Detailed Action
This is in response to the amendment filed 02/05/2026.
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.
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.
Claim(s) 23-26, 30, 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,649,959 (Hannam et al.) in view of U.S. Patent Publication Number 2007/0060911 (Webster et al.)
Regarding claims 23-26, 36 Hannam et al. discloses as shown in Figures 1,2 a blood vessel access and closure assist system, comprising: an access sheath (sheath 26, see col. 6, lines 55, 66) having an internal lumen capable of delivery of an interventional device into a blood vessel when the access sheath is inserted into an artery; a vessel closure device delivery sheath (tubular body 32, see col. 9, lines 39-64), the vessel closure device delivery sheath having an internal lumen capable of delivering a vessel closure device, a procedural device (intravascular instrument, see col. 6, lines 42-66) capable of being advanced through the access and closure assembly into the artery to treat the artery at a location spaced from the opening of the artery; wherein the vessel closure device delivery sheath and the access sheath are capable of coupling together to one another to form a single assembly and so that the procedural device can be used to perform an intravascular procedure within the artery while the single assembly is inserted into the artery, that can be inserted into an artery such that a distal end of the first sheath extends beyond a distal tip of the closure device delivery sheath when the two sheaths are coupled to one another, wherein the first sheath couples to the vessel closure device delivery sheath by being inserted into the internal lumen of the vessel closure device delivery sheath, wherein the first sheath includes a first hub and the vessel closure device delivery sheath includes a second hub, and wherein the first and second hubs couple to one another to immobilize the first sheath relative to the vessel closure device delivery sheath, wherein the first and second hubs couple to one another via a threaded connection, wherein the single assembly is capable of providing access for a procedural device to the artery, wherein the single assembly defines a treatment lumen, wherein the procedural device is capable of being advanced through the treatment lumen to perform an intravascular procedure within the artery while the single assembly is inserted into the artery. See col. 10, lines 34-64.
Hannam fails to disclose the procedural device is thrombectomy catheter.
Webster et al., from the same field of endeavor teaches a similar system as shown in Figure 1, where the system includes a procedural device in the form of a thrombectomy catheter for the purpose of performing a thrombectomy. See paragraph [0138].
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 system disclosed by Hannam by substituting the procedural device disclosed by Hannam for the one taught by Webster in order to perform a thrombectomy and seal the initial incision afterwards, or because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007); MPEP § 2143.
Regarding claim 30, The office interprets Hannam as disclosing wherein the vessel closure device applier includes a blade that can split the vessel closure device applier as a vessel closure device is delivered to the artery, because claim 1 does not positively recite the vessel closure device applier only the ability the be used with one. It is the position of the Office that Lenker teaches blood vessel access and closure assist system capable of use with a vessel closure device applier includes a blade that can split the vessel closure device applier as a vessel closure device is delivered to the artery as recited in claims.
Claim(s) 23, 25, 28, 29, 31-35, 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2001/0003158 (Kensey et al.) in view of U.S. Patent Number 5,649,959 (Hannam et al.), U.S. Patent Publication Number 2007/0060911 (Webster et al.)
Regarding claim 23, 25 Kensey et al. discloses as shown in figures 1-15, 26, 28, 30 a blood vessel access and closure assist system, comprising: an access sheath (positioning device 200, 300, 400, 600 see paragraph [0065]) having an internal lumen for delivery of an interventional device into a blood vessel when the access sheath is inserted into an artery; a vessel closure device delivery sheath, the vessel closure device delivery sheath (sheath 28, 28', see paragraph [0046], [0072]) having an internal lumen adapted to deliver a vessel closure device; a procedural device (intravascular instrument, see paragraph [0044]) wherein the vessel closure device delivery sheath and the access sheath couple to one another to form a single assembly that can be inserted and so that the procedural device can be used to perform an intravascular procedure within the artery while the single unit assembly is inserted into the artery, into an artery such that a distal end of the first sheath extends beyond a distal tip of the closure device delivery sheath when the two sheaths are coupled to one another, wherein the single assembly is capable of providing access for a procedural device to the artery.
Kensey fails to disclose the vessel closure device delivery sheath and the access sheath are capable of fixedly coupling to one another, the procedural device comprises a thrombectomy catheter.
Hannam et al., from the same field of endeavor teaches a system as shown in Figures 2, 3 with similar a similar procedural introducer sheath (tubular body 32) and vessel closure device delivery sheath (sheath 26) used for the same purpose of delivering a vessel closure device, wherein the method includes the step of inserting the vessel closure device delivery sheath into the lumen (inside luer lock 48) of the procedural introducer sheath, immobilizing the procedural introducer sheath relative to the vessel closure device delivery sheath, for the purpose of temporarily fixing the sheaths relative to one another. see col. 10, lines 34-46.
