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 .
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 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.
Response to Amendment
Acknowledgement is made to the amendment received 02/20/2026.
Acknowledgement is made to the amendment of claims 2-4, 6, 8, 10, 35, 51, and 57-61.
Acknowledgement is made to the cancellation of claims 1, 5, 7, 11, 13, 15-22, 24-35, and 37-49.
Acknowledgement is made to the newly added claims 62-66.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 2-4, 6, 8-10, 12, 14, 23, 36, and 50-66 are pending. A complete action on the merits appears below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 4, 9, 12, 56, and 64 are rejected under 35 U.S.C. 102(a)(a) as being anticipated by di Palma (US 20160228681 A1).
Regarding claim 4, di Palma teaches an excision catheter system (Abstract), comprising:
an excision catheter assembly having:
a catheter (Fig. 7A-E; procedure sheath 5) having a distal end, a proximal end, and a channel that extends from the distal end toward the proximal end; and
a cutting assembly having:
a cutting shaft (Fig. 7A-E; elongate hollow member 110; [0047]- [0048]) with a leading end, a trailing end spaced from the leading end in a distal direction along a central axis, and an inner channel that extends from the leading end toward the trailing end, and at least one port that extends to the inner channel ([0028] discusses the elongated shaft 10 as being hollow, [0033] discusses the fluid as exiting through the plurality of ports 35); and
at least one cutting element ([0038], [0047]- [0048] discuss the sharpened edges, referred to as skives for scraping tissue) carried by the cutting shaft and having a terminal end, the at least one cutting element having an insertion configuration, where the at least one cutting element is located inside the inner channel, a deployed configuration, where the terminal end of the at least one cutting element is located distal to the leading end in the distal direction, and a cutting configuration where the terminal end of the at least one cutting element is angularly offset with respect to the central axis (Fig. 7A-E; the device is shown as being advanced from a compressed position where the device is located within the lumen of the sheath in a way which is collapsed along the central axis of the device to one where the device is fully expanded to contact the vessel wall, providing the skives of the arms which scrape the tissue to be placed out of line with the central axis as they round to contact tissue, therefore teaching the claim limitation of angularly offset as broadly as is claimed in view of the Oxford Languages definition of the term offset with relationship to an angle or alignment).
Regarding claim 9, di Palma teaches the excision catheter system of claim 4, wherein the at least one cutting element is a pair of cutting elements ([0044]).
Regarding claim 12, di Palma teaches the excision catheter system of claim 9, wherein the pair of cutting elements are aligned when in the insertion configuration and distal-most terminal ends are splayed apart when in the cutting configuration (Fig. 7A-E; shows the arms which contain the skives for scraping tissue as being aligned when located within the sheath and separated from one another when in the expanded configuration to contact and scrape the tissue with the skives).
Regarding claim 56, di Palma teaches the excision catheter system of claim 4, further comprising a retention member configured to retain an excised leaflet (Fig. 7A-E; segment 20).
Regarding claim 64, di Palma teaches the excision catheter system of claim 4, further comprising an extraction member (Fig. 7A-E; expandable capture sheath 125) disposed in the channel, the extraction member having a retracted configuration, where the extraction member is located inside the channel of the catheter, and an expanded configuration, where the extraction member is expanded and positioned outside the catheter ([0051]- [0053]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 6, 8, 10, 23, 36, 57-63, and 65-66 are rejected under 35 U.S.C. 103 as being unpatentable over di Palma (US 20160228681 A1) in view of Sibbitt (US-20070060895-A1).
