow. The specification at p. 4 states that the atherectomy subsystem comprises a lateral transmission assembly comprising a guidewire and the guidewire is present within the guidewire lumen. The specification at p. 4 discloses that the guidewire is used to introduce into luminal tissue a distal balloon of a pulsatile intravascular lithotripsy subsystem of the system. The specification at 11 discloses that handle 111, comprising oscillator 141, is connected to atherectomy subsystem 160 for transmitting pulsatile energy (i.e., second pulse energy) or static energy to atherectomy tool 169 via connector 113, rotational assembly 161 and lateral transmission assembly 164. Atherectomy subsystem 160 is further configured to translate in distal and proximal directions, as shown by arrows 168. Accordingly, an “atherectomy subsystem” is broadly interpreted as a component of a system used for transmitting rotational energy from a rotational assembly to an atherectomy tool.
The phrase “pulsatile intravascular lithotripsy subsystem” is interpreted under the broadest reasonable interpretation standard. The Specification at page 11 discloses that handle 111, comprising oscillator 141, is connected to pulsatile intravascular lithotripsy subsystem 150 for transmitting pulsatile energy (i.e., second pulse energy) or static energy to distal balloon 159 via proximal connector 151 and catheter 154, for pressurizing balloon 159. Accordingly, a “pulsatile intravascular lithotripsy subsystem” is broadly interpreted as a component of a system used for transmitting pulsatile energy or static energy to a distal balloon using a proximal connector and catheter for pressurizing the balloon.
Regarding claim 2, Phan teaches the system according to claim 1, wherein the handle (22) is operably connected to the atherectomy subsystem (¶50, handle 22 includes an entry port for receiving the guidewire 20 and an electrical connection port 24).
The atherectomy subsystem is broadly interpreted as set forth above and includes electrical connectors and a guidewire.
Regarding claim 3, Phan teaches the system according to claim 1, wherein the handle (22) is operably connected to the pulsatile intravascular lithotripsy subsystem (handle 22 includes an entry port for receiving the guidewire 20 and an electrical connection port 24 is also located on the proximal end 22 to provide an electrical connection between the distal shockwave generator 16 and an external high pulsed high voltage source 28, such as the IVL generator in FIG 1A).
The atherectomy subsystem is broadly interpreted as set forth above and includes electrical connectors and a guidewire.
Regarding claim 4, Phan teaches the system according to any of the preceding claims, wherein the atherectomy subsystem and the pulsatile intravascular lithotripsy subsystem each comprises an interface (¶50, electrical connection between the distal shock wave generator 16 and an external pulsed high voltage source 28) configured to operably connect to an interface (electrical connection port 24) of the handle (22).
The atherectomy subsystem is broadly interpreted as set forth above and includes electrical connectors and a guidewire.
Regarding currently amended claim 5, Phan teaches the system according to claim 1, as set forth above, for the reasons set forth above, wherein the atherectomy subsystem comprises: an atherectomy tool that is a rotational atherectomy tool or an orbital atherectomy tool or a laser tool or an ultrasound tool or an electrohydraulic lithotripsy (EHL) cavitation emitter tool or a mechanotransduction tool (FIG 1D, pulsed voltage shock wave generator, ¶58).
Regarding currently amended claim 9, Phan teaches 9 the system according to claim 1, as set forth above, for the reasons set forth above, wherein the pulsatile intravascular lithotripsy subsystem (FIG 1A, pulsed IVL generator 28, ¶50) comprises: a proximal connector configured to operably connect to the handle (FIG 1A, handle 22, ¶50); a distal balloon (FIGs 1B-C, flexible balloon 18, ¶46); and a catheter (10, ¶46), wherein the distal balloon is operably connected to the catheter (¶46), and the catheter is operably connected to the proximal connector (FIG 1A).
Regarding currently amended claim 10, Phan teaches the system according to claim 9, as set forth above, for the reasons set forth above, wherein the proximal connector (FIG 1A, electrical connection port 24 located on the proximal end of handle 22, ¶50) and a connector of the atherectomy subsystem (“proximal end 22 include an entry port for receiving guidewire 20”, ¶50) each comprise an identical handle interface (22; ¶50).
