DETAILED ACTION
Applicant’s amendments and remarks, filed August 31, 2026, are fully acknowledged by the Examiner. Currently, claims 1-9 and 11-20 are pending with claim 10 cancelled, and claims 1 and 14 amended. The following is a complete response to the August 31, 2026 communication.
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 .
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 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barnes et al. (WO 2016/044072 A1).
Regarding claim 14, Barnes provides for a medical device (see figures 8-13, device 100), the device comprising: a catheter (shaft 120),
an incision device operably coupled to a distal end of the catheter (distal end 114 including the tip 122 at the end of the shaft 120), wherein the incision device comprises an incision channel defined along the incision device (opening 124 extending into the device as in figures 10/11),
a first row of suction devices and a second row of suction devices (a first and a second row of 138 as in figures 10/11), wherein the rows are positioned on opposite sides of the incision channel (see figures 10/11),
one or more stabilizing members structured to maintain the incision device at a given location (134a/134b/136), and
a cutting surface disposed within the incision channel (126/132), wherein the cutting surface is fixed along the longitudinal axis (the fixed relationship relative to the longitudinal axis depicted in figures 8/9 at X is provided by the surface 126/132 being fixed relative to the shaft opening 124 as well as fixed relationship to the elevator balloon 130 such that the inflation of the elevator balloon 130 latitudinally extends the surface 126/132 through the opening 124. Such is shown in figures 8 and 9 as well as described in paragraphs [106] and [109]),
wherein in an instance in which the cutting surface is in the retracted position, the cutting surface is disposed within the incision channel (as in figure8 with the structure of 126/132 within the opening and cavity), and
wherein in an instance in which the cutting surface is in the deployed position, the cutting surface at least partially protrudes from the incision channel (See figure 9 with 126/132 at least partially protruding).
Regarding claim 15, Barnes provides for a cutting apparatus actuation mechanism structured to move the cutting surface between the retracted position and the deployed position (at least balloon 30).
Regarding claim 16, Barnes provides that the first row of suction devices defines a first row length and the second row of suction devices defines a second row length, wherein at least one of the first row length or the second row length is a same length as a cutting surface length of the cutting surface. The Examiner is of the position that each of a first row length and a second row length can be defined, for example, as the length along two sequential and adjacent ones of 138. Accordingly, this ‘row length’ would then correspond to the same length along the cutting surface 126/132.
Regarding claim 17, Barnes provides that the first row of suction devices defines a first row length and the second row of suction devices defines a second row length, wherein at least one of the first row length or the second row length is a greater length than a cutting surface length of the cutting surface. The Examiner is of the position that each of a first row length and a second row length can be defined, for example, as the length along two sequential and adjacent ones of 138. Accordingly, this ‘row length’ can then be defined as a length that is greater than a portion of the overall length of entirety of the cutting surface 126/132 as defined from the distalmost end to the proximal-most end.
Regarding claim 18, Barnes provides that the cutting surface is structured to be moveable between the retracted position and the deployed position upon placement of the incision device (the structure of 126/132 is capable of being retracted and deployed when the device is placed at a desired location).
Regarding claim 19, Barnes provides that the cutting surface is at least one of a blade or an electrode (126/132 is a blade as in [107]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 9, 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (WO 2016/044072 A1) further in view of Hilton et al. (WO 2017/176800 A1).
Regarding claim 1, Barnes provides for a medical device (see figures 8-13, device 100), the medical device comprising: a catheter (shaft 120), an incision device operably coupled to a distal end of the catheter (distal end 114 including the tip 122 at the end of the shaft 120), wherein the incision device comprises an incision channel defined along the incision device (opening 124 extending into the device as in figures 10/11), a first row of suction devices and a second row of suction devices (a first and a second row of 138 as in figures 10/11), wherein the rows are positioned on opposite sides of the incision channel (See figures 10/11), and a cutting surface disposed within the incision channel (126/132), wherein the cutting surface is structured to move between a retracted position (see figure 8) and a deployed position (see figure 9), wherein in an instance in which the cutting surface is in the retracted position, the cutting surface is disposed within the incision channel (as in figure8 with the structure of 126/132 within the opening and cavity), and wherein in an instance in which the cutting surface is in the deployed position, the cutting surface at least partially protrudes from the incision channel (See figure 9 with 126/132 at least partially protruding).
