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 17, 2026 has been entered. The previous rejections of claims under 35 U.S.C. 112(b) are withdrawn in light of Applicant’s amendments to the claims.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 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 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu (U.S. Patent No. 9510836).
Regarding claim 15, Zhu discloses a medical clip comprising:
an arm (11),
a tube (12) into which at least a part of the arm is inserted,
a sheath (combination of spring tube (311) and connecting head (312); Fig. 5) into which a proximal end of the tube is inserted,
a wire (321) inserted through the sheath,
a first connector (322) connecting the arm and the wire,
a second connector (313) connecting the tube and the sheath,
wherein when the first connector pushes the second connector proximally, the tube is removed from the sheath (col. 11, ln. 39 – col. 12, ln. 5),
the tube has a hole (123) on a side of the tube (Fig. 12a; col. 7, ll. 30-34),
the second connector engages with the tube when inserted into the hole (col. 7, ll. 28-34),
the second connector has an engaging portion (31310, 31320; Fig. 11) inserted into the hole and protruding outwardly from the hole (Fig. 6a),
the sheath has a distal tube (312) fixed to a distal end of the sheath,
the distal tube has a bent distal end portion (curved wall of connecting head (312) has a bent shape; Fig. 6a) having an inner surface (inner surface of hole (123); Fig. 12a), and
the engaging portion protruding outwardly from the hole engages with the inner surface (Fig. 6a; col. 7, ll. 30-34).
Regarding claim 16, Zhu discloses wherein when the first connector applies a force to the second connector in the proximal direction, the second connector deforms, and the second connector separates the tube and the sheath (col. 11, ll. 45-51).
Regarding claim 17, Zhu discloses wherein
the tube has a hole (123) at its proximal end (Fig. 12; col. 7, ll. 49-53),
the second connector includes the engaging portion (31310) insertable into the hole and a main body (3131) positioned inwardly of the engaging portion in the radial direction of the tube (Fig. 3), and
the engaging portion protruding outwardly from the hole in the radial direction engages with the inner surface (Fig. 6a).
Regarding claim 18, Zhu discloses wherein
when the first connector pushes the second connector proximally, an engagement between the engaging portion and the inner surface of the sheath is released, and the engaging portion is removed from the hole (col. 11, ln. 39 – col. 12, ln. 5), and
the engaging portion is removed from the hole while at least a part of the second connector is deformed (col. 11, ln. 39 – col. 12, ln. 5).
Regarding claim 19, Zhu discloses wherein
the first connector is movable relative to the sheath along with the wire in the longitudinal direction of the wire (col. 11, ll. 52-57), and
the first connector is movable relative to the second connector (col. 11, ll. 52-57).
Regarding claim 20, Zhu discloses
20. The medical clip according to claim 17, wherein
the first connector (322) includes a hook (3222) and a pushing surface (3224) positioned proximally of the hook (Fig. 10; col. 9, ll. 17-34),
the main body (3131) of the second connector has a receiving surface (3133) facing the pushing surface (Fig. 5), and
when the pushing surface pushes the receiving surface, the tube is removed from the sheath (col. 11, ln. 52 – col. 12, ln. 5).
Claim Rejections - 35 USC § 102/103
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 1-4, 6, and 21 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Zhu.
Regarding claim 1, Zhu discloses a medical clip comprising:
an arm (11),
a holder (12) supporting the arm,
a wire (321) operating the arm,
a sheath (311) through which the wire is inserted,
a first connector (322; Fig. 4) connecting the arm and the wire,
a second connector (313; Fig. 3) engaging both the sheath and the holder (Fig. 6a),
wherein
when the wire moves proximally relative to the sheath, the first connector disconnects the arm and the wire, the second connector is at least partially released from the sheath, and the second connector disconnects the sheath and the holder (col. 11, ln. 39 – col. 12, ln. 5),
the holder has a hole (123) on a side of the holder (Fig. 12a; col. 7, ll. 30-34),
the second connector engages with the holder when inserted into the hole (col. 7, ll. 28-34,
the second connector has an engaging portion (31310, 31320; Fig. 11) inserted into the hole and protruding outwardly from the hole (Fig. 6a),
the sheath has a distal tube (312) fixed to a distal end of the sheath,
the distal tube has a distal surface (inner surface of circular hole (3121); Figs. 2a and 6a),
the engaging portion protruding outwardly from the hole engages with the distal surface (Fig. 6a, col. 7, ll. 30-34).
