DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
Election/Restrictions
Applicant’s election without traverse of claims 1-11 and 18-22 in the reply filed on 09/01/2026 is acknowledged. Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/01/2026. Claims 16, 17, and 23-27 were previously canceled.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
In claim 8, “the plunger having a plurality of threads” lacks antecedent basis due to different terminology in the claims and in the specification. It is assumed that the plunger having a plurality of threads is the deployment assist 1668 with a threaded shaft 1661 (Paragraph [0101]).
In claim 18, “a primary fluid cylinder” lacks antecedent basis due to different terminology in the claims and in the specification. It is assumed that a primary fluid cylinder is the annular chamber 357 (Paragraph [0077]).
Claim Objections
Claims 6-7 are objected to because of the following informalities: In claims 6-7 the feature of a “cap” is assumed to be a typo and refers to the “endcap” in paragraph [0096] and has been examined as such. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: In line 5 “the rotational movement” is assumed to be typo. The examiner suggests amending this to be “a rotational movement” and has been examined as such. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 9-11, and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mauch et al. (US PG Pub No. 2018/0344454 A1).
Regarding claim 1, Mauch discloses a system (Figs. 6-10, delivery system 100, delivery system 200b) for deploying a valve prosthesis (Figs. 6-10, prosthetic device 102) comprising: a deployment device (Figs. 6-10, catheter 104) including:
an elongated catheter body (Figs. 6-10, catheter body 106) having a distal end (Figs. 6-10, distal portion 106a) and a proximal end (Figs. 6-10, proximal portion 106b), the catheter body (106) further including a lumen (Paragraph [0068], Figs. 6-10, fluid lines 158 and tether 135 are within 106) extending a length of the catheter body (106);
a tension cable (Figs. 6-10, tether 135) having a first end (Paragraph [0068], “extends through catheter body 106”) and a second end (Paragraph [0068], “via actuator”), the tension cable (135) positioned within (Paragraph [0068]) the catheter body (106), a capsule (Figs. 6-10, delivery capsule 108) having a delivery configuration (Paragraph [0049]) and a deployed configuration (Paragraph [0049]), the capsule (108) positioned at the distal end (Fig. 6, at 106a) of the catheter body (106) and operatively coupled to the lumen (Paragraph [0063], Fig. 7A) and the first end of the tension cable (Paragraph [0068], “extends through catheter body 106”), wherein the tension cable (135) inhibits (Paragraphs [0051 and 0054])) the capsule (108) from transitioning between the delivery configuration and the deployed configuration (Paragraphs [0051 and 0054]);
a handle (Figs. 6-10, handle 110) positioned at the proximal end (106b) of the catheter body (106) and operatively coupled to the second end (Paragraph [0068], “via actuator”) of the tension cable (135) and the lumen (Fig. 8D); and a deployment assist (Figs. 6-10, control assembly 126) positioned at the handle (Fig. 6, 110) and is configured to place a force (Paragraphs [0050 and 0068]) on the second end of the tension cable (Paragraph [0068], “via actuator”) in order to assist in transitioning (Paragraphs [0050, 0054, and 0068]) the capsule (108) from the delivery configuration to the deployed configuration (Paragraphs [0050, 0054, and 0068]);
wherein the lumen (Paragraph [0068], Figs. 6-10, fluid lines 158 and tether 135 are within 106) and the capsule (108) are configured to hold a hydraulic fluid (Figs. 6-10, fluid lines 158 go through lumen of 106 and capsule 108);
and a hydraulic system (Figs. 6-10, fluid system 116) fluidly connected (Paragraphs [0051 and 0062], Figs. 6-10, fluid lines 158) to the capsule (108) and the lumen (Paragraph [0068], Figs. 6-10, fluid lines 158 and tether 135 are within 106), wherein the hydraulic system (116) is configured to transition the capsule (108) from the delivery configuration to the deployed configuration via delivery of the hydraulic fluid into the capsule (108) through the lumen (Paragraph [0051]).
Regarding claim 2, Mauch discloses wherein the deployment assist (Figs. 6-10, control assembly 126) is rotatable (Paragraph [0050], “include rotational elements”) relative to the handle (110), wherein the rotational movement (Paragraph [0050]) of the deployment assist (126) places the force on the second end of the tension cable (Paragraph [0068], “via actuator”), wherein the force is an axial force in a distal direction (Paragraph [0068]).
Regarding claim 9, Mauch discloses wherein the deployment assist (Figs. 6-10, control assembly 126) further includes a lever including a cam (Paragraph [0050], “control assembly may include levers and/or other actuators) that is configured to place the force onto the second end of the tension cable (135) as the lever is rotated. Mauch’s control assembly (126) and tension cable (135) are within the handle (110) and initiates deployment of the prosthetic device.
