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
This office action is responsive to the amendment filed on 05/06/2026. As directed by the amendment: claims 1-3, 5, 11-12, 15-16 have been amended and claims 9 and 19 are withdrawn. Thus, claims 1-8, 10-18 and 20 are presently pending in the application.
Response to Arguments
In light of the amendment to remove the term “tricuspid” in claim 11, the examiner has withdrawn the previous 112(b) rejection over claim 11.
Applicant argues on page 2, the prior art references Gross and Perrin does not disclose “attaching the prosthetic heart valve to one or more delivery catheters using removable sutures.” The examiner respectfully disagrees. Gross et al. discloses attaching the prosthetic heart valve 42 to one or more delivery catheter 154 via removable sutures 490 (e.g. pull wires are coupled to the prosthetic heart valve and disengages to allow the valve to expand or can be reattached to reposition, see paragraphs [0204-0207]).
Applicant argues on page 2, the prior art does not disclose “causing the prosthetic heart valve to emerge from a sheath catheter, wherein the removable sutures maintain the occluder frame and anchoring flaps removably attached to the one or more delivery catheters. The examiner respectfully disagrees. Gross et al. discloses causing the prosthetic heart valve to emerge from a sheath catheter 154 (as seen in Figures 9A-9E and paragraph [0204], [0210]]and [0479-0480]), wherein the removable sutures 490 maintain the occluder frame 42 removably attached to the one or more delivery catheters in the low-profile delivery configuration after the emergence of the prosthetic heart valve from the sheath catheter (as seen in Figures 9A-9E, and paragraphs [0207-0214]) and after controllably expanding the occluder frame 42, detaching the prosthetic heart valve from the one or more delivery catheters (as seen in Figures 9A-9E and paragraphs [0207-02014]).
Applicant argues on page 2, the prior art does not expressly disclose “controllably deploying a first anchoring flap in contact with a first anatomical area and after controllably deploying the first anchoring flap, controllably deploying a second anchoring flap from attachment of the one or more delivery catheters.” The examiner respectfully disagrees. Gross teaches a prosthetic heart valve 1040 (paragraph [0337]) comprising an occluder frame and a plurality of anchoring flaps 900, 900a, 910 removably attached to the one or more delivery catheters 1044 in the low-profile delivery configuration after the emergence of the prosthetic heart valve from the sheath catheter (as seen in Figure 37C-37D and paragraphs [0361-0362]); after the emergence of the prosthetic heart valve from the sheath catheter 1044, controllably deploying a first and a second anchoring flaps 900, 900a, 910, including an anterior and posterior anchoring flaps from attachment to the one or more delivery catheters 1044 by slacking tension of at least a first one of the removable sutures 924 (paragraphs [0362-0364]), wherein the anchoring flaps are controllably deployed into contact with anatomical areas near the native heart valve site. Gross discloses independently controlling the release and expansion of the frame and the anchoring flaps to couple to the leaflet.
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.
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) 1-2, 5-8 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. U.S. Publication 2014/0324164 A1.