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 system disclosed by Kensey to include the hubs with the threaded connections on the ends of the vessel closure device delivery sheath and the procedural sheath disclosed by Hannam such that the vessel closure device delivery sheath and the procedural sheath are capable of fixedly coupling to one another, in order to temporarily fix the sheaths relative to one another, to avoid inadvertent movement which would cause damage to the surrounding tissue.
Webster et al., from the same field of endeavor teaches a similar system as shown in Figure 1, where the system includes a procedural device in the form of a thrombectomy catheter for the purpose of performing a thrombectomy. See paragraph [0138].
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 system disclosed by Kensey in view of Hannam by substituting the procedural device disclosed by Kensey in view of Hannam for the one taught by Webster in order to perform a thrombectomy and seal the initial incision afterwards, or because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007); MPEP § 2143.
Regarding claims 28, 29, 31, 33-35 Kensey et al. discloses the vessel closure device (closure device 22, see paragraph [0046]) and vessel closure device applier (deployment instrument 20, see paragraph [0048]), wherein the vessel closure device is a vessel closure clip, wherein the vessel closure device applier includes a handle (luer 112) and an elongated delivery shaft (carrier 100), wherein the elongated delivery shaft inserts into the vessel closure device applier, and an introducer guide wire (filament 34, see paragraph [0047]). See Figure 1.
Regarding claim 32 Kensey et al. discloses a sheath dilator (device 200, see paragraph [0065]).
Regarding claim 40, Kensey et al. discloses as shown in Figures 1-15, 26, 28, 30 a medical device assembly, comprising: an access sheath (positioning device 200, 300, 400, 600 see paragraph [0065]) configured to be inserted into an artery; a vessel closure device delivery sheath (sheath 28, 28', see paragraph [0046], [0072]); a procedural device (intravascular instrument, see paragraph [0044]); a vessel closure device; wherein the vessel closure device delivery sheath and the access sheath are coupled to one another to define a subassembly, the subassembly defining a lumen for advancing the procedural device therethrough; and wherein the vessel closure device delivery sheath and the access sheath are configured to uncouple from one another so that the access sheath can be removed from the artery and so that the vessel closure device can be advanced through the vessel closure device delivery sheath.
Hannam et al., from the same field of endeavor teaches a system as shown in Figures 2, 3 with similar a similar procedural introducer sheath (tubular body 32) and vessel closure device delivery sheath (sheath 26) used for the same purpose of delivering a vessel closure device, wherein the method includes the step of inserting the vessel closure device delivery sheath into the lumen (inside luer lock 48) of the procedural introducer sheath, immobilizing the procedural introducer sheath relative to the vessel closure device delivery sheath, for the purpose of temporarily fixing the sheaths relative to one another. see col. 10, lines 34-46.
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 system disclosed by Kensey to include the hubs with the threaded connections on the ends of the vessel closure device delivery sheath and the procedural sheath disclosed by Hannam such that the vessel closure device delivery sheath and the procedural sheath are capable of fixedly coupling to one another, in order to temporarily fix the sheaths relative to one another, to avoid inadvertent movement which would cause damage to the surrounding tissue.
Webster et al., from the same field of endeavor teaches a similar system as shown in Figure 1, where the system includes a procedural device in the form of a thrombectomy catheter for the purpose of performing a thrombectomy. See paragraph [0138].
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 system disclosed by Kensey in view of Hannam by substituting the procedural device disclosed by Kensey in view of Hannam for the one taught by Webster in order to perform a thrombectomy and seal the initial incision afterwards, or because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007); MPEP § 2143.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2001/0003158 (Kensey et al.) in view of U.S. Patent Number 5,649,959 (Hannam et al.), U.S. Patent Publication Number 2007/0060911 (Webster et al.) as applied to claim 25 above, and further in view of U.S. Patent Publication Number 2015/0201963 (Snow)
Regarding claim 27, Kensey et al. in view of Hannam fails to disclose wherein the first and second hubs couple to one another via a snap fit.
Snow, from a related field of endeavor taches a similar system with similar hubs, used for the same purpose of detachably coupling as shown in Figures 2A-4, wherein the first and second hubs couple to one another via a snap fit is recognized alternative to a threaded connection. See paragraph [0046].
It would have been obvious to one for ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Kensey et al. in view of Hannam by substituting the thread connection for the snap fit connection taught by Snow because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Response to Arguments
Applicant's arguments filed 02/05/2026 have been fully considered but moot in view of the new grounds of rejection.
In particular, Kensey and Hannam disclose a catheter, or other intravascular instrument (not shown) is then inserted through the introducer sheath 26, 28. See col. 6, lines 42-66 of Hannam and paragraph [0044] of Kensey. The applicant’s remarks do not address this section.
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 RICHARD G LOUIS whose telephone number is (571)270-1965. The examiner can normally be reached on Monday – Friday, 9:30 am – 6 pm.
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/RICHARD G LOUIS/ Primary Examiner, Art Unit 3771
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