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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, and 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2019/0167967 to Mottola et al. (“Mottola”) in view of U.S. Patent No. 6,217,555 to Hart et al. (“Hart”).
Regarding claim 1, Mottola teaches a hemostasis valve hub (110, Fig. 1A) for an introducer sheath (401, Fig. 4D), comprising a hub base (110, Fig. 110), a hub cap (140) configured for engagement with the hub base, the hub cap having a first wall defining a face (146), the first wall having a first opening (142b/242c) and a second opening (142a/242a) extending through the first wall, a manifold (130) positioned within the hub cap and adjacent the hub base, a primary seal (132b/232c) positioned adjacent the first opening of the hub cap, a secondary seal (132a/232a) positioned adjacent the second opening of the hub cap, and wherein the primary seal and the secondary seal are configured to provide a fluid seal between the first opening and the second opening, respectively, and the hub base ([0056]), but does not show the protruding portion.
Hart teaches a protruding portion (196, Fig. 12) extending from a face (as better shown as 121, Fig. 10), a first opening (opening adjacent 196, Fig. 12) extending into the protruding portion. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mottola with a protruding portion as taught by Hart as such cylinders aid in aligning instruments that are extended therethrough (column 11, lines 16-21).
Regarding claim 2, Mottola and Hart teach the hemostasis valve hub of claim 1 as shown above, Mottola further teaching the first opening has a first diameter and the second opening has a second diameter, the first diameter being greater than the second diameter (242c is bigger than 242a, Fig. 2).
Regarding claim 7, Mottola and Hart teach the hemostasis valve hub of claim 1 as shown above, Mottola further teaching the primary seal and the secondary seal are each composed of cylindrical seals having a partial cross slit within a center of each the first seal and the second seal (as best seen as 1032a/b in Fig. 10)
Regarding claim 8, Mottola and Hart teach the hemostasis valve hub of claim 1 as shown above, Mottola further teaching the hub base comprises at least one ring configured for receiving a suture to secure the hemostasis valve hub positioning (see annotated Fig. 4D below, the ring is capable of receiving a suture).
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Regarding claim 9, Mottola and Hart teach the hemostasis valve hub of claim 1 as shown above, Mottola further teaching the hub base comprises an access port (112) extending radially outward from the hub base.
Regarding claim 10, Mottola teaches a delivery system (Fig. 1D) for a plurality of medical devices into a blood vessel, comprising an introducer sheath (401, Fig. 4D) for insertion into the blood vessel, the introducer sheath having a proximal end and a distal end (Fig. 4D), and a hemostasis valve hub (110) for attachment to the proximal end of the introducer sheath, the hemostasis valve hub including a hub base (110), a hub cap (140) configured for engagement with the hub base, the hub cap having a first face (146) with a first opening (142b/242c) and a second opening (142a/242a) extending through the first face, a manifold (130) positioned within the hub cap and adjacent the hub base, a primary seal (132b/232c) positioned adjacent the first opening of the hub cap, a secondary seal (132a/232a) positioned adjacent the second opening of the hub cap, and wherein the primary seal and the secondary seal are configured to provide a fluid seal between the first opening and the second opening, respectively, and the hub base ([0056]), but does not show the protruding portion.
Hart teaches a protruding portion (196, Fig. 12) extending from a face (as better shown as 121, Fig. 10), a first opening (opening adjacent 196, Fig. 12) extending into the protruding portion. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mottola with a protruding portion as taught by Hart as such cylinders aid in aligning instruments that are extended therethrough (column 11, lines 16-21).
Regarding claim 11, Mottola and Hart teach the delivery system of claim 10 as shown above, Mottola further teaching the first opening has a first diameter and the second opening has a second diameter, the first diameter being greater than the second diameter (242c is bigger than 242a, Fig. 2).
Regarding claim 12, Mottola and Hart teach the delivery system of claim 10 as shown above, Mottola further teaching the hub base comprises at least one ring configured for receiving a suture to secure the hemostasis valve hub positioning (see annotated Fig. 4D above, the ring is capable of receiving a suture).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Mottola in view Hart as applied to claim 1 above, and further in view of U.S. Patent No. 5,911,710 to Barry et al. (“Barry”).
Regarding claim 3, Mottola and Hart teach the hemostasis valve hub of claim 1 as shown above, Mottola further teaching the primary seal has a first thickness and the secondary seal has a second thickness, but do not teach the first thickness being greater than the second thickness.
Barry teaches increasing a thickness of a seal. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have increased the thickness of the primary seal of Mottola as taught by Barry, in order to make it easier to maintain hemostasis and beneficially increasing the fluid pressure at which the seal would fail (column 5, lines 26-35).
Claims 4, 5, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mottola in view Hart as applied to claim 1 above, and further in view of WO 98/13083 to Giurtino et al. (“Giurtino”).
Regarding claim 4, Mottola and Hart teach the hemostasis valve hub of claim 1 as shown above, Mottola further teaching the hub base comprises a distal end and a proximal end (proximal and distal end of 110), but do not teach the ferrule.
Giurtino teaches a hub base (14, Fig. 2) having a ferrule (32) positioned within the distal end of the hub base (Fig. 2). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the friction-type sheath retainer of Mottola with the ferrule-type sheath retainer of Giurtino to yield the predictable result of retaining a sheath at the distal end of a hub base of hemostasis valve. Both Mottola and Giurtino secure a sheath at a distal end of a hub base, Giurtino merely shows one alternative example of sheath retention.
Regarding claim 5, Mottola, Hart, and Giurtino teach the hemostasis valve hub of claim 4 as shown above, Giurtino further teaching the ferrule is configured for securing the introducer sheath (12) with hub base (Fig. 2).
Regarding claim 13, Mottola and Hart teach the delivery system of claim 10 as shown above, Mottola further teaching the hub base comprises a distal end and a proximal end (proximal and distal end of 110), but do not teach the ferrule.
Giurtino teaches a hub base (14, Fig. 2) having a ferrule (32) positioned within the distal end of the hub base (Fig. 2). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the friction-type sheath retainer of Mottola with the ferrule-type sheath retainer of Giurtino to yield the predictable result of retaining a sheath at the distal end of a hub base of hemostasis valve. Both Mottola and Giurtino secure a sheath at a distal end of a hub base, Giurtino merely shows one alternative example of sheath retention.
Response to Arguments
The drawings were received on 06/03/2026. These drawings are acceptable.
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments and amendments with respect to claim objections have been fully considered and are persuasive. The claim objections have been withdrawn.
Applicant’s arguments and amendments with respect to art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mottola and Hart as shown above in response to the new amendments.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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