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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 4th, 2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/933,007, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The embodiment as claimed in independent claims 1 & 21 are shown in Figures 7A-7H and in [0069]-[0073] of the instant application; the embodiment of independent claim 8 is shown in Figures 11-17 [0076]-[0079] of the instant application; the provisional patent application (Application No. 62/933,007) only provides disclosure for the embodiment as shown in figures 5A-5, of the instant application (see figures 1-6 & paragraphs [0001]-[0032] of the provision patent application 62/933,007). Accordingly, claims 1-2, 5-10, 13-14, & 21 are not entitled to the benefit of the prior application.
Response to Amendment
The amendment filed March 4th, 2026 has been entered. Claims 1-2, 8, & 21 are amended. Claims 3-4, 11-12, & 15-20 are canceled. Claims 1-2, 5-10, 13-14, & 21 remain pending.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 8 & 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rafiee et al. (US 20210137579 A1), hereinafter “Rafiee”.
Regarding claim 8, in a first interpretation, Rafiee discloses a system for making modifications to native leaflets comprising: a delivery catheter ([0104]; Figures 70 & 76—element “outer shaft”; the examiner is considering the delivery catheter to be the outer shaft); a cutting element comprising an electrical looped wire ([0103] & [0104]; Figures 66 & 71-78—element “T-lacerator”; the examiner is considering the electrical looped wire to be the “T-lacerator” which comprises an expandable cutting wire) and having 1) a first configuration ([0103] & [0104]; Figures 64, 70, 71, & 76; the examiner is considering the first configuration to be the collapsed position of the T-lacerator) in which a distal crossing portion is positioned to pierce a leaflet via radiofrequency energy ([0040], [0103], & [0104]; Figures 64, 70, 71, & 76—element “guidewire”; in the first interpretation the examiner is considering the distal crossing portion to be the guidewire that is configured to be electrified to burn through the leaflet while the T-lacerator is in the collapsed configuration) and allow the cutting element to pass through the leaflet ([0103] & [0104]; Figures 66 & 70-78—element “T-lacerator” after the guidewire is electrified and burned through the leaflet, the T-lacerator is advanced and positioned past the leaflet), and 2) an expanded second configuration in which the electrical looped wire of the cutting element forms a continuous wing-shaped radio frequency cutting contour shaped to cut a slit through the leaflet by translation of the cutting contour through the leaflet while energized ([0040], [0103], & [0104]; Figures 66, 68-69, 73-75 & 77-78; the “T” lacerator is then deployed by withdrawing the inner shaft; the lacerator is then electrified and pulled to cut through the leaflet such that “T” shaped lacerations can be accomplished in the aortic leaflet; the lacerator is formed of an expandable wire); and, a push rod connected to the cutting element ([0104]; Figure 72—element “Mid Shaft”/ “intermediate shaft” ; the examiner is considering the push rod to be the intermediate shaft).
Regarding claim 10, in the first interpretation, Rafiee discloses all of the limitations of claim 8, as described above.
Rafiee further discloses wherein the cutting element is configured to cut through the leaflet when retracted ([0103] & [0104]; Figures 66, 68, & 69).
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.
Claims 1-2, 7-10, & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Rafiee in view of Brown et al. (US 20130310833 A1), hereinafter “Brown”.