Regarding claim 2, di Palma teaches an excision catheter system (Abstract), comprising:
a catheter (Fig. 7A-E; procedure sheath 5) having a distal end, a proximal end, and a channel that extends from the distal end toward the proximal end; and
a cutting assembly (Fig. 7A-E; device 1, [0047]- [0048] teaches the arms of the treatment device as having sharpened edges which scrape tissue) with a leading end, a trailing end spaced from the leading end in a distal direction, an inner channel that extends from the leading end toward the trailing end, at least one port that extends to the inner channel ([0028] discusses the elongated shaft 10 as being hollow, [0033] discusses the fluid as exiting through the plurality of ports 35) and at least one cutting element ([0038], [0047]- [0048] discuss the sharpened edges, referred to as skives for scraping tissue), wherein the leading end is configured to move outside of the catheter ([0051]- [0053]); and
a retention member (Fig. 7A-E; expandable cone member 120) configured to retain an excised leaflet.
However, di Palma fails to teach the cutting assembly including a piercing tip configured to pierce a leaflet of a valve.
Sibbitt teaches an expandable distal device for insertion into a blood vessel of a patient the expandable element comprising a plurality of elongate elements having a sharp cutting surface for contacting tissue (Abstract, [0027]).
Sibbitt further teaches the elements for engaging the tissue within the vessel of the patient as being hooks which are sharp to penetrate tissue without cutting the tissue as other surfaces along the hook ([0027]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the elements for contacting and cutting patient tissue within a vessel as being a plurality of hooks, as is taught by Sibbitt, into the element for removing a thrombosis as is taught by di Palma, to produce the predictable result of treating tissue along a blood vessel as is taught Sibbitt, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 6, di Palma teaches the excision catheter system of claim 2, wherein the at least one cutting element includes an elongate shaft and a cutting element that extends from the elongate shaft.
However, di Palma fails to teach the cutting element as being a cutting hook which has a leg that is offset with respect to the elongate shaft.
Sibbitt teaches an expandable distal device for insertion into a blood vessel of a patient the expandable element comprising a plurality of elongate elements having a sharp cutting surface for contacting tissue (Abstract, [0027]).
Sibbitt further teaches the elements for engaging the tissue within the vessel of the patient as being hooks ([0027]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the elements for contacting and cutting patient tissue within a vessel as being a plurality of hooks, as is taught by Sibbitt, into the element for removing a thrombosis as is taught by di Palma, to produce the predictable result of treating tissue along a blood vessel as is taught Sibbitt, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 8, in accordance with the above rejection of claim 6, Sibbitt further teaches the excision catheter system of claim 6, wherein the leading end of the cutting assembly includes a piercing tip configured to pierce a leaflet of a valve ([0027]).
Regarding claim 10, in accordance with the above rejection of claim 6, Sibbitt further teaches the excision catheter system of claim 6, wherein the cutting hook has a curved body that curves around a central axis of the cutting shaft, the curved body defining a forward cutting edge and a rearward cutting edge ([0027]).
Regarding claim 23, di Palma teaches the excision catheter system of claim 2 further comprising comprises a retention member configured to retain an excised leaflet (Fig. 7A-E; segment 20).
Regarding claim 36, di Palma teaches the excision catheter system of claim 23, wherein the extraction catheter is a steerable catheter ([0055]- [0057] teaches the control of the positioning of the device by the use of a guidewire).
Regarding claim 57, di Palma teaches the excision catheter system of claim 2, further comprising an introducer configured to slide within the channel of the catheter, the introducer having a lumen (Fig. 8; guidewire lumen 213).
Regarding claim 58, di Palma teaches the excision catheter system of claim 4, further comprising a retention member configured to retain an excised leaflet (Fig. 7A-E; expandable cone member 120).
In accordance with the above rejection of claim 6, Sibbitt further teaches the excision catheter system of claim 4, wherein the cutting assembly includes a piercing tip configured to pierce a leaflet of a valve ([0027]).
Regarding claim 59, in accordance with the above rejection of claim 6, Sibbitt further teaches the excision catheter system of claim 58, wherein the at least one cutting element includes an elongate shaft and at least one cutting hook that extends from the elongate shaft, wherein the at least one cutting hook has a leg that is offset with respect to the elongate shaft ([0027]).
Regarding claim 60, di Palma teaches the excision catheter system of claim 4, wherein the at least one cutting element is a pair of cutting elements ([0044]).
