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 .
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 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.
Response to Amendment
The Response filed July 6, 2026 has been entered. Claims 36-50 are pending in the application. The previous objections to the claims are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 15, 2026 was filed after the mailing date of the non-final Office Action on April 15, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Terminal Disclaimer
The terminal disclaimer filed on July 6, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 12178445 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 36, 38, 40-42, 44-47, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Baur et al. (U.S. Patent Application Publication No. 20110208210; hereinafter “Baur”) in view of Ouchi (U.S. Patent No. 5897487).
Regarding claim 36, Baur discloses a method for treating tissue, comprising:
inserting a clip (4) to a target area in a body lumen via an endoscope (2) in an insertion configuration in which the clip is mounted over a distal end of the endoscope via a cap (3), a proximal portion of the cap extending over the distal end of the endoscope and a distal portion of the cap extending distally of the distal end of the endoscope (Fig. 2), the clip mounted over the proximal portion of the cap so that first and second jaws of the clip are separated from one another, in the insertion configuration (Fig. 2);
applying a force through the endoscope so that tissue is drawn into a channel of the cap and between the jaws of the clip (para. [0057]);
moving a deployment element (11) releasably coupled to the clip proximally relative to the endoscope so that the clip so that the clip is moved distally along the cap to a review configuration in which the clip extends over the distal portion of the cap such that at least a part of the clip is in a field of view of the endoscope (e.g., while clip (4) has advanced but is still held by tab (9); para. [0057]);
determining, when the clip is in the review configuration, whether the clip is in a desired position relative to a target tissue (para. [0057]); and
moving, when it is determined that the clip is in the desired position relative to the target tissue, the deployment element further proximally relative to the endoscope to move the clip distally off of the cap to a deployed configuration in which the clip closes under a natural bias of the clip with the jaws drawn toward one another to grip the tissue therebetween (para. [0057]).
The method of Baur discloses the invention substantially as claimed, except for the cap being transparent.
Ouchi, a reference in the endoscopic ligation device field of endeavor, teaches configuring a cap to be transparent cap to provide excellent observation image of tissue to be treated (col. 6, ln. 34 – col. 7, ln. 19).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the cap to be a transparent cap, as taught by Ouchi, in order to improve visualization of tissue to be treated for more effective positioning of the clip to treat the tissue.
Regarding claim 38, Bauer discloses wherein the deployment element is releasably coupled to the clip via a distal portion of the deployment element looped about and crimped to the first jaw of the clip (Fig. 2) such that when the clip is moved distally off the cap in the deployed configuration, the distal portion of the deployment element is released from the first jaw to release the clip (Figs. 2-5; para. [0057])).
Regarding claim 40, Bauer discloses wherein in the review configuration the clip engages a first protrusion (9) extending from an exterior surface of the cap providing tactile feedback to a user indicating that the clip is in the review configuration (Figs. 2-5; para. [0056])).
Regarding claim 41, Bauer discloses wherein a biasing element (11) extending between a distal end of the cap and a stop at the distal end of the endoscope on which the cap is mounted (Fig. 2; para. [0056]), moving the clip toward the insertion configuration via the biasing element, and adjusting the position of the cap such that an entirety of the clip mounted over the cap is proximal to the distal-most end of the endoscope (Figs. 2-5; paras. [0056]-[0057]).
Regarding claim 42, Bauer discloses wherein the deployment element extends through a working channel of the endoscope between a proximal end accessible to a user and a distal portion extending out of the working channel, through the cap to a distal end releasably coupled to the clip (Figs. 2-5).
Regarding claim 44, Bauer discloses wherein the tissue is drawn into the channel of the cap and between the jaws of the clip by a suction force (para. [0057]).
Regarding claim 45, Bauer disclose wherein tissue is drawn into the channel of the cap and between the jaws of the clip via a grasping device inserted through a working channel of the endoscope (para. [0057]).
Regarding claim 46, Baur discloses wherein in the review configuration a distal most portion of the clip extends distally beyond a distal end of the cap (e.g., as clip (4) has advanced but is still held by tab (9); para. [0057]).
Regarding claim 47, Bauer discloses wherein the proximal end of the deployment element is coupled to a first actuator (paras. [0055]-[0059]).
Regarding claim 49, Bauer discloses wherein a second protrusion (9) positioned on the cap so that in the review configuration the clip engages the second protrusion (Figs. 2-5).
Allowable Subject Matter
Claim 37 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 37, the prior art does not show by itself or in combination, the limitation “moving a repositioning element releasably coupled to the clip proximally relative to the endoscope so that the clip is moved proximally relative to the cap from the review configuration to the insertion configuration,” as recited with all the limitations of the claim.
Claims 39, 43, 48, and 50 would be allowable as being dependent upon allowable claim 37.
Response to Arguments
The previous double patenting rejections of claims 36-50 are withdrawn in light of the terminal disclaimer filed July 6, 2026.
Applicant's arguments concerning rejections of claims 36, 38, 40-42, 44-47, and 49 filed July 6, 2026 have been fully considered but they are not persuasive.
On pages 6-8, Applicant argues that Baur does not disclose “moving a deployment element releasably coupled to the clip proximally relative to the endoscope so that the clip is moved distally along the cap to a review configuration” and “moving, when it is determined that the clip is in the desired position relative to the target tissue, the deployment element further proximally relative to the endoscope to move the clip distally off of the cap to a deployed configuration,” as recited in claim 36 (Response pg. 8). This argument is not persuasive.
Paragraph [0057] of Baur discloses that thread (11) is releasably coupled to clip (4) which is held in place on endoscope sleeve (3; Fig. 2) for insertion into a patient (para. [0057]; “the expanding sleeve 3 is pressed against the organ wall”).
When a user determines that clip (4) is to be deployed (para. [0057]; “If the dip 4 now is to be stripped off”), thread (11) is moved to advance clip (4) along tab (9; para. [0057] “thread 11 . . . exerts a force in axial direction on the clip 4 . . . thereby the clip 4 being displaced in the direction of the distal end of the endoscope cap 1”).
Notably, Baur does not state that determining whether the clip is to be stripped off stops once the thread begins to be pulled.
Thus, the clip is in a review configuration while the clip is advanced but still held by the tab.
Therefore, Baur discloses moving a deployment element releasably coupled to the clip proximally relative to the endoscope so that the clip is moved distally along the cap to a review configuration.
Baur further discloses that once clip (4) is no longer held by tab (9), the clip is deployed to pinch tissue (para. [0057]; “As soon as the rear edge of the clip 4 . . . can no longer be held by the tab 9, the biasing force stored in the clip 4 causes the clip 4 to come off the expanding sleeve 3, thereby the organ wall being pinched off in the area directly ahead of the expanding sleeve 3.”).
Again, Baur does not state that determining whether the clip is to be stripped off stops once the thread begins to be pulled.
Therefore, Baur discloses moving, when it is determined that the clip is in the desired position relative to the target tissue, the deployment element further proximally relative to the endoscope to move the clip distally off of the cap to a deployed configuration.
Applicant’s argument that Baur does not disclose the thread being “pulled more than once” (Response pg. 7) is not persuasive because such feature is not recited in the rejected claim(s).
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
For the reasons above, Examiner maintains that the invention of claim 36 is not allowable over the prior art of record.
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 Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
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