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 .
Response to Amendment
The amendment filed February 23, 2026 has been entered. Claims 1-14 remain pending in the application. Applicant’s amends to the Specification, Drawings and Claims have overcome each and every objection and 112(b) rejection previously forth in the Non-Final Office Action mailed 11/24/2025.
Response to Arguments
Applicant’s arguments, see pages 9-10, filed February 23 2026, with respect to
claims 1, 4-5, 8-10 and 15 rejected under U.S.C 102 (b) as anticipated by Gifford et al. (20210308433) have been considered but are moot in view of the new ground(s) of rejection.
Applicant’s arguments, see pages 9-10, filed February 23 2026, with respect to dependent claims 2-3, 9, and 11-14 under U.S.C. 103 (a) as unpatentable over Gifford in view of secondary cited prior art have been considered but are moot in view of the new ground(s) of rejection.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. US 6602226 B1, herein referred to as Smith, in view of Gifford III (US 20210308433 A1), herein referred to as Gifford.
*Applicant’s amendments are underlined.
Regarding claim 1, Smith discloses a method of delivering a transcatheter heart valve prosthesis (Smith Col 7, lines 1-6; Fig 1, delivery system 120), the method comprising: loading the transcatheter heart valve prosthesis (Smith Fig 1, prosthesis 124) in a crimped configuration within a dilator shaft (Smith Fig 1, 148 sheath; Col 6, lines 48-58, teaches inflating ballon while housed inside of the delivery sheath for dilation, as configured in Fig 1 would result in the sheath dilating vessel) of a dilator prior to inserting the dilator shaft into a vasculature of a patient (Smith Col 2, 36-54; teaches loading of treatment element into the dilator shaft prior to the shaft entering vessels); after loading the transcatheter heart valve prosthesis in a crimped configuration within the dilator shaft) (Smith col 2, lines 36-56), tracking the dilator shaft within the vasculature of the patient such that a distal end of the dilator shaft is located at a desired site with the transcatheter heart valve prosthesis loaded therewithin in the crimped configuration (Smith Col 2, lines 36-54; “The balloon is moved relative to the inner tube such that at least a portion of the balloon lies between the medical device and the inner tube and inflated thereby engaging the medical device and positioning the medical device in a desired bodily location”);
advancing a delivery device (Fig 1, balloon 140) through the dilator shaft to the distal end of the dilator shaft wherein the delivery device is advanced through the dilator shaft with the heart valve prosthesis distal of a distal end of the delivery device such that the heart valve prosthesis is not loaded onto the delivery device (Smith Col 4, lines 14-28 Smith teaches the step of advancing the balloon distally (sliding over member 160) within the dilator shaft without the prosthesis being loaded onto the ballon);
advancing the delivery device through a central lumen of the transcatheter heart valve prosthesis while the transcatheter heart valve prosthesis is disposed within the dilator shaft at the desired site such that the transcatheter heart valve prosthesis is loaded onto the delivery device (Fig 1; Col 3, lines 32-50); advancing the delivery device with the transcatheter heart valve prosthesis mounted thereon past the distal end of the dilator shaft to a treatment site within the vasculature of the patient (Smith Col. 6, 59-67, Fig 8 deploying state of prosthesis)
But does not explicitly disclose deploying the transcatheter heart valve prosthesis from the delivery device at the treatment site.
However, Gifford discloses a similar treatment (Gifford Fig 1) delivery method (Gifford teaches delivering to the heart, see [0005]). Gifford teaches deploying the transcatheter heart valve prosthesis (Gifford Fig 1 explicitly shows a replacement heart valve for implantation; also see [0080]) from the delivery device at the treatment site (Gifford Fig 1 depicts a conventional balloon catheter and replacement valve positioned at the aortic valve during a typical TAVR procedure”; (¶ 0130, 0160).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Smith to incorporate the steps of deploying the transcatheter heart valve prosthesis from the delivery device at the treatment site, as taught and suggested by Gifford in order to deliver an implant during active blood flow (Gifford [0095]).
Regarding claim 2, Smith/Gifford discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches advancing the delivery device through a central lumen of the transcatheter heart valve prosthesis such that the transcatheter heart valve prosthesis is loaded onto the delivery device comprises the transcatheter heart valve prosthesis being loaded onto a balloon of the balloon catheter1; (Gifford ¶ 0132, lines 1-2: the expandable element 104 comprises an inflatable element, such as a balloon, see Fig 1 and 8B) and deploying the transcatheter heart valve prosthesis from the delivery device comprises inflating the balloon to radially expand the transcatheter heart valve prosthesis at the treatment site (Gifford ¶ 0130, 0160).
Regarding claim 7, Smith/Gifford discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the desired site to which the distal end of the dilator shaft is advanced with the transcatheter heart valve prosthesis loaded therein is a descending aorta of the patient (Gifford ¶ 0130: “treatment systems 100 of the present technology may be used for delivery of repair or replacement devices to any of the four major cardiac valves (aortic, mitral, tricuspid, and pulmonic), as well as dilation of strictures or stents in the aorta or any of the great vessels or other blood vessels”).
