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 .
Response to Amendment
The objection to drawings is withdrawn in light of the amendments.
Response to Arguments
Applicant's arguments filed on April 13th, 2026 have been fully considered but they are not persuasive.
Regarding the claim rejection of claim 1, applicant’s argument is not persuasive. Applicant argues that Hewitt does not disclose individual wire ends extending distally from the distal edge of the marker band, this is not persuasive. As shown in Fig.2 of Hewitt, the reference illustrates marker band 51 having a portion extending beyond the distal edge of the marker band. Although the corresponding wire ends are not depicted extending from beneath marker band 50 in the same view, Fig.1 of Hewitt, demonstrate that the wire structure includes wire ends extending from the marker band region. Therefore, it would be understood to one in the ordinary skill in the art that the exposed wire portions distal to marker band 51 are the individual wire ends extending from the distal edge of the marker band, thereby satisfying the claimed feature.
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.
Claims 1, 3-4, 6, 12-13, 15-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hewitt in view of Perkins-Neaton et al. (US Pub No. 20190314574 A1, herein, Perkins-Neaton).
Regarding claim 1, Hewitt discloses a medical device comprising:
an elongate shaft (Fig.1) comprising:
an inner polymeric liner (10 – Fig.3C, “low friction polymer” – Para [0034]) defining a lumen extending therethrough (Fig.3C);
an outer polymeric sheath (30 – Fig.1, “outer jacket can be formed of segments of one or more polymers” – Para [0047]); and
a reinforcing braid (20 – Fig.1) extending within the outer polymeric sheath (Fig.1, Fig.3C); and
a member (51 – Fig.2) secured relative to the elongate shaft;
wherein the reinforcing braid includes a plurality of wire ends, comprising terminal ends of wires of the reinforcing braid, that extend beyond a distal edge of the member (Fig.2, the distal end of the braid extending beyond a distal edge of the member 51 so that the wire ends extend beyond a distal edge of the member);
wherein the limitation, “wherein a distal region of the elongate shaft is adapted for delivering and/or recapturing an implant” is interpreted to be a functional limitation (the catheter system of Hewitt is capable of performing this function since the system comprises all the elements provided above, which can be used to deliver an implant, Hewitt also mentions “Wire coils and filaments can also be delivered through catheters” – Para [0005]);
wherein the member is disposed within the distal region of the elongate shaft, and wherein the plurality of wire ends extend distally from the distal edge of the member (See annotated Fig.1 and Fig.2 below); and
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wherein the plurality of wire ends form ramps (see annotated Fig.2 above, Marriam-Webster defines the term “ramp” to mean a sloping way or plane, the wire ends comprise a plurality of sloping surfaces, providing a gradual transition between portions). The limitation, “that are adapted to keep the implant, when recaptured, from contacting the distal edge of the rigid member, even if the inner polymeric liner is damaged” is interpreted to be a functional limitation (the catheter system of Hewitt is capable of performing this function since the system comprises all the elements provided above, which can be used to keep the implant from contacting the distal edge of the rigid member, even if the inner polymeric liner is damaged, Fig.9B shows the braid as inward relative to the member so that this relative positioning would help adapt the braid to keep the implant from contacting the member).
However, Hewitt does not expressly disclose that the member is rigid.
Perkins-Neaton teaches a rigid member (2710 – Fig.27B, “rigid features…such as marker bands” – Para [0108]) secured relative to an elongate shaft (2700 – Fig.27A).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the member of Hewitt to be rigid as taught by Perkins-Neaton since Perkins-Neaton teaches that a rigid member near the tip of the shaft does not collapse, keeping the shaft rigid during insertion (Perkins-Neaton, Para [0108]) this would improve the control, accuracy, and safety when advancing the device of Hewitt into the body.
Regarding claim 3, Hewitt, as modified, discloses a medical device as recited above, wherein the plurality of wire ends also extend radially inwardly from the distal edge of the rigid member (see annotated Fig.1 and Fig.2 above).
Regarding claim 4, Hewitt, as modified, discloses a medical device as recited above, wherein the plurality of wire ends also extend radially outwardly (examiner interprets “radially outwardly” as extending in a direction away from the central longitudinal axis of the helical braid, there are wire ends that extend at an angle away from the central longitudinal axis) from the distal edge of the rigid member (Fig.2, Fig.9B).
Regarding claim 6, Hewitt, as modified, is fully capable of preventing the implant from contacting the distal edge of the rigid member even when the inner polymeric liner is damaged as claimed as the wire ends are positioned inward relative to the distal edge of the rigid member so that the implant would contact the wire ends prior to contacting the rigid member.
Regarding claim 12, Hewitt, as modified, discloses a medical device as recited above, wherein the rigid member comprises a marker band (51 – Fig.2, “marker bands 50 and 51” – Para [0051]).
Regarding claim 13, Hewitt discloses a device comprising:
an elongate shaft (Fig.1) comprising:
an inner polymeric liner (10 – Fig.3C, “low friction polymer” – Para [0034]) defining a lumen extending therethrough (Fig.3C);
an outer polymeric sheath (30 – Fig.1, “outer jacket can be formed of segments of one or more polymers” – Para [0047]); and
a reinforcing braid (20 – Fig.1) extending within the outer polymeric sheath (Fig.1, Fig.3C); and
a marker band secured relative to the elongate shaft (51 – Fig.2);
wherein the reinforcing braid includes a plurality of wire ends, comprising terminal ends of wires of the reinforcing braid, that extend beyond a distal edge of the marker band (See annotated Fig.1 and Fig.2 above, the distal end of the braid extending beyond a distal edge of the member 51 so that the wire ends extend beyond a distal edge of the member).
