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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/17/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically none of either Gillespie, Cartledge or Sherburne are relied upon to disclose limitations of claims 1 or 27 expressly challenged in the submitted arguments and are instead relied upon as secondary teaching references to provide supporting structural elements to the new primary reference as described in the updated rejection below.
Applicant's arguments filed 2/17/2026 in regards to the rejections of claims 26 under Baig in view of Gillespie have been fully considered but they are not persuasive.
Regarding claim 26, Applicant contends that the device of Baig does not expressly disclose the amended limitations of “wherein the compression balloon defines a distal end of the removal device” on the grounds that a distal tip (12) and balloon (19) are required to extend distally beyond the “compression balloon” (18) and thus the balloon (18) cannot be classified as a “distal end” of the removal device. The examiner respectfully disagrees. While the tip (12) and balloon (19) may be configured to extend distally from the balloon structure (18) during operation of the device, the “distal end” may be defined as any portion distal a structure proximal thereto. The Examiner understands that Applicant may intend the term “end” to me the distal-most terminal point beyond which no structure may at any point extend, but the currently-applied language reciting merely the phrase “distal end” does not limit the interpretation to the intended language. The Examiner respectfully maintains that, so long as a portion or structure of the device of Baig lies or exists proximally of the balloon (18), the balloon (18) may be defined as the “distal end” (i.e., the delineation point between proximal and distal) even if additional structure may extend distally thereof.
Claim Rejections - 35 USC § 112
Applicant’s arguments, see “Remarks”, filed 2/17/2026, with respect to the 35 USC 112(b) rejection of claim 27 for reciting “wherein the diameter reduction element and the lumen of the control handle” which lacked proper antecedent basis within the claim have been fully considered and are persuasive in light of Applicant’s amendment to remove the cited language from the limitations of claim 27. The 35 USC 112(b) rejection of claim 27, and claims dependent therefrom, has been withdrawn.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the tapered portion supplied as a wire mesh, as recited in claim 29, and “wherein the compression balloon…comprises a first portion having a cylindrical outer surface with a first diameter and a second portion that is distal of the first portion having a second diameter smaller than the first diameter” recited in claim 47 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “engagement element” in claim 1, 26, 27 and claims dependent therefrom.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 47 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 47 recites, “wherein the compression balloon is configured to be inflated to have a first portion having a cylindrical outer surface with a first diameter and a second portion that is distal of the first portion, wherein the second portion has an outer diameter with a second diameter that is smaller than the first diameter” which does not appear to have written or express support with the disclosed specification or drawings. The Examiner notes that the “compression balloon” is shown in Fig. 10B but the drawings to not show a “first portion” (i.e., the proximal portion of the balloon) having a cylindrical shape. Rather the “first portion” appears to have a tapered, conical shape. Further, the conical “first portion” appears to have a diameter that is smaller than the diameter of the distal “second portion”, which is the opposite of the currently-recited claim language. Further, there appears to be no express written support pertaining to the shape of the balloon within Para. [0051] of the specification pertaining to this claimed feature.
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.
Claim(s) 1-4, 8, 21, 27-28, 32, 34-35, 39, 41, 44 and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekvall (US 2018/0028314 A1) in view of Cartledge (US 2023/0338140 A1)(previously of record) in view of Finch (US 2011/0071624 A1).
Regarding claim 1, Ekvall discloses:
A method for removing a transcatheter heart valve from a heart in a patient, the method comprising:
providing a removal device (recapture device 410, see Fig. 14) externally to the patient while the patient has the transcatheter heart valve implanted in the heart (see Para. [0113]-[0115] mentioning wherein the recapture device is intended to be utilized to recapture a deployed heart valve and is thus seen to be positioned externally to the patient before the recapture procedure begins), wherein the removal device comprises:
a control handle (handle assembly 420, see Fig. 14);
a flexible shaft (outer sheath 444, see Fig. 14; the outer sheath is understood to be flexible unless otherwise stated to permit flexibility and bending during navigation through the vasculature to the target site), the flexible shaft having a proximal end coupled to the control handle (see Fig. 14 and Para. [0113]), a lumen (see Para. [0113] mentioning a lumen extending through the outer sheath), and a distal opening (see Figs. 14-16); and
positioning the distal end of the flexible shaft such that the distal opening is disposed next to the transcatheter heart valve in the heart (see Figs. 14-17).