Regarding currently amended claim 11, Phan teaches the system according to claim 1, as set forth above, for the reasons set forth above, further comprising an integrated atherectomy (¶50, handle 22 includes an entry port for receiving the guidewire 20 and an electrical connection port 24) and pulsatile intravascular lithotripsy subsystem (FIG 1A, pulsed IVL generator 28, ¶50) comprising: the atherectomy subsystem (¶50, handle 22 includes an entry port for receiving the guidewire 20 and an electrical connection port 24), and the pulsatile intravascular lithotripsy subsystem(FIG 1A, pulsed IVL generator 28, ¶50).
Regarding currently amended claim 12, Phan teaches the system according to claim 1, as set forth above, for the reasons set forth above, wherein the pulsatile intravascular lithotripsy subsystem comprises a guidewire lumen (FIG 1A, “a guidewire sheath includes a lumen for receiving the guidewire 20”, ¶51), the atherectomy subsystem comprises a lateral transmission assembly comprising a guidewire (FIG 1A, “handle 22 includes an entry port for receiving the guidewire 20”, ¶50) and the guidewire is present within the guidewire lumen (FIG 1A).
Regarding new claim 16, Phan teaches the system according to claim 1, as set forth above, for the reasons set forth above, wherein the console (FIG 1A, voltage pulse generator, 28) is operably connected to the handle (FIG 1A, handle 22) configured to provide energy to each of the atherectomy subsystem and the pulsatile intravascular lithotripsy subsystem (handle 22 includes an entry port for receiving the guidewire 20 and an electrical connection port 24 is also located on the proximal end 22 to provide an electrical connection, ¶50).
The atherectomy subsystem is broadly interpreted as set forth above and includes electrical connectors and a guidewire.
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.
Claim 13 is rejected and claims 14 and 15 remain rejected under 35 U.S.C. 103 as being unpatentable over Phan et al., US 20210085347 (25 March 2021) in view of Grace et al., US 20160184570 (30 June 2016), for the reasons of record and the reasons set forth herein.
Regarding currently amended claim 13, Phan teaches the system according to claim 12, as set forth above, for the reasons set forth above.
Phan does not expressly teach wherein the atherectomy tool is present on a distal region of the guidewire.
Phan generally teaches that other catheters comprising atherectomy devices have rotating members for drilling out the lesion (¶3).
Grace teaches an atherectomy device, an ablation device including a laser catheter (FIG 9, ¶159).
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 Phan and Grace, given that the prior art included each element claimed, although not necessarily in a single reference. Phan and Grace teach methods of using medical devices for the treatment of vascular conditions.
Although, Phan discloses the claimed base system according to claim 1, as set forth above, (the system comprising a console (FIG 1A, voltage pulse generator, 28) and a handle (FIG 1A, handle 22; ¶50), Phan does not expressly disclose a specific atherectomy tool present on a distal region of the guidewire, other than generally teaching that other catheters comprising atherectomy devices have rotating members for drilling out the lesion (¶3).
Grace specifically addresses an atherectomy tool for treating a diseased vessel (FIG 9, an atherectomy device as an ablation device including a laser catheter ¶159). Grace also teaches that this tool is placed adjacent to an occlusion of a diseased vessel (FIG 9, ¶159) and is actuated such that the atherectomy tool creates a channel in the occlusion of the diseased vessel (FIG 9, ¶159). Because Phan includes a handle comprising a common connector for an atherectomy subsystem, including a guidewire, and a pulsatile intravascular lithotripsy subsystem, a person of ordinary skill in the art, seeking to coordinate the use of multiple tools with the base treatment system of Phan would reasonably consult Grace’s atherectomy tool solution comprising an ablation device including a laser catheter, considering that both Phan and Grace teach using electrically-induced pressure waves to disrupt vascular blockages. Grace’s atherectomy tool solution can be incorporated alongside Phan’s multi-connector handle (same general connector and location) using known assembly methods without redesigning Phan’s core handle design.
