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 .
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.
Claims 1-2, 4-8 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Krivoruchko (7625403) in view of Buchanan (2002/0173842).
Regarding claims 1-2, Krivoruchko discloses a valved conduit prosthesis 500 (Figs. 5A-5B) comprising: a secondary conduit 510 having a secondary conduit inner surface 512 defining a secondary conduit lumen 514 therethrough (Fig. 5A); and a valved conduit subassembly 550 including: a primary conduit having a primary conduit exterior surface and a primary conduit interior surface defining a primary conduit lumen (the exterior and interior surfaces of the strut members 554) and a slot therethrough (the spacing present between strut members 554); and at least one leaflet (col. 8, lin. 47-48 disclose trileaflet valve 560) having an internal portion arranged within the primary conduit lumen so as to be operable as a one-way valve, the leaflet defining a valve structure (col. 8, lin. 46-54), wherein the valved conduit subassembly is located within the secondary conduit lumen and coupled to the secondary conduit inner surface (col. 8, lin. 55-67 and Fig. 5A disclose the valved conduit subassembly 550 is coupled to the secondary conduit inner surface 512). Krivoruchko is silent regarding a slot therethrough and at least one leaflet having an external portion coupled to the primary conduit exterior surface; and wherein the external portion of the at least one leaflet is adhered to the primary conduit exterior surface by adhesive, thermal bonding, or chemical bonding.
However, Buchanan teaches a similar stent valve 10 (Fig. 1) comprising a slot 18 (Fig. 6) therethrough and at least one leaflet 42 having an external portion 44 coupled to an exterior surface 20 (Figs. 1 and 6; claim 12) and wherein the external portion of the at least one leaflet is adhered to the primary conduit exterior surface by adhesive, thermal bonding, or chemical bonding (par. 0021 discloses the leaflet is wound and attached by an adhesive). 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 valved conduit subassembly in Krivoruchko to include a slot therethrough and at least one leaflet having an external portion coupled to the primary conduit exterior surface and wherein the external portion of the at least one leaflet is adhered to the primary conduit exterior surface by adhesive, thermal bonding, or chemical bonding, as taught and suggested by Buchanan for allowing a secured attachment of the leaflets preventing removal from the stent/primary conduit (par. 0021).
Regarding claims 4-5, Krivoruchko discloses wherein the valved conduit subassembly 550 defines at least one step (shown at mating portion 580; Fig. 5B) with the secondary conduit 510 inner surface 512 (Figs. 5A-5B); wherein the at least one step is defined by the secondary conduit having a larger inner diameter compared with the inner diameter of the valved conduit subassembly (the channel 532 located in the inner surface 512 allows for the secondary conduit 510 to have a larger inner diameter than valved conduit subassembly 550; Fig. 5A).
Regarding claim 6, Krivoruchko discloses wherein the step may have a step height defined by the primary conduit inner surface and the secondary conduit inner surface at the step, wherein the step height is operable as a barrier to prevent pannus or other biological material from advancing into an upstream or downstream portion of the valved conduit subassembly (the space between the inner surface 512 and the inner surface of valved conduit subassembly 550 is fully capable of performing this intended use).
Regarding claim 7, Krivoruchko discloses wherein the valved conduit subassembly defines an upstream length between the leaflet and the step (the space between the valve 560 and the mating portion 580; Fig. 5A); except for wherein the upstream length has a dimension of 0.1 mm to 3 mm, and a step height has a dimension of 0 mm to 3 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the upstream length has a dimension of 0.1 mm to 3 mm, and a step height has a dimension of 0 mm to 3 mm, since these are result effective variables that contribute to the clearance between the leaflets and the step, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and modifying the upstream length has a dimension of 0.1 mm to 3 mm, and a step height has a dimension of 0 mm to 3 mm, would allow for the valve leaflets to function without interference. MPEP 2144.05.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. MPEP 2144.05.
Regarding claim 8, Krivoruchko discloses wherein the valved conduit has an inflow portion defining an inflow end and an outflow portion defining an outflow end, wherein the at least one leaflet is coupled to the primary conduit is operable to open to allow flow from the inflow end to pass through the outflow end in antegrade flow conditions, and are operable to close to restrict flow from flowing from the outflow end through the inflow end in retrograde flow conditions (col. 8, lin. 18-22 disclose the lumen 514 allows fluid flow and lin. 47-48 disclose a trileaflet venous valve which would obviously perform this intended use).