Regarding claim 10, Mauch discloses wherein the system (Fig. 9B, 200b) further includes a distal push assist (Fig. 9B, biasing devices 262a and 262b) at the capsule (108), the distal push assist (262a and 262b) being configured to assist in transitioning the capsule (108) between the delivery and deployed configurations (Paragraphs [0073-0074]).
Regarding claim 11, Mauch discloses wherein the distal push assist (262a and 262b ) is a spring (Paragraph [00073], Fig. 9B).
Regarding claim 18, Mauch discloses a system (Figs. 6-10, delivery system 100, delivery system 200b) for deploying a valve prosthesis (Figs. 6-10, prosthetic device 102) comprising: a deployment device (Figs. 6-10, catheter 104) including: an elongated catheter body (Figs. 6-10, catheter body 106) having a distal end (Figs. 6-10, distal portion 106a) and a proximal end (Figs. 6-10, proximal portion 106b), the catheter body (106) further including a lumen (Paragraph [0068], Figs. 6-10, fluid lines 158 and tether 135 are within 106) extending a length of the catheter body (106);
a tension cable (Figs. 6-10, tether 135) having a first end (Paragraph [0068], “extends through catheter body 106”) and a second end (Paragraph [0068], “via actuator”), the tension cable (135) positioned within (Paragraph [0068]) the catheter body (106),
a capsule (Figs. 6-10, delivery capsule 108) having a delivery configuration (Paragraph [0049]) and a deployed configuration (Paragraph [0049]), the capsule (108) positioned at the distal end (Fig. 6, at 106a) of the catheter body (106) and operatively coupled to the lumen (Paragraph [0063], Fig. 7A) and the first end of the tension cable (Paragraph [0068], “extends through catheter body 106”), wherein the tension cable (135) inhibits (Paragraphs [0051 and 0054]) the capsule (108) from transitioning between the delivery configuration and the deployed configuration (Paragraphs [0051 and 0054]);
a handle (Figs. 6-10, handle 110) positioned at the proximal end (106b) of the catheter body (106) and operatively coupled to the tension cable (135) and the lumen (Fig. 8D); and
wherein the lumen (Paragraph [0068], Figs. 6-10, fluid lines 158 and tether 135 are within 106) and the capsule (108) are configured to hold a hydraulic fluid (Figs. 6-10, fluid lines 158 go through lumen of 106 and capsule 108);
a hydraulic system (Figs. 6-10, fluid system 116) configured to transition the capsule (108) from the delivery configuration to the deployed configuration including:
a primary fluid cylinder (Fig. 7A, first fluid chamber 142) fluidly connected (Paragraph [0062], Fig. 7A, first fluid port 160a) to the lumen (158a is within lumen of 106 and connects to 160a) and the capsule (108), the primary fluid cylinder (142) being configured to increase the pressure of the hydraulic system to a specified pressure level (Paragraphs [0062 and 0066]);
a secondary fluid cylinder (Fig. 7A, second fluid chamber 144) fluidly connected (Paragraph [0062], Fig. 7A, second fluid port 160b ) to the lumen (158b is within lumen of 106 and connects to 160b) and the capsule (108), the secondary fluid cylinder (144) being configured to supplement fluid volumes within the lumen and the capsule (Paragraphs [0058, 0062, and 0067]).
Regarding claim 19, Mauch discloses wherein the first end of the tension cable (Paragraph [0068], “extends through catheter body 106” at proximal cap 136 of capsule 108) exerts a first axial force in a first direction (Paragraph [0066], 136 “pulled in a proximal direction”) on the capsule (108, housing 112).
Regarding claim 20, Mauch discloses wherein the pressure within the lumen (Paragraph [0068], Figs. 6-10, fluid lines 158 and tether 135 are within 106) and the capsule (108) exerts a second axial force in a second direction (Paragraph [0067]) on the capsule (108, housing 114), the second direction being opposite the first direction (Paragraph [0067], 114 “moves in a distal direction”, Fig. 8C, arrow 103).
Regarding claim 21, Deem as modified by Mauch discloses wherein the capsule (108) transitions from the delivery configuration to the deployed configuration when the second axial force is larger than the first axial force (Paragraph [0067]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Mauch et al. (US PG Pub No. 2018/0344454 A1) in view of Deem et al. (US PG Pub No. 2022/0008194 A1).
Regarding claim 3, Mauch discloses wherein the capsule (108) further includes a body (Figs. 6-10, first housing 112, second housing 114), but fails to disclose a deployment piston, wherein transitioning the capsule from the delivery configuration to the deployed configuration moves the body axially relative to the deployment piston.
