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 9, 2025 has been entered. Claims 1, 3, and 5-22 are pending in the application. The previous objections to the claims and rejections of claims under 35 U.S.C. 112(b) are withdrawn in light of Applicant’s amendments to the claims.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.
Claim Objections
Claim 19 is objected to because of the following informalities:
In claim 19, a period should be inserted at the end of the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation “the mucous membrane” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitations “the third portion,” “the fourth portion,” and “the second type-implant” in lines 3-4. There is insufficient antecedent basis for each of these limitations in the claim.
Claim 9 recites the limitation “the second-type indwelling member” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation “the mucous membrane” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 1, 3, 5-7, 9-12, and 14-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryan et al. (U.S. Patent Application Publication No. 20200093496; hereinafter “Ryan”).
Regarding claim 1, Ryan discloses an endoscopic suturing method (figs. 13-16; para. [0050]), comprising:
penetrating an implant into a first portion of a mucosa (e.g., piercing with spikes (128) into first edge (12); Fig. 13; para. [0050]);
with the implant penetrated into the first portion of the mucosa, penetrating the implant into a second portion of the mucosa (e.g., piercing spikes (128) into second edge (14); Fig. 14; para. [0050]);
with the implant penetrated into the first portion of the mucosa and the second portion of the mucosa, bringing the first portion of the mucosa and the second portion of the mucosa closer together (e.g., dragging first edge (12) towards second edge (14); Fig. 13; para. [0050]), wherein a gap is present in a longitudinal direction of the implant between the first portion of the mucosa and the second portion of the mucosa (a gap exists along a longitudinal axis of clip (102) between first edge (12) and second edge (14) while clip arms (110, 112) are attached to the edges and moved from the opened position to a the closed position; para. [0050]; Figs. 14-15); and
leaving the implant in a body in a state in which the implant penetrates the first portion of the mucosa and the second portion of the mucosa (Fig. 15; para. [0050]).
Regarding claim 3, Ryan discloses wherein:
in a suturing direction (e.g., direction across defect (10) between the first and second edges; Fig. 13), the first portion of the mucosa and the second portion of the mucosa face each other across a defective portion (10) of the mucosa (Fig. 13), and
a width between the first portion of the mucosa and the second portion of the mucosa is a largest width in the suturing direction of the defective portion (Figs. 13-15 each show a width being a largest width in the suturing direction).
Regarding claim 5, Ryan discloses the method further comprising:
pressing the implant against the first portion of the mucosa before penetrating the implant into the first portion of the mucosa (e.g., clip arm (110) presses against first edge (12) just before spikes (128) pierce the first edge; Fig. 13; para. [0050]).
Regarding claim 6, Ryan discloses the method further comprising:
pressing the implant against the second portion of the mucosa before penetrating the implant into the second portion of the mucosa (e.g., clip arm (112) presses against second edge (14) just before spikes (128) pierce the first edge; Fig. 13; para. [0050]).
Regarding claim 7, Ryan discloses wherein the implant is a first-type implant (clip assembly (102); Figs. 1-4), and
wherein the method further comprises:
penetrating a second first-type implant (102) through a third portion of the mucosa and a fourth portion of the mucosa (e.g., other portions of first edge (12) and second edge (14); Fig. 16; para. [0050]), and
indwelling the second first-type implant (Fig. 16; para. [0050]) when a distance in the suturing direction between the third portion of the mucous membrane and the fourth portion of the mucosa is equal to or longer than a length that can be sutured by a second-type implant (e.g., placing a second clip assembly (102) at a position along defect (10) that can be sutured by a different type of clip, such as those depicted in Figs. 5-12),
wherein the third portion is a part of the first portion (e.g., a portion of the first edge (12)), and the fourth portion is a part of the second portion of the mucosa (e.g., a portion of the second edge (14)), and
wherein the third portion of the mucosa and the fourth portion of the mucosa face each other in the suturing direction (e.g., the second clip assembly (102) draws together portions of the first and second edges that face each other; Fig. 16).
Regarding claim 9, Ryan discloses the method including wherein a second-type indwelling member (additional clip (102); para. [0050]) is a clip (102).
Regarding claim 10, Ryan discloses the method further comprising:
before penetrating the implant into the first portion of the mucous membrane, holding portions of the mucosa around the first portion of the mucosa (e.g., when multiple clip assemblies (102) are applied, a previously applied clip assembly holds portions of the mucous membrane around the first portion when the next clip assembly is applied; Fig. 16; para. [0050]).
Regarding claim 11, Ryan discloses the method further comprising:
before penetrating the implant into the second portion of the mucosa, holding portions of the mucosa around the second portion of the mucosa (e.g., when multiple clip assemblies (102) are applied, a previously applied clip assembly holds portions of the mucous membrane around the second portion when the next clip assembly is applied; Fig. 16; para. [0050]).
Regarding claim 12, Ryan discloses the method further comprising:
after penetrating the implant through the first portion of the mucosa, removing the implant from the first portion, and penetrating the implant through another portion of the mucosa (e.g., after reopening the clip arms; para. [0050]).
Regarding claim 14, Ryan discloses the method further comprising:
during penetrating the implant into the first portion of the mucosa, regulating an amount of puncture of the implant into the first portion of the mucosa (e.g., by the amount the clip arms are opened or closed; para. [0050]).
Regarding claim 15, Ryan discloses the method further comprising:
during penetrating the implant into the second portion of the mucosa, regulating an amount of puncture of the implant into the second portion of the mucosa (e.g., by the amount the clip arms are opened or closed; para. [0050]).