However, di Palma fails to teach the cutting element as being a cutting hook.
Sibbitt teaches an expandable distal device for insertion into a blood vessel of a patient the expandable element comprising a plurality of elongate elements having a sharp cutting surface for contacting tissue (Abstract, [0027]).
Sibbitt further teaches the elements for engaging the tissue within the vessel of the patient as being hooks ([0027]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the elements for contacting and cutting patient tissue within a vessel as being a plurality of hooks, as is taught by Sibbitt, into the element for removing a thrombosis as is taught by di Palma, to produce the predictable result of treating tissue along a blood vessel as is taught Sibbitt, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 61, di Palma further teaches the excision catheter system of claim 60, wherein the pair of cutting elements are aligned when in the insertion configuration and distal-most terminal ends are splayed apart when in the cutting configuration (Fig. 7A-E; shows the arms which contain the skives for scraping tissue as being aligned when located within the sheath and separated from one another when in the expanded configuration to contact and scrape the tissue with the skives).
In accordance with the above rejection of claim 60, Sibbitt further teaches the cutting elements as being cutting hooks ([0027]).
Regarding claim 62, di Palma teaches the excision catheter system of claim 2, further comprising an extraction member (Fig. 7A-E; expandable capture sheath 125) disposed in the channel of the catheter, the extraction member having a retracted configuration, where the extraction member is located inside the channel of the catheter, and an expanded configuration, where the extraction member is expanded and positioned outside the catheter ([0051]- [0053]).
Regarding claim 63, di Palma teaches the excision catheter system of claim 2, further comprising an extraction member disposed in the channel and configured to exit the channel and expand ([0051]- [0053]).
Regarding claim 65, di Palma teaches the excision catheter system of claim 2, further comprising a retention member configured to retain an excised leaflet (Fig. 7A-E; expandable cone member 120).
However, di Palma fails to teach the cutting assembly including a piercing tip configured to pierce a leaflet of a valve.
Sibbitt teaches an expandable distal device for insertion into a blood vessel of a patient the expandable element comprising a plurality of elongate elements having a sharp cutting surface for contacting tissue (Abstract, [0027]).
Sibbitt further teaches the elements for engaging the tissue within the vessel of the patient as being hooks which are sharp to penetrate tissue without cutting the tissue as other surfaces along the hook ([0027]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the elements for contacting and cutting patient tissue within a vessel as being a plurality of hooks, as is taught by Sibbitt, into the element for removing a thrombosis as is taught by di Palma, to produce the predictable result of treating tissue along a blood vessel as is taught Sibbitt, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 66, di Palma teaches the excision catheter system of claim 3, further comprising a retention member configured to retain an excision leaflet (Fig. 7A-E; expandable cone member 120).
However, di Palma fails to teach the cutting shaft including a piercing tip configured to pierce a leaflet of a valve.
Sibbitt teaches an expandable distal device for insertion into a blood vessel of a patient the expandable element comprising a plurality of elongate elements having a sharp cutting surface for contacting tissue (Abstract, [0027]).
Sibbitt further teaches the elements for engaging the tissue within the vessel of the patient as being hooks which are sharp to penetrate tissue without cutting the tissue as other surfaces along the hook ([0027]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the elements for contacting and cutting patient tissue within a vessel as being a plurality of hooks, as is taught by Sibbitt, into the element for removing a thrombosis as is taught by di Palma, to produce the predictable result of treating tissue along a blood vessel as is taught Sibbitt, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claims 3 and 53-55 rejected under 35 U.S.C. 103 as being unpatentable over di Palma (US 20160228681 A1) in view of Nguyen (US-20200390458-A1).
