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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/25/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Although Applicant states that support for the claim amendments are found in the specification and drawings, Applicant did not point out where specific support can be found. The new language specifying “each leaflet having a bottom edge coincident with a blood inflow terminal end of the expandable tubular member” does not appear to be supported by the original specification. For instance, Fig. 5C illustrates a bottom edge (222) of a leaflet (200) above the terminal end (115) of the expandable tubular member.
Claim Objections
Claim 2 is objected to because of the following informalities: “wherein polymeric web comprising…” should read “the polymeric web comprises”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The new language specifying “each leaflet having a bottom edge coincident with a blood inflow terminal end of the expandable tubular member” does not appear to be supported by the original specification. The phrase “coincident with” does not appear in the originally filed specification, so the scope of this term is unclear. For instance, Fig. 5C illustrates a bottom edge of a leaflet (200) offset from the terminal end (115) of the expandable tubular member.
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.
Claims 1-10 are 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. Because the new language “each leaflet having a bottom edge coincident with a blood inflow terminal end of the expandable tubular member” does not appear to be supported by the original specification, the language renders the claims indefinite. It is unclear what distance from the bottom edge meets the scope of “coincident with”, since Fig. 5C illustrates a bottom edge of a leaflet (200) above the terminal end (115) of the expandable tubular member.
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) 1-3 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2013/0090729 (Gregg ‘729) in view of USPAP 2013/0066419 (Gregg ‘419), and further in view of US 8,945,209 (Bonyuet et al.) and USPAP 2014/0188221 (Chung et al.).
Gregg ‘729 discloses a prosthetic heart valve (100) comprising an expandable tubular member (stent 200) and a plurality of leaflets (see description of heart replacement valve [0031]; Fig. 4);
and a tubular seal (see 50 in Figure 1; 450 in Figure 4) comprising a polymeric web secured to the bottom edge of the tubular member (200) (see sutures 442 in Fig. 4) and along an outer portion (440) of the expandable tubular member, wherein the tubular seal (50/450) comprising an outflow end region and an inflow end region, the inflow end region (40/440) being a portion of polymeric web retaining a woven fabric (see description of band 40 being formed of woven fabric incorporated within a multilayer seal body [0017], [0019]; the seal layers 80 and 84 being formed of polymeric web such as polycarbonate or polyurethane [0023]; Fig. 5; the term “web” given its broadest reasonable interpretation to encompass a thin membrane).
Gregg ’729 is silent with respect to sites of attachment of the leaflets to the tubular member and polymeric web. Gregg ‘419 discloses a similar heart valve prosthesis and teaches that the leaflets (30a, 30b, 30c) are secured together alongside edges (see suture line 32 in Figure 4; [0041]), retained within the expandable tubular member (18), wherein each leaflet (30a, 30b, 30c) has a bottom edge coincident with a blood inflow terminal end (22) of the expandable tubular member (18) (see leaflets attached to terminal inflow end 22 at suture line 36 in Fig 4; [0048]) and a free edge at a blood outflow end (see 21 in Fig 2) of the expandable tubular member. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to secure the bottom edge of the leaflets of Gregg ‘729 to the terminal inflow end of the tubular member, as taught by Gregg ‘419, as the modification merely involves a combination of known prosthetic heart valves that obtains a predictable result of attaching leaflets to a support frame. The modification results in the seal (50) being secured to the bottom edge of the leaflets.
As illustrated in Figure 1 of Gregg ‘729, the outflow end of the seal has a non-linear edge (20/22), but the reference fails to disclose that the woven fabric at (40/440) has a non-linear edge defining the interface between the inflow end region and the outflow end region of the prosthesis. Bonyuet is in the same field of endeavor and teaches a seal for a prosthetic valve, wherein the seal comprises a polymeric web (layers 84 and 86 formed of woven polyester or PTFE yarns meets the limitation “web”; col 6, lines 37-50), wherein the inflow portion of the seal has a woven fabric (skirt 56 formed of fabric such as Dacron) encapsulated by the polymer layers (col 6, lines 3-16; col 7, lines 30-50). Bonyuet teaches the concept of forming the woven fabric such that it has a non-linear edge (the outflow end of the woven fabric skirt 56 has an undulating pattern) defining an interface between an inflow end region (having the woven fabric) and an outflow end region (does not contain woven fabric). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to configure the woven fabric of the Gregg ‘729 seal to have a non-linear edge at its outflow end, as taught by Bonyuet, as the modification merely involves a combination of known prosthetic heart valves that obtains a predictable result of a fabric reinforced seal having a non-linear edge.