Regarding claim 16, Ryan discloses wherein, in the state in which the implant penetrates the first portion of the mucosa and the second portion of the mucosa, the method further comprises:
removing at least a first part of the implant while a second part of the implant continues to penetrate the first portion of the mucosa and the second portion of the mucosa ( e.g., after dragging the edges together; para. [0050]).
Regarding claim 17, Ryan discloses wherein moving the implant toward a second portion of the mucosa while pushing the first portion of the mucosa includes moving the first portion of the mucosa toward the second portion of the mucosa (Fig. 13; para. [0050]).
Regarding claim 18, Ryan discloses wherein leaving the implant in the body includes leaving the implant disposed under the mucosa, between the first portion of the mucosa and the second portion of the mucosa (e.g., as spikes (128) pierce into the mucosa portions at the first and second edges, implant (102) is considered under the mucosa between the portions of the mucosa; para. [0050]).
Regarding claim 19, Ryan discloses wherein bringing the first portion of the mucosa and the second portion of the mucosa closer together by penetrating the implant into the first portion of the mucosa and the second portion of the mucosa forms the gap between the first portion and the second portion (e.g., .the gap between first edge (12) and second edge (14) is formed by clip (102) while clip arms (110, 112) are attached to the edges and re-closed; para. [0050]; Figs. 14-15).
Regarding claim 20, Ryan discloses the method further comprising:
with the implant penetrated into the first portion of the mucosa (e.g., spikes (128) penetrate the first portion (12); para. [0050]), moving the implant toward the second portion of the mucosa while pushing the first portion of the mucosa (first portion (12) is pushed toward the second portion of the mucosa while being dragged towards second edge (14); Fig. 13; para. [0050]),
and penetrating the implant into the second portion of the mucosa (e.g., spikes (128) pierce the second portion (14); para. [0050]).
Regarding claim 21, Ryan discloses wherein:
penetrating the implant into the first portion of the mucosa includes moving the implant in a direction approaching the mucosa (e.g., spikes (128) approach the mucosa in order to pierce first portion (12) of the mucosa; para. [0050]), and
penetrating the implant into the second portion of the mucosa includes moving the implant in a direction away from the mucosa (e.g., as one of clip arms (110, 112) is moved away from first edge (12) as clip (102) is opened to enable piercing second portion (14) of the mucosa).
Regarding claim 22, Ryan discloses the method further comprising:
fixing the mucosa by an auxiliary member (102) to place the mucosa in a fixed state (the first delivered clip (102) constitutes an auxiliary member fixing the mucosa for additional clip (102) placed to close the defect; Fig. 16; para. 0050]),
wherein penetrating the implant into the first portion of the mucosa occurs when the mucosa is in the fixed state (e.g., an additional clip (102) penetrates the first portion of the mucosa while the first delivered clip (102) fixes the mucosa; Fig. 16; para. [0050])), and
wherein the auxiliary member is provided on a device (104) for introducing the implant (first delivered clip (102) is provided on applicator (104) for delivery and additional clips (102) are provided on applicator (104); para. [0050]).
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 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan.
Regarding claim 8, Ryan disclose the invention substantially as claimed, except for suturing the third and fourth portions of mucosa using the second-type indwelling member. However, Ryan teaches that different types of clips (Figs. 5-12; paras. [0046]-[0049]) may be used to improve tissue retention during a procedure.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method further comprise suturing the third portion of the mucosa and the fourth portion of the mucosa using the second type implant, in order to improve tissue retention by the clip to close the defect.
Regarding claim 13, Ryan discloses the invention substantially as claimed except for pulling out the indwelling member from the second portion of the mucous membrane. However, Ryan discloses that a portion of the mucous membrane may be released when clip arms (110, 112) are reopened during a procedure (para. [0050]).
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 method to further comprise: after penetrating the implant into the second portion of the mucosa, pulling out the implant from the second portion of the mucosa and penetrating the implant through another portion of the mucosa, in order to reposition a clip assembly to an appropriate location to close the target defect during a procedure.
Response to Arguments
Applicant's arguments filed July 9, 2025 have been fully considered but they are not persuasive.
On pages 10-11 of the Response, Applicant argues that Ryan does not disclose “wherein a gap is present in a longitudinal direction of the implant between the first portion of the mucosa and the second portion of the mucosa,” as recited in claim 1. This argument is not persuasive.
Ryan discloses that clip (102) spans defect (10) in the mucosa while arms (110, 112) penetrate first (12) and second (14) portions of mucosa (Figs. 14-15; para. [0050]).
Thus, a gap exists along a longitudinal axis of clip (102) between first edge (12) and second edge (14) while clip arms (110, 112) are attached to the edges and re-closed. In other words, the gap between the tissue edges is present between the clip arms; thus, along the longitudinal axis of the clip.
Applicant’s further argument that the method of Ryan “necessarily results in the edges 12, 14 touching each other and NO GAP EXISTS between the first edge 12 and the second edge 14,” (Response pg. 11) is not persuasive. Assuming arguendo that Applicant’s interpretation of Fig. 15 of Ryan is accurate (Response pg. 11), Fig. 14 of Ryan shows clip (102) engaged with both first and second edges with a gap being present. As explained above, such gap is present between the arms of the clip while the clip moves the first and second edges toward each other.
Therefore, Ryan discloses “wherein a gap is present in a longitudinal direction of the implant between the first portion of the mucosa and the second portion of the mucosa,” as recited in claim 1.
On pages 12-13 of the Response, Applicant argues that the claimed invention is not obvious over the applied prior art because Ryan does not disclose all the limitations of claim 1. This argument is not persuasive for the reasons above.
For all the reasons above, Examiner maintains that the claimed invention is not allowable over the applied prior art.
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 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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/J.A.H/Jonathan HollmExaminer, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771