However, while Ekvall discloses wherein the implanted valve is captured and pulled within the lumen of the outer dilator after initially contacting the implanted valve with the an inner dilator (see Para. [0113]-[0117] and Figs. 14-17), Ekvall does not provide an express disclosure pertaining to how the valve is initially engaged and captured by the recapture device (i.e., the disclosure merely provides mention of wherein a tether of the implanted valve is inserted into the inner dilator) and thus does not expressly disclose:
one or more engagement elements;
after providing the removal device externally to the patient while the patient has the transcatheter heart valve implanted in the heart, deploying the one or more transcatheter engagement elements from the lumen through the distal opening of the flexible shaft such that the one or more engagement elements engage the transcatheter heart valve; and
retracting the one or more engagement elements such that the transcatheter heart valve is:
drawn proximally relative to a diameter reduction element so that the diameter reduction element reduces the diameter of the transcatheter heart valve, wherein the diameter reduction element defines a taper, wherein retraction of the one or more engagement elements relative to the diameter reduction element reduces the diameter of the transcatheter heart valve; and
removed from the heart.
In the same field of endeavor, namely transcatheter manipulation systems, Cartledge teaches wherein a transcatheter heart valve removal device (see Fig. 212; see also Para. [0440]-[0443]) comprises an elongate shaft (delivery sheath 10040, see Fig. 212) having a tapered diameter reduction element at the distal end thereof (sheath entry device 21200, see Fig. 212) which help to guide and gradually collapse the transcatheter heart valve within the lumen of the elongate shaft (see Para. [0441]-[0442] and Figs. 212-217).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the distal tip of the outer dilator of Ekvall to comprise a slightly conical tapered shape as taught and suggested by Cartledge to, in this case, help to initially guide and gradually collapse the transcatheter heart valve as the heart valve is beginning to be pulled into the lumen of the outer dilator (see Cartledge Para. [0441]-[0442] and Figs. 212-217).
In the same field of endeavor, namely removing implanted valve devices from within the heart, Finch teaches a prosthetic heart valve removal device (see Figs. 41-42 and Para. [0307]-[0311]) comprising an elongate shaft (outer sheath 2752, see Fig. 41) and an inner shaft disposed therein (inner sheath 2753, see Fig. 41-42); wherein the inner shaft comprises a plurality of engagement elements (grasper 2755, see Figs. 41-12 and para. [0308]-[0311]) disposed therein configured to be distally extended relative to the outer elongate shaft to contact and engage with an implanted valve prosthesis (see Figs. 41-42 and Para. [0308]-[0311]), providing an engaging means to secure the prosthesis to the removal device.
Since Ekvall does not provide an express disclosure as to how the recapture device initially engages with the deployed heart valve, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to the prior art for known engagement mechanisms to initially engage with and secure an implanted heart valve to a recapture device so that the device of Ekvall would be capable of initially engaging with the implanted valve before recapturing and removing said heart valve as disclosed in Para. [0113]-[0117]. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the inner dilator of Ekvall to comprise a plurality of grasper devices therein as taught and suggested by Finch to, in this case, provide a known engagement mechanism to allow the recapture device of Ekvall to engage and secure the implanted valve to more easily facilitate recapture and removal of the implanted valve (see Finch Para. [0308]-[0311]). Resulting from the combination, as the inner dilator is retracted within the outer dilator (see Ekvall Para. [0113]-[0117] and Figs. 14-17), the grasper would aid in pulling the implanted valve within the lumen of the inner dilator which (see Finch Para. [0308]-[0311]), with assistance from the tapered conical tip of the outer dilator as incorporated from the teachings of Cartledge, would radially compress the valve as shown in Figs. 14-17 of Ekvall before fully removing the valve (see Ekvall Para. [0115]-[0117]).
Regarding claim 2, the combination of Ekvall, Cartledge and Finch disclose the method of claim 1, Ekvall further discloses wherein the step of retracting the one or more engagement elements comprises pulling the transcatheter heart valve through the distal end into the lumen of the flexible shaft using the control handle (see Para. [0113]-[0117] and Figs. 14-17).