While Barnes contemplates portions of the tip 122 to have properties that aid in the visualization of the placement of the tip (see [105] providing for 122 to be echogenic), Barnes fails to specifically provides that the cutting surface comprises a radiopaque edge portion. Hilton provides for a cutting device similar to embodiments as in the Barnes reference, and specifically contemplates the use of a radiopaque portion on the blade of the device (see [0055]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a radiopaque edge portion for the cutting surface of Barnes in view of the teaching of Hilton. Hilton readily contemplates the placement of the visualization portion of the device at the tip of the device (as in Barnes) or on the cutting portion of the device (again, see [0055]) with either functioning equally as well to provide for the requisite visualization of the location of cutting within the body. The Examiner further notes that Hilton readily contemplates the use of ultrasound in combination with the radiopaque markers for similar real-time visualization as contemplated in Barnes (see [0056] of Hilton).
Regarding claim 2, Barnes provides for a cutting apparatus actuation mechanism structured to move the cutting surface between the retracted position and the deployed position (at least balloon 30).
Regarding claim 3, Barnes provides that the first and second rows of suction devices are parallel (see figures 10/11 with the parallel rows of 138).
Regarding claim 4, Barnes provides that the first row of suction devices defines a first row length and the second row of suction devices defines a second row length, wherein at least one of the first row length or the second row length is a same length as a cutting surface length of the cutting surface. The Examiner is of the position that each of a first row length and a second row length can be defined, for example, as the length along two sequential and adjacent ones of 138. Accordingly, this ‘row length’ would then correspond to the same length along the cutting surface 126/132.
Regarding claim 5, Barnes provides that the first row of suction devices defines a first row length and the second row of suction devices defines a second row length, wherein at least one of the first row length or the second row length is a greater length than a cutting surface length of the cutting surface. The Examiner is of the position that each of a first row length and a second row length can be defined, for example, as the length along two sequential and adjacent ones of 138. Accordingly, this ‘row length’ can then be defined as a length that is greater than a portion of the overall length of entirety of the cutting surface 126/132 as defined from the distalmost end to the proximal-most end.
Regarding claim 6, Barnes provides that the first and second row of suction devices are structured to connect to a vacuum source (the 138 are readily capable and structure to be connected to a source of vacuum).
Regarding claim 7, Barnes provides that the cutting surface is at least one of a blade or an electrode (126/132is a blade as in [107]).
Regarding claim 9, Barnes provides that the catheter is steerable (via the structural capability of 120 to be steered in some manner such as by manual manipulation relative to a tissue site)
Regarding claim 11, Barnes provides for one or more stabilizing members structured to maintain the incision device at a given location (134a/134b/136).
Regarding claim 13, Barnes provides for a controller engaged to the incision device (handpiece 16), wherein the controller is structured to provide at least one of suction to first and second rows of suction devices, movement of the blade between the retracted position and the deployed position, movement of the cutting apparatus along the incision device, energy to the incision device, or movement of one or more stabilizing members (see [77] providing for various functions provided by the structure of 16 including the controls 18).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (WO 2016/044072 A1) in view of Hilton et al. (WO 2017/176800 A1) as applied to claim 1 above, and further in view of Bramlet (US Pat. No. 5,649,946)
Regarding claim 12, while Barnes fails to explicitly state that the device is sterilized, the Examiner is of the position that the sterilization of an invasive medical device for treatment within the body is a well-known and obvious consideration to one of ordinary skill in the art at the time of filing. For example, Bramlet teaches a similar device as that of Barnes that is sterilized for use (see col. 4; 8-15). Therefore, the Examiner is of the position that it would have been obvious to one of ordinary skill in the art to sterilize the device of Barnes in view of the teaching of Bramlet to provide for a sterilized device that is safe to use for a treatment with a reduced chance of infection in the patient.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (WO 2016/044072 A1) as applied to claim 19 respectively above, and further in view of Deem et al. (US Pat. Pub. 2010/0125266 A1).
