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 under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the clip unit configured to be separable from the sheath by moving the wire in a proximal direction must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
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.
Claims 43-47, 49, 51-53, 56-61, 63-67 are rejected under 35 U.S.C. 103 as being unpatentable over Uesaka et al (US 2019/0133598 A1) in view of Mueller (US 2012/0179151 A1).
Regarding claim 43, Uesaka discloses a clip device, comprising: a sheath 1 including: a first tube 7, a bendable tube 5 (para. [0033]) located at a distal end of the first tube (i.e., tube 5 can extend distally from 7), and a second tube 50 located at a distal end of the bendable tube (Fig. 5); and a clip unit 100 connected to the sheath (Fig. 2) and including: an arm member 2, and a holder 3 having a channel into which at least a portion of the arm member is insertable (Fig. 2); and a wire 6 configured to operate the arm member, wherein: the bendable tube is more flexible than the first tube (i.e., at least because when inserted through the first tube, the first tube overlapping makes it less flexible than 5 extending distally out of 7) and the second tube (i.e., 50 is rigid), the first tube overlaps the bendable tube (Fig. 1) and the second is joined to the bendable tube (para. [0034]), and the clip unit is configured to be separable from the sheath by moving the wire in a proximal direction (Fig. 6; clip member is capable of being separable when the wire is moved proximally).
Uesaka doesn’t disclose that the first tube is fixed to the bendable tube or the second tube overlaps the bendable tube.
In the same field of endeavor, namely ferrofluidic locks, Mueller discloses a similar device to Mueller including a clip delivery device (Fig. 1), comprising: a sheath 20 including: a first tube 24, a bendable tube 28 located at a distal end of the first tube (Fig. 2), and a second tube 22a located at a distal end of the bendable tube (Fig. 2) and a clip unit 16 wherein: the bendable tube is more flexible than the first tube and the second tube (i.e., as shown in Fig. 4), each of the first tube and the second tube overlaps the bendable tube and is fixed to the bendable tube (para. [0032] discloses a reduced diameter coupling the flexible portion 28 between the end effector support tube 22a and the outer tubular member 24 (Fig. 2) such that the first and second tube at least partially overlap the bendable tube).
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 device of Uesaka to have the first and second tubes overlapping the bendable tube and fixed to the bendable tube for purposes of allowing the end effector to articulate while still maintaining strength of the device to navigate through the body (para. [0023]).
Regarding claim 44, Uesaka and Mueller disclose the clip delivery device according to claim 43. Mueller also discloses wherein the bendable tube is fixed to the first tube to maintain a position of the bendable tube relative to the first tube in a longitudinal direction of the bendable tube (para. [0032]; see also Fig. 1).
Regarding claim 45, Uesaka and Mueller disclose the clip device according to claim 43. Uesaka also discloses wherein the holder is detachably engaged with the sheath (Fig. 2).
Regarding claim 46, Uesaka and Mueller disclose the clip device according to claim 43. Uesaka also discloses wherein the holder is in detachable abutment with the sheath (Fig. 2; para. [0052]).
Regarding claim 47, Uesaka and Mueller disclose the clip device according to claim 43. Uesaka also discloses wherein the holder is detachably connected to the second tube (Fig. 2).
Regarding claim 49, Uesaka and Mueller disclose the clip device according to claim 43. Uesaka also discloses wherein the bendable tube is longer than the first tube (Fig. 2), and the first tube is longer than the second tube (Fig. 2).
Regarding claim 51, Uesaka and Mueller disclose the clip device according to claim 43. Uesaka also discloses further comprising a connector 62 located at the distal end of the wire (Fig. 2), wherein the connector is configured to be connected to the arm member (Fig. 2), and wherein, when the arm member is opened, the connector is located distally relative to the bendable tube and is located in the second tube (Fig. 2).
Regarding claim 52, Uesaka and Mueller disclose the clip device according to claim 43. Uesaka also discloses further comprising a handle 8 connected to the sheath and the wire (Fig. 2), wherein the bendable tube is connected to the handle (Fig. 2).
Regarding claim 53, Uesaka discloses a clip device, comprising: a sheath 1 including: a first portion 7, a bendable portion 5 (para. [0033]) located at a distal end of the first portion (i.e., tube 5 can extend distally from 7), and a second portion 50 located at a distal end of the bendable portion (Fig. 2); and a clip unit 100 connected to the second portion (Fig. 2) and including: an arm member 2, and a holder 3 having a channel into which at least a portion of the arm member is insertable (Fig. 2); and a wire 6 configured to operate the arm member (para. [0036]-[0037]), wherein: the bendable portion is more flexible than the first portion and the second portion (para. [0033]; i.e., at least by way of being a single layer with regard to 7 such that it extends distally), and the first portion comprises a bendable tube 5 and a first tube 7 covering the bendable tube, the bendable portion is the bendable tube, the second portion comprises the bendable tube and a second tube (para. [0034]), and the clip unit is configured to be separable from the sheath by moving the wire in a proximal direction (Fig. 6).
Uesaka discloses that the coil sheath 5 includes a sheath distal end member 50 and that they are joined, but not that the second tube (sheath distal end member 50) covers the bendable tube (coil sheath 5).
