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 .
Election/Restrictions
Applicant’s election without traverse of Invention I and Species A1 in the reply filed on 02/25/2026 is acknowledged.
Claims 6 and 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/25/2026.
Drawings
The drawings are objected to because of the following informalities:
Fig. 6, reference numeral “240” on the right side should be changed to “236.”
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2-5, 7-9, and 11-13 are objected to because of the following informalities:
In the first line of each of claims 2-5, 7-9, and 11-13, all capitalized versions of the word “Claim” should be changed to “claim” for further clarification.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, and 7-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 2019/0167967 to Mottola et al. (“Mottola”).
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 (146) with 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]).
Regarding claim 2, Mottola teaches 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 teaches 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 teaches 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 teaches 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]).
Regarding claim 11, Mottola teaches 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 teaches 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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Mottola in view of U.S. Patent No. 5,911,710 to Barry et al. (“Barry”).
Regarding claim 3, Mottola teaches 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 does 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 of WO 98/13083 to Giurtino et al. (“Giurtino”).
Regarding claim 4, Mottola teaches 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 does 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 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 teaches 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 does 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.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783