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 of Group I (claims 1-8) in the reply filed on 01/27/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 9-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/27/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/30/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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 1-3, 6, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benjamin et al. (U.S. Patent Application Publication No. 20100004730 A1).
Regarding claim 1, Benjamin et al. discloses an apparatus (Fig. 4, catheter system 100) comprising:
an outer catheter (Fig. 4, introducer catheter 102) comprising an outer catheter shaft (Fig. 4, introducer sheath 110) and an outer catheter hub (Fig. 5, introducer main body 106), wherein the outer catheter defines an outer catheter passageway extending along a catheter axis (see Fig. 12, structures such as the distal tip 162 can be advanced through introducer catheter 102), wherein the outer catheter hub is located at a proximal end of the outer catheter shaft (see Fig. 4, distal end of introducer sheath 110 is defined at distal tip 162);
an inner catheter (Fig. 4, delivery catheter 104) comprising an inner catheter shaft (Fig. 7, outer sheath 122) and an inner catheter hub (Fig. 4, main body 140) located at a proximal end of the inner catheter shaft (see Fig. 7, distal end of outer sheath 122 is defined at distal tip 162), the inner catheter shaft is adapted to be inserted into the outer catheter (see Fig. 12); and
an intermediate hub located between the inner and outer catheters (Fig. 5, hub portion 108), wherein the intermediate hub comprises a deformable component positioned around at least a portion of the inner catheter shaft (see Fig. 12, para. 0068, annular seal member 120), wherein the deformable component is adapted to be inserted into the outer catheter hub such that the inner catheter is restricted, rotationally about and axially along the catheter axis, relative to the outer catheter (para. 0068, para. 0077-0078).
Regarding claim 2, Benjamin et al. discloses apparatus of claim 1,
wherein the outer catheter passageway at the outer catheter hub defines a constant diameter (see Fig. 6B, para. 0059, the proximal end of main body 106 must have a constant diameter in order for its threads to engage with hub portion 108).
Regarding claim 3, Benjamin et al. discloses the apparatus of claim 1,
wherein the deformable component extends from an outer surface of the inner catheter shaft by a thickness of less than or equal to 10 mm (see Fig. 12, annular seal member 120 extends a non-zero distance from the outer surface of delivery catheter 104).
Regarding claim 6, Benjamin et al. discloses the apparatus of claim 1,
wherein the deformable component completely surrounds the inner catheter shaft (para. 0068).
Regarding claim 8, Benjamin et al. discloses the apparatus of claim 1,
wherein the deformable component comprises an elastomeric material (para. 0068).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Benjamin et al. (U.S. Patent Application Publication No. 20100004730 A1) in view of Drake et al. (U.S. Patent Application Publication No. 20130123753 A1).
Regarding claim 4, Benjamin et al. discloses the apparatus of claim 1. Benjamin et al. fails to teach wherein the deformable component extends along a length of the inner catheter shaft for a distance of about 15-20 mm.
However, Drake et al. teaches an apparatus (Fig. 2a, catheter 100), comprising an inner catheter shaft (see Fig. 2b, a sub-selecting catheter can be exchanged for large diameter guide wire 200') and a deformable component (Fig. 3a, sealing assembly 30). The deformable component extends along a length of the inner catheter shaft for a distance of about 15-20 mm (see para. 0032, para. 0042, Figs. 5a-5d, the maximum unexpanded diameter of funnel-like segment 503 dofm is 0.05 in, the seal zone 101s diameter can expand from approximately 1% to 1000% (the circumference of funnel-like segment 503 can range from 3.99 mm to 43.88 mm)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the deformable component of Benjamin et al. to extend along a length of the inner catheter shaft for a distance of about 3.99 mm to 43.88 mm, as taught by Drake et al., in order to accommodate passage therethrough of a variety of catheters that range in outer diameter (para. 0032).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Benjamin et al. (U.S. Patent Application Publication No. 20100004730 A1) in view of Schertiger et al. (U.S. Patent Application Publication No. 20100211049 A1).
Regarding claim 5, Benjamin et al. discloses the apparatus of claim 1, wherein the deformable component extends between a proximal region (see Fig. 12, proximal end of annular seal member 120) and a distal region (see Fig. 12, distal end of annular seal member 120). Benjamin et al. fails to teach wherein the deformable component tapers inwardly from the proximal region to the distal region.
However, Schertiger et al. teaches an apparatus (Fig. 1, telescoping intermittent catheter 1), comprising an inner shaft (Fig. 1, proximal section 2) and a deformable component (Fig. 5, coupling ring 16). The deformable component tapers inwardly from a proximal region to a distal region (see Fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the deformable component of Benjamin et al. to taper inwardly from the proximal region to the distal region, as taught by Schertiger et al., in order to lock the catheter in its position (para. 0065).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Benjamin et al. (U.S. Patent Application Publication No. 20100004730 A1) in view of Goral et al. (U.S. Patent Application Publication No. 20180361119 A1).
Regarding claim 7, Benjamin et al. discloses the apparatus of claim 1. Benjamin et al. fails to teach wherein the deformable component is inserted into the outer catheter hub by a distance of about 5-10 mm.
However, Goral et al. teaches an apparatus (Fig. 1, catheter assembly 10), wherein the deformable component (Fig. 1, membrane 72 of seal member 18) is inserted into the outer catheter hub (Fig. 1, catheter hub 12) by a distance of about 5-10 mm (see Fig. 1, Fig. 6, para. 0055, para. 0058, para. 0062, the proximal end of membrane 72 is spaced from the opening 21 at the proximal end 20 of the catheter hub 12 by about 0.28 inches (the sum of lp and dp, about 7.112 mm)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the apparatus component of Benjamin et al. to contain the deformable component inserted into the outer catheter hub by a distance of about 7.122 mm, as taught by Goral et al., in order to seal a cavity of the outer catheter hub (para. 0058).
Conclusion
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/AMBER R VENTURA/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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