Regarding Claims 1, 5, Gross et al. discloses a method for deploying a prosthetic heart valve at a native heart valve site as seen in Figures 55A-56D (see paragraphs [0159], [0185], [0478]), the method comprising: attaching the prosthetic heart valve 40/42 to one or more delivery catheters 60 using removable sutures 490 (as seen in Figures 9A-9E, paragraphs [0164-0165] and [0466-0470]), wherein the prosthetic heart valve comprises: an occluder frame 42; an occluder disposed in the occluder frame and comprising valve leaflets (see Figures 28B, 28D, 29B paragraphs [0165]; and one or more anchoring flaps 62, 64, 320 extending from the occluder frame 42 (as seen in Figures 55A-55E and paragraph [0166]), wherein the occluder frame and the one or more anchoring flaps are collapsible to a low-profile delivery configuration and expandable to a deployed configuration (paragraphs [0473-0474], [0477-0478] and as seen in Figures 55C-55E); navigating, using the one or more delivery catheters 60, the prosthetic heart valve in the low-profile delivery configuration to the native heart valve site (paragraphs [0477-0478]); at the native heart valve site, causing the prosthetic heart valve to emerge from a sheath catheter 154 (as seen in Figures 9A-9E and paragraph [0204], [0210]]and [0479-0480]), wherein the removable sutures 490 maintain the occluder frame 42 removably attached to the one or more delivery catheters in the low-profile delivery configuration after the emergence of the prosthetic heart valve from the sheath catheter (as seen in Figures 9A-9E, and paragraphs [0207-0214]) and after controllably expanding the occluder frame 42, detaching the prosthetic heart valve from the one or more delivery catheters (as seen in Figures 9A-9E and paragraphs [0207-02014]). However, in the embodiment used in the rejection above, Figures 9A-9D does not expressly disclose the anchoring flaps removably attached to the one or more delivery catheters in the low-profile delivery configuration after the emergence of the prosthetic heart valve from the sheath catheter; after the emergence of the prosthetic heart valve from the sheath catheter, controllably deploying the anchoring flaps from attachment to the one or more delivery catheters by slacking tension of at least a first one of the removable sutures, wherein the anchoring flaps are controllably deployed into contact with anatomical areas near the native heart valve site; after expanding the anchoring flaps, controllably expanding the occluder frame into contract with an annulus of the native heart valve site. In an alternative embodiment as seen in Figures 37A-37D, Gross teaches a prosthetic heart valve 1040 (paragraph [0337]) comprising an occluder frame and a plurality of anchoring flaps 900, 900a, 910 removably attached to the one or more delivery catheters 1044 in the low-profile delivery configuration after the emergence of the prosthetic heart valve from the sheath catheter (as seen in Figure 37C-37D and paragraphs [0361-0362]); after the emergence of the prosthetic heart valve from the sheath catheter 1044, controllably deploying the anchoring flaps 900, 900a, 910, including an anterior and posterior anchoring flaps from attachment to the one or more delivery catheters 1044 by slacking tension of at least a first one of the removable sutures 924 (paragraphs [0362-0364]), wherein the anchoring flaps are controllably deployed into contact with anatomical areas near the native heart valve site; after expanding the anchoring flaps 900, 900a, 910, controllably expanding the occluder frame into contract with an annulus of the native heart valve site (paragraphs [0363-0364]); and after expanding the occluder frame, detaching the prosthetic heart valve from the one or more delivery catheters 60 (as seen in Figures 37A-37F and paragraphs [0363-0364]) for the purpose of independently controlling the release and expansion of the frame and the anchoring flaps to couple to the leaflet and allow for repositioning of the device by the user (paragraphs [0358-0359]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Figures 9A-9E to further include controllably deploying the anchoring flaps using removable sutures as taught in Figures 37A-37F for the purpose of independently controlling the release and expansion of the frame and the anchoring flaps to couple to the leaflet and allow for repositioning of the device by the user.
Regarding Claim 2, Gross et al. discloses wherein the on woe more anchoring flaps comprise a posterior anchoring flap 62, 64, 320 and one or more anterior anchoring flaps 62, 64, 320 (as seen in Figures 55A-55E).
Regarding Claim 6, Gross et al. discloses wherein the posterior flap 62, 64, 320 extends from the occluder frame 42 directionally opposite of the one or more anterior anchoring flaps 62, 64, 320 (as seen in Figures 55A-56D).
Regarding Claim 7, Gross et al. discloses wherein the one or more anterior anchoring flaps 62, 64, 320 and/or the posterior anchoring flap 62, 64, 320 occlude a portion of an opening defined by the annulus of the native heart valve site (as seen in Figures 56C-56D, the flaps extend along both sides of the annulus).
Regarding Claim 8, Gross et al. discloses wherein the occluder frame and the anchoring flaps are self- expandable (paragraphs [0473-0474], [0477-0479] and as seen in Figures 55A-55D).
Regarding Claim 10, in the embodiment used in the rejection above, Figures 9A-9E, 55A-55E does not expressly disclose wherein the prosthetic heart valve is navigated, using the one or more delivery catheters, to the native heart valve site via a transfemoral access route. In an alternative embodiment as seen in Figures 74A-74B, Gross et al. teaches a method of delivering a prosthetic heart valve 2040 using a delivery catheter 2960, the prosthetic valve is delivered transcatheterally via a transfemoral access route (paragraph [0611]) to allow the prosthetic valve to be delivered percutaneously from a femoral artery toward the native heart valve based on the desired location of the delivery site to be upstream or downstream of the native valve (paragraphs [0586] and [0611]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Figures 55A-55E to further include the prosthetic valve to be delivered via a transfemoral access route as taught in Figures 74A-74B for the purpose of allowing the prosthetic valve to be delivered percutaneously from a femoral artery toward the native heart valve based on the desired location of the delivery site to be upstream or downstream of the native valve.
