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 .
Acknowledgement
This Office action is a non-final Office action because new grounds of rejection have been made. Further rationale has been provided in the original rejections, and a new 102 rejection has been made. Because of the new grounds, the Office action is a non-final Office action.
Response to Arguments
The Applicant’s arguments with respect to the claims have been considered are not persuasive, however new ground of rejections have been made based on an updated search (new art); thus the rejection is being made a non-final action.
With respect to Benjamin, the arguments are not persuasive. Regarding claim 1, Applicant argues that Benjamin fails to teach an intermediate hub that comprises a deformable component, the deformable component is adapted to be inserted into an outer catheter hub, and the deformable component functions to restrict rotational and axial movement of an inner catheter. The arguments are found not to be persuasive because Benjamin teaches a deformable component, seal (reference number 120) that is being interpretated to be part of the hub portion (108) based on the figures and paragraphs cited. This interpretation is reasonable because paragraph 0068 states “[t]he seal member 120 can be configured such that, when the hub portion 108 is threaded onto the main body 106, the surface 118 of the hub portion 108 can be moved axially toward the surface 116 of the main body 106, thereby compressing or squeezing the seal member 120” thus teaching that the hub portion is in a direct relationship with the seal member and also controls the movement of the seal member toward the surface of the main body which implies that the seal is part of the hub portion. A reasonable interpretation would be that the seal member is part of the hub portion (which is being interpretated as the claimed intermediate hub). Additionally, Benjamin teaches in paragraph 0068, that the deformable component forms a seal with delivery catheter, which would teach the deformable component restricting rotationally and axial movement. Lastly, the deformable component (seal, 120) is adapted to be inserted into the outer catheter hub based on paragraph 0068 but also as illustrated in figure 6A, 12, 13, and 15, since figure 6A illustrates the parts of the outer catheter hub (106) that includes a threaded portion that extends past the deformable component (seal, 120), see figures 6A, 12, 13, and 15. The arguments are not found persuasive based on the teachings of the prior art as explained above and the rejection below. The rejection of the claims in view of Benjamin is maintained.
If applicant disagrees with the interpretation of the prior art and rejections, it is suggested to conduct an interview to help expedite prosecution.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed 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).
Claims 1, 5, 6, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGinley et al. (US Patent 8,968,250).
McGinley discloses an apparatus includes an outer catheter (5) comprising an outer catheter shaft and an outer catheter hub (see fig. 7-8, 17, ), wherein the outer catheter defines an outer catheter passageway extending along a catheter axis (the lumen of the shaft), wherein the outer catheter hub is located at a proximal end of the outer catheter shaft; an inner catheter (10, fig. 49A-49B) comprising an inner catheter shaft and an inner catheter hub (10e/10c/10b – see fig. 49A-49B) located at a proximal end of the inner catheter shaft, the inner catheter shaft is adapted to be inserted into the outer catheter (fig. 54-55); and
an intermediate hub (3) located between the inner and outer catheters, wherein the intermediate hub comprises a deformable component (seal – 101+103, see fig. 40, col. 18, ll. 50-67) positioned around at least a portion of the inner catheter shaft, wherein the deformable component is adapted to be inserted into the outer catheter hub (see, e.g. fig. 17, 18, 28, 52) such that the inner catheter is restricted, rotationally about and axially along the catheter axis, relative to the outer catheter (col. 12, ll. 35 – col. 13, ll. 51, col. 17, ll. 35 – 67 – the seal/valve elements restrict the movement of the inner catheter).
Regarding claim 5, McGinley teaches that the deformable component extends between a proximal region and distal region, wherein the deformable component tapers inwardly from the proximal region to the distal region, see fig. 17, 18, 28, and 40 (fig. 28, 40, 41, illustrates the seal 101 and 103 taper from a proximal region to a distal region.
With regards to claim 6, McGinley teaches the deformable component completely surrounds the inner catheter shaft (since the inner shaft passes through the seal to restrict movement).
With regards to claim 8, McGinley teaches the material of the deformable component is polyisoprene, which is an elastomeric material, see col. 18.
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). Furthermore, modifying the size/length/shape are all well known and obvious modifications that are made in the medical art. Therefore, modifying the deformable component to extend along a length of the inner catheter shaft a distance of 15-20mm would be an obvious modification that only take routine skill in the art.
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). Furthermore, modifying the shape is a well known and obvious modification in the medical art. Therefore, modifying the deformable component to include an inwardly tapered section from the proximal region to the distal region would be an obvious modification that only take routine skill in the art.
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., to seal a cavity of the outer catheter hub (para. 0058). Furthermore, modifying the size/length/shape are all well known and obvious modifications that are made in the medical art. Therefore, modifying the size and shape of the deformable component so that it is configured to be inserted into the outer catheter hub by a distance of about 5-10 mm would be an obvious modification that only takes routine skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Blanchard US Patent 11,278,702.
Nakajima et al. US Patent 9,844,648.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW F DESANTO whose telephone number is (571)272-4957. The examiner can normally be reached M-F 7:30am-4pm(est.).
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Matthew DeSanto
/MATTHEW F DESANTO/Primary Examiner, Art Unit 3700