Regarding claim 3, di Palma teaches an excision catheter system (Abstract), comprising:
a catheter (Fig. 7A-E; procedure sheath 5) having a distal end, a proximal end, and a channel that extends from the distal end toward the proximal end; and
a cutting shaft (Fig. 7A-E; elongated shaft 10; [0047]- [0048]) with at least one cutting element (Fig. 7A-E; holes 62 which comprise sharpened elements), including an inner channel, at least one port that extends to the inner channel ([0028] discusses the elongated shaft 10 as being hollow, [0033] discusses the fluid as exiting through the plurality of ports 35) and at least one cutting element being moveable relative to the catheter ([0047]- [0048] teaches the sharped elements located on the arms as being rotatable to scrape the tissue, [0051] teaches the expandable capture sheath as being independently movable relative to the shaft of the infusion device) and
a retention member configured to retain an excised leaflet (Fig. 7A-E; expandable cone member 120).
However, di Palma fails to teach the cutting element as being responsive to electric energy.
Nguyen teaches a treatment device having an elongate member, a distal element having an expandable structure and an elongate member, wherein the distal element is configured to expand into a blood vessel wall to facilitate the removal of a thrombus from a treatment site ([0581]).
Nguyen further teaches the distal element and the elongated member as being electrodes to treat the tissue along the lumen ([0651]- [0653]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the element for removal of thrombosis within a blood vessel as being an electrode, as is taught by Nguyen, into the element for removing a thrombosis as is taught by di Palma, to produce the predictable result of treating thrombosis along a blood vessel as is taught Nguyen, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 53, di Palma further teaches the excision catheter system of claim 3, wherein the at least one cutting element is a pair of cutting elements ([0044]).
Regarding claim 54, di Palma teaches the excision catheter system of claim 53, wherein the pair of cutting elements are aligned when in an insertion configuration and distal-most terminal ends are splayed apart when in a cutting configuration (Fig. 7A-E; shows the arms which contain the skives for scraping tissue as being aligned when located within the sheath and separated from one another when in the expanded configuration to contact and scrape the tissue with the skives).
Regarding claim 55, di Palma teaches the excision catheter system of claim 3, further comprising a retention member configured to retain an excised leaflet (Fig. 7A-E; segment 20).
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over di Palma (US 20160228681 A1) in view of McCartney (US-20060247572-A1).
Regarding claim 14, di Palma teaches the excision catheter system of claim 4.
However, di Palma fails to teach the system further comprising one or more actuators, the one or more actuators, wherein the cutting catheter has a first actuator configured to cause the at least one cutting element to transition from the insertion configuration into the deployed configuration, and separately a second actuator configured to cause the at least one cutting element to transition between the deployed configuration and the cutting configuration.
McCartney teaches a medical device removal system having a gripper to grip elements within a body vessel (Abstract).
McCartney further teaches the device as including a plurality of actuators for controlling and moving portions of the device ([0067]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the actuators for controlling elements within a device, as is taught by McCartney, into the device having a plurality of elements which are individually movable and actuatable as is taught by di Palma, to produce the predictable result of controlling the movement and actuation of a variety of elements which are individually movable and controllable as is taught McCartney, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claims 50-52 are rejected under 35 U.S.C. 103 as being unpatentable over di Palma (US 20160228681 A1) in view of Sibbitt (US-20070060895-A1) and Nguyen (US-20200390458-A1).
Regarding claim 50, Nguyen further teaches the excision catheter system of claim 2 wherein the at least one cutting element is an electrode that is responsive to electrical energy ([0651]- [0653]).
Regarding claim 51, in accordance with the above rejection of claim 6, Sibbitt further teaches the excision shaft system of claim 3, wherein a leading end of the cutting catheter includes a piercing tip configured to pierce a leaflet of a valve ([0027]).
Regarding claim 52, in accordance with the above rejection of claim 6, Sibbitt further teaches the excision catheter system of claim 3, wherein the at least one cutting element includes an elongate shaft and a cutting hook that extends from the elongate shaft, wherein the cutting hook has a leg that is angularly offset with respect to the elongate shaft ([0027]).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the di Palma reference are moot in view of the new rejections under the modified rejection of di Palma and the newly provided rejection of di Palma and Sibbitt.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794