Regarding claim 8, Smith/Gifford discloses the invention substantially as claimed and as discussed above with respect to claim 7 teaches wherein the treatment site is a native aortic valve of the patient (Gifford ¶ 0126 “methods for percutaneous replacement of a native aortic valve).
Regarding claim 10, Smith/Gifford discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches a balloon catheter (Gifford Fig 2A 100) including a balloon (Gifford Fig 2A 104) and an inflation lumen (Gifford Fig 2C lumen of 110) in fluid communication with an interior (Gifford Fig 2D 106) of the balloon; a dilator including a dilator shaft (Smith Fig 1, 148 sheath; Col 6, lines 48-58, teaches ballon while housed inside of sheath for dilation, as configured in Fig 1 would result in the sheath dilating vessel; a transcatheter heart valve prosthesis (Gifford teaches delivering to the heart, see [0005]) loaded into a distal end of the dilator shaft in a crimped configuration (Gifford ¶ 0129, “treatment element 101 may be delivered in the collapsed state through a guide catheter; crimped configuration being interpreted to be the collapsed configuration of the prosthetic heart valve prosthesis on the collapsed expandable element 104 of treatment element 101); wherein the distal end of the dilator shaft with the transcatheter heart valve prosthesis disposed therein is configured to be advanced to a desired site within a vasculature of a patient with the transcatheter heart valve prosthesis not loaded onto the balloon catheter (Smith Col 2, 36-54; teaches loading of treatment element into the dilator shaft prior to the shaft entering vessels), wherein the balloon catheter (100) is configured to be inserted through the dilator shaft and through a central lumen of the transcatheter heart valve prosthesis to load the transcatheter heart valve prosthesis onto the balloon of the balloon catheter (¶ 0130, 0160; expandable element 104 of treatment system 100 is used to dilate a prosthetic valve, thereby the prosthesis is loaded on the balloon as claimed), and wherein the balloon catheter (100) with the transcatheter heart valve prosthesis loaded thereon is configured to be advanced past the dilator to a desired treatment site within the vasculature of the patient (Gifford see Fig. 1).
Regarding claim 13, Smith/Gifford discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the desired site to which the distal end of the dilator shaft is configured to be advanced is a descending aorta of the patient (Gifford ¶ 0130: “The treatment systems 100 of the present technology may be used for delivery of repair or replacement devices to any of the four major cardiac valves (“(aortic, mitral, tricuspid, and pulmonic), as well as dilation of strictures or stents in the aorta or any of the great vessels or other blood vessels, and others”).
Regarding claim 14, Smith/Gifford discloses the invention substantially as claimed and as discussed above with respect to claim 13 teaches wherein the treatment site is a native aortic valve of the patient (¶ 0108: “FIG. 1 depicts a conventional balloon catheter and replacement valve positioned at the aortic valve during a typical TAVR procedure”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Smith/Gifford applied to claim 2 above, and further in view of Roberts US 5545209, herein referred to as Roberts.
Smith/Gifford discloses the invention substantially as claimed and as discussed above with respect to claim 2 teaches including expanding the balloon after the transcatheter heart valve prosthesis is loaded onto the balloon (Gifford ¶ 0130, 0160; expandable element 104 of treatment system 100 is used to dilate a prosthetic valve).
Smith/Gifford fails to disclose partially expanding the balloon such that a first portion of the balloon distal of the transcatheter heart valve prosthesis and a second portion of the balloon proximal of the transcatheter heart valve prosthesis expand to form a dog-bone shaped balloon.
However, Roberts discloses a similar medical device delivery method comprising a medical device (12) loaded onto a ballon (10) (Abstract, lines 5-7). Roberts teaches partially expanding the balloon such that a first portion of the balloon distal of the medical device and a second portion of the balloon proximal of the medical device expand to form a dog-bone shaped balloon (Column 10, lines 32-49)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Smith/Gifford’s transcatheter delivery to incorporate the ballon element to inflate to a dog-bone shaped balloon and perform the step of partially expanding the balloon such that a first portion of the balloon distal of the medical device and a second portion of the balloon proximal of the medical device expand to form a dog-bone shaped balloon, as taught by Roberts in order to permit predictable, controlled inflation and prosthesis expansion (column 5, lines 37-45).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Smith/Gifford as applies to claim 1 above, and further in view of Scott et al. WO 2022047160, herein referred to as Scott.
Smith/Gifford discloses the invention substantially as claimed and as discussed above with respect to claim 1, but fails to disclose wherein loading the transcatheter heart valve prosthesis in a crimped configuration within the dilator shaft comprises using a dilator insert, the dilator insert having a dilator insert shaft, a distal end of which pushes the transcatheter heart valve prosthesis through the dilator shaft.