The claim limitation of “a distal surface formed by bending a distal end portion of the distal tube” is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
Here, the structure implied by “bending a distal end portion of the distal tube” includes a curved surface.
As the inner surface of hole (123) includes a curved surface, such surface meets the claim limitation of a “a distal surface formed by bending a distal end portion of the distal tube,” as recited in claim 1.
Alternatively, it would have been an obvious matter of design choice to form the inner surface of hole (123) by bending a distal end portion of the distal tube, such as by using an awl to puncture and bend a portion connecting head (312), since Applicant has not disclosed that forming a distal surface by bending solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the device of Zhu.
Regarding claim 2, Zhu discloses wherein when the first connector moves proximally relative to the sheath, the engagement between the sheath and the second connector is released, and the engagement between the holder and the second connector is released (col. 11, ln. 39 – col. 12, ln. 5).
Regarding claim 3, Zhu discloses wherein:
the first connector has a pushing surface (3224; Fig. 10),
the second connector has a receiving surface (3133) facing the pushing surface, and
when the sheath and the second connector are engaged, the pushing surface and the receiving surface are separated (by distance L1; Fig. 6; col. 11, ll. 52-57)), and
when the engagement between the sheath and the second connector is released, the pushing surface and the receiving surface are in contact (Fig. 9; col. 11, ll. 52-62).
Regarding claim 4, Zhu discloses wherein when the engagement between the holder (12) and the second connector (313) is released, at least a part of the first connector and the second connector are retained inside the sheath (Fig. 9).
Regarding claim 6, Zhu discloses wherein
the holder is a tube (12) into which the arm is inserted (Fig. 3),
a proximal end of the tube is inserted into the sheath (Fig. 3),
the hole (123) includes a first hole (123) and a second hole (123) positioned opposite each other across a central axis of the holder (Fig. 12; col. 7, ll. 49-53),
the engaging portion includes a first engaging portion (31310) and a second engaging portion (31320; Fig. 11);
the second connector (313) has the first engaging portion (31310) insertable into the first hole, and the second engaging portion (31320) insertable into the second hole (Fig. 11 and 6a; col. 7, ll. 28-38), and
the first and second engaging portions protrude outwardly from the first and second holes in the radial direction (Fig. 6a), and
the first and second engaging portions engage with the distal surface (inner surface of circular hole (3121); Figs. 2a and 6a).
Regarding claim 21, Zhu discloses wherein
the distal tube (312) has a circumferentially extending groove (formed between step (3125) and far end face (3124; Fig. 13), and
the distal surface formed by bending the distal end portion of the distal tube (i.e., inner surface of circular hole (3121); Figs. 2a and 6a) is provided in the groove (Fig. 6a).
Claims 8-14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Zhu.
Regarding claim 8, Zhu discloses a medical clip comprising:
an arm (11),
a tube (12) into which at least a part of the arm is inserted, the tube having a hole (123) on a side of its proximal end (Fig. 12; col. 7, l. 49-53),
a sheath (combination of spring tube (311) and connecting head (312); Fig. 5) into which the proximal end of the tube is inserted,
a connector (313) engaging both the tube and the sheath (Fig. 6a),
wherein
the connector engages with the tube when inserted into the hole (Fig. 6a),
the connector has an engaging portion (31310, 31320; Fig. 11) inserted into the hole and protruding outwardly from the hole (Fig. 6a),
the sheath has a distal tube (312) fixed to a distal end of the sheath,
the distal tube has a contacting portion (inner surface of circular hole (123); Figs. 2a and 6a), and
the engaging portion protruding outwardly from the hole contacts the contacting portion (Fig. 6a; col. 7, ll. 30-34).
The claim limitation of “a contacting portion formed by bending a distal end portion of the distal tube” is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
Here, the structure implied by “bending a distal end portion of the distal tube” includes a curved surface.
As the inner surface of hole (123) includes a curved surface, such surface meets the claim limitation of a “a contacting portion formed by bending a distal end portion of the distal tube,” as recited in claim 1.