Because the references address the same engineering problem (methods of treating vascular occlusions using multiple methods) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an atherectomy tool of Grace to the subsystem connections of Phan), 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.
The atherectomy subsystem is broadly interpreted as set forth above and includes electrical connectors and a guidewire. The pulsatile intravascular lithotripsy subsystem is broadly interpreted as set forth above and includes electrical connectors between a distal shockwave generator and external high pulsed high voltage source.
Regarding claim 14, Phan teaches a method for treating a diseased vessel (Abstract; ¶52), the method comprising: deploying a system according to any of any of [sic] claims 1 to 13 (FIG 1A, ¶50), guiding a distal balloon of the system through the channel (¶52); and actuating the system to impart pulsatile energy to the diseased vessel (¶52).
Phan does not expressly teach an atherectomy tool of the system is adjacent to an occlusion of a diseased vessel and actuating the system such that the atherectomy tool creates a channel in the occlusion of the diseased vessel.
Phan teaches that other catheters comprising atherectomy devices have rotating members for drilling out the lesion (¶3).
Graces teaches the use of medical devices for the treatment of vascular conditions including using electrically-induced pressure waves to disrupt vascular blockages (Abstract). Grace teaches a method for treating a diseased vessel comprising an atherectomy tool (¶159, atherectomy device) that is placed adjacent to an occlusion of a diseased vessel (FIG 9; ¶159); actuating the system such that the atherectomy tool creates a channel in the occlusion of the diseased vessel (FIG 9; ¶159); guiding a distal balloon of the system through the channel (FIG 9, 920; ¶159); and actuating the system to impart pulsatile energy to the diseased vessel (FIG 9, 950; ¶159).
Phan and Grace teach methods of using medical devices for the treatment of vascular conditions. Although, Phan discloses the claimed base system according to claim 1, as set forth above (the system comprising a console (FIG 1A, voltage pulse generator, 28) and
a handle (FIG 1A, handle 22; ¶50), wherein the handle is configured to be interchangeably operably connectable to: an atherectomy subsystem, and a pulsatile intravascular lithotripsy subsystem (¶50, handle 22 includes an entry port for receiving the guidewire 20 and an electrical connection port 24 is also located on the proximal end 22 to provide an electrical connection between the distal shockwave generator 16 and an external high pulsed high voltage source 28, such as the IVL generator in FIG 1A), Phan does not expressly disclose an atherectomy tool (which is not expressly required in the system of claim 1).
Grace specifically addresses a method of using an atherectomy tool for treating a diseased vessel (¶159, atherectomy device) that is placed adjacent to an occlusion of a diseased vessel (FIG 9; ¶159); actuating the system such that the atherectomy tool creates a channel in the occlusion of the diseased vessel (FIG 9; ¶159); guiding a distal balloon of the system through the channel (FIG 9, 920; ¶159); and actuating the system to impart pulsatile energy to the diseased vessel (FIG 9, 950; ¶159). Because Phan includes a handle comprising a common connector for an atherectomy subsystem, including a guidewire, and a pulsatile intravascular lithotripsy subsystem, a person of ordinary skill in the art, seeking to coordinate the use of multiple tools for the treatment of vascular conditions would reasonably consult Grace’s atherectomy tool solution considering that Grace also teaches using electrically-induced pressure waves to disrupt vascular blockages (Abstract). Grace’s atherectomy tool solution can be incorporated alongside Phan’s multi-connector handle (same general connector and location) using known assembly methods without redesigning Phan’s core handle design.
Because the references address the same engineering problem (methods of treating vascular occlusions using multiple methods) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an atherectomy tool of Grace to the subsystem connections of Phan), 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.
The atherectomy subsystem is broadly interpreted as set forth above and includes electrical connectors and a guidewire. The pulsatile intravascular lithotripsy subsystem is broadly interpreted as set forth above and includes electrical connectors between a distal shockwave generator and external high pulsed high voltage source.
