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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/13/2026 has been entered.
Response to Amendment
The amendment filed 04/13/2026 has been entered. Claims 1-8, 18-20, and 30-38 remain pending in the application, and claims 9-17 and 21-29 are canceled. Applicant’s amendments to the claims have overcome the previous interpretation of the prior art rejection as previously set forth in the Final Office Action mailed 11/13/2025, however a new prior art rejection is made in view of Deem et al. (see rejection below).
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Arguments directed to the claims as amended are addressed in the body of the rejection below.
With regards to Applicant’s arguments on pages 7-9 with respect to the 112(f) claim interpretations and that the term “control unit” in claim 18 should not invoke 112(f), the Office agrees due to the claim reciting “a control unit comprising a control handle.” The handle is interpreted as sufficient structure, and 112(f) is not invoked for the control unit of claim 18. However, the terms “control unit,” “first control element,” and “second control element” in claim 1 and “sheath control element” and “position control element” in claim 8 still invoke 112(f). These terms 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 limitations use 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, as explained below.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 lines 10-11 “a collapsed configuration” is suggested to read “the collapsed configuration” for better antecedent basis.
Appropriate correction is required.
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: “control unit” in claim 1, “first control element” in claim 1, “second control element” in claim 1, “sheath control element” in claim 8, and “position control element” in claim 8.
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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 8, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deem et al. (US PGPub 2013/0231735), hereinafter known as “Deem.”
With regards to claim 1, Deem discloses (Figures 1-14) a valve delivery device 100 (paragraphs 105-106) comprising:
a distal carrier assembly 122 having a proximal enclosure 284 and a distal enclosure 275, the proximal enclosure 284 configured to enclose a proximal end portion of a valve frame of a valve prosthesis 150 (figure 4; paragraphs 106 and 114) in a collapsed configuration during delivery (figure 2A), the proximal enclosure 284 comprising a proximal tapered surface 287 and a cylindrical wall defining an interior cavity of the proximal enclosure 284 for receiving the proximal end portion of the valve frame 150 and retaining the proximal end portion of the valve frame 150 in the collapsed configuration (figures 2A and 4 – see cylindrical wall and cavity of proximal enclosure 284 where 150 lies inside), wherein the cylindrical wall extends from a distal end portion of the proximal tapered surface 287 toward the distal enclosure 275 and an opening of the cavity is oriented towards the distal enclosure 275 (figures 2A and 4);
a sheath 110 configured to support a valve anchor of the valve prosthesis 150 in a collapsed configuration during delivery (figure 11; paragraph 134), the sheath 110 being movable relative to the distal carrier assembly 122 to release the valve anchor such that when the valve anchor is released from the valve delivery device 100, the distal carrier assembly 122 can be moved to release the valve frame (figures 2B and 12-14; paragraphs 109 and 133), and the sheath 110 being longitudinally slidable over the proximal tapered surface 287 to axially align the sheath 110 with the proximal enclosure 284 (functional limitation; see annotated figure 2A below; paragraph 101 discloses the catheter 124 is flexible, therefore the inner catheter body 124 deflects upon exiting the sheath 110 along the annotated dashed axis below, when the sheath 110 is pushed distally or when the inner catheter body 124 is withdrawn proximally, the sheath hits the proximal tapered surface 287 and pushes the inner catheter body 124 back into alignment with the sheath 110); and
a control unit 206/210 (paragraphs 104, 109-111 and 127; see Note below) operatively coupled to the distal carrier assembly 122 and the sheath 110 for actuation motion thereof, the control unit 206/210 comprising:
a first control element 210 (paragraphs 109 and 134-135; see Note below) configured to move the sheath 110 relative to the distal carrier assembly 122 for permitting the valve anchor to expand and for moving the sheath 110 over the proximal tapered surface 287 of the proximal enclosure 284 to an axially aligned configuration after release of the valve anchor (functional limitation – first control element 210 steers distal carrier assembly 122 relative to the sheath 110, therefore is also capable of withdrawing the sheath 110 relative to the distal carrier assembly 122); and
a second control element 206 (paragraphs 109 and 133; see Note below) configured to actuate the proximal enclosure 284 and the distal enclosure 275 of the distal carrier assembly 122 for permitting expansion of the valve frame (figures 2B and 12-14), wherein the distal enclosure 275 is distal to the proximal enclosure 284 and configured to enclose a distal portion of the valve frame (figures 2A and 4; paragraph 133).
Note – 112(f) interpretation – Applicant’s control unit is a handle actuator 500 that controls the operation of the delivery device 200 (Spec. [0044]); Deem’s control unit 206/210 is similarly a handle that controls the operation of the device (figures 3 and 7-10; paragraphs 109-111 and 127-132); therefore both control units are equivalent in controlling the operation of the device.