Alternatively, it would have been an obvious matter of design choice to form the inner surface of hole (123) by bending a distal end portion of the distal tube, such as by using an awl to puncture and bend a portion connecting head (312), since Applicant has not disclosed that forming a distal surface by bending solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the device of Zhu,.
Regarding claim 9, Zhu discloses wherein
the hole (123) includes a first hole (123) and a second hole (123) positioned opposite each other across a central axis of the tube (Fig. 12; col. 7, ll. 49-53),
the engaging portion includes a first engaging portion (31310) and a second engaging portion (31320; Fig. 11).
the connector (313) includes a first engaging portion (31310) insertable into the first hole and a second engaging portion (31320) insertable into the second hole (Fig. 11 and 6a; col. 7, ll. 28-38), and
the first and second engaging portions protrude outwardly from the holes in the radial direction (Fig. 6a).
Regarding claim 10, Zhu discloses wherein
the sheath includes a distal tube portion (312) fixed to the distal end of the sheath (Fig. 3),
the distal tube portion has the contacting portion with which the connector engages (Fig. 6a), and
the first and second engaging portions protruding outwardly from the holes in the radial direction contact the contacting portion (Fig. 6a).
Regarding claim 11, Zhu discloses wherein
the connector further includes a main body (3131) positioned between the first and second engaging portions in the radial direction of the tube, and
when the main body moves proximally in the longitudinal direction of the sheath, the first and second engaging portions deform (col. 7, ll. 38-45).
Regarding claim 12, Zhu discloses wherein
when the main body moves proximally in the longitudinal direction of the sheath, the first and second engaging portions are drawn inwardly in the radial direction (col. 11, ln. 52 – col. 12, ln. 5), and
when the first and second engaging portions are drawn inwardly in the radial direction, an engagement between the first engaging portion (31330) and the contacting portion and an engagement between the second engaging portion (31320) and the contacting portion are released (col. 11, ln. 52 – col. 12, ln. 5).
Regarding claim 13, Zhu discloses wherein when the first engaging portion and the second engaging portion are drawn inwardly in the radial direction while the engagement between the first engaging portion and the contacting portion and the engagement between the second engaging portion and the contacting portion are released, the first engaging portion is removed from the first hole and the second engaging portion is removed from the second hole (col. 11, ln. 52 – col. 12, ln. 5).
Regarding claim 14, Zhu discloses the medical clip further comprising a wire (321) inserted through the sheath and a first connector (322) connecting the arm and the wire (Fig. 4),
wherein the first connector moves the main body of the connector proximally (col. 11, ll. 52-62).
Allowable Subject Matter
Claim 22 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 22, the prior art does not show by itself or in combination, the limitation “the pair of grooves open in different directions along a circumferential direction of the sheath, and the distal surf ace formed by bending the distal end portion of the distal tube is provided in each of the pair of grooves,” as read with all the limitations of the claim.
Response to Arguments
Applicant's arguments filed July 17, 2026 have been fully considered but they are not persuasive.
Applicant’s argument on pages 8-9 of the Response that Zhu “does not disclose a bent distal surface” (Response pg. 9) as recited in claim 1 is not persuasive.
As explained above, the inner surface of circular hole (3121) has a bent or curved shape (Fig. 2a). Therefore, Zhu discloses a bent distal surface.
Also, Examiner notes that independent claim 1 recites “a distal surface formed by bending a distal end portion of the distal tube” and independent claim 8 recites “a contacting portion formed by bending a distal end portion of the distal tube.” As explained above, these recitations are being interpreted as product-by-process limitations, and Zhu discloses structure that meets or renders obvious the structure implied by the process of “bending a distal end portion of the distal tube” (i.e., a curved surface).
Furthermore, Examiner notes that claim 15 recites “a bent distal end portion having an inner surface.” As explained above, Fig. 6a of Zhu shows that the curved wall of connecting head (312) has a circular shape and defines the inner surface of circular hole (3121); Fig. 2a and 6a). Therefore, the curved wall of the connecting head meets the limitation of “a bent distal end portion having an inner surface,” as recited in claim 15.
Conclusion
Applicant's amendment necessitated any 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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/JONATHAN A HOLLM/Examiner, Art Unit 3771
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