Deem also discloses a system (Figs. 2-9, system 100) for deploying a valve prosthesis (Fig. 4, prosthetic device 150) comprising a deployment device (Figs. 2-9, catheter 102), a capsule (Figs. 2-7, delivery capsule 122) with a body (Figs. 4-5, housing 268 (proximal sheath 272, distal sheath 270)), a catheter body (Figs. 2-9, catheter body 124), and a handle (Figs. 7-9, housing 517 with knobs 240). Deem teaches a deployment piston (Fig. 5, piston 292, Fig. 6, proximal head assembly 304 of piston 292), wherein transitioning the capsule (122) from the delivery configuration (Fig. 2A) to the deployed configuration (Fig. 2B) moves the body axially relative (Paragraph [0122], Fig. 6, distal sheath 270 of body 268 moves with arrow 416) to the deployment piston (292, 304). Therefore, 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 capsule of Mauch to further include a deployment piston, wherein transitioning the capsule from the delivery configuration to the deployed configuration moves the body axially relative to the deployment piston, as taught by Deem, in order to unsheathe the prosthetic (Paragraph [0122]).
Regarding claim 4, Mauch as modified by Deem further discloses wherein the capsule (Figs. 2-7, delivery capsule 122) further includes a deployment chamber (Fig. 6, fluid chamber 410) between the body (268) and the deployment piston (292, 304) and fluidly coupled to the lumen (Paragraph [0126]), the deployment chamber (410) is configured to fill with hydraulic fluid (Paragraphs [0122 and 0126]) to transition (Paragraphs [0122 and 0126]) the capsule (122) from the delivery configuration (Fig. 2A) to the deployed configuration (Fig. 2B).
Regarding claim 5, Mauch in view of Deem discloses wherein the first end of the tension cable (Paragraph [0068], “extends through catheter body 106”) is coupled (Fig. 8D) to the body (112) of the capsule (108), the first end of the tension cable (Paragraph [0068], “extends through catheter body 106”) being configured to place an axial force on the body (112) of capsule (108) as to move (Paragraphs [0049 and 0068]) the body (112) of the capsule (108) axially relative (Fig. 8A, arrow 101) to the deployment piston (Deem 292 is in the same position on the capsule as the proximal cap 136 of Mauch).
Regarding claim 8, Mauch fails to disclose wherein the deployment assist is a plunger that is positioned within the proximal end of the handle, the plunger extends radially from the distal end of the handle and is configured to have a plurality of threads that convert the rotational movement of the plunger into the force that is placed on the second end of the tension cable.
Deem also discloses a system (Figs. 2-9, system 100) for deploying a valve prosthesis (Fig. 4, prosthetic device 150) comprising a deployment device (Figs. 2-9, catheter 102), a capsule (Figs. 2-7, delivery capsule 122), a deployment assist (Fig. 3, knob 224, Figs. 3 and 7, locking feature 529), a tension cable (Figs. 3 and 7, tubular member 531, a catheter body (Figs. 2-9, catheter body 124), and a handle (Figs. 7-9, housing 517). Deem teaches wherein the deployment assist (Fig. 3, knob 224, Figs. 3 and 7, locking feature 529) is a plunger (Fig. 7, locking feature 529) that is positioned within the proximal end (see fig. 7) of the handle (517), the plunger (529) extends radially from the distal end (see Fig. 7) of the handle (517) and is configured to have a plurality of threads (Paragraph [0128], 529 can be a screw) that convert a rotational movement of the plunger (Paragraph [0128]) into the force that is placed on the second end of the tension cable (531). Therefore, 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 deployment assist of Mauch to be a plunger that is positioned within the proximal end of the handle, the plunger extends radially from the distal end of the handle and is configured to have a plurality of threads that convert the rotational movement of the plunger into the force that is placed on the second end of the tension cable, as taught by Deem, in order to lock and unlock the rotation of the catheter (Paragraph [0128]) which allows for delivery and deployment of the prosthesis.
The phrase “…that convert the rotational movement of the plunger into the force that is placed on the second end of the tension cable” is a functional recitation that is not given full patentable weight. The system is not positively recited here, but is instead merely recited as part of the intended use of the system. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability for the endcap to be rotated to cause a force on the second end of the tension cable in order to meet that claim requirements. In the case, modified Mauch discloses all of the claimed structural features, such as the plunger (529) has threads (Paragraph [0128]) that can lock and unlock the tension cable (531) for rotation of the catheter body.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Mauch et al. (US PG Pub No. 2018/0344454 A1) in view of Morrissey et al. (US PG Pub No. 2018/0325669 A2).