Regarding claim 3, the combination of Ekvall, Cartledge and Finch disclose the method of claim 1, Ekvall, as modified by Cartledge, further discloses deploying the diameter reduction element from the distal end of the flexible shaft (as the tapered portion of the outer dilator of Ekvall, as incorporated from the teachings of Cartledge, is configured to be passed through the lumen of the outer sheath (see Ekvall Para. [0113]-[0117]) during removal of the implanted valve, the tapered diameter reduction portion is understood to be deployable from the distal end of the outer sheath along with the outer dilator main body as shown in Figs. 14-17).
Regarding claim 4, the combination of Ekvall, Cartledge and Finch disclose the method of claim 3, Ekvall, as modified by Cartledge, further discloses wherein the diameter reduction element is a funnel (see Cartledge Fig. 212 and Para. [0442] mentioning wherein the sheath entry device has a conical shape), and wherein the transcatheter heart valve is drawn proximally through the funnel (see Cartledge Figs. 212-217 and Ekvall Para. [0113]-[0117] mentioning wherein the implanted valve is pulled proximally through the lumen of the inner dilator which itself is then pulled through the lumen of the outer dilator and thus the conical tapered portion at the distal the thereof).
Regarding claim 8, the combination of Ekvall, Cartledge and Finch disclose the method of claim 1, Ekvall, as modified by Finch, further discloses wherein each engagement element comprises: a pre-shaped hook (see Finch Figs. 41-42 showing wherein the grasper(s), as incorporated into the device of Ekvall, are in the form of pre-shaped hooks).
Regarding claim 21, the combination of Ekvall, Cartledge and Finch disclose the method of claim 1, Ekvall, as modified by Finch, further discloses wherein the transcatheter heart valve comprises: (a) one or more wire docking extensions (see Ekvall Fig. 16 showing wherein the implanted valve comprises a plurality of looped cell structures which constitute wire docking extensions) and the engagement element comprises a central shaft (portion of grasper elements labeled as “2755a” as shown in Finch Fig. 41), one or more engagement wires (distal portions of the grasper comprising hooks as shown in Finch Fig. 41), and a wire hub (proximal control wire, see Finch Para. [0310]).
Regarding claim 27, Ekvall discloses:
A removal device (recapture device 410, see Fig. 14) for removing a transcatheter heart valve from a heart in a patient (see Para. [0113]-[0117]), the removal device comprising:
a control handle (handle assembly 420, see Fig. 14) and a flexible shaft (outer sheath 444, see Fig. 14; the outer sheath is understood to be flexible unless otherwise stated to permit flexibility and bending during navigation through the vasculature to the target site), the flexible shaft having a proximal end coupled to the control handle (see Fig. 14 and Para. [0113]), a lumen (see Para. [0113] mentioning a lumen extending through the outer sheath), and a distal opening (see Figs. 14-16).
However, while Ekvall discloses wherein the implanted valve is captured and pulled within the lumen of the outer dilator after initially contacting the implanted valve with the an inner dilator (see Para. [0113]-[0117] and Figs. 14-17), Ekvall does not provide an express disclosure pertaining to how the valve is initially engaged and captured by the recapture device (i.e., the disclosure merely provides mention of wherein a tether of the implanted valve is inserted into the inner dilator) and thus does not expressly disclose:
one or more transcatheter engagement elements disposed in the lumen and coupled to the control handle, the one or more engagement elements capable of being:
deployed through the distal opening of the flexible shaft to extend toward the transcatheter heart valve when the transcatheter heart valve is uncoupled from the one or more transcatheter engagement elements; and
subsequently, coupled to the transcatheter heart valve; and
a diameter reduction element defining a taper, wherein the one or more transcatheter engagement elements are axially movable relative to the diameter reduction element;
wherein the diameter reduction element is configured to radially compress the transcatheter heart valve to reduce the diameter of the transcatheter heart valve when the one or more engagement elements pull the transcatheter heart valve along the diameter reduction element wherein the removal device has a distal end; and
wherein the taper of the diameter reduction element extends to the distal end of the removal device when the one or more transcatheter engagement elements are retracted within the flexible shaft.
