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 amendments filed on 02/18/2026 have been entered. Claims 1-9 and 11-21 remain pending in the application.
Response to Arguments
Applicant’s arguments, see page 8, filed 02/18/2026, with respect to the rejection(s) of claim(s) 1 and 18 under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in further view of Bagaoisan to teach the newly recited limitations regarding the pyramid point shape of the tissue grasping member.
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.
Claim(s) 1-6, 18 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Satake et al. (US 2008/0255427) in view of Bagaoisan et al. (US 2014/0243862).
Regarding claim 1, Satake et al. discloses a tissue closure device (A, FIGs 1-4, [0060-0083]) comprising: a bushing (4) having a distal end (as shown in FIG 1), a proximal end (End attached to operator main body 20), and a lumen extending therethrough (See lumen in cross section of FIG 1 and 3-5); a clip (12, 13, FIG 2) including at least a first arm and a second arm (See two arms in FIGs 1-5), wherein a proximal end region of the clip (13b, FIG 2) is configured to be coupled to the distal end of the bushing (13b is received within the distal end of 4, [0085]); a control wire (5) having a proximal end (attached to slider 22, FIG 1) and a distal end (attached to 18, FIG 1), the control wire configured to extend through the lumen of the bushing (FIG 1 and 3-5 show control wire 5 extending through the lumen of 4); and a helical member (53, FIG 12, [0097]. [0090] discloses that retracting portion 51 can be substituted for suction tube 14 of FIG 1 and attached to the operational wire in the same manner) configured to be coupled to the distal end of the control wire ([0090], connection plate 18 is understood to attach to 52a, thereby coupling the helical member to the control wire); wherein the control wire is configured to advance the helical member in a distal direction along a longitudinal axis of the tissue closure device, and retract the helical member in a proximal direction along the longitudinal axis of the tissue closure device (Because slider 22 can be used to advance and retract control wire 5 [0060], and the helical member is constrained to the distal end of the control wire); and wherein at least one of the first arm and the second arm includes a tissue grasping member (The angled distal tips of the arms are interpreted as tissue grasping members, best shown in FIG 17. See FIGs 3-5 where these hooked/angled tips are used to grasp the tissue T1). Satake et al. further discloses a desire for repeated grasping and re-rasping of the tissue by the clip arms with minimized damage to the tissue ([0081]), thus showing that the tissue grasping members are intended to retain but not puncture tissue.
Satake et al. is silent regarding the tissue grasping member having a pyramid point.
However, Bagaoisan teaches a clip (100) having tissue grasping members (114, FIG 2) in the shape of pyramids (0066]) among other surface projection shapes which are configured to enable effective securement of a tissue without trauma to the tissue ([0006 and 0071] disclose that except for the intended puncture member, other surfaces which grasp tissue are atraumatic and are not intended to lacerate tissue).
Therefore, it would have been obvious to one of ordinary skill int eh art at the time of filing to modify the triangular shape of the tissue grasping member of Satake et al. to be pyramid shaped and have a pyramid point, as taught by Bagaoisan, for the purpose of substituting one commonly known tissue grasping shape for another and thereby achieving the predictable result of releasably grasping the tissue without causing undesired damage to the tissue in the event of repeat grasping. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976).
Regarding claim 2, Satake et al./ Bagaoisan disclose the invention substantially as claimed, as set forth above for claim 1. Satake further discloses the tissue grasping member is a hook (FIGs 1-5, the angled tips are interpreted as hooks).
Regarding claim 3, Satake et al./ Bagaoisan disclose the invention substantially as claimed, as set forth above for claim 1. Satake further discloses the helical member is coupled to the control wire via a cam member (52 is the cam member, FIG 12).
Regarding claim 4, Satake et al./ Bagaoisan disclose the invention substantially as claimed, as set forth above for claim 3. Satake further discloses when the control wire is retracted in the proximal direction (As is shown in the movement from FIGs 1 and 3-5), the cam member engages with a proximal end of the first arm and a proximal end of the second arm (As 5 is retracted, the cam member is also retracted. See change of positioning between FIGs 1 and 3, where 17 is equivalent to cam member 52. In the movement between FIG 1 and 3, the cam member is moved into contact with the abutment between 13a, and 13b, wherein 13b is interpreted as a proximal end of the arms), thereby causing the first arm and the second arm to move toward one another to a closed position (As 5 continues to be retracted, this abutment between the cam member 17/52 conveys the retracting force such that 13/12 is also pulled proximally. As 13/12 is pulled proximally, the clip arms move towards one another to the closed position, see FIGs 3-5, [0074-0075]).
Regarding claim 5, Satake et al./ Bagaoisan disclose the invention substantially as claimed, as set forth above for claim 4. Satake further discloses when the control wire is retracted proximally the cam member is positioned within a proximal end of the clip thereby locking the first arm and the second arm in the closed position (FIG 5 shows cam member 17/52 is positioned within proximal end 13a of the clip. Continuous application of tension in this position locks the arms in the closed position because they cannot open until this proximal retraction force is released).
Regarding claim 6, Satake et al./ Bagaoisan disclose the invention substantially as claimed, as set forth above for claim 1. Satake further discloses the proximal end of the control wire is coupled to a handle (FIG 1, the proximal end of control wire 5 is coupled to slider 22 and therefore to the main handle body 20).