Regarding claim 15, Phan teaches a method (¶100) comprising: introducing a guidewire into luminal tissue (¶52); an atherectomy subsystem of a system according to any of claims 1 to 13 (¶50, handle 22 includes an entry port for receiving the guidewire 20 and an electrical connection port 24 is also located on the proximal end 22 to provide an electrical connection between the distal shockwave generator 16 and an external high pulsed high voltage source 28, such as the IVL generator in FIG 1A); using the guidewire to introduce into luminal tissue a distal balloon of a pulsatile intravascular lithotripsy subsystem of the system (¶52).
Phan does not expressly teach using the guidewire to introduce into luminal tissue an atherectomy tool and removing the atherectomy subsystem from the luminal tissue.
Phan teaches that other catheters comprising atherectomy devices have rotating members for drilling out the lesion (¶3).
Grace teaches the use of medical devices for the treatment of vascular conditions including using electrically-induced pressure waves to disrupt vascular blockages (Abstract). Grace teaches a method for using the guidewire to introduce into luminal tissue an atherectomy tool (FIG 9, 915; ¶159); and removing the atherectomy subsystem from the luminal tissue (¶FIG 9, 970; ¶170).
Phan and Grace teach methods of using medical devices for the treatment of vascular conditions. Although, Phan discloses the claimed base system according to claim 1, as set forth above (the system comprising a console (FIG 1A, voltage pulse generator, 28) and a handle (FIG 1A, handle 22; ¶50), wherein the handle is configured to be interchangeably operably connectable to: an atherectomy subsystem, and a pulsatile intravascular lithotripsy subsystem (¶50, handle 22 includes an entry port for receiving the guidewire 20 and an electrical connection port 24 is also located on the proximal end 22 to provide an electrical connection between the distal shockwave generator 16 and an external high pulsed high voltage source 28, such as the IVL generator in FIG 1A). Phan does not expressly teach using the guidewire to introduce into luminal tissue an atherectomy tool and removing the atherectomy subsystem from the luminal tissue. It is noted that an atherectomy tool is not expressly required in the system of claim 1, as written.
Grace specifically addresses a method of using an atherectomy tool for treating a diseased vessel (¶159, atherectomy device) that is placed adjacent to an occlusion of a diseased vessel (FIG 9; ¶159); actuating the system such that the atherectomy tool creates a channel in the occlusion of the diseased vessel (FIG 9; ¶159); guiding a distal balloon of the system through the channel (FIG 9, 920; ¶159); and removing the atherectomy subsystem from the luminal tissue (¶FIG 9, 970; ¶170). Because Phan includes a handle comprising a common connector for an atherectomy subsystem, including a guidewire, and a pulsatile intravascular lithotripsy subsystem, a person of ordinary skill in the art, seeking to coordinate the use of multiple tools for the treatment of vascular conditions would reasonably consult Grace’s atherectomy tool solution considering that Grace also teaches using electrically-induced pressure waves to disrupt vascular blockages (Abstract). Grace’s atherectomy tool solution can be incorporated alongside Phan’s multi-connector handle (same general connector and location) using known assembly methods without redesigning Phan’s core handle design.
Because the references address the same engineering problem (methods of treating vascular occlusions using multiple methods) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an atherectomy tool of Grace to the subsystem connections of Phan), 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.
The atherectomy subsystem is broadly interpreted as set forth above and includes electrical connectors and a guidewire. The pulsatile intravascular lithotripsy subsystem is broadly interpreted as set forth above and includes electrical connectors between a distal shockwave generator and external high pulsed high voltage source.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Phan et al., US 20210085347 (25 March 2021) in view of Bonnette et al., US 20140005699 (2 January 2014).
Regarding currently amended claim 6, Phan teaches the system according to claim 1, as set forth above, for the reasons set forth above.
Phan does not expressly teach wherein the atherectomy subsystem comprises: a rotational assembly configured to transduce energy transmitted from the console into rotational energy.
Phan teaches that other catheters comprising atherectomy devices have rotating members for drilling out the lesion (¶3).
Bonnette teaches wherein the atherectomy subsystem comprises: a rotational assembly (FIG 11, atherectomy assembly 200, ¶41) configured to transduce energy transmitted from the console (atherectomy control 110; ¶25) into rotational energy (FIGs 1, 3B, ¶25). Additionally, Bonnette teaches atherectomy control fitting 312 including a flexible fitting sized and shaped for reception of a control wire from the atherectomy control 110 shown in FIG 1 (¶36).