However, Scott et al. discloses a similar dilator shaft (610; Fig. 6B). Scott teaches loading the transcatheter heart valve prosthesis in a crimped configuration within the dilator shaft comprises using a dilator insert (Fig 6E 336) having a dilator insert shaft (Figure 6E), a distal end of which pushes the transcatheter heart valve prosthesis through the dilator shaft (Figure 6F) (pg. 2, col. 2, ¶ 0032, lines 17-23). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Gifford’s transcatheter method of delivering a transcatheter heart valve prosthesis to include a dilator insert having a dilator insert shaft, a distal end of which pushes the transcatheter heart valve prosthesis through the dilator shaft as taught by Scott in order to provide interchangeable access to the vasculature (pg. 1, ¶0007, lines 5-11).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Smith/Gifford as applied to claim 1 above, in view of Nguyen et al. US 20120083877 A1, herein referred to as Nguyen, and further in view of Ohri et al. US 20090259286 A1, herein referred to as Ohri.
Regarding claim 5, Smith/Gifford discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose the dilator shaft is a peelable dilator shaft and as the delivery device is advanced through the peelable dilator shaft, an outer shaft of the delivery device splits the peelable dilator shaft proximal of where the transcatheter heart valve prosthesis is located in the peelable dilator shaft.
However, Nguyen discloses a similar medical device delivery method: comprising a dilator shaft (100). Nguyen teaches the dilator shaft is a peelable dilator shaft (for example, peelable from the configuration in Fig. 39 to the configuration in Fig. 40) and wherein as the delivery device (10) is advanced through the peelable dilator shaft (100), an outer shaft of the delivery device splits the peelable shaft (at 102; see [0130]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Smith/Gifford’s method of delivering a transcatheter heart valve prosthesis to include the teaching of Nguyen to incorporate a peelable dilator shaft such that as the delivery device is advanced through the peelable dilator shaft, an outer shaft of the delivery device splits that peelable shaft in order to facilitate the passing of the prosthetic device therethrough (see [0130]).
Smith/Gifford as modified by Nguyen fails to teach the dilator shaft splits proximal to where the heart valve prosthesis is located in the peelable dilator shaft. However, Ohri et al. teaches a similar medical device delivery method: comprising a dilator shaft (sheath 218). Ohri teaches the outer shaft of the delivery device (212) splits the peelable dilator shaft (218) proximal of where the medical device (stent 100) is located in the peelable dilator shaft (Fig. 5). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the peelable dilator shaft of Smith/Gifford in view of Nguyen such that it splits proximal to where the heart valve prosthesis is located in the peelable dilator shaft as taught by Ohri in order to ensure sufficient release of the heart valve prosthesis from the dilator shaft (Ohri see [0107]).
Regarding claim 6, Smith/Gifford/Nguyen/Ohri discloses the invention substantially as claimed and as discussed above with respect to claim 13 teaches wherein as the delivery device with the transcatheter heart valve prosthesis mounted thereon is advanced past the distal end of the dilator shaft to the treatment site, the delivery device splits the peelable dilator shaft where the transcatheter heart valve prosthesis is located in the peelable dilator shaft and distal of where the transcatheter heart valve prosthesis is located in the peelable dilator shaft (see Ohri’s Fig. 5).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Smith/Gifford as applied to claim 10 above, and further in view of Nguyen.
Regarding Claim 11, Smith/Gifford discloses the invention substantially as claimed and as discussed above with respect to claim 10, but fails to disclose the dilator shaft is a peelable dilator shaft, wherein the peelable dilator shaft and the balloon catheter are configured such that advancing the balloon catheter through the peelable dilator shaft causes the dilator shaft to split. Nguyen also teaches a similar medical device delivery system comprising a dilator shaft (100). Nguyen teaches the dilator shaft is a peelable dilator shaft (for example, peelable from the configuration in Fig. 39 to the configuration in Fig. 40), wherein the peelable dilator shaft (100) and the balloon catheter are configured such that advancing the balloon catheter through the peelable dilator shaft causes the dilator shaft to split (at 102, see [0130] in which the prosthetic device is passed through 100 via a balloon catheter as shown in Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Smith/Gifford’s transcatheter heart valve prosthesis delivery system to include the teaching of Nguyen to incorporate a peelable dilator shaft wherein the peelable dilator shaft and the balloon catheter are configured such that advancing the balloon catheter through the peelable dilator shaft causes the dilator shaft to split in order to maintain a low profile (Nguyen pg.1, ¶ 0007 lines 3-6) while facilitating the passing of the prosthetic device therethrough (Nguyen see ¶ 0130]).
Regarding Claim 12, Smith/Gifford/Nguyen discloses the invention substantially as claimed and as discussed above with respect to claim 11 teaches wherein the peelable dilator shaft (Nguyen 100) includes a peel line (Nguyen ¶ 0130 a weakened portion, such as an axially extending score line or perforated line), wherein the balloon catheter is configured to split the peelable dilator shaft along the peel line (Nguyen see ¶ 0130).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.F./ Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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