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 .
DETAILED ACTION
Status of Claims
This office action is responsive to the amendment filed on 07/22/2026. As directed by the amendment: claims 9-16 are withdrawn. Thus, claims 1-8 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to claim 1 rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Bokros (3546711); claims 2, 4 and 8 rejected under 35 U.S.C. 103 as being unpatentable over Bokros (3546711) in view of Shepherd et al. (5776188) “Shepherd”; claims 3 and 6-7 rejected under 35 U.S.C. 103 as being unpatentable over Bokros (3546711) in view of Shepherd et al. (5776188) “Shepherd” further in view of Miller et al. (2013/0245534) “Miller” and claim 5 rejected under 35 U.S.C. 103 as being unpatentable over Bokros (3546711) in view of Shepherd et al. (5776188) “Shepherd” further in view of Meyer (4363142) have been considered but are moot in view of the new grounds of rejection.
Outstanding objections of claims 2 and 6 are withdrawn.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Bokros (3546711) in view of Miller et al. (2013/0245534) “Miller”.
Regarding claim 1, Bokros discloses a vascular valve 11 (Fig. 1; abstract, col. 1, comprising: a ring 17 (Fig. 2; col. 2, lin. 39-42 disclose a ring) having a first diameter in an original shape (as shown in Fig. 2); and a valve flap 25 (Figs. 4-5) adapted to open and close based on vascular pressure (col. 2, lin. 16-21 disclose the valve flap 25 pivotally opens and closes based on flow of blood), the valve flap 25 comprising ribs (support fins 53; col. 3, lin. 64-68; Fig 5) extending across at least a portion of the valve flap (as shown in Fig. 5) , wherein the ring 17 provides support to the valve flap 25 during and after deployment of the vascular valve (as shown in Figs. 3 and 5, the ring 17 has an inner wall 26 which supports the valve flap 25). Bokros is silent regarding wherein the ring is adapted to fold and twist into a configuration having a diameter equal to approximately one half of the first diameter during deployment of the vascular valve, and to unfold to the original shape when deployment of the vascular valve is completed.
However, Miller teaches a similar vascular valve 5 (Fig. 1) comprising a resilient ring 10 (par. 0047; Fig. 1) wherein the ring is adapted to fold and twist into a configuration (abstract discloses the valve ring is compressible to allow disposition within a delivery tool) having a diameter equal to approximately one half of the first diameter during deployment of the vascular valve, and to unfold to the original shape when deployment of the vascular valve is completed (par. 0074 disclose the valve is made of Nitinol where the shape memory material allows for the ring to have the capability to perform the intended use of being adapted to fold and twist into a configuration which is fully capable of having a diameter equal to approximately one half of the first diameter during deployment of the vascular valve, and to unfold to the original shape when deployment of the vascular valve is completed).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vascular valve in Bokros to include the ring is adapted to fold and twist into a configuration having a diameter equal to approximately one half of the first diameter during deployment of the vascular valve, and to unfold to the original shape when deployment of the vascular valve is completed, as taught and suggested by Miller, for allowing the valve ring to be flexible in order to facilitate ease of insertion (abstract of Miller).
Claims 2, 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Bokros (3546711) in view of Miller et al. (2013/0245534) “Miller” further in view of Shepherd et al. (5776188) “Shepherd”.
Regarding claims 2, 4 and 8, Bokros in view of Miller discloses the claimed invention of claim 1 including the ribs 53 have a length that is less than a diameter of the ring 17 (as shown in Fig. 2 of Bokros) and further comprising a pivot 59 (Fig. 2) along one portion of the front ring (Figs. 2 and 4); except for wherein the ring is a front ring and the vascular valve further comprises a rear ring, and the front and rear ring each have a substantially circular shape and wherein the front ring has a substantially circular shape. However, Shepherd teaches a similar vascular valve 100 (Fig. 3A) comprising a front ring 104 and the vascular valve further comprises a rear ring 106, and the front and rear ring each have a substantially circular shape and wherein the front ring has a substantially circular shape (circular shape of rings 104/106 shown in Fig. 3A). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vascular valve in Bokros in view of Miller to include the ring is a front ring and the vascular valve further comprises a rear ring, and the front and rear ring each have a substantially circular shape and wherein the front ring has a substantially circular shape, as taught and suggested by Shepherd, for secure attachment of the rings to the valve annulus for reducing blood leakage (claim 1 of Shepherd).
Regarding claims 3, 6 and 7 Bokros in view of Miller and Shepherd disclose the claimed invention of claims 1 and 2; except for wherein the front and rear rings are both adapted to fold during deployment of the vascular valve, and to unfold when deployment of the vascular valve is completed; wherein the front and rear rings ring each comprise a memory material; and wherein the memory material comprises a nickel-titanium alloy. However, Miller further teaches a similar vascular valve 5 (Fig. 1) comprising a resilient ring 10 (par. 0047; Fig. 1) adapted to fold during deployment of the vascular valve, and to unfold when deployment of the vascular valve is completed (abstract discloses the valve ring is compressible to allow disposition within a delivery tool); wherein the ring comprises a memory material; and wherein the memory material comprises a nickel-titanium alloy (par. 0074 disclose the valve is made of Nitinol). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vascular valve in Bokros in view of Miller and Shepherd to further include the front and rear rings are both adapted to fold during deployment of the vascular valve, and to unfold when deployment of the vascular valve is completed; wherein the front and rear rings ring each comprise a memory material; and wherein the memory material comprises a nickel-titanium alloy, as taught and suggested by Miller, for allowing the valve ring to be flexible in order to facilitate ease of insertion (abstract of Miller).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bokros (3546711) in view of Miller et al. (2013/0245534) “Miller” further in view of Shepherd et al. (5776188) “Shepherd” further in view of Meyer (4363142).
Bokros in view of Miller and Shepherd disclose the claimed invention of claims 1, 2 and 4 including a first fin 37 (Fig. 3) disposed at a lower surface of the ring 17 (Fig. 3 and col. 3, lin. 16-20 disclose the shoulder/fin disposed on the wall of the ring 17); except for a second fin disposed at an upper surface of the rear ring. However, Meyer teaches a similar valve ring 12 (Fig. 1) comprising a fin 17 (Fig. 1) disposed at an upper surface of the ring (col. 3, lin. 57-60 disclose a collar/fin disposed on an upstream side of the valve ring 12). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rear ring in Bokros in view of Miller and Shepherd to include a second fin disposed at an upper surface of the rear ring, as taught and suggested by Meyer, for proper positioning of the valve assembly in place (col. 3, lin. 59-60 of Meyer).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri. If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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