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 Phan and Bonnette, given that the prior art included each element claimed, although not necessarily in a single reference. Phan and Bonnette teach methods of using medical devices for the treatment of vascular conditions
Although, Phan discloses the claimed base system according to claim 1, as set forth above (the system comprising a console (FIG 1A, voltage pulse generator, 28) and a handle (FIG 1A, handle 22; ¶50), Phan does not expressly disclose a specific atherectomy tool as part of the system, other than generally teaching that other catheters comprising atherectomy devices have rotating members for drilling out the lesion (¶3).
Bonnette specifically addresses intravascular treatment devices comprising a rotational assembly (FIG 11, atherectomy assembly 200, ¶41) configured to transduce energy transmitted from the console (atherectomy control 110; ¶25) into rotational energy (FIGs 1, 3B, ¶25). Additionally, Bonnette teaches atherectomy control fitting 312 including a flexible fitting sized and shaped for reception of a control wire from the atherectomy control 110 shown in FIG 1 (¶36). Because Phan includes a handle comprising a common connector for an atherectomy subsystem, including a guidewire, and a pulsatile intravascular lithotripsy subsystem, a person of ordinary skill in the art, seeking to coordinate the use of multiple tools with the base treatment system of Phan would reasonably consult Bonnette’s atherectomy tool solution with a flexible control fitting and wire. Bonnette’s atherectomy assembly 200 (FIGs 1, 11) can be readily incorporated alongside Phan’s multi-connector handle (same general connector and location) using known assembly methods without redesigning Phan’s core handle design.
Because the references address the same engineering problem (intravascular treatment devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an atherectomy tool of Bonnette to the subsystem connections of Phan), 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.
The atherectomy subsystem is broadly interpreted as set forth above and includes electrical connectors and a guidewire. The pulsatile intravascular lithotripsy subsystem is broadly interpreted as set forth above and includes electrical connectors between a distal shockwave generator and external high pulsed high voltage source.
Regarding currently amended claim 7, Phan teaches the system according to claim 1, as set forth above, for the reasons set forth above.
Phan does not expressly teach wherein the atherectomy subsystem comprises: a lateral transmission assembly configured to propagate rotational energy from the rotational assembly to an atherectomy tool.
However, Phan teaches that handle 22 includes an entry port for receiving the guidewire 20 and an electrical connection port 24 is also located on the proximal end of handle 22 to provide an electrical (FIG 1A; ¶50).
Bonnette teaches a consolidated atherectomy and thrombectomy catheter (¶68) wherein the atherectomy subsystem comprises: a lateral transmission assembly (drive shaft 324) configured to propagate rotational energy (drive motor configured to rotate the drive shaft, an onboard battery electrically coupled with the drive motor, ¶88) from the rotational assembly to an atherectomy tool (¶41). Additionally, Bonnette teaches wherein the atherectomy subsystem comprises: a rotational assembly (FIG 11, atherectomy assembly 200, ¶41) configured to transduce energy transmitted from the console (atherectomy control 110; ¶25) into rotational energy (FIGs 1, 3B, ¶25). Further, Bonnette teaches atherectomy control fitting 312 including a flexible fitting sized and shaped for reception of a control wire from the atherectomy control 110 shown in FIG 1 (¶36).
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 Phan and Bonnette given that the prior art included each element claimed, although not necessarily in a single reference. Phan and Bonnette teach methods of using medical devices for the treatment of vascular conditions
Although, Phan discloses the claimed base system according to claim 1, as set forth above (the system comprising a console (FIG 1A, voltage pulse generator, 28) and a handle (FIG 1A, handle 22; ¶50), Phan does not expressly disclose wherein the atherectomy subsystem comprises: a lateral transmission assembly configured to propagate rotational energy from the rotational assembly to an atherectomy tool, as part of the system, other than generally teaching that other catheters comprising atherectomy devices have rotating members for drilling out the lesion (¶3).