Regarding claim 1, Rafiee discloses a valve leaflet modification device comprising: a delivery catheter ([0104]; Figure 72—element “Mid Shaft”/ “intermediate shaft” ; the examiner is considering the delivery catheter to be the intermediate shaft); and, a cutting unit connected at a distal portion of the delivery catheter ([0103] & [0104]; Figures 71-78; elements “T-lacerator”, “guidewire”, & “dilator tip”; the examiner is considering the cutting unit to comprise the deployable T-lacerator , the guidewire, and the dilator tip); the cutting unit including: a piercing element located on a distal end of the cutting unit ([0103] & [0104]; Figures 64-66 & 71-78—element “guidewire”; the examiner is considering the piercing element to be the guidewire that is configured to be electrified to burn through a leaflet); and, a cutting element comprising an electrical looped wire ([0103] & [0104]; Figures 66 & 71-78—element “T-lacerator”; the examiner is considering the electrical looped wire to be the “T-lacerator” which comprises an expandable cutting wire); having a first radially compressed configuration ([0103] & [0104]; Figures 70, 71, & 76) in which a distal crossing portion is positioned to distally pierce tissue ([0103] & [0104]; Figures 66 & 71-78—element “dilator tip”; the examiner is considering the dilator tip to be the distal crossing portion, the dilator tip is configured to enlarge the hole in the leaflet formed by the guidewire/piercing element) and a second radially expanded configuration in which the electrical looped wire forms a continuous radiofrequency energy cutting contour in elliptical, oblong, or oval wing shapes that are positioned to cut a slit through a leaflet via radiofrequency energy by proximal translation of the wing shapes through the leaflet while energized ([0040], [0103], & [0104]; Figures 66, 68-69, 73-75 & 77-78; the “T” lacerator is advanced in the collapsed position past the leaflet, and is then deployed by withdrawing the inner shaft; the lacerator is then electrified and pulled to cut through the leaflet such that “T” shaped lacerations can be accomplished in the aortic leaflet; the lacerator is formed of an expandable wire).
Rafiee does not disclose the distal crossing portion positioned to pierce tissue with radiofrequency energy.
Brown teaches a device for cutting tissue comprising a cutting unit including a piercing element ([0059] & [0061]; Figures 5A & 5B; an initial puncture hole can be made using an electrosurgical needle) and a distal crossing portion is positioned to distally pierce tissue ([0061]; Figure 5A & 5B—element 32/35; the hole is dilated by the distal crossing portion 32/35 in order to enlarge the initial penetration in tissue); the distal crossing portion positioned to pierce tissue with radiofrequency energy ([0049]-[0051], & [0061]; Figures 2A, & 5A-5B—element 32/35; electrical (RF) energy can be supplied to the distal crossing portion 32/35 in order to enlarge the initial penetration in tissue).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the distal crossing portion/dilator tip that is configured to pierce tissue, as disclosed by Rafiee, to include the distal crossing portion/dilator tip configured to pierce tissue with radiofrequency energy, as taught by Brown, as both references and the claimed invention are directed toward cutting devices configured to cut cardiac tissue and comprising a piercing element and a distal crossing element. As disclosed by Rafiee, the cutting device includes a piercing element that is configured to puncture through a leaflet and a distal crossing portion/dilator tip that is configured to enlarge the hole created by the piercing element ([0103] & [0104]). As disclosed by Brown, the cutting device includes a piercing element configured to puncture through tissue and a distal crossing portion/dilator tip that is configured to enlarge the hole created by the piercing element via radiofrequency energy ([0051] & [0061]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the distal crossing portion/dilator tip that is configured to pierce tissue, as disclosed by Rafiee, to include the distal crossing portion/dilator tip configured to pierce tissue with radiofrequency energy, as taught by Brown, as such a modification would provide for a suitable and known distal crossing tip that produces the predictable result of enlarge the hole created by the piercing element.
Regarding claim 2, Rafiee in view of Brown disclose all of the limitations of claim 1, as described above.
Rafiee further discloses wherein the wing shapes are configured to be swept back in the second radially expanded configuration ([0103] & [0104]; Figures 75 & 78; the examiner is considering the swept back wings to be the further collapsed/fully deployed configuration of the cutting wires in the cutting position (as shown in Figures 75 & 78)).
Regarding claim 7, Rafiee in view of Brown disclose all of the limitations of claim 1, as described above.
Rafiee further discloses wherein the cutting element is connected to a push rod ([0103] & [0104]; Figures 72-75—element “Inner Shaft”).