In the same field of endeavor, namely transcatheter manipulation systems, Cartledge teaches wherein a transcatheter heart valve removal device (see Fig. 212; see also Para. [0440]-[0443]) comprises an elongate shaft (delivery sheath 10040, see Fig. 212) having a tapered diameter reduction element at the distal end thereof (sheath entry device 21200, see Fig. 212) which help to guide and gradually collapse the transcatheter heart valve within the lumen of the elongate shaft (see Para. [0441]-[0442] and Figs. 212-217).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the distal tip of the outer dilator of Ekvall to comprise a slightly conical tapered shape as taught and suggested by Cartledge to, in this case, help to initially guide and gradually collapse the transcatheter heart valve as the heart valve is beginning to be pulled into the lumen of the outer dilator (see Cartledge Para. [0441]-[0442] and Figs. 212-217).
In the same field of endeavor, namely removing implanted valve devices from within the heart, Finch teaches a prosthetic heart valve removal device (see Figs. 41-42 and Para. [0307]-[0311]) comprising an elongate shaft (outer sheath 2752, see Fig. 41) and an inner shaft disposed therein (inner sheath 2753, see Fig. 41-42); wherein the inner shaft comprises a plurality of engagement elements (grasper 2755, see Figs. 41-12 and para. [0308]-[0311]) disposed therein configured to be distally extended relative to the outer elongate shaft to contact and engage with an implanted valve prosthesis (see Figs. 41-42 and Para. [0308]-[0311]), providing an engaging means to secure the prosthesis to the removal device.
Since Ekvall does not provide an express disclosure as to how the recapture device initially engages with the deployed heart valve, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to the prior art for known engagement mechanisms to initially engage with and secure an implanted heart valve to a recapture device so that the device of Ekvall would be capable of initially engaging with the implanted valve before recapturing and removing said heart valve as disclosed in Para. [0113]-[0117]. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the inner dilator of Ekvall to comprise a plurality of grasper devices therein as taught and suggested by Finch to, in this case, provide a known engagement mechanism to allow the device of Ekvall to secure against and engage the implanted valve to more easily facilitate recapture and removal of the valve (see Finch Para. [0308]-[0311]). Resulting from the combination, as the inner dilator is retracted within the outer dilator (see Ekvall Para. [0113]-[0117]), the grasper would aid in pulling the implanted valve within the lumen of the inner dilator (see Finch Para. [0308]-[0311]) which, with assistance from the tapered conical tip of the outer dilator as incorporated from the teachings of Cartledge, would radially compress the valve as shown in Figs. 14-17 of Ekvall before fully removing the valve (see Ekvall Para. [0115]-[0117]). Further, as the grasper and conical tapered portion are positioned on different tubular members configured to more relative to one-another (see Ekvall Para. [0113]-[0117]), the grasper within the inner dilator is understood to be axially movable relative to the conical tapered portion on the outer dilator.
Regarding the limitations “wherein the implanted valve is retracted within the lumen of the outer sheath while the outer dilator remains extended distally therefrom”, as the three sheaths of Ekvall are disclosed to be axially movable relative to one-another (see Para. [0113]-[0117]), a user is reasonably capable of using the device of Ekvall to retract the implanted valve within the lumen of the outer sheath while the outer dilator, and conical tapered portion thereof, remain distally beyond the distal end of the outer sheath (see for example Ekvall Fig. 16 showing wherein the implanted valve is being retracted within the outer sheath lumen while the outer dilator remains distally exposed therefrom).
Regarding claim 28, the combination of Ekvall, Cartledge and Finch disclose the invention of claim 27, Ekvall, as modified by Cartledge, further discloses wherein the diameter reduction element is funnel shaped (see Cartledge Fig. 212 and Para. [0442] mentioning wherein the sheath entry device has a conical shape), and wherein the diameter reduction element is deployable from the distal opening of the flexible shaft (the conical portion has been incorporated onto the distal end of the outer dilator of Ekvall and Para. [0113]-[0117] of Ekvall discloses wherein the outer dilator is axially movable relative to the outer sheath).
Regarding claim 32, the combination of Ekvall, Cartledge and Finch disclose the invention of claim 27, Ekvall, as modified by Finch further discloses wherein each engagement element comprises: (a) an elongate element that enables the engagement element to reach the transcatheter heart valve (see Finch Figs. 41-42 showing wherein the grasper elements comprise an elongate body to engage the implanted valve); and (b) a jaw or a locking gate that grips the transcatheter heart valve (distal hooked portion constitutes a jaw that engages with the implanted valve as recited in Finch Para. [0308]).