Bonnette specifically addresses intravascular treatment devices comprising a rotational assembly (FIG 11, atherectomy assembly 200, ¶41) configured to transduce energy transmitted from the console (atherectomy control 110; ¶25) into rotational energy (FIGs 1, 3B, ¶25). Additionally, Bonnette teaches atherectomy control fitting 312 including a flexible fitting sized and shaped for reception of a control wire from the atherectomy control 110 shown in FIG 1 (¶36). Because Phan includes a handle comprising a common connector for an atherectomy subsystem, including a guidewire, and a pulsatile intravascular lithotripsy subsystem, a person of ordinary skill in the art, seeking to coordinate the use of multiple tools with the base treatment system of Phan would reasonably consult Bonnette’s atherectomy tool solution with a flexible control fitting and wire. Bonnette’s atherectomy assembly 200 (FIGs 1, 11) can be readily incorporated alongside Phan’s multi-connector handle (same general connector and location) using known assembly methods without redesigning Phan’s core handle design.
Because the references address the same engineering problem (intravascular treatment devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an atherectomy tool of Bonnette to the subsystem connections of Phan), 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.
The atherectomy subsystem is broadly interpreted as set forth above and includes electrical connectors and a guidewire. The pulsatile intravascular lithotripsy subsystem is broadly interpreted as set forth above and includes electrical connectors between a distal shockwave generator and external high pulsed high voltage source.
Regarding currently amended claim 8, Phan teaches the system according to claim 1, as set forth above, for the reasons set forth above.
Phan does not expressly teach wherein the atherectomy subsystem comprises: a sensor configured to sense one or more of: current, rotational position, speed, acceleration, temperature, linear position, torque, pressure or flow.
Bonnette teaches wherein the atherectomy subsystem (comprising catheter 112, ¶65) comprises: a sensor configured to sense one or more of: current, rotational position, speed, acceleration, temperature, linear position, torque, pressure or flow (flow sensor, pressure sensor, ¶65).
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 Phan and Bonnette given that the prior art included each element claimed, although not necessarily in a single reference. Phan and Bonnette teach methods of using medical devices for the treatment of vascular conditions
Although, Phan discloses the claimed base system according to claim 1, as set forth above (the system comprising a console (FIG 1A, voltage pulse generator, 28) and a handle (FIG 1A, handle 22; ¶50), Phan does not expressly teach wherein the atherectomy subsystem comprises: a sensor configured to sense one or more of: current, rotational position, speed, acceleration, temperature, linear position, torque, pressure or flow.
Bonnette specifically addresses intravascular treatment devices wherein the atherectomy subsystem (comprising catheter 112, ¶65) comprises: a sensor configured to sense one or more of: current, rotational position, speed, acceleration, temperature, linear position, torque, pressure or flow (flow sensor, pressure sensor, ¶65). Bonnette also teaches atherectomy control fitting 312 including a flexible fitting sized and shaped for reception of a control wire from the atherectomy control 110 shown in FIG 1 (¶36). Because Phan includes a handle comprising a common connector for an atherectomy subsystem, including a guidewire, and a pulsatile intravascular lithotripsy subsystem, a person of ordinary skill in the art, seeking to coordinate the use of multiple tools with the base treatment system of Phan would reasonably consult Bonnette’s combination atherectomy and thrombectomy tool solution with a flexible control fitting and wire. Bonnette’s atherectomy assembly 200 (FIGs 1, 11) can be readily incorporated alongside Phan’s multi-connector handle (same general connector and location) using known assembly methods without redesigning Phan’s core handle design.
Because the references address the same engineering problem (intravascular treatment devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an atherectomy tool of Bonnette to the subsystem connections of Phan), 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.
The atherectomy subsystem is broadly interpreted as set forth above and includes electrical connectors and a guidewire. The pulsatile intravascular lithotripsy subsystem is broadly interpreted as set forth above and includes electrical connectors between a distal shockwave generator and external high pulsed high voltage source.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Phan et al., US 20210085347 (25 March 2021) in view of Bonnette et al., US 20140005699 (2 January 2014) and further in view of Schmitt et al., US 20260090840 (2 April 2026, benefit to 21 September 2022).