Regarding Claim 11, Gross et al. discloses wherein, when the prosthetic heart valve is implanted at the native heart valve site (paragraphs [0473-0474], [0477-0479]), an inlet end portion of the prosthetic heart valve is positioned in an atrium and an outlet end portion of the prosthetic heart valve is positioned in a ventricle (as seen in Figures 56C-56D).
Claim(s) 3-4 and 12-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. U.S. Publication 2014/0324164 A1 in view of Perrin et al. U.S. Publication 2020/0188097 A1.
Regarding Claim 3, 15, Gross et al. discloses wherein the one or more anterior anchoring flaps are controllably deployed (see rejections above). However, Gross et al. does not expressly disclose wherein the one or more anterior anchoring flaps extend into a right ventricular outflow tract (RVOT). Perrin et al. teaches a method for deploying a prosthetic heart valve (abstract and paragraphs [0179]) in the same field of endeavor comprising a prosthetic heart valve 202 (as seen in Figures 35-41 comprises one or more anterior anchoring flaps 248 and a posterior flap 212, wherein the anterior anchoring flap 248 extends into the RVOT (paragraphs [0259-0260], [0270-271] and as seen in Figures 38-41) for the purpose of delivering a valve prosthesis in the native tricuspid annulus to mitigate regurgitation or leakage problems in the tricuspid valve (paragraph [0014]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Gross’s method of delivering a prosthetic valve to further include one or more anterior anchoring flaps to extend into the right ventricular outflow tract as taught by Perrin et al. for the purpose of delivering a valve prosthesis in the native tricuspid annulus to mitigate regurgitation or leakage problems in the tricuspid valve.
Regarding Claim 4, Gross et al. discloses wherein the one or more anterior anchoring flaps 62, 64, 320 comprise two anterior anchoring flaps (as seen in Figures 55A-55D).
Regarding Claim 12, 16, Gross et al. discloses a method for deploying a prosthetic heart valve at a native heart valve site as seen in Figures 9A-9E and 55A-56D (see paragraphs [0159], [0185], [0478]), the method comprising: navigating, using one or more delivery catheters 60 (paragraphs [0164-0165], [0466-0470] and [0477-0478]) the prosthetic heart valve in a low-profile delivery configuration to the native heart valve site (paragraph [0466-0470]), wherein the prosthetic heart valve 40/42 is attached to one or more delivery catheters 60 using removable sutures 490 (as seen in Figures 9A-9E, paragraphs [0164-0165] and [0466-0470]), wherein the prosthetic heart valve comprises: an occluder frame 42; an occluder disposed in the occluder frame and comprising valve leaflets (see Figures 28B, 28D, 29B paragraphs [0165]); and anchoring flaps 62, 64, 320 extending from the occluder frame 42 (as seen in Figures 55A-55E and paragraph [0166]), wherein the occluder frame and the anchoring flaps are collapsible to a low-profile delivery configuration and self-expandable to a deployed configuration (paragraphs [0161], [0164-0165], [0473-0474], [0477-0478] and as seen in Figures 55C-55E) and controllably expanding the occluder frame within the annulus of the native heart valve (via from the one or more delivery catheters 60, see paragraphs [0478-0479] and as seen in Figures 1E-G and 55A-55D). Gross et al. discloses the occluder frame is controllably deployed via the removable sutures 490 (as seen in Figures 9A-9E, and paragraphs [0205-0214]). However, in the embodiment used in the rejection, Figures 55A-55E does not expressly disclose at the native heart valve site, controllably deploying a first anchoring flap of the anchoring flaps into contact with first anatomical areas near the native heart valve site; after controllably deploying the first anchoring flap, controllably deploying a second anchoring flap of the anchoring flaps from attachment to the one or more delivery catheters, wherein the second anchoring flap is controllably deployed into contact with second anatomical area near the native heart valve site. In an alternative embodiment as seen in Figures 37A-37D, Gross teaches a prosthetic heart valve 1040 (paragraph [0337]) comprising an occluder frame and a plurality of anchoring flaps 900, 900a, 910 removably attached to the one or more delivery catheters 1044 in the low-profile delivery configuration after the emergence of the prosthetic heart valve from the sheath catheter (as seen in Figure 37C-37D and paragraphs [0361-0362]); after the emergence of the prosthetic heart valve from the sheath catheter 