Regarding claim 34, the combination of Ekvall, Cartledge and Finch disclose the invention of claim 27, Ekvall, as modified by Finch further discloses wherein each engagement element comprises a pre-shaped hook and a hook containment tube (see Finch Fig. 41 showing wherein the grasper device, as incorporated into the device of Ekvall, is in the form of a pre-shaped hook).
Regarding claim 35, the combination of Ekvall, Cartledge and Finch disclose the invention of claim 27, Ekvall, as modified by Finch further discloses wherein each engagement element comprises a pre-shaped hook (see Finch Fig. 41 showing wherein the grasper device, as incorporated into the device of Ekvall, is in the form of a pre-shaped hook).
Regarding claim 39, the combination of Ekvall, Cartledge and Finch disclose the invention of claim 27, Ekvall, as modified by Finch further discloses wherein each engagement element comprises a self-expanding tube and an engagement hook (see Finch Figs. 41-42 showing wherein the grasper comprise distal hook elements; see also Para. [0310]-[0311] mentioning wherein the grasper automatically expands or contracts as it is moved axially along the length of the inner sheath 2753), wherein the engagement hook is an integrated engagement hook or an attached engagement hook (see Finch Figs. 41-42 showing wherein the distal hook elements are integrally formed with the elongate body of the grasper).
Regarding claim 41, the combination of Ekvall, Cartledge and Finch disclose the invention of claim 1, Ekvall, as modified by Finch, further discloses wherein the transcatheter heart valve comprises: (a) one or more wire docking extensions (see Ekvall Fig. 16 showing wherein the implanted valve comprises a plurality of looped cell structures which constitute wire docking extensions) and the engagement element comprises a central shaft (portion of grasper elements labeled as “2755a” as shown in Finch Fig. 41), one or more engagement wires (distal portions of the grasper comprising hooks as shown in Finch Fig. 41), and a wire hub (proximal control wire, see Finch Para. [0310]).
Regarding claim 44, the combination of Ekvall, Cartledge and Finch disclose the invention of claim 27, Ekvall, as modified by Cartledge, further discloses wherein the diameter reduction element is a funnel that defines the taper (see Cartledge Fig. 212 and Para. [0442] mentioning wherein the sheath entry device has a conical shape), wherein, when the at least one engagement element is retracted within the diameter reduction element (see Ekvall Para. [0113]-[0117] mentioning wherein the inner dilator (within which the engagement hook of Finch is disposed) is axially movable relative to the outer dilator), the diameter reduction element defines a distal end of the removal device, and wherein the taper extends to the distal end of the removal device (see Cartledge Fig. 212 showing wherein the tapered portion is disposed at the distal end of the tubular body and the taper extends along the length thereof).
Regarding claim 46, the combination of Ekvall, Cartledge and Finch disclose the invention of claim 27, Ekvall, as modified by Cartledge, further discloses wherein the diameter reduction element comprises a wall (see Cartledge Fig. 212), and wherein the wall comprises a continuous, uninterrupted surface that defines the taper of the diameter reduction element (see Cartledge Fig. 212).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baig (US 2014/0171958 A1)(previously presented) in view of Gillespie (US 2017/0065299 A1)(previously presented).
Regarding claim 26, Baig discloses:
A method for removing a transcatheter heart valve from a heart in a patient (see Para. [0012]), the method comprising:
providing a removal device (see Para. [0026] mentioning the use of a delivery catheter (not shown) to advance device 10 to a heart valve) comprising a flexible shaft (the delivery catheter is seen to be flexible to navigate the vasculature to arrive at the patient’s heart; by definition, catheters are flexible tubes unless otherwise stated), the flexible shaft having a proximal end (seen to be located at and proximal to element 20 shown in Fig. 3) and a lumen (see Para. [0026] mentioning where a delivery catheter and guidewire are used to introduce device 10 into a patient’s vasculature; the catheter would need to be hollow to allow the device 10 to be housed therein and delivered to the target site via the catheter);
deploying and advancing a compression balloon (compression balloon 18, see Fig. 1) from the lumen through the flexible shaft until the compression balloon peripherally surrounds at least a portion of the transcatheter heart valve (see Paras. [0024] and [0027]-[0028] mentioning wherein compression balloon 18 is advanced to engage a prosthetic (i.e., a heart valve prosthetic as noted to be an intended use in Paras. [0001] and [0012]) which is seen to peripherally surround at least the portion of the prosthetic that is engaged with);
wherein the compression balloon defines a distal end of the removal device (see Fig. 1 showing wherein the balloons 18 are distal to a portion of the device and thus may define a distal end of the device as other components are located proximally thereto);
inflating the compression balloon to compress inwardly against the transcatheter heart valve (see Para. [0028]); and
retracting the transcatheter heart valve via the compression balloon or one or more engagement elements such that the transcatheter heart valve is removed (see Para. [0024] and [0027]-[0029] mentioning wherein device 10, including compression balloon attached thereto (seen to be equivalent under 112f to the structure disclosed in the specification as corresponding to the claimed means plus function limitation, which is a pair of jaws for gripping a heart valve – see Specification Para. [0041]), is withdrawn back into the delivery catheter after engaging the prosthetic).