Note – 112(f) interpretation – Applicant’s first control element 520 is a knob or button configured to move the sheath (Spec. [0044-0045]; claim 1); Deem’s first control element 210 is used to move the distal carrier assembly 122 relative to the sheath 110 (paragraphs 109 and 134-135); therefore both first control elements are equivalent in controlling relative movement of the sheath and distal carrier assembly.
Note – 112(f) interpretation – Applicant’s second control element 522 is a knob or button that actuates the distal carrier assembly (Spec. [0044-0045]; claim 1); Deem’s second control element 206 is a hydraulic mechanism actuating the distal carrier assembly 122 for permitting expansion of the valve frame (paragraphs 109 and 133; figures 12-14); therefore both second control elements are equivalent in in actuating the distal carrier assembly for permitting expansion of the valve frame.
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With regards to claim 4, Deem discloses wherein the distal enclosure 275 is configured to enclose the distal portion of the valve frame during delivery (figures 2A and 11) and is movable relative to the proximal enclosure 284 to release the distal portion of the valve frame from the distal carrier assembly 122 (paragraphs 109 and 133; figures 2B and 12-14).
With regards to claim 8, Deem discloses further comprising a sheath control element (balloon; see Note below) configured to enable a surgeon to permit expansion of the valve anchor (paragraph 138 – balloon – “an expander in the form of a balloon can be positioned within the prosthetic device 150 and can be inflated to deploy the atrial end 424”) and a position control element 224 (see Note below) configured to enable the surgeon to control a rotational position of the valve anchor during placement of the valve anchor in a patient (paragraph 109).
112(f) interpretation – Applicant’s sheath control element 522 is a knob or button that permits expansion of the valve anchor [spec. 0044-0045]; Deem’s sheath control element is a balloon that controls expansion of the prosthesis 150 (paragraph 138); therefore both sheath control elements are equivalent in permitting expansion of the valve anchor.
112(f) interpretation - Applicant’s position control element 520 is a knob or button that controls a rotational or longitudinal position of the valve anchor [spec. 0044-0045]; Deem’s position control element 224 is a knob that controls rotational movement of the device 150 (paragraph 109); therefore both position control elements are equivalent in controlling a rotational position of the valve anchor.
With regards to claim 32, Deem discloses wherein the proximal enclosure 284 of the distal carrier assembly 122 is separable relative to the distal enclosure 275 of the distal carrier assembly 122 (paragraphs 109 and 133; figures 2A-2B and 11-14).
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Deem in view of Zhang (US PGPub 2016/0015512), hereinafter known as “Zhang 512.”
With regards to claims 2-3 and 5, Deem discloses the valve delivery device as claimed in claim 1. Deem is silent wherein a link mechanism is slidable along the valve anchor, the valve anchor comprising an engagement area where the link mechanism can be engaged and constrained from further sliding movement (claim 2); wherein the link mechanism comprises a suture that is slidably coupled to the valve anchor and fixedly coupled to the valve frame (claim 3); and wherein the link mechanism is coupled to the valve frame at a substantially fixed position when the valve frame is engaged by the distal carrier assembly, prior to release of the valve frame therefrom (claim 5).
However, in a similar field of endeavor of heart valve prosthesis delivery, Zhang 512 teaches (Figures 1-7) wherein a link mechanism 60 (suture loop, paragraphs 72, 82, and 91) is slidable along the valve anchor (paragraph 72 and 91), the valve anchor 140/150 (alternatively 10 in figure 1 to show the link mechanism 60) comprising an engagement area (figure 1; paragraph 72 – “engagement position” - lumen 50 within leg member 30) where the link mechanism 60 can be engaged and constrained from further sliding movement (suture 60 can only slide within the lumen 50 of the leg member 30);
wherein the link mechanism 60 comprises a suture 60 that is slidably coupled to the valve anchor 140/150 (alternatively 10 in figure 1 to show the suture 60) and fixedly coupled to the valve frame 170 (alternatively 15 in figure 1) (paragraphs 43, 70, 72, 82, and 91); and
wherein the link mechanism 60 is coupled to the valve frame 170 at a substantially fixed position (paragraphs 43, 70, and 72 – “suture loop is fixed to the support frame and movably attached to the leg member”) when the valve frame 170 is engaged by the distal carrier assembly 110, prior to release of the valve frame 170 therefrom (figure 1 shows the link mechanism 60 attached to the valve frame 10, paragraph 91 discloses the attachment of the valve frame to the link mechanism prior to movements of the first 110 and second 120 sheaths to deploy the valve prosthesis).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the implant of Deem for the heart valve prosthesis of Zhang 512. The difference between the prior art and the claimed invention is that Deem does not teach a link mechanism. Zhang 512 teaches (see Figs. 1-7) a similar heart valve prosthesis comprising a link mechanism. Accordingly, the prior art references teach that it is known that the heart valve prosthesis of Deem and the heart valve prosthesis of Zhang 512 are elements that are functional equivalents for providing pumping of blood of the heart. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the heart valve prosthesis taught by Zhang 512 for the heart valve prosthesis of Deem because both elements were known equivalents for providing and would have resulted in the predictable results of providing pumping of blood to the heart.