Regarding new claim 17, Phan teaches the system according to claim 1, as set forth above, for the reasons set forth above.
Phan does not expressly teach the system further comprising: the atherectomy subsystem; and the pulsatile intravascular lithotripsy subsystem, wherein the atherectomy subsystem and the pulsatile intravascular lithotripsy subsystem are integrated together.
Phan does not use the same terminology as the current claims.
Phan teaches devices for treating occlusions in blood vessels including components of atherectomy systems comprising guidewires and electrical connections, and components of pulsatile intravascular lithotripsy systems comprising balloons and pulse shock wave generators (FIG 1A, ¶50). Phan also generally teaches that other catheters comprising atherectomy devices have rotating members for drilling out the lesion (¶3).
Bonnette specifically addresses a consolidated atherectomy and thrombectomy catheter (¶68) wherein the atherectomy subsystem comprises: a lateral transmission assembly (drive shaft 324) configured to propagate rotational energy (drive motor configured to rotate the drive shaft, an onboard battery electrically coupled with the drive motor, ¶88) from the rotational assembly to an atherectomy tool (¶41). Additionally, Bonnette teaches wherein the atherectomy subsystem comprises: a rotational assembly (FIG 11, atherectomy assembly 200, ¶41) configured to transduce energy transmitted from the console (atherectomy control 110; ¶25) into rotational energy (FIGs 1, 3B, ¶25). Further, Bonnette teaches atherectomy control fitting 312 including a flexible fitting sized and shaped for reception of a control wire from the atherectomy control 110 shown in FIG 1 (¶36). Additionally, Bonnette teaches the addition of an eccentrically mounted balloon (FIG 11, inflatable balloon 1102, ¶69). Bonnette teaches that balloon 1102 may be repeatedly inflated and deflated along with rotation of catheter 112 to reposition the balloon 1102 between each inflation (¶70). Bonnette also teaches a combination of the consolidated multi-device treatment systems, as set forth in Example 30 (comprising optional combinations of the subject matter of Examples 1-29 and an inflatable balloon) (¶100). See also, ¶103.
Schmitt specifically addresses intravascular treatments comprising devices including intravascular lithotripsy (IVL) subsystems including balloons that deliver shock wave pulses (claim 11), specific atherectomy tools including laser atherectomy catheters (claim 11), orbital atherectomy devices (claim 11), and rotational assemblies comprising rotablation atherectomy devices (claim 11). Schmitt utilizes a computer-implemented models to assess the patient-specific plaque and generate a recommendation for at least one parameter from the available systems/subsystems (claim 11) to affect treatment.
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 Phan, Bonnette, and Schmitt, given that the prior art included each element claimed, although not necessarily in a single reference. Phan, Bonnette, and Schmitt teach methods of using atherectomy and IVL devices for the treatment of occlusive vascular conditions.
Although, Phan discloses the claimed base system according to claim 1, as set forth above, (the system comprising a console (FIG 1A, voltage pulse generator, 28) and a handle (FIG 1A, handle 22; ¶50), Phan does not expressly disclose a specific atherectomy tool as part of the system, other than generally teaching that other catheters comprising atherectomy devices have rotating members for drilling out the lesion (¶3).
Bonnette specifically addresses a consolidated atherectomy and thrombectomy catheter (¶68) that also optionally includes a balloon that can be pulsed along with the rotation of the catheter (¶¶69-70), such that all of the components are integrated together, as provided in Example 30 (¶100). Schmitt specifically addresses intravascular treatments comprising devices including intravascular lithotripsy (IVL) subsystems including balloons that deliver shock wave pulses (claim 11), specific atherectomy tools including laser atherectomy catheters (claim 11), orbital atherectomy devices (claim 11), and rotational assemblies comprising rotablation atherectomy devices (claim 11). Schmitt also provides express motivation for utilizing a consolidated/integrated IVL atherectomy system by utilizing computer-implemented models to assess the patient-specific plaque and generate a recommendation for at least one parameter from the available IVL/atherectomy (claim 11) to affect treatment. Bonnette provides a similar motivation to combine the consolidated multi-device treatment systems, as set forth in Example 30 (comprising optional combinations of the subject matter of Examples 1-29 and an inflatable balloon) (¶100). See also, ¶103.