However, while Baig discloses wherein device 10 may be withdrawn into and thereby deployed from the delivery catheter, see Paras. [0026] and [0029] (noting that such a function is only possible should there be an opening at the distal end of the delivery catheter), and wherein device 10 is introduced into a patient’s veins via a delivery catheter (see Para. [0026]), Baig does not expressly disclose:
a handle coupled to a proximal end of the flexible tube, wherein the flexible tube as an opening at the distal end thereof; and
positioning the distal end of the flexible shaft such that the distal opening is disposed next to the transcatheter heart valve in the heart.
In the same field of endeavor, namely devices configured for treating heart valves, Gillespie teaches a flexible sheath (outer sheath 2, see Fig. 1, the outer sheath seen to be flexible to navigate the vasculature to arrive at the mitral annulus as mentioned in Para. [0074]-[0075]), the flexible shaft having a proximal end coupled to a control handle (proximal end of outer sheath 2 coupled to handle 54 as shown in Fig. 8A to actuate an inner and outer sheath (see Para. [0067]), wherein the flexible sheath comprises a distal opening (see at least Fig. 6 showing outer sheath 2 having a distal opening allowing the inner sheath 12 and retrieval end 14 to extend therefrom and Para. [0075] mentioning wherein inner sheath is passed through the outer sheath until the retrieval end is deployed therefrom) and the step of positioning the distal end of the flexible shaft such that the distal opening is disposed next to the transcatheter heart valve in the heart (see Para. [0075] mentioning wherein outer tube is advanced to a mitral annulus which is next to a transcatheter heart valve) to allow for access to the valve prosthetic by the manipulation tools shown in Fig. 5A (see Para. [0075]-[0076]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Baig to include the handle coupled to both the delivery catheter and device 10 as taught and suggested by Gillespie to, in this case, provide a mechanism for actuation of the delivery catheter and device 10 (see Gillespie Para. [0067]), in addition to providing an opening at the distal end of the delivery catheter as disclosed by Gillespie to allow for the guidewire of Baig to pass therethrough (see Baig Para. [0026] and [0029]). Lastly, it would have been obvious to one of ordinary skill in the art to have used the delivery catheter of Baig to be placed next to the heart valves to allow the device 10 to have access to the prosthetic intended to be manipulated as disclosed by both Baig Para. [0001] and [0012] and by Gillespie Para. [0075]-[0076]).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekvall (US 2018/0028314 A1) in view of Cartledge (US 2023/0338140 A1)(previously of record) in view of Finch (US 2011/0071624 A1), further in view of Gillespie (US 2017/0065299 A1) (previously of record).
Regarding claim 29, the combination of Ekvall, Cartledge and Finch disclose all of the limitations of the invention of claim 28.
However, neither Ekvall nor Cartledge expressly disclose wherein the diameter reduction portion comprises a wire mesh.
In the same field of endeavor, namely device for removing valve prostheses from biological spaces, Gillespie teaches a valve removal device (see Fig. 1) comprising an elongate member (2, see Fig. 1) and a diameter reduction portion (retrieval end 14, see Fig. 3) configured to gradually reduce the diameter of the captured implanted device (tapering portion of retrieval end would radially-compress the implanted device passing therethrough); wherein the diameter reduction portion comprises a wire mesh (see Fig. 3 and Para. [0057]) which more easily collapses when withdrawn within the outer elongate member (see Para. [0057]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the conical tapering portion of the outer dilator of Ekvall, as incorporated from the teaching of Cartledge, to be formed from a wire mesh material as disclosed by Gillespie to, in this case, more easily collapse when retracted within the lumen of the outer sheath of Ekvall.
