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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on July 30, 2025 and July 20, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1-15 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 1 recites the limitation “fixed to an edge portion thereof” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim because claim 1 is unclear as to what structure “thereof” refers to in the limitation. In other words, claim 1
is unclear as to what structure includes the claimed “edge portion.” Thus, claim 1 is indefinite. For examination purposes, claim 1 is interpreted as referring to an edge portion of the endoscope clip recited in the preamble.
Claims 2-15 are rejected as being dependent upon rejected claim 1 and failing to remedy the indefiniteness issue.
Claim 10 recites the limitation “the preset original shape angle” in line 3. There is insufficient antecedent basis for this limitation in the claim because there is no previous reference to a “preset original shape angle” in the claim, thus rendering the claim indefinite.
Claim 14 recites the limitation “the biopsy forceps of the endoscope” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim because there is no previous reference to a “biopsy forceps” in the claim, thus rendering the claim indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 1-2 and 5-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McLawhorn (U.S. Patent Application Publication No. 20100145362).
Regarding claim 1, McLawhorn discloses an endoscope clip (20; Fig. 1) using a shape memory alloy comprising:
a shape memory clip (45, 46, and/or 47) which is made of a shape memory alloy (para. 0023]), fixed to an edge portion thereof, and restored to its original shape at a preset shape change temperature (para. 0024]);
wherein the shape memory clip includes a coupling part and a pin part (49) that is bent at an end of the coupling part to be inserted and fixed into the edge portion (annotated Fig. 1 below).
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Regarding claim 2, McLawhorn discloses wherein the shape memory clip further includes a bending part bent at a preset shape change angle at both ends of the coupling part (annotated Fig. 1 above).
Regarding claim 5, McLawhorn discloses the clip further comprising a gripping part (22) that is gripped by an endoscope and to which the shape memory clip is fixed (Fig. 1; para. [0026]).
Regarding claim 6, McLawhorn discloses wherein the gripping part (22) includes a body in which a fixing groove (29) into which the shape memory clip is inserted and fixed is formed on one side surface thereof and a protrusion portion (50) formed on the other side surface of the body to be gripped by the endoscope (Figs. 1-2; paras. [0019], [0026]).
Regarding claim 7, McLawhorn discloses wherein the gripping part further includes an uneven portion (55) protruding at least one on an outer surface of the protrusion portion to prevent slipping when gripped by the endoscope (Fig. 2; para. [0037]).
Regarding claim 8, McLawhorn discloses wherein an adhesive is applied on one side surface of the body (para. [0019]), or the body is provided with a bioabsorbable material.
Regarding claim 9, McLawhorn discloses wherein the coupling part and a bending portion of the pin part is restored to the original shape from a preset shape change angle (Fig. 2) to a preset original shape angle (Fig. 1) at the preset shape change temperature (para. [0024]), and in the edge portion, fixed portions fixed into the pin part are pulled and narrowed together by restoring the original shape of the bending portion (e.g., to achieve the configuration with ends secured in recess (29); Fig. 1; para. [0023]).
Regarding claim 10, McLawhorn discloses wherein the coupling part and a bending portion of the bending part are restored to an original shape from the preset shape change angle (Fig. 2) to the preset original shape angle (Fig. 1) at the preset shape change temperature, and in the edge portion, fixed portions fixed into the pin part are pulled and narrowed together by restoring the original shape of the bending portion (e.g., to achieve the configuration with ends secured in recess (29); Fig. 1; para. [0023]).
Regarding claim 11, McLawhorn discloses the clip further comprising a cap (80) provided at a tip of the endoscope (Figs. 2-4), wherein the cap is open on both sides, one side thereof (portion containing slit (87)) is coupled to the tip of the endoscope (e.g., by being inserted into a working channel of the endoscope; Fig. 4), and an insertion groove (85) into which the shape memory clip may be inserted is formed on the other side thereof (Fig. 3).
Regarding claim 12, McLawhorn discloses wherein the shape memory clip has elasticity to be bent and inserted into the insertion groove (such as during retraction or loading of the clip device; para. [0048]).
Regarding claim 13, McLawhorn discloses wherein, in the cap (80), a fitting groove (87) into which the pin part of the shape memory clip is fitted and fixed is formed on an inner wall of the insertion groove (Figs. 2-3).
Regarding claim 14, McLawhorn discloses wherein the cap (80) has a coupling hole (87) formed on one side thereof so as to be coupled to the endoscope (e.g., by being inserted into a working channel of the endoscope; Fig. 4), and the coupling hole is formed eccentrically from a center of the cap so that the biopsy forceps of the endoscope is disposed closer to the center of the cap than an outer periphery of the cap (slit (87) is formed on the side of instrument (80) such that a biopsy forceps introduced through another channel of the endoscope is capable of being positioned closer to the center of the cap than an outer periphery of the cap).
Claim Rejections - 35 USC § 103
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 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over McLawhorn in view of Warner et al. (U.S. Patent No. 10226270; hereinafter “Warner”).
Regarding claim 3, the device of McLawhorn discloses the invention substantially as claimed, except for the shape memory clip bending part being bent in a point-symmetrical structure. However, McLawhorn teaches that the clip (45, 46, or 47) may have any shape suitable to engage, penetrate and/or abut tissue (para. [0020]).
Warner, a reference in the tissue fastener field of endeavor, teaches configuring a shape memory clip (2; Fig. 2A) to be bent in a point-symmetrical structure based on the coupling part at the both ends of the coupling part to form a "Z" shape (the “S” shape (col. 4, ll. 55-56) forms a “Z” shape when viewed from the perspective opposite that shown in Fig. 2A) to allow the clip to adjust to tissue movement and prevent the clip from disengaging tissue (col. 4, ll. 34-50).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the shape memory clip bending part to be bent in a point-symmetrical structure based on the coupling part at the both ends of the coupling part to form a "Z" shape, in view of Warner, in order to provide the clip with a suitable shape to engage tissue while also preventing undesired disengagement from the tissue.
Regarding claim 4, the modified device discloses wherein, in the shape memory clip, a pair of bending parts are formed to be bent vertically with respect to the coupling part on a plane parallel to a longitudinal direction of the coupling part, and the pin part is formed to protrude in a direction perpendicular to the plane from end portions of the pair of the bending parts (annotated Fig. 2A below).
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Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over McLawhorn in view of Suzuki et al. (U.S. Patent Application Publication No. 20150039008; hereinafter “Suzuki”).
Regarding claim 15, the device of McLawhorn is not explicitly disclosed with the preset shape change temperature being 40°C to 45°C.
Suzuki, a reference in the tissue fastener field of endeavor, teaches configuring adjusting the material composition of a shape memory clip (6; Figs. 5(a)-5(c)) to have a transition temperature of 40°C to allow the fastener to be malleable before implantation in tissue (para. [0033]).
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 shape memory clip material such that the preset shape change temperature is 40°C to 45°C, in view of Suzuki, in order to allow the clip to be easily deformed into its delivery configuration to facilitate delivery to tissue within a patient.
Conclusion
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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