Because Phan includes a console and a handle comprising a common connector for an atherectomy subsystem, including a guidewire, and a pulsatile intravascular lithotripsy subsystem, a person of ordinary skill in the art, seeking to coordinate the use of multiple tools with the base treatment system of Phan would reasonably consult Bonnette’s consolidated tool solution, specifically addressing a consolidated atherectomy and thrombectomy catheter (¶68) that also optionally includes a balloon that can be pulsed along with the rotation of the catheter (¶¶69-70), such that all of the components are integrated together, as provided in Example 30 (¶100). Moreover, Schmitt provides additional express motivation for the consolidation/integration by utilizing computer-implemented models to assess the patient-specific plaques and generate a recommendation for at least one parameter from the available multiple IVL/atherectomy systems (claim 11) to affect treatment. One of ordinary skill in the
Bonnette’s consolidated devices along with motivation for the combination/integration using Schmitt’s computer-implemented model recommender system for personalized plaque remediation can be incorporated alongside Phan’s multi-connector handle (same general connector and location) using known assembly methods without redesigning Phan’s core handle design.
Because the references address the same engineering problem (intravascular treatment devices to reduce plaques) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (providing consolidated/integrated tool systems/subsystems as taught by Bonnette, as motivated by Schmitt, and as guided by Phan, with the subsystem connections of Phan), 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.
The atherectomy subsystem is broadly interpreted as set forth above and includes electrical connectors and a guidewire. The pulsatile intravascular lithotripsy subsystem is broadly interpreted as set forth above and includes electrical connectors between a distal shockwave generator and external high pulsed high voltage source.
Regarding new claim 18, Phan modified by Bonnette and Schmitt teach the system according to claim 17, as set forth above, for the reasons set forth above.
Bonnette teaches wherein the atherectomy subsystem and the pulsatile intravascular lithotripsy subsystem comprise a unitary tool (Example 30, ¶100), as set forth above.
Regarding new claim 19, Phan modified by Bonnette and Schmitt teach the system according to claim 17, as set forth above, for the reasons set forth above.
Bonnette teaches wherein the atherectomy subsystem and the pulsatile intravascular lithotripsy subsystem comprise a common distal region (FIG 11, distal catheter portion 116, comprising distal tip cutter 204, expandable cutter 206, macerator 208, and inflatable balloon 1102, ¶69). Bonnette also teaches that balloon 1102 may be repeatedly inflated and deflated along with rotation of catheter 112 to reposition the balloon 1102 between each inflation (¶70), as set forth above. See also Example 30 (¶100).
Regarding new claim 20, Phan modified by Bonnette and Schmitt teach the system according to claim 18, as set forth above, for the reasons set forth above.
Bonnette teaches wherein the unitary tool comprises an atherectomy tool and a balloon, wherein the atherectomy tool is located distal to the balloon (FIG 11, distal catheter portion 116, comprising distal tip cutter 204, expandable cutter 206, macerator 208, and inflatable balloon 1102, ¶69).
New Claim Rejections – Necessitated by Amendment
Claim Rejections - 35 USC § 112(b)
Amended claim 11 is 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 11 recites “the system according to claim 1, further comprising an integrated atherectomy and pulsatile intravascular lithotripsy subsystem comprising: the atherectomy subsystem, and the pulsatile intravascular lithotripsy subsystem.” The claim, as written, is unclear and confusing. The claim is dependent on claim 1 and recites that the two systems are integrated as A and B comprising themselves as A and B. It is unclear whether the claim is duplicative in nature or whether the “integrated” language intends to capture more than the sum of the component “comprising” parts (or subsystems) or some other intent/interpretation.
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).
Amended claim 13 is 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.
Amended claim 13 recites the limitation "the atherectomy tool" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 13 is dependent on claim 12, which is dependent on claim 1. None of these claims provide antecedent basis for “the atherectomy tool” of claim 13.
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.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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