Claim(s) 43 /are rejected under 35 U.S.C. 103 as being unpatentable over Ekvall (US 2018/0028314 A1) in view of Cartledge (US 2023/0338140 A1)(previously of record) in view of Finch (US 2011/0071624 A1), further in view of Baig (US 2014/0171958 A1)(previously of record).
Regarding claim 43, the combination of Ekvall, Cartledge and Finch discloses all of the limitations of the invention of claim 27.
However, none of the combination expressly disclose wherein the removal device further comprises a compression balloon.
In the same field of endeavor, namely prosthetic heart valve retrieval devices, Baig teaches wherein a balloon (balloon 19, see Figs 1-3) may be utilized to capture and retrieve a heart valve prosthesis by radially compressing the prosthesis within the confines of the distal end of an elongate tubular member before being retracted and removed from the body (see Para. [0025]-[0028]).
Since Ekvall did not provide an express engagement tool used to initially grasp and capture the implanted valve, Ekvall did not appear to indicate any criticality favoring one valve capture mechanism over another and it would have thus been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known valve capture element for another (see KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)) to have obtained the predictable result of having the heart valve prosthesis manipulation tool of Ekvall, as incorporated from the teachings of Finch, comprise an axial inflatable compression balloon, as disclosed by Baig. The type of manipulation tool is not seen to be a critical feature in the function of the device of Ekvall so long as the tool is capable of and configured to engage with an implanted valve device to facilitate removal thereof and thus one of ordinary skill in the art would have expected the device of Ekvall to function equally well with either a compression balloon or a hooked grasper without negatively impacting the function of the device as both the engagement tool of Finch and Baig are known valve removal tools taught within the field of endeavor.
Claim(s) 45 /are rejected under 35 U.S.C. 103 as being unpatentable over Ekvall (US 2018/0028314 A1) in view of Cartledge (US 2023/0338140 A1)(previously of record) in view of Finch (US 2011/0071624 A1) in view of Duffy (US 2013/0268064 A1) (previously of record).
Regarding claim 45, the combination of Ekvall, Cartledge and Finch discloses all of the limitations of the invention of claim 27.
However, none of the combination expressly discloses wherein the diameter reduction element comprises a folded sheet of elastic metal or polymer that is configured to deploy to form the taper once extended out of the distal opening of the control handle.
In the same field of endeavor, namely heart valve recapture devices, Duffy discloses wherein a variable-diameter recapture mesh (recapture sleeve 102, see Fig. 1a-1b), formed from polymeric materials and configured to radially expand and contract to capture a heart valve (see Figs. 1a-1b and Para. [0033]) is made by folding portions of the recapture body over itself which allow the recapture sleeve to be radially expandable and collapsible (see Para. [0033]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the tapered portion of Cartledge, as incorporated into the device of Ekvall, to be formed from a folded polymeric material as disclosed by Duffy to, in this case, provide a known structural configuration within the art that achieves the function of having a heart valve capture mesh be able to expand and contract when deployed from an outer delivery sheath (see Duffy Para. [0033] and Figs. 1a-1b).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 20250152353 A1 to Fallon, US 20250049569 A1 to Mauch, US 20080039881 A1 to Greenberg, US 20230149157 A1 to Licht, US 20150142103 A1 to Vidlund, US 20120010699 A1 to Vesely, US 20160074158 A1 to Glazier, US 20140214159 A1 to Vidlund, US 20230038490 A1 to Grisworld, US 20070239254 A1 to Chia, US 12064349 B2 to Iyer, US 20170156859 A1 to Chang, US 20190231520 A1 to Desrosiers, US 20170231765 A1 to Desrosiers, US 20180206990 A1 to Marchand, US 10813753 B2 to Rothstein, US 20180296339 A1 to McLean, US 20110251682 A1 Murray and US 20250248814 A1 Leschecz all disclose transcatheter heart valve or normal cardiac heart valve removal devices comprising a valve engagement mechanism and sheathed elongate body.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