Regarding claims 8 and 20, while Barnes provides for the inclusion of a blade, Barnes fails to specifically provide for the inclusion of an electrode that is structured to receive current and/or radio frequency energy to ablate, burn, vaporize, and/or separate tissue. Deem discloses a similar device as that of Barnes and specifically contemplates the use of a cutting blade (32) or an electrode (45) on an external portion of a balloon for cutting through locations of tissue including those contemplated in Barnes. Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have modified the blade of Barnes to be electrically conductive as an electrode in view of the teaching in Deem to provide for a combined arrangement that can cut tissue utilizing a cutting current applied thereto. The application of energy during cutting tissue is a well-known and appreciated modality in the art which provides advantages such as a reduction in the amount of force needed to be applied as well as cauterizing tissue during the cutting.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (WO 2016/044072 A1) in view of Hilton et al. (WO 2017/176800 A1) as applied to claim 7 above, and further in view of Deem et al. (US Pat. Pub. 2010/0125266 A1).
Regarding claims 8 and 20, while Barnes provides for the inclusion of a blade, Barnes fails to specifically provide for the inclusion of an electrode that is structured to receive current and/or radio frequency energy to ablate, burn, vaporize, and/or separate tissue. Deem discloses a similar device as that of Barnes and specifically contemplates the use of a cutting blade (32) or an electrode (45) on an external portion of a balloon for cutting through locations of tissue including those contemplated in Barnes. Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have modified the blade of Barnes to be electrically conductive as an electrode in view of the teaching in Deem to provide for a combined arrangement that can cut tissue utilizing a cutting current applied thereto. The application of energy during cutting tissue is a well-known and appreciated modality in the art which provides advantages such as a reduction in the amount of force needed to be applied as well as cauterizing tissue during the cutting.
Response to Arguments
Applicant's arguments on page 7 of the Remarks filed August 31, 2026 with respect to the rejection of claim 14 under 35 U .S.C. 102(a)(1) as anticipated by Barnes have been fully considered but they are not persuasive.
Applicant argues therein that “Barnes does not disclose, teach, or suggest a cutting surface that is fixed along the longitudinal axis, but can move latitudinally into a deployed position” as currently set forth in the amended version of claim 14. Applicant contends that “Barnes’ blade ‘moves longitudinally along the ‘x’ axis along the guide rail 28 in a forward distal direction and backwards proximal direction.” This is not persuasive.
Applicant’s arguments on page 7 of the Remarks incorrectly reference a separate embodiment of Barnes not relied upon by the Examiner in the rejection of claim 14. Specifically, the guide rail 28 arrangement argued for by Applicant as evidence of longitudinal movement in Barnes appears in the embodiment in figures 1-7, and is not part of the relied upon embodiment in figures 8-13.
To this end, the Examiner has relied upon the embodiment depicted in figures 8-13 to display a cutting surface disposed within the incision channel at elements 126/132, wherein the cutting surface is fixed along the longitudinal axis. The Examiner is of the position that this fixed relationship relative to the longitudinal axis depicted in figures 8/9 at X is provided by the surface 126/132 being fixed relative to the shaft opening 124 as well as fixed relationship to the elevator balloon 130 such that the inflation of the elevator balloon 130 latitudinally extends the surface 126/132 through the opening 124. Such is shown in figures 8 and 9 as well as described in paragraphs [106] and [109].
As such, it is for at least the reasoning above that the Examiner maintains that Barnes does indeed anticipate the subject matter set forth in independent claim 14, and that the rejection of claims 14-19 under 35 U.S.C. 102(a)(1) as anticipated by Barnes remains tenable.
Applicant’s arguments with respect to the prior rejection of independent claim 1 as anticipated by the Barnes reference in light of amended claim 1 on page 6 of the Remarks filed August 31, 2026, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-7, 9, 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (WO 2016/044072 A1) further in view of Hilton et al. (WO 2017/176800 A1).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (WO 2016/044072 A1) in view of Hilton et al. (WO 2017/176800 A1) as applied to claim 1 above, and further in view of Bramlet (US Pat. No. 5,649,946)
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (WO 2016/044072 A1) as applied to claim 19 respectively above, and further in view of Deem et al. (US Pat. Pub. 2010/0125266 A1).
It is the Examiner’s position that the newly cited Hilton reference readily cures the noted deficiency in Barnes with respect to the requirement in claim 1 for the cutting surface to comprise a radiopaque edge portion.
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 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 RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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