Regarding claim 8, in a second interpretation, Rafiee discloses a system for making modifications to native leaflets comprising: a delivery catheter ([0104]; Figures 70 & 76—element “outer shaft”; the examiner is considering the delivery catheter to be the outer shaft); a cutting element comprising an electrical looped wire ([0103] & [0104]; Figures 66 & 71-78—element “T-lacerator”; the examiner is considering the electrical looped wire to be the “T-lacerator” which comprises an expandable cutting wire) and having 1) a first configuration ([0103] & [0104]; Figures 64, 70, 71, & 76; the examiner is considering the first configuration to be the collapsed position of the T-lacerator) in which a distal crossing portion is positioned to pierce a leaflet ([0040], [0103], & [0104]; Figures 64-66, 70, 71, & 76—element “dilator tip”; in the second interpretation the examiner is considering the dilator tip to be the distal crossing portion, the dilator tip is configured to enlarge the hole in the leaflet formed by the guidewire/piercing element) and allow the cutting element to pass through the leaflet ([0103] & [0104]; Figures 66 & 70-78—element “T-lacerator”; after the guidewire is electrified and burned through the leaflet, the T-lacerator is advanced and positioned past the leaflet), and 2) an expanded second configuration in which the electrical looped wire of the cutting element forms a continuous wing-shaped radio frequency cutting contour shaped to cut a slit through the leaflet by translation of the cutting contour through the leaflet while energized ([0040], [0103], & [0104]; Figures 66, 68-69, 73-75 & 77-78; the “T” lacerator is then deployed by withdrawing the inner shaft; the lacerator is then electrified and pulled to cut through the leaflet such that “T” shaped lacerations can be accomplished in the aortic leaflet; the lacerator is formed of an expandable wire); and, a push rod connected to the cutting element ([0104]; Figure 72—element “Mid Shaft”/ “intermediate shaft” ; the examiner is considering the push rod to be the intermediate shaft).
Rafiee does not disclose the distal crossing portion to pierce via radiofrequency energy.
Brown teaches a device for cutting tissue comprising a cutting unit including a piercing element ([0059] & [0061]; Figures 5A & 5B; an initial puncture hole can be made using an electrosurgical needle) and a distal crossing portion is positioned to distally pierce tissue ([0061]; Figure 5A & 5B—element 32/35; the hole is dilated by the distal crossing portion 32/35 in order to enlarge the initial penetration in tissue); the distal crossing portion to pierce via radiofrequency energy ([0049]-[0051], & [0061]; Figures 2A, & 5A-5B—element 32/35; electrical (RF) energy can be supplied to the distal crossing portion 32/35 in order to enlarge the initial penetration in tissue).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the distal crossing portion/dilator tip that is configured to pierce tissue, as disclosed by Rafiee, to include the distal crossing portion/dilator tip configured to pierce via radiofrequency energy, as taught by Brown, as both references and the claimed invention are directed toward cutting devices configured to cut cardiac tissue and comprising a piercing element and a distal crossing element. As disclosed by Rafiee, the cutting device includes a piercing element that is configured to puncture through a leaflet and a distal crossing portion/dilator tip that is configured to enlarge the hole created by the piercing element ([0103] & [0104]). As disclosed by Brown, the cutting device includes a piercing element configured to puncture through tissue and a distal crossing portion/dilator tip that is configured to enlarge the hole created by the piercing element via radiofrequency energy ([0051] & [0061]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the distal crossing portion/dilator tip that is configured to pierce tissue, as disclosed by Rafiee, to include the distal crossing portion/dilator tip configured to pierce via radiofrequency energy, as taught by Brown, as such a modification would provide for a suitable and known distal crossing tip that produces the predictable result of enlarge the hole created by the piercing element.
Regarding claim 9, in the second interpretation, Rafiee in view of Brown disclose all of the limitations of claim 8, as described above.
Rafiee further discloses a tether extending from a proximal end of the system, through the delivery catheter and connected to the distal crossing portion and usable to expand the cutting element to the second configuration ([0103] & [0104]; Figures 71-78—element “Inner Shaft”; the examiner is considering the tether to be the inner shaft which is configured to be pulled to deploy the cutting element/ T-lacerator).
Regarding claim 10, in the second interpretation, Rafiee in view of Brown disclose all of the limitations of claim 8, as described above.
Rafiee further discloses wherein the cutting element is configured to cut through the leaflet when retracted ([0103] & [0104]; Figures 66, 68, & 69).
Regarding claim 14, in the second interpretation, Rafiee in view of Brown disclose all of the limitations of claim 9, as described above.
