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 Group I (claims 1-16 and 23-30) in the reply filed on 12/1/05 is acknowledged.
Claims 17-22 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/1/05.
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.
Claim(s) 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (hereafter Nguyen) 2012/0259409.
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Regarding claim 1 and noting figures 3A and 3B supra Nguyen discloses a prosthetic heart valve comprising: an annular frame (12) comprising a plurality of interconnected struts, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state (see fig. 2) and a plurality of leaflets (22) situated within the frame, each leaflet comprising a main body (33), two opposing commissure tabs (34) arranged on opposite sides of the main body and two opposing sub-commissure tabs (36) arranged on opposite sides of the main body; wherein each commissure tab of a leaflet is paired with an adjacent commissure tab of an adjacent leaflet (see [0052] which states “…while lateral ends 30 and 31 are folded and joined to adjacent leaflets to form commissures..”, and [0055] which states “Adjoining leaflets 22 are then fastened together along adjacent seams 42…”) to form a commissure (24) that is coupled to the frame.
Nguyen discloses that sub-commissure tabs of each pair of sub-commissure tabs are sutured to each other.
However, Nguyen does not specify that “each sub-commissure tab is paired with an adjacent sub-commissure tab of an adjacent leaflet and connected thereto, wherein each pair of sub-commissure tabs extends radially inwardly relative to the frame.” It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Nguyen and join the sub-commissure tabs to adjacent leaflets and extend them radially inwardly to the frame in order to efficiently distribute and transmit forces along the leaflets and to the frame.
Regarding claim 2, Nguyen does not specifically state that the sub-commissure tabs of each pair of sub-commissure tabs are sutured to each other. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Nguyen and suture the sub-commissure tabs to each other because Nguyen already utilizes sutures (see for example [0048]).
Regarding claims 3-4, Nguyen discloses a cusp edge see markup supra that extends from one sub-commissure tab to the other sub-commissure tab and includes a reinforcing member (see fig. 4B e.g. 44) sutured to the cusp edge. It is obvious that the cusp edge portion is “coupled” to the frame as the illustrated in fig 5 around stitch area 44.
Regarding claim 5, further comprising a second reinforcement member (e.g. 42) sutured to the cusp edge portions of the leaflets, wherein the first and second reinforcing members are positioned on opposite sides of the cusp edge portions of the leaflets (see [0058]).
Regarding claim 6, the pairs of sub-commissure tabs are not directly connected to the frame rather to the support skirt (21).
11. Regarding claim 7, this claim is interpreted as a product by process recitation. See MPEP 2113. Products by Process claims are NOT limited to the manipulations of the recited steps only to the structure implied by the steps.
Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. A statement or argument by the attorney is not factual evidence. See MPEP 716.01.
10. Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (hereafter Nguyen) 2012/0259409 in view of Salahieh et al. 2005/0137699 (hereafter Salahieh).
11. Nguyen has been disclosed however does not disclose “plurality of commissure support posts, and the commissures are mounted to the commissure support posts wherein the commissure support posts are components of actuators that are configured to produce radial expansion and compression of the frame.
Salahieh teaches a heart valve frame (see figure 2B-2C) with actuator anchor commissure post (see e.g. 32/106). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Nguyen et al. and utilize a frame with actuator commissure post in order to improve radial strength of the implant and improve placement accuracy.
12. Claim(s) 23- 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. 2012/0123529 (hereafter Levi).
Regarding claim 23 and noting figures 21-24 Levi discloses
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A prosthetic heart valve comprising: an annular frame (12) comprising a plurality of interconnected struts (see fig. 4), wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state (see figures 17-18); and a plurality of leaflets situated within the frame, each leaflet comprising a main body, a cusp edge portion (see mark-up supra), two opposing commissure tabs (112) arranged on opposite sides of the main body, two sub-commissures edges forming notches (114) on opposite sides of the main body between the commissure tabs and upper end portions of the cusp edge portion, and two opposing sub-commissure tabs (116) arranged on opposite sides of the main body and extending laterally from the sub-commissures edges; wherein each sub-commissure tab of a leaflet is paired with an adjacent sub-commissure tab of an adjacent leaflet and connected thereto (see fig. 24). However, Levi does not specify that each commissure tab of a leaflet is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure that is coupled to the frame.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Levi and attached each commissure tab of a leaflet is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure that is coupled to the frame because Levi envisions utilizing flexible connectors which could be utilized to form a continuous leaflet structure to be attached to the frame.
13. Regarding claims 24-25 see [0080] which states “the commissure tab assembly (comprised of a pair of lower tab portions 116 connected by connector 124) is inserted (here it is obvious that the tabs are capable of extending radially inward) through the commissure window 20 of a corresponding window frame portion 30. FIG. 32 is a side view of the frame 12 showing the commissure tab assembly extending outwardly (and in this instance it is obvious that the tabs can extend outwardly) through the window frame portion….”.
14. Regarding claim 26 see sutures 150 of figure 30 where the tabs are sutured together. Regarding claim 27 figure 30 illustrates suturing of the tabs. It is obvious that the sutures extend through the tabs thus not directly being attached to the frame.
Allowable Subject Matter
15. Claims 8-14 and 28-30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
16. The following is a statement of reasons for the indication of allowable subject matter: The closes prior art (regarding claims 1-16) is considered to be Nguyen et al. 2012/0259409 (see supra) which discloses a prosthetic heart valve with an annular frame comprising a plurality of interconnected struts, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state; and a plurality of leaflets situated within the frame, each leaflet comprising a main body, two opposing commissure tabs arranged on opposite sides of the main body and two opposing sub-commissure tabs arranged on opposite sides of the main body; wherein each commissure tab of a leaflet is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure that is coupled to the frame; wherein each sub-commissure tab is paired with an adjacent sub-commissure tab of an adjacent leaflet and connected thereto, wherein each pair of sub-commissure tabs extends radially inwardly relative to the frame.
The prior art fails to teach or disclose that the sub-commissure tabs comprise lower sub-commissure tabs and wherein each leaflet comprises two opposing upper sub-commissure tabs arranged on opposite sides of the main body, wherein each upper sub-commissure tab is paired with an adjacent upper sub-commissure tab of an adjacent leaflet and connected thereto.
The closes prior art (regarding claims 23-30) is Levi et al. 2012/0123529. Levi discloses a prosthetic heart valve with an annular frame comprising a plurality of interconnected struts, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state; and a plurality of leaflets situated within the frame, each leaflet comprising a main body, a cusp edge portion, two opposing commissure tabs arranged on opposite sides of the main body, two sub-commissures edges forming notches on opposite sides of the main body between the commissure tabs and upper end portions of the cusp edge portion, and two opposing sub-commissure tabs arranged on opposite sides of the main body and extending laterally from the sub-commissures edges; wherein each commissure tab of a leaflet is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure that is coupled to the frame; wherein each sub-commissure tab is paired with an adjacent sub-commissure tab of an adjacent leaflet and connected thereto.
The prior art fails to teach or disclose that each sub-commissure tab is arranged between and spaced from an adjacent commissure tab and an adjacent upper end portion of the cusp edge portion on one side of the corresponding leaflet.
Conclusion
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 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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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 February 4, 2026
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