In the same field of endeavor, namely ferrofluidic locks, Mueller discloses a similar device to Mueller including a clip delivery device (Fig. 1), comprising: a sheath 20 including: a first portion 24, a bendable portion 28 located at a distal end of the first tube (Fig. 2), and a second portion 22a located at a distal end of the bendable tube (Fig. 2) and a clip unit 16.
Mueller also discloses the first portion comprises a bendable tube (i.e, portion of 28) and a first tube 24 covering the bendable tube (i.e., para. [0032]), the bendable portion is the bendable tube, and the second portion comprises the bendable tube and a second tube covering the bendable tube (para. [0032]).
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 device of Uesaka to have the second tube covering the bendable tube for purposes of allowing the end effector to articulate while still maintaining strength of the device to navigate through the body (para. [0023]).
Regarding claim 56, Uesaka and Mueller disclose the clip device according to claim 53. Uesaka also discloses further comprising a handle 8 connected to the sheath and the wire (Fig. 2), wherein the bendable tube is connected to the handle (Fig. 2).
Regarding claim 57, Uesaka and Mueller disclose the clip device according to claim 53. Uesaka also discloses wherein the bendable tube is formed by a coil (para. [0030]).
Regarding claim 58, Uesaka discloses a clip device (Fig. 2), comprising: a clip unit 100 including: an arm member 2, and a holder 3 having a channel into which at least a portion of the arm member is insertable (Fig. 2); a wire 6 configured to operate the arm member (paras. [0036]-[0037]); a sheath 1 through which the wire is inserted (Fig. 2); and a handle connected to the sheath (Fig. 2), wherein the clip unit is configured to be separable from the sheath by moving the wire in a proximal direction (i.e., as shown in Fig. 6), wherein the sheath includes: a first portion 7,5, a second portion 50 located distal to the first portion (i.e., Fig. 2), and a bendable portion 5 located between the first portion and the second portion (Fig. 2), wherein the first portion is covered by a first tube 7, and wherein the bendable portion is more flexible than the first portion and the second portion (para. [0033]).
Uesaka doesn’t directly disclose wherein the second portion is covered by a second tube.
In the same field of endeavor, Mueller discloses a clip delivery device (Fig. 1), comprising: a clip unit 16 including an arm member 30, 32; a wire 60 configured to operate the arm member (para. [0029]); a sheath 18 through which the wire is inserted (Figs. 1-4; para. [0023]); and a handle 46 connected to the sheath (Fig. 1), wherein the sheath includes: a first portion 20, a second portion (i.e., at 22) located distal to the first portion (Fig. 2), and a bendable portion 28 located between the first portion and the second portion (Fig. 2), wherein the first portion is covered by a first tube 24 (para. [0023]), wherein the second portion is covered by a second tube 22a (i.e., note also that alternatively the bendable piece 28 that is covered by 22a may be interpreted as the second portion), and wherein the bendable portion is more flexible than the first portion and the second portion (Fig. 4).
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 device of Uesaka to have the second portion is covered by a second tube for purposes of allowing the end effector to articulate while still maintaining strength of the device to navigate through the body (para. [0023]).
Regarding claim 59, Uesaka and Mueller disclose the clip device according to claim 58. Uesaka also discloses wherein the holder is detachably engaged with the sheath (Figs. 5-6).
Regarding claim 60, Uesaka and Mueller disclose the clip device according to claim 58. Uesaka also discloses wherein the holder is in detachable abutment with the sheath (Figs. 5-6).
Regarding claim 61, Uesaka and Mueller disclose the clip device according to claim 58. Uesaka also discloses wherein the holder is detachably connected to the second portion (Figs. 5-6).
Regarding claim 63, Uesaka and Mueller disclose the clip device according to claim 43. Uesaka also discloses further comprising a connector 92 connecting the wire to the arm member (Fig. 6), wherein, when the arm member is closed, a distal end of the connector is located proximally relative to a distal end of the second tube (Fig. 3), and wherein, when the arm member is opened, the distal end of the connector is located distally relative to the distal end of the second tube (i.e., for example as shown in Fig. 2).
Regarding claim 64, Uesaka and Mueller disclose the clip device according to claim 43. Uesaka also discloses wherein the sheath and the clip unit are configured to be insertable into a channel of an endoscope (para. [0003]).
Regarding claim 65, Uesaka and Mueller disclose the clip device according to claim 43. Uesaka also discloses in a longitudinal direction of the sheath, a length of a first overlapping region between the first tube and the bendable tube is greater than a length of a second overlapping region between the second tube and the bendable tube (Fig. 2).
Regarding claim 66, Uesaka and Mueller disclose the clip device according to claim 53. Uesaka also discloses a connector 92 connecting the wire to the arm member (Fig. 6), wherein, when the arm member is closed, a distal end of the connector is located proximally relative to a distal end of the second portion (Fig. 3), and wherein, when the arm member is opened, the distal end of the connector is located distally relative to the distal end of the second portion (i.e., for example as shown in Fig. 2).
Regarding claim 67, Uesaka and Mueller disclose the clip device according to claim 58. Uesaka also discloses a connector 92 connecting the wire to the arm member (Fig. 6), wherein, when the arm member is closed, a distal end of the connector is located proximally relative to a distal end of the second portion (Fig. 3), and wherein, when the arm member is opened, the distal end of the connector is located distally relative to the distal end of the second portion (i.e., for example as shown in Fig. 2).
Response to Arguments
Applicant’s arguments with respect to claim(s) 43, 53, 58 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 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 RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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