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 .
Status of Claims
This office action is responsive to the amendment filed on 05/15/2026. As directed by the amendment: new claims 14-19 have been added. Thus, claims 1-19 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to claims 1-2, 4-8 and 10-11 rejected under 35 U.S.C. 103 as being unpatentable over Krivoruchko (7625403) in view of Buchanan (2002/0173842); claims 3 and 12 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); claim 9 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” and claim 13 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) have been considered but are moot in view of the new grounds of rejection.
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.
Claim 19 recites the limitation "the at least one step”. There is insufficient antecedent basis for this limitation in the claim.
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) further in view of Osborne (2008/0288044).
Regarding claims 1-2, 15, 16 and 18, 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 (combination of the stent framework 555 and an inner graft; col. 2, lin. 25-32) comprising a tubular member having a wall, the wall having an exterior and an interior surface defining a primary conduit lumen (the exterior and interior surfaces of the tubular wall formed by the stent graft) and a slot therethrough (the spacing present between strut members 554); the wall having a first end defining an inflow end of the primary conduit and a second end defining an outflow end of the primary conduit (the inflow and outflow ends of the stent 555; Fig. 5A) 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);
a support frame disposed around the tubular member (stent framework 555 is the support frame with a tubular graft on its inner surface; col. 2, lin. 25-32); 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); wherein the secondary conduit 510 has an inflow portion that extends longitudinally beyond the inflow end of primary conduit 555 in an upstream direction and outflow portion that extends longitudinally beyond the outflow end of the primary conduit in a downstream direction (the inflow and outflow ends of the secondary conduit 510 extend beyond the inflow and outflow ends of primary conduit 555; Fig. 5A)
Krivoruchko is silent regarding a slot therethrough and at least one leaflet having an external portion coupled to the exterior surface of the wall; and wherein the external portion of the at least one leaflet is adhered to the exterior surface of the wall by adhesive, thermal bonding, or chemical bonding and a primary conduit comprising a polymer tubular member having a wall that is impermeable to fluid transfer.
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 of the stent wall (Figs. 1 and 6; claim 12) and wherein the external portion of the at least one leaflet is adhered to the exterior surface of the stent wall 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 exterior surface of the wall and wherein the external portion of the at least one leaflet is adhered to the exterior surface of the wall 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).
Furthermore, Krivoruchko discloses a primary conduit that can include a graft on its interior or exterior surface (col. 2, lin. 25-32). Osborne teaches a similar primary conduit 10 (Fig. 2B) comprising a polymer tubular member having a wall 40 that is impermeable to fluid transfer (Fig. 2B and par. 0056 disclose the stent graft has an elastomeric film which makes the stent graft impermeable).
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 tubular primary graft conduit in Krivoruchko to include polymer tubular member having a wall that is impermeable to fluid transfer, as taught and suggested by Osborne, for allowing the primary conduit to have a fluid barrier (par. 0027 of Osborne).
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 has a step height defined by the interior surface of the wall 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 8, Krivoruchko discloses wherein the at least one leaflet 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 at the inner surface of the wall 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 at the inner surface of the wall. However, Buchanan teaches a similar valved conduit subassembly 10 (Fig. 2B) comprising the more than one leaflets are separated from one another at the inner surface of the conduit wall 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 at the inner surface of the wall 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 at the inner surface of the wall, 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 Osborne (2008/0288044) further in view of Drasler et al. (2018/0147061).
Krivoruchko in view of Buchanan and Osborne disclose the claimed invention of claim 1; except for wherein the external portion of the at least one leaflet is coupled to the exterior surface of the wall 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 and Osborne to include wherein the external portion of the at least one leaflet is coupled to the exterior surface of the wall 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 Osborne (2008/0288044) further in view of Bruchman et al. (2013/0197631) “Bruchman”.
Krivoruchko in view of Buchanan and Osborne 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. 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). 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 and Osborne 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, 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 Osborne (2008/0288044) further in view of Robicsek (5139515).
Krivoruchko in view of Buchanan and Osborne 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 and Osborne 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).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Krivoruchko (7625403) in view of Buchanan (2002/0173842) further in view of Osborne (2008/0288044) further in view of Davila et al. (6296661) “Davila”
Krivoruchko in view of Buchanan and Osborne discloses the claimed invention of claim 1; except for wherein the secondary conduit is elastic and is stretched to conform to a shape of the valve conduit subassembly. However, Davila teaches a similar conduit 60 (Fig. 6) which is elastic and stretchable (col. 5, lin. 2-4). 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 and Osborne to include the secondary conduit is elastic and is stretched to conform to a shape of the valve conduit subassembly, as taught and suggested by Davila, for using a biocompatible material with flexibility and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
Furthermore, the claimed phrase “is stretched to conform” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Allowable Subject Matter
Claims 7, 17 and 19 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 and rewritten to overcome the 112 (b) rejection.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter is allowable due to the limitations of “wherein the valved conduit subassembly defines an upstream length between the leaflet and the step, 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” as set forth in claim 7 and “the at least one step comprises a first step at the inflow end of the primary conduit and a second step at the outflow end of the primary conduit; the wall has a first end surface at the first end of the wall facing in the upstream direction, the first end surface extending radially from the exterior surface of the wall to the interior surface of the wall; the wall has a second end surface at the second end of the wall facing in the downstream direction, the second end surface extending radially from the exterior surface of the wall to the interior surface of the wall; the secondary conduit extends partially over the first end surface of the wall in a radial direction so as to define the first step between the secondary conduit inner surface and the interior surface of the wall; and the secondary conduit extends partially over the second end surface of the wall in a radial direction so as to define the second step between the secondary conduit inner surface and the interior surface of the wall” as set forth in claims 17 and 19. The closest prior art of record fails to disclose these limitations, therefore, they’re not found anticipated by or obvious over prior art.
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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