Regarding claims 10-11, Krivoruchko discloses the claimed invention of claim 1 and wherein the at least one leaflet includes more than one leaflets (col. 8, lin. 47-48 disclose a trileaflet valve 560); except for the more than one leaflets are separated from one another within the primary conduit inner surface of the primary conduit by commissure gaps and the primary conduit includes lands separating each leaflet at a conduit attachment section of each of the leaflets to form the commissure gaps between the leaflets within the primary conduit inner surface of the primary conduit. However, Buchanan teaches a similar valved conduit subassembly 10 (Fig. 2B) comprising the more than one leaflets are separated from one another within the primary conduit inner surface of the primary conduit by commissure gaps 16 (Fig. 2B; par. 0016) and the primary conduit includes lands (space between vertical slit portion 15; Fig. 1) separating each leaflet at a conduit attachment section of each of the leaflets to form the commissure gaps 16 between the leaflets within the primary conduit inner surface of the primary conduit (Figs. 1 and 2B). 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 valved conduit subassembly in Krivoruchko to include the more than one leaflets are separated from one another within the primary conduit inner surface of the primary conduit by commissure gaps and the primary conduit includes lands separating each leaflet at a conduit attachment section of each of the leaflets to form the commissure gaps between the leaflets within the primary conduit inner surface of the primary conduit, as taught and suggested by Buchanan for allowing a secured attachment of the leaflets preventing removal from the stent/primary conduit (par. 0021).
Claims 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Krivoruchko (7625403) in view of Buchanan (2002/0173842) further in view of Drasler et al. (2018/0147061).
Krivoruchko in view of Buchanan disclose the claimed invention of claim 1; except for wherein the external portion of the at least one leaflet is coupled to the primary conduit exterior surface by a layer of adhesive film and wherein the valved conduit subassembly is attached to the secondary conduit inner surface by an adhesive, thermal bonding, or chemical bonding. However, Drasler teaches a similar valved conduit subassembly (Fig. 4A) comprising an adhesive film 285 (par. 0155 discloses the covering 285 is a polymeric film comprising adhesive to attach to the frame 15) and wherein a valved conduit subassembly 15 (Fig. 4A) is attached to the secondary conduit 285 inner surface by an adhesive, thermal bonding, or chemical bonding (par. 0155 discloses the covering 285 is attached to frame 15 via adhesives). 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 valved conduit subassembly in Krivoruchko in view of Buchanan to include wherein the external portion of the at least one leaflet is coupled to the primary conduit exterior surface by a layer of adhesive film and wherein the valved conduit subassembly is attached to the secondary conduit inner surface by an adhesive, thermal bonding, or chemical bonding, as taught and suggested by Drasler, for allowing a secured attachment and preventing perivalvular leakage (par. 0155).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Krivoruchko (7625403) in view of Buchanan (2002/0173842) further in view of Bruchman et al. (2013/0197631) “Bruchman”.
Krivoruchko in view of Buchanan disclose the claimed invention of claim 1; except for wherein the at least one leaflet comprises a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores, and optionally TFE-PMVE copolymer comprising from 27 to 32 weight percent perfluoromethyl vinyl ether and respectively from 73 to 68 weight percent tetrafluoroethylene on at least a portion of the composite material, and optionally, the elastomer or elastomeric material comprises a TFE-PMVE copolymer, and optionally, the porous synthetic fluoropolymer membrane is ePTFE.
However, Bruchman teaches a similar valved conduit subassembly comprising leaflets (abstract) wherein the at least one leaflet comprises a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores (par. 0091 discloses the leaflets comprise porous ePTFE having pores filled with an eloastomer), the elastomer or elastomeric material comprises a TFE-PMVE copolymer (par. 0092) and optionally TFE-PMVE copolymer comprising from 27 to 32 weight percent perfluoromethyl vinyl ether and respectively from 73 to 68 weight percent tetrafluoroethylene on at least a portion of the composite material (the alternative language “optionally” is interpreted to not positively claim the limitations it precedes). 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 leaflets in Krivoruchko in view of Buchanan to include wherein the at least one leaflet comprises a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores, and optionally TFE-PMVE copolymer comprising from 27 to 32 weight percent perfluoromethyl vinyl ether and respectively from 73 to 68 weight percent tetrafluoroethylene on at least a portion of the composite material, and optionally, the elastomer or elastomeric material comprises a TFE-PMVE copolymer, and optionally, the porous synthetic fluoropolymer membrane is ePTFE, as taught and suggested by Bruchman, for improving the fatigue performance of the leaflets and to prevent wrinkling and creasing of the leaflets (par. 0091).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Krivoruchko (7625403) in view of Buchanan (2002/0173842) further in view of Robicsek (5139515).
Krivoruchko in view of Buchanan disclose the claimed invention of claim 1 and providing a valved conduit prosthesis of claim 1 (see claim 1 above); except for a method of treating aortic valve disease by replacing an aortic root, comprising the step of surgically implanting the valved conduit prosthesis. However, Robicsek teaches a similar valved conduit prosthesis (abstract) and a method of treating aortic valve disease by replacing an aortic root (claim 1), comprising the step of surgically implanting the valved conduit prosthesis (abstract). 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 Krivoruchko in view of Buchanan to include a method of treating aortic valve disease by replacing an aortic root, comprising the step of surgically implanting the valved conduit prosthesis, as taught and suggested by Robicsek, for allowing a more natural functioning of the aortic valve (abstract).
Conclusion
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 (MT).
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