Gregg ’729, Gregg ‘419 and Bonyuet fail to disclose a radiopaque marker, but Chung teaches that it is beneficial to include a radiopaque marker (73) on a prosthetic valve in order to aid in proper placement with the patient’s body (Fig. 2A; [0087]; [0158]). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to include a radiopaque marker on the modified Gregg prosthesis, as taught by Chung, in order to aid in visualization and proper placement of the device within the patient’s body.
Regarding claims 2 and 3, Gregg ‘729 discloses elastomeric polymeric web material such as polyurethane [0023], the woven fabric (40) may be polyester fibers [0019], which is a known inelastic material, and the fabric (40) is retained within the polymer matrix (between layers [0017]; [0024]). Additionally, Bonyuet discloses the polymeric web may comprise an elastomeric material such as ePTFE, silicones, polyurethane, etc. (col 6, lines 37-53), the woven fabric is Dacron, which is known to be inelastic (skirt 56 formed of fabric such as Dacron), and the woven fabric (56) is encapsulated between the inner and outer layers (84 and 86) forming the polymeric web (col 6, lines 3-16; col 7, lines 30-50).
In regards to claim 8, the non-linear edge of the woven fabric (skirt 56) taught by Bonyuet can be described as sinusoidal, as it has an undulating pattern.
In regards to claim 9, one of ordinary skill in the art would ascertain that the outflow end of the seal (50) disclosed by Gregg ‘729 has a thickness less than the inflow region, due to the additional thickness of the fabric of the woven fabric (band 40). Additionally, the outflow end of Bonyuet has a thickness less than the inflow end due to the absence of the woven fabric layer (56).
Regarding claim 10, Gregg ‘729 and Gregg ‘020 disclose a plurality of grommets (34) placed at various locations on the prosthesis including an outflow end. Bonyuet also discloses the outflow end comprises a plurality of grommets (see 58 in Figure 4).
Claim(s) 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Gregg ‘729 in view of Gregg ‘419, Bonyuet et al, and Chung, and further as applied to claim 3 above, and further in view of USPAP 2012/0277850 (Bertini).
Gregg ‘729 and Bonyuet fails to disclose the woven fabric comprises fibers oriented in warp and weft directions that are angled with respect to the central axis of the seal. Bertini teaches a similar invention comprising an implantable graft 220 (Fig. 6) having a woven fabric ([0018] discloses a woven polypropylene graft) comprising fibers in a warp direction and fibers in a waft direction ([0018] discloses warp yarn 202 and weft yarns 204), wherein the fibers in both the warp direction and the waft direction are angled with respect to a central axis of the tubular graft ([0010 and 0018] disclose the yarns are not disposed parallel or perpendicular to the longitudinal axis but are disposed at an angle). In regards to claims 5 and 6, Bertini teaches the fibers in both the warp direction and the waft direction are arranged within the tubular member to form an angle of about 45 degrees with respect to the central axis of the tubular graft ([0010] discloses the angle is approximately 45 degrees), which meets the requirement of the fibers angled between 5 degrees and 70 degrees with respect to the central axis of the tubular graft. Bertini teaches that by orienting the fibers at an angle relative to the central axis of the prosthesis, the prosthesis exhibits enhanced flexibility, smaller packing profile and greater resistance to internal radial pressure. Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention was made to configure the woven fabric of the modified Gregg ‘729 seal such that warp and weft fibers are angled about 45 degrees relative to the central axis of the tubular seal in order to achieve a predictable result of improving performance characteristics of the prosthesis (Bertini [0009]).
In regards to claim 7: The term “allow” is not considered to be a positive recitation of any particular features/characteristics, and therefore the prior art is not required to disclose these functions. The modified Gregg device having non-elastic fibers of the woven fabric arranged at an angle relative to the central axis, as taught by Bertini, provides the seal with the capability of stretching both axially and radially in response to sufficient forces applied to the seal in the corresponding directions.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent App. Pub. No. 2013/0150956 discloses a bottom edge of leaflets (516) intersecting the terminal inflow end (518) of the frame (see fig. 28; [0095]).
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774