Claims 6-7 is rejected under 35 U.S.C. 103 as being unpatentable over Deem in view of Macoviak et al. (US PGPub 2009/0043381), hereinafter known as “Macoviak.”
With regards to claims 6-7, Deem discloses the device as claimed in claim 1. Deem is silent wherein the device comprises a system length of less than 4 feet as recited in claim 6, or less than 3 feet as recited in claim 7.
However, in a similar field of endeavor of heart valve prosthesis delivery, Macoviak teaches wherein the device comprises a system length of less than 3 feet (paragraph 12 – “These devices, systems and methods may be applied by any established beating heart or open heart direct surgical approach using relatively short catheters or tools, e.g., less than approximately 80 cm in length, or with standard surgical tools” – 80 cm equals 2.62 feet, which is less than 3 feet).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system length of Deem to be less than 3 feet as taught by Macoviak for the purpose of enabling improved control of the device.
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Deem in view of Zhang (US 2010/0249916), hereinafter known as “Zhang 916.”
With regards to claim 30, Deem discloses the delivery device as claimed in claim 1. Deem is silent wherein the first control element slides to move the sheath relative to the distal carrier assembly.
Zhang 916 teaches in an alternative embodiment wherein the control unit may comprise one or more dial portions wherein individual movable components of the implantation device (e.g., first sheath, second sheath, track wires, locking wires, pusher wires) may be moved proximally or distally by rotating a dial; and it is understood that a single implantation device control unit may comprise both rotational control elements such as the threaded sections, and control elements such as switches and handles that are moved along the longitudinal axis (paragraph 267).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first control element of Deem to include wherein the first control element is also slidable as taught by Zhang 916 for the purpose of increased efficiency by applying a single implantation device control unit to comprise of both rotational and slidable control elements (paragraph 267 of Zhang 916).
With regards to claim 31, Deem further discloses further comprising a plurality of graspers 364 configured to engage and form a releasable connection with the valve anchor (of the valve prosthesis 150; paragraphs 118-119), wherein the first control element 210 rotates in a first direction to release a plurality of graspers 364 from the valve anchor to permit disengagement of the anchor (paragraphs 109, 118-119, and 133-134 – functional limitation – knobs 214/216 of 210 rotate to rotate and steer the distal carrier assembly 122, the first control element 210 is capable of performing the claimed functions due to the knobs 214/216 being rotatable to translate the distal carrier assembly 122 relative the sheath 110, therefore once the implant 150 is uncovered, the plurality of grasper members 364 can disengage from the anchor).
Claims 18-19 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Deem in view of Zhang 916.
With regards to claim 18, Deem discloses (Figures 1-14) a heart valve prosthesis delivery device control system 100 (paragraphs 105-106) comprising:
a core member 124 (paragraph 105; figures 2A-2B);
a distal carrier assembly 122 coupled to the core member 124 (figures 2A-2B), wherein the distal carrier assembly 122 is configured to support a frame of a valve prosthesis 150 in a collapsed configuration (figures 2A and 4) during delivery, wherein the distal carrier assembly comprises a proximal enclosure 284 and a distal enclosure 275, wherein the proximal enclosure 284 is configured to enclose a proximal end portion of the frame (of a valve prosthesis 150; figure 4; paragraphs 106 and 114), wherein the proximal enclosure 284 comprises a cavity with an opening oriented toward the distal enclosure 275 and the cavity is configured to receive the proximal end portion of the frame, wherein the distal enclosure 275 is configured to enclose a distal end portion of the frame (figures 2A and 4 – see cylindrical wall and cavity of proximal enclosure 284 where 150 lies inside);
a sheath 110 configured to support an anchor of the valve prosthesis 150 in the collapsed configuration during delivery (figure 11; paragraph 134);
a plurality of grasper members 364 configured to engage and form a releasable connection with the anchor (figure 5; paragraph 118-119);
a control unit 206/210 (paragraphs 104, 109-111 and 127) comprising a control handle (any area that a user can grab on the control unit 206/210 is a control handle) configured to permit step-wise release of the anchor from the sheath and the frame from the distal carrier assembly 122 (figures 11-14 – functional limitation – control unit is capable of permitting set-wise release of an anchor and a frame of a valve prosthesis 150 due to the features on the control unit 206/210);
an anchor expansion actuator 210 (paragraphs 109 and 133-14) coupled to the control handle for (i) longitudinally sliding the sheath 110 over a proximal tapered surface 287 of the proximal enclosure 284 of the distal carrier assembly 122 to axially align the sheath 110 with the proximal enclosure 284 (functional limitation; see annotated figure 2A below; paragraph 101 discloses the catheter 124 is flexible, therefore the inner catheter body 124 deflects upon exiting the sheath 110 along the annotated dashed axis below, when the sheath 110 is pushed distally or when the inner catheter body 124 is withdrawn proximally, the sheath hits the proximal tapered surface 287 and pushes the inner catheter body 124 back into alignment with the sheath 110), and (ii) moving the sheath 110 relative to the anchor to expose the anchor and permit expansion of the anchor relative to the sheath 110 (figures 2B and 12-14), and the anchor expansion actuator 210 being rotatable relative to the control handle for disengaging the plurality of grasper members 364 from the anchor to permit disengagement of the anchor from the control system 100 (paragraphs 109, 118-119, and 133-134 – functional limitation – knobs 214/216 rotate to rotate and steer the distal carrier assembly 122, the anchor expansion actuator 210 is capable of performing the claimed functions due to the knobs 214/216 being rotatable to translate the distal carrier assembly 122 relative the sheath 110, therefore once the implant 150 is uncovered, the plurality of grasper members 364 can disengage from the anchor); and
a valve frame release actuator 206 coupled to the control handle for permitting expansion of the frame from the distal carrier assembly 122 coupled to the core member 124 (paragraphs 109 and 133).