Rafiee further discloses wherein the tether is attached to the distal crossing portion ([0103] & [0104]; Figures 71-78—elements “Inner Shaft” & “dilator tip”)
Claims 5-6, & 13 are rejected under 35 U.S.C. 103 as being unpatentable over Rafiee in view of Brown and Arevalos et al. (previously presented- US 20200289196 A1), hereinafter “Arevalos”.
Regarding claim 5, Rafiee in view of Brown disclose all of the limitations of claim 1, as described above.
Rafiee does not disclose wherein electrical looped wire self- expands from the first radially compressed configuration to the second radially expanded configuration.
Arevalos teaches an expandable cutting element comprising an electrical loop wire ([0110]; Figures 20A-20D—elements 2003/2009), wherein electrical looped wire self-expands from the first radially compressed configuration to the second radially expanded configuration ([0110]; the expandable cutting element may be made of a self-expanding material).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the expansion of the electrical looped wire, as disclosed by Rafiee, to include wherein electrical looped wire self-expands from the first radially compressed configuration to the second radially expanded configuration, as taught by Arevalos, as both references and the claimed invention are directed toward expandable cutting elements. As disclosed by Rafiee, the expandable cutting element may be expanded and collapsed by pulling the inner shaft ([0103] & [0104]). As disclosed by Arevalos, the expandable cutting element may be self-expanding or may be connected to an actuation catheter to expand the cutting element ([0110] & [0114]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the expansion of the electrical looped wire, as disclosed by Rafiee, to include wherein electrical looped wire self-expands from the first radially compressed configuration to the second radially expanded configuration, as taught by Arevalos, as providing a self-expanding cutting element is a known and suitable alternative to providing a mechanically expanded cutting element and would produce the predictable result of providing a cutting element that is configured to transition from a first collapsed configuration to a second expanded configuration.
Regarding claim 6, Rafiee in view of Brown disclose all of the limitations of claim 1, as described above.
Rafiee does not disclose wherein the electrical looped wire comprises a memory shape metal and is heat set to assume the second radially expanded configuration.
Arevalos teaches an expandable cutting element comprising an electrical loop wire ([0110]; Figures 20A-20D—elements 2003/2009), wherein the electrical looped wire comprises a memory shape metal and is heat set to assume the second radially expanded configuration ([0110] & [0131]). ([0131]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the expansion of the electrical looped wire, as disclosed by Rafiee, to include wherein the electrical looped wire comprises a memory shape metal and is heat set to assume the second radially expanded configuration, as taught by Arevalos, as both references and the claimed invention are directed toward expandable cutting elements. As disclosed by Rafiee, the expandable cutting element may be expanded and collapsed by pulling the inner shaft ([0103] & [0104]). As disclosed by Arevalos, the expandable cutting element may be self-expanding or may be connected to an actuation catheter to expand the cutting element ([0110], [0114], & [0131]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the expansion of the electrical looped wire, as disclosed by Rafiee, to include wherein the electrical looped wire comprises a memory shape metal and is heat set to assume the second radially expanded configuration, as taught by Arevalos, as providing a self-expanding cutting element is a known and suitable alternative to providing a mechanically expanded cutting element and would produce the predictable result of providing a cutting element that is configured to transition from a first collapsed configuration to a second expanded configuration.
Regarding claim 13, in the second interpretation, Rafiee in view of Brown disclose all of the limitations of claim 8, as described above.
Rafiee does not disclose wherein the cutting element self-expands from the first configuration to the second configuration.
