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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 2 – Fig.1. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
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.
(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 13-15 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hewitt et al. (US Pub No. 20040153049 A1).
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 that extend beyond a distal edge of the marker band (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).
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).
Regarding claim 14, Hewitt discloses a device as recited above, wherein the plurality of wire ends (the ends of the wire is not further defined, the examiner interprets the wire ends to be the portion of the braid where the wire ends terminate) extend distally from the distal edge of the marker band (See annotated Fig.2 below).
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Regarding claim 15, Hewitt discloses a 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 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 and not distally from the distal edge of the marker band (see annotated Fig. 1 below).
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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]); and
a reinforcing braid (20 – Fig.1) extending within the outer polymeric sheath (Fig.1, Fig.3C); and
a marker band (51 – Fig.2) disposed between the inner polymeric layer and the outer polymeric sheath (“disposed over the braid and under the outer jacket” – Para [0051]);
wherein the reinforcing braid includes a plurality of wire ends that extend beyond the marker band (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).
The limitations, “defining a lumen adapted to accommodate the implant therein” 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 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).
Regarding claim 18, Hewitt discloses a medical device as recited above, wherein the plurality of wire ends (the ends of the wire is not further defined, the examiner interprets the wire ends to be the portion of the braid where the wire ends terminate) extend distally from the marker band (see annotated 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 outwardly and not distally from the marker band (see annotated Fig.1 above).
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 1-8 and 12 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 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).
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 2, Hewitt, as modified, discloses a medical device as recited above, 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]) and the rigid member is disposed within the distal region of the elongate shaft (Fig.2).
Regarding claim 3, Hewitt, as modified, discloses a medical device as recited above, wherein the plurality of wire ends (the ends of the wire is not further defined, the examiner interprets the wire ends to be the portion of the braid where the wire ends terminate) extend distally from the distal edge of the rigid member (see annotated 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, the wire ends extend at an angle away from the central longitudinal axis) from the distal edge of the rigid member (Fig.2, Fig.9B).
Regarding claim 5, Hewitt, as modified, discloses a medical device as recited above, 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).
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 7, Hewitt, as modified, discloses a medical 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 rigid member (Fig.2, Fig.9B).
Regarding claim 8, Hewitt, as modified, discloses a medical device as recited above, wherein the plurality of wire ends that extend radially outwardly from the distal edge of the rigid member 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).
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]).
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
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
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783