DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/8/2025.
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 4 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 4 depends from claim 1, which specifies a femoral implantation (claim 1, line 3). Claim 4 states, “the method further comprises pulling a track wire, coupled to the valve clasper, until a U-shaped member of the valve clasper contacts a floor of an aortic valve sinus” (emphasis added). This limitation is indefinite, as it appears the embodiments describing pulling to engage the aortic valve sinus are not femoral approaches. Figure 8 depicts pulling, however, the relative position of the leaflets and implantation catheter do not suggest a femoral implantation approach. Figure 24C depicts pulling to engage the native sinus, however, this is a transapical delivery approach. Figure 25 depicts pulling, however, the pulling occurs within the mitral valve and not the aortic valve.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-10 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Salahieh et al. (Pub. No.: US 2005/0137689).
Salahieh et al. (hereinafter, Salahieh) discloses a method for deploying a heart valve prosthesis within a native heart valve (abstract), the method comprising:
inserting an implantation device 700 into a femoral artery of a patient (e.g., fig. 45B; para. 147), the implantation device carrying a valve prosthesis having an expandable support frame 600 and a valve clasper 560 movably coupled to the support frame;
advancing the implantation device to the native heart valve (e.g., fig. 45A-B); and
releasing the valve prosthesis at the native heart valve (e.g., fig. 45A-I).
For claim 2, Salahieh discloses the method of Claim 1, further comprising adjusting a position of the support frame such that a distal edge 624 of the support frame 600 is disposed longitudinally adjacent to the valve clasper (e.g., fig. 45F-G).
For claim 3, Salahieh discloses the method of Claim 1, wherein the releasing comprises interposing a native heart valve leaflet between the valve clasper and the support frame (e.g., fig. 45H).
For claim 4, Salahieh discloses the method of Claim 1, wherein the native heart valve is an aortic valve (e.g., fig. 45A, para. 147), and the method further comprises pulling a track wire 720, coupled to the valve clasper 560, until a U- shaped member of the valve clasper contacts a floor of an aortic valve sinus (para. 149-150, fig. 45C).
For claim 5, Salahieh discloses the method of Claim 1, wherein the valve clasper 560 is movably coupled to the support frame 600 to permit the valve clasper to be movable relative to the support frame from an engagement configuration in which the valve clasper and the support frame are collapsed against the implantation device to a configuration in which the support frame is offset from the valve clasper (e.g., fig. 45A-I).
For claim 6, Salahieh discloses a method for deploying a heart valve prosthesis within a native heart valve (abstract), the method comprising:
inserting a delivery device 700 into a patient, the delivery device carrying a valve prosthesis 610 with an expandable support frame 620 of the prosthesis being longitudinally offset from a valve clasper 560 of the prosthesis along the delivery device (e.g., fig. 45A-I);
advancing the delivery device 700 to the native heart valve (e.g., fig. 45A);
engaging the valve clasper with the native heart valve (e.g., fig. 45C, para. 149-150);
after engaging the valve clasper with the native heart valve, longitudinally positioning the support frame within the valve clasper (e.g., fig. 45F-H); and
removing the delivery device from the patient (e.g., fig. 45I).
For claim 7, Salahieh discloses the method of Claim 6, wherein the native heart valve is an aortic valve (e.g., fig. 45A, para. 147), and the engaging the valve clasper comprises proximally retracting the valve clasper through the aortic valve to engage the valve clasper within valve sinuses of the aortic valve (e.g., para. 149-150).
For claim 8, Salahieh discloses the method of Claim 6, wherein the native heart valve is an aortic valve (e.g., fig. 45A, para. 147), and the engaging the valve clasper comprises distally advancing the valve clasper through the aortic valve to engage the valve clasper within valve sinuses of the aortic valve (e.g., para. 149-150).
For claim 9, Salahieh discloses the method of Claim 6, further comprising permitting the support frame to expand and compress valve leaflets of the native heart valve against the valve clasper (e.g., fig. 45G-H).
For claim 10, Salahieh discloses the method of Claim 6, wherein during the longitudinal positioning, the valve clasper is movably coupled to the support frame for permitting relative movement of the valve clasper relative to the support frame (e.g., fig. 45F-I).
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rowe et al. (Pub. No.: US 2009/0319037) discloses a method of deploying a heart valve prosthesis in a native valve including a valve clasper 10 and a support frame 250.
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774