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 .
Election/Restrictions
Applicant’s election without traverse of species b, transfemoral access route in the reply filed on 12/31/2025 is acknowledged. Claims 9 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "the prosthetic tricuspid heart valve" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-2, 5-8 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gross et al. U.S. Publication 2014/0324164 A1.
Regarding Claim 1, 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 (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 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-profiled delivery configuration to the native heart valve site (paragraphs [0477-0478]); at the native heart valve site, expanding the anchoring flaps into contact with anatomical areas near the native heart valve site (paragraphs [0479-0480]); after expanding the anchoring flaps, expanding the main body into contract with an annulus of the native heart valve site; and after expanding the main body, detaching the prosthetic heart valve from the one or more delivery catheters 60 (paragraphs [0478-0489] and as seen in Figures 1E-G and 55A-55D and paragraphs [0478-0479]).
Regarding Claim 2, 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 5, Gross et al. discloses wherein the posterior anchoring flap 62, 64, 320 is expanded into contact with a wall of a ventricle (as seen in Figures 56C, 56D).
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 11, Gross et al. discloses wherein, when the prosthetic tricuspid 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 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) 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. does not expressly disclose wherein the one or more anterior anchoring flaps are expanded to 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, 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: 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 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 expandable to a deployed configuration (paragraphs [0473-0474], [0477-0478] and as seen in Figures 55C-55E); at the native heart valve site, expanding the anchoring flaps into contact with anatomical areas near the native heart valve site (paragraphs [0479-0480]); after expanding the anchoring flaps, expanding the main body into contract with an annulus of the native heart valve site; and after expanding the main body, detaching the prosthetic heart valve from the one or more delivery catheters 60 (paragraphs [0478-0489] and as seen in Figures 1E-G and 55A-55D and paragraphs [0478-0479]). 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 16, Gross et al. discloses wherein the posterior anchoring flap 62, 64, 320 is expanded into contact with a wall of a ventricle (as seen in Figures 56C, 56D).
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. U.S. Publication 2014/0324164 A1.
Regarding Claim 10, 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
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
Prosecution Insights