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Deem is silent wherein the anchor expansion actuator is slidable relative to the control handle.
However, Zhang 916 teaches in an alternative embodiment wherein the control unit may comprise one or more dial portions wherein individual movable components of the implantation device (e.g., first sheath, second sheath, track wires, locking wires, pusher wires) may be moved proximally or distally by rotating a dial; and it is understood that a single implantation device control unit may comprise both rotational control elements such as the threaded sections, and control elements such as switches and handles that are moved along the longitudinal axis (paragraph 267).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anchor expansion actuator of Deem to include wherein the anchor expansion actuator is also slidable relative to the control handle as taught by Zhang 916 for the purpose of increased efficiency by applying a single implantation device control unit to comprise of both rotational and slidable control elements (paragraph 267 of Zhang 916).
With regards to claim 19, Deem further discloses wherein the distal enclosure 275 is movable relative to the proximal enclosure 284 to release the frame (of the valve prosthesis 150) from the distal carrier assembly 122 (paragraphs 109 and 133; figures 2B and 12-14).
With regards to claim 38, Deem further discloses wherein an outer surface of the proximal enclosure 284 is aligned with an outer surface of the sheath 110 when the sheath 110 is axially aligned with the proximal enclosure 284 (functional limitation; see annotated figure 2A above; paragraph 101 discloses the catheter 124 is flexible, therefore the inner catheter body 124 deflects upon exiting the sheath 110 along the annotated dashed axis above, when the sheath 110 is pushed distally or when the inner catheter body 124 is withdrawn proximally, the sheath hits the proximal tapered surface 287 and pushes the inner catheter body 124 back into alignment with the sheath 110).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Deem in view of Zhang 916, and further in view of Macoviak.
With regards to claim 20, Deem/Zhang 916 disclose the control system as claimed in claim 18. Deem/Zhang 916 are silent wherein the control system comprises a system length of less than 3 feet.
However, in a similar field of endeavor of heart valve prosthesis delivery, Macoviak teaches wherein the control system comprises a system length of less than 3 feet (paragraph 12 – “These devices, systems and methods may be applied by any established beating heart or open heart direct surgical approach using relatively short catheters or tools, e.g., less than approximately 80 cm in length, or with standard surgical tools” – 80 cm equals 2.62 feet, which is less than 3 feet).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system length of Deem/Zhang 916 to be less than 3 feet as taught by Macoviak for the purpose of enabling improved control of the device.
Allowable Subject Matter
Claims 33-37 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With regards to claim 33, Deem does not disclose or make obvious wherein the proximal enclosure further comprises an abutment surface at the distal end portion of the proximal tapered surface, the abutment surface having a radius equal to an outer radius of the sheath. Deem’s proximal enclosure 284 cannot have an abutment surface with the same radius as the outer radius of the sheath 110 since Deem’s proximal enclosure 284 is not the same size as the sheath 110, the proximal enclosure 284 travels through the sheath 110. Claims 34-35 are dependent off of claim 33 and thus would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
With regards to claim 36, Deem does not disclose or make obvious wherein the proximal tapered surface comprises a plurality of circumferential nodes configured to contact an inner surface of the sheath as the sheath longitudinally slides over the proximal tapered surface. Deem’s proximal enclosure 284 does not have circumferential nodes that would be able to contact a sheath 110 to axially align the proximal enclosure 284 with the sheath 110. Claim 37 is dependent off of claim 36 and thus would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 06/25/2026
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