The limitations, “a device adapted for delivering and/or recapturing an implant” and “the plurality of wire ends adapted to keep the implant, when recaptured, from contacting the distal edge of the marker band, even if the inner polymeric liner is damaged” is interpreted to be functional limitations (the catheter system of Hewitt is capable of performing these functions since the system comprises all the elements provided above, which can be used to deliver and/or recapture an implant and keep the implant, when recaptured, from contacting the distal edge of the marker band, Fig.9B shows the braid as inward relative to the marker band so that this relative positioning would help adapt the braid to keep the implant from contacting the marker band);
Wherein the plurality of wires ends extend distally and radially from the distal edge of the marker band (See annotated Fig.1 and Fig.2 above).
Regarding claim 15, Hewitt discloses a device as recited above, wherein the plurality of wire ends extend radially outwardly (examiner interprets “radially outwardly” as extending in a direction away from the central longitudinal axis of the helical braid, the wire ends extend at an angle away from the central longitudinal axis) from the distal edge of the marker band (Fig.2, Fig.9B).
Regarding claim 16, Hewitt discloses a device as recited above, wherein the plurality of wire ends extend radially outwardly from the distal edge of the marker band (see annotated Fig. 1 and Fig.2 above).
Regarding claim 17, Hewitt discloses a medical device, comprising:
an elongate shaft (Fig.1) having a distal region, the distal region (Fig.4) comprising:
an inner polymeric liner (10 – Fig.3C, “low friction polymer” – Para [0034]) defining a lumen (Fig.3C)
an outer polymeric sheath (30 – Fig.1, “outer jacket can be formed of segments of one or more polymers” – Para [0047]);
wherein the reinforcing braid (20 – Fig.1) includes a plurality of wire ends, comprising terminal ends of wires forming the reinforcing braid, that extend beyond the marker band (See annotated Fig.1 and Fig.2 above, the distal end of the braid extending beyond a distal edge of the member 51 so that the wire ends extend beyond a distal edge of the member),
The limitation “the plurality of wire ends adapted to keep the implant, when recaptured, from contacting the distal edge of the marker band, even if the inner polymeric liner is damaged” is interpreted to be functional limitations (the catheter system of Hewitt is capable of performing these functions since the system comprises all the elements provided above, which can be used to accommodate the implant therein and keep the implant, when recaptured, from contacting the distal edge of the marker band, Fig.9B shows the braid as inward relative to the marker band so that this relative positioning would help adapt the braid to keep the implant from contacting the marker band); and
Wherein the plurality of wire ends extend distally from the distal edge of the marker band (See annotated Fig.1 and Fig.2 above).
Regarding claim 19, Hewitt discloses a medical device as recited above, wherein the plurality of wire ends also extend radially outwardly (examiner interprets “radially outwardly” as extending in a direction away from the central longitudinal axis of the helical braid, the wire ends extend at an angle away from the central longitudinal axis) from the marker band (Fig.2, Fig.9B).
Regarding claim 20, Hewitt discloses a medical device as recited above, wherein the plurality of wire ends extend radially inwardly from the marker band (see annotated Fig.1 and Fig.2 above).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hewitt in view of Perkins-Neaton as applied to claim 1 above, and further in view of Bagaoisan et al. (US Pub No. 20200206483 A1, herein, Bagaoisan).
Regarding claim 9, Hewitt, as modified, discloses a medical device as recited above, comprising a rigid member (51 – Fig.2) but Hewitt does not expressly disclose wherein the rigid member comprises a metallic member.
Bagaoisan teaches a medical device wherein a rigid member (“marker band” – Para [0015]) comprises a metallic member (“platinum” – Para [0015]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the
applicant’s claimed invention to modify the rigid member of Hewitt to comprise a metallic member since Bagaoisan teaches that platinum is a well-known material to use for a rigid member to help visualize the location and/or state of any component of the catheter (Bagaoisan, Para [0015]).
Regarding claim 10, Hewitt, as modified, discloses a medical device as recited above, comprising a rigid member (51 – Fig.2) but Hewitt does not expressly disclose wherein the rigid member comprises a polymeric member.
Bagaoisan teaches a medical device wherein a rigid member (“marker band” – Para [0015]) comprises a polymeric member (“polymers with fillers” – Para [0015]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the
applicant’s claimed invention to modify the rigid member of Hewitt to comprise a polymeric member since Bagaoisan teaches that polymers is a well-known material to use for a rigid member to help visualize the location and/or state of any component of the catheter (Bagaoisan, Para [0015]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hewitt in view of Perkins-Neaton as applied to claim 1 above, and further in view of Musbach et al. (US Pub No. 20070135763 A1).
Regarding claim 11, Hewitt, as modified, discloses a medical device as recited above, comprising a rigid member (51 – Fig.2) but Hewitt does not expressly disclose wherein the rigid member comprises a section of hypotube.
Musbach teaches a medical device wherein a rigid member (202 – Fig.19) comprises a section of hypotube (“Marker bands are unique in that they are sections of micromachined hypotubes” – Para [0105]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the
applicant’s claimed invention to modify the rigid member of Hewitt to comprise a section of hypotube as taught by Musbach since Musbach teaches that using a section of hypotube on the rigid member causes additional flexibility (Musbach, Para [0105]) which would allow the shaft of Hewitt to follow curves without kinking or buckling in the body.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARISSA TAYLOR/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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