Arevalos teaches an expandable cutting element comprising an electrical loop wire ([0110]; Figures 20A-20D—elements 2003/2009), wherein the cutting element self-expands from the first configuration to the second configuration ([0110]; the expandable cutting element may be made of a self-expanding material).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the expansion of the electrical looped wire, as disclosed by Rafiee, to include wherein the cutting element self-expands from the first configuration to the second configuration, as taught by Arevalos, as both references and the claimed invention are directed toward expandable cutting elements. As disclosed by Rafiee, the expandable cutting element may be expanded and collapsed by pulling the inner shaft ([0103] & [0104]). As disclosed by Arevalos, the expandable cutting element may be self-expanding or may be connected to an actuation catheter to expand the cutting element ([0110] & [0114]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the expansion of the electrical looped wire, as disclosed by Rafiee, to include wherein the cutting element self-expands from the first configuration to the second configuration, as taught by Arevalos, as providing a self-expanding cutting element is a known and suitable alternative to providing a mechanically expanded cutting element and would produce the predictable result of providing a cutting element that is configured to transition from a first collapsed configuration to a second expanded configuration.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Rafiee in view of Moriyama et al. (US 11980412 B2), hereinafter “Moriyama”.
Regarding claim 21, Rafiee discloses system for making modifications to native leaflets comprising: a delivery catheter ([0104]; Figure 72—element “Mid Shaft”/ “intermediate shaft” ; the examiner is considering the delivery catheter to be the intermediate shaft); a cutting unit connected at a distal portion of the delivery catheter ([0103] & [0104]; Figures 71-78; element “T-lacerator”; the examiner is considering the cutting unit to comprise the deployable T-lacerator), the cutting unit including: an electrical looped wire ([0103] & [0104]; Figures 71-78; element “T-lacerator”; the examiner is considering the electrical looped wire to be the T-lacerator which comprises an expandable wire) and having 1) a first configuration in which the electrical looped wire is positioned to allow the electrical looped wire to pass through the leaflet ([0103] & [0104]; Figures 64, 70, 71, & 76; the examiner is considering the first configuration to be the collapsed position of the T-lacerator; after the guidewire is electrified and burned through the leaflet and the dilator tip enlarges the hole in the leaflet, the T-lacerator is advanced in the collapsed position and positioned past the leaflet), and 2) a laterally expanded second configuration in which the electrical looped wire forms a continuous wing-shaped radio frequency cutting contour that is shaped to cut a slit through the leaflet by translation of the cutting contour through the leaflet while energized ([0040], [0103], & [0104]; Figures 66, 68-69, 73-75 & 77-78; the “T” lacerator is then deployed by withdrawing the inner shaft; the lacerator is then electrified and pulled to cut through the leaflet such that “T” shaped lacerations can be accomplished in the aortic leaflet; the lacerator is formed of an expandable wire).
Rafiee does not disclose the electrical looped wire positioned in the first configuration to pierce a leaflet via radiofrequency energy.
Moriyama teaches an electrical looped wire configured to cut tissue, the electrical looped wire comprising a first collapsed configuration and a second expanded configuration ([Col. 5, lines 29-52]; Figures 3-5—element 200), the electrical looped wire is positioned in the first configuration to pierce a leaflet via radiofrequency energy ([Col. 7, lines 14-31]; Figure 3—elements 200 & 300A).
A person of ordinary skill in the art, before the effective filing date of the claimed invention would have been motivated to modify the electrical looped wire in the first configuration and the dilator tip and guidewire, as disclosed by Rafiee, to include the electrical looped wire positioned in the first configuration to pierce a leaflet via radiofrequency energy, as taught by Moriyama, as both references and the claimed invention are directed toward expandable cutting assemblies configured to deliver RF energy to cut tissue. As disclosed by Rafiee, a dilator tip and guidewire configured to pierce a leaflet when the electrical looped wire is in the first collapsed position ([0103] & [0104]). As disclosed by Moriyama, the distal end of the expandable cutting wire is configured to deliver radiofrequency energy to the tissue in order to puncture the tissue while in the first collapsed position ([Col. 7, lines 14-31]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the electrical looped wire in the first configuration and the dilator tip and guidewire, as disclosed by Rafiee, to include the electrical looped wire positioned in the first configuration to pierce a leaflet via radiofrequency energy, as taught by Moriyama, as such a modification would provide for a known and suitable configuration for creating an initial puncture in tissue using the electrical looped wire.
Conclusion
Accordingly, claims 1-2, 5-10, 13-14, & 21 are rejected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Laufer (US 20130041373 A1) discloses a cutting unit comprising an electrical looped wire having a distal crossing portion ([0021]-[0023]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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