Regarding claim 18, Satake et al. discloses a tissue clip (11, FIG 1, particularly the embodiment where 14 is replaced by 51 of FIG 12, [0090, 0097]) comprising: a bushing (13) having a distal end (13a), a proximal end (13b); a first arm (One of arms 12) including a first tissue grasping member (The angled distal tips of the arms are interpreted as tissue grasping members, best shown in FIG 17. See FIGs 3-5 where these hooked/angled tips are used to grasp the tissue T1) positioned adjacent to a distal end of the first arm (FIG 2), wherein a proximal end of the first arm coupled to the distal end of the bushing (See FIG 2 where the proximal ends of the arms are coupled to 13a); a second arm (another of arms 12), including a second tissue grasping member (The angled distal tips of the arms are interpreted as tissue grasping members, best shown in FIG 17. See FIGs 3-5 where these hooked/angled tips are used to grasp the tissue T1) positioned adjacent to a distal end of the second arm (FIG 2), wherein a proximal end of the second arm coupled to the distal end of the bushing (See FIG 2 where the proximal ends of the arms are coupled to 13a); and a helical member (53, FIG 12, [0097]. [0090] discloses that retracting portion 51 can be substituted for suction tube 14 of FIG 1 and attached to the operational wire in the same manner) configured to be positioned between the first arm and the second arm (As shown in the positioned of FIG 1 and 3-5 where 14 is replaced with 51 having the helical member 53), wherein the helical member is configured to advance distally along a longitudinal axis of the tissue clip (Because slider 22 can be used to advance and retract control wire 5 [0060], and the helical member is constrained to the distal end of the control wire); and wherein the tissue clip is configured to move from a first, closed position (FIG 5) to a second, open position (FIG 1, proximal pavement of 22 results in movement of the clip form the open to closed configuration and distal advancement of slider 22 would result in movement of the clip from the closed to the open configurations). Satake et al. further discloses a desire for repeated grasping and re-rasping of the tissue by the clip arms with minimized damage to the tissue ([0081]), thus showing that the tissue grasping members are intended to retain but not puncture tissue.
Satake et al. is silent regarding at least one of the first tissue grasping member and the second tissue grasping member including a pyramid point.
However, Bagaoisan teaches a clip (100) having tissue grasping members (114, FIG 2) in the shape of pyramids (0066]) among other surface projection shapes which are configured to enable effective securement of a tissue without trauma to the tissue ([0006 and 0071] disclose that except for the intended puncture member, other surfaces which grasp tissue are atraumatic and are not intended to lacerate tissue).
Therefore, it would have been obvious to one of ordinary skill int eh art at the time of filing to modify the triangular shape of the at least the first or second tissue grasping member of Satake et al. to be pyramid shaped and have a pyramid point, as taught by Bagaoisan, for the purpose of substituting one commonly known tissue grasping shape for another and thereby achieving the predictable result of releasably grasping the tissue without causing undesired damage to the tissue in the event of repeat grasping. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976).
Regarding claim 20, Satake et al./ Bagaoisan disclose the invention substantially as claimed, as set forth above for claim 18. Satake further discloses one of the first tissue grasping member or the second tissue grasping member includes a hook (FIGs 1-5, the angled tips are interpreted as hooks).
Regarding claim 21, Satake et al./ Bagaoisan disclose the invention substantially as claimed, as set forth above for claim 4. Satake further discloses when the control wire is retracted proximally (“when” is interpreted as an optional step and therefore the following limitations are understood to be not necessarily required by the claim. Examiner suggests amending language to recite “where the device is congifured such that when the control wire is retracted proximally” or similar) the cam member abuts a first tab on the proximal end of the first arm and a second tab on the proximal end of the second arm to cause the cam member to apply a compressive force to the tabs, the compressive force causing radially inward movement of the distal ends of the first and second arms towards one another to the closed position.
Claim(s) 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Satake et al. (US 2008/0255427) in view of Bagaoisan et al. (US 2014/0243862), further in view of Suzuki (US 2005/0033312).
Regarding claims 7 and 19, Satake et al./ Bagaoisan discloses the invention substantially as claimed, as set forth above for claims 1 and 18.
Satake is silent regarding when the clip is in an open position, a proximal end of the first arm and a proximal end of the second arm engage with one another to control an opening angle.
However, Suzuki teaches a tissue closure device (1, Fig 1-2) having a clip (10) with a first and second arm (21 and 22) and a tissue engagement member (7 and 13, [0033-0034]) slidably disposed between the clip arms (FIG 2, 4, and 7-11; comparable in function to the helical member of the claimed invention), wherein when the clip is in an open position (FIG 2 and 4), a proximal end of the first arm and a proximal end of the second arm engage with one another to control an opening angle (Due to the pivotal connection of the first and second arms, there is an abutment of the proximal ends of the arms, which physically restricts the arms for extending open past a certain angle).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the clip to be two separate arms which are pivotally attached, as taught by Suzuki, instead of being integrally formed/cut from the same piece as taught in Satake, for the purpose of substituting one commonly known jaw arrangement for another while achieving the predictable result of reliably opening and closing the clip jaws on a target tissue. This modification to the jaws maintains the lumen passing therethrough, as demonstrated in FIG 4 of Suzuki, therefore it would not alter or prohibit the intended function and design of the device of Satake. Further, in the device as modified, the proximal ends of the jaws engage one another in the open position to define an opening angle.
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771