Regarding claim 6, Mauch fails to disclose wherein the deployment assist is an endcap that is positioned radially over the proximal end of the handle, the endcap is configured to have a plurality of threads that convert rotational movement of the endcap into the force that is placed on the second end of the tension cable.
Morrissey also discloses a system (Figs. 3-5, delivery device 1010) for deploying a valve prosthesis (Paragraph [0048]) comprising a handle (Figs. 3-5, handle 1020), a deployment assist (Figs. 3-5, carriage assembly 1040), and an endcap (Figs. 3-5, 1041). Morrissey teaches wherein the deployment assist (1040) is an endcap (1041) that is positioned radially over the handle (1020), the endcap (1041) is configured to have a plurality of threads (Fig. 4, threaded rod 1036) that convert rotational movement of the endcap into the force that is placed on the second end of the tension cable. Morrisey fails to disclose wherein an endcap is positioned radially over the proximal end of the handle, and instead teaches wherein an endcap is positioned radially over the distal end (Fig. 3A, proximal to 1022) of the handle (Fig. 3A, 1020). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the endcap from the distal end of the handle to the proximal end of the handle, as doing so would have yielded predictable results, namely deploying the prosthetic valve from the system.
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the end cap deployment assist of Morrissey for the control assembly deployment assist of Mauch as modified by Deem. Substituting the control assembly deployment assist (Mauch: Paragraph [0050], can include rotational elements) of Mauch as modified by Deem with the end cap deployment assist of Morrissey would allow the second end of the tension cable (Mauch: Paragraph [0068], “via actuator”) to be engaged through rotational force.
Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
The phrase “that convert rotational movement of the endcap into the force that is placed on the second end of the tension cable” is a functional recitation that is not given full patentable weight. The system is not positively recited here, but is instead merely recited as part of the intended use of the system. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability for the endcap to be rotated to cause a force on the second end of the tension cable in order to meet that claim requirements. In the case, Mauch as modified by Deem and Morrissey discloses all of the claimed structural features, such as the threads (1036) of the endcap (1041) through the rotation of the deployment actuator (1021) to deploy the valve.
Regarding claim 7, Mauch as modified by Morrissey further discloses wherein the deployment assist (1040) further includes a locking aperture (Fig. 5, hole 1046), the locking aperture (1046) configured to receive a pin (Fig. 5, pin 1044) that secures the endcap (1041) to the handle (Fig. 3C, 1020).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Mauch et al. (US PG Pub No. 2018/0344454 A1) in view of Randall et al. (US Patent No. 6,514,261 B1).
Regarding claim 22, Mauch fails to disclose further comprising a check valve configured to control how much fluid volume is supplemented by the secondary cylinder.
Randall also discloses a system (Fig. 8) for deploying a valve prosthesis (Col. 6, line 14, “stent delivery mechanism”) comprising a deployment device (Figs. 8-12, stent 16), a first cylinder (Figs. 8-12, chamber 70), and a second cylinder (Figs. 8-12, chamber 64). Randall teaches a check valve (Figs. 8-12, check valves 76, and 78) configured to control how much fluid volume is supplemented (Col. 6, lines 33-41) by the secondary cylinder (64). Therefore, 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 Mauch to comprise a check valve configured to control how much fluid volume is supplemented by the secondary cylinder, as taught by Randall, in order to deploy the prosthesis (Col. 6, lines 33-41).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
McLean et al. (US PG Pub No. 2013/0304200 A1) also discloses a system (Figs. 54A-56) for deploying a valve prosthesis (Figs. 54A-56, device 100) comprising a deployment device (Figs. 54A-56, delivery system 40), a capsule (Figs. 54A-56, sheath 402, cavity 408), a catheter body (Figs. 54A-56, catheter 400), a handle (Paragraphs [0299 and 0303]), a deployment assist (Paragraph [0299], “adjustable stop on the handle”), and a tension cable (Paragraph [0299], “a wire”).
Dueri et al. (US PG Pub No. 2020/0261226 A1) also discloses a system (Fig. 6, hydraulic delivery system 100) for deploying a valve prosthesis (Fig. 6, prosthetic heart valve 110) comprising a deployment device (Fig. 6, catheter 102), a capsule (Fig. 6, capsule 106), a catheter body (Fig. 6, catheter body 108), a handle (Fig. 6, control unit 104), and a deployment assist (Fig. 6, control assembly 122).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.L.C./ Patent Examiner, Art Unit 3774
/SARAH W ALEMAN/ Primary Examiner, Art Unit 3774
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