1044, controllably deploying a first and a second anchoring flaps 900, 900a, 910, including an anterior and posterior anchoring flaps from attachment to the one or more delivery catheters 1044 by slacking tension of at least a first one of the removable sutures 924 (paragraphs [0362-0364]), wherein the anchoring flaps are controllably deployed into contact with anatomical areas near the native heart valve site; after expanding the anchoring flaps 900, 900a, 910, controllably expanding the occluder frame into contract with an annulus of the native heart valve site (paragraphs [0363-0364]); and after expanding the occluder frame, detaching the prosthetic heart valve from the one or more delivery catheters 60 (as seen in Figures 37A-37F and paragraphs [0363-0364]) for the purpose of independently controlling the release and expansion of the frame and the anchoring flaps to couple to the leaflet and allow for repositioning of the device by the user (paragraphs [0358-0359]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Figures 9A-9E to further include controllably deploying a first and a second anchoring flaps using removable sutures as taught in Figures 37A-37F for the purpose of independently controlling the release and expansion of the frame and the anchoring flaps to couple to the leaflet and allow for repositioning of the device by the user. However, Gross et al. does not expressly disclose the method of delivering the prosthetic heart valve to a tricuspid valve. Perrin et al. teaches a method for deploying a prosthetic heart valve (abstract and paragraphs [0179]) in the same field of endeavor comprising a prosthetic heart valve 202 (as seen in Figures 35-41 comprises one or more anterior anchoring flaps 248 and a posterior flap 212, wherein the prosthetic heart valve is deployed via a catheter system to the tricuspid valve (as seen in Figures 35-41) for the purpose of delivering a valve prosthesis in the native tricuspid annulus to mitigate regurgitation or leakage problems in the tricuspid valve (paragraph [0014]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Gross’s method of delivering a prosthetic valve to further include delivering to a tricuspid valve as taught by Perrin et al. for the purpose of delivering a valve prosthesis in the native tricuspid annulus to mitigate regurgitation or leakage problems in the tricuspid valve.
Regarding Claim 13, Gross et al. discloses wherein the anchoring flaps comprise a posterior anchoring flap 62, 64, 320 and one or more anterior anchoring flaps 62, 64, 320 (as seen in Figures 55A-55E).
Regarding Claim 14, Gross et al. discloses wherein the one or more anterior anchoring flaps comprise two anterior anchoring flaps 62, 64, 320 (as seen in Figures 55A-55E).
Regarding Claim 17, Gross et al. discloses wherein the posterior flap 62, 64, 320 extends from the occluder frame 42 directionally opposite of the one or more anterior anchoring flaps 62, 64, 320 (as seen in Figures 55A-55D).
Regarding Claim 18, Gross et al. discloses wherein the one or more anterior anchoring flaps 62, 64, 320 and/or the posterior anchoring flap 62, 64, 320 occlude a portion of an opening defined by the annulus of the native heart valve site (as seen in Figures 56C-56D, the flaps extend along both sides of the annulus).
Regarding Claim 20, in the embodiment used in the rejection above, Figures 55A-55E does not expressly disclose wherein the prosthetic heart valve is navigated, using the one or more delivery catheters, to the native heart valve site via a transfemoral access route. In an alternative embodiment as seen in Figures 74A-74B, Gross et al. teaches a method of delivering a prosthetic heart valve 2040 using a delivery catheter 2960, the prosthetic valve is delivered transcatheterally via a transfemoral access route (paragraph [0611]) to allow the prosthetic valve to be delivered percutaneously from a femoral artery toward the native heart valve based on the desired location of the delivery site to be upstream or downstream of the native valve (paragraphs [0586] and [0611]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Figures 55A-55E to further include the prosthetic valve to be delivered via a transfemoral access route as taught in Figures 74A-74B for the purpose of allowing the prosthetic valve to be delivered percutaneously from a femoral artery toward the native heart valve based on the desired location of the delivery site to be upstream or downstream of the native valve.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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