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 Arguments
Applicant's arguments filed 01/26/2026 have been fully considered but they are not persuasive. Applicant argues that the device of Zhu does not satisfy the requirements of the claim limitations. Applicant argues that Zhu fails to teach a medical device for causing hemostasis of blood vessel because the device is disclosed as being used for living tissue ligation. It is the examiners position that “for causing hemostasis of blood vessel” in the preamble of the claim recites an intended use of the device. The device of Zhu has all of the claimed structural elements that are defined by the claim as forming a device for causing hemostasis of blood vessel. Therefore, the device of Zhu is at least capable of being used to ligate a blood vessel instead of a “living tissue”.
Applicant further argues that Zhu fails to teach a “pivot pin” as required by the claim, and describes that the pin 323, equated in the rejection to the pivot pin, is used as a connecting pin between the clamp and the control wire. Although Examiner does not disagree with Applicants characterization of the disclosure regarding pin 323 of Zhu, Examiner maintains that this pin meets the requirements of the claims. The claims recite “a pivot pin extending through corresponding through holes in the clamp arms”, which Applicant does not contest. The claim further recites the pivot pin protrudes laterally on both sides from the clamp arm, which is shown in FIG 5. The claim lastly recites the positional relationship between the pivot pin and locking noses. Therefore, applicants’ arguments regarding the function of the pin 323 are seen to be moot because they do not address specific claim limitations which are not being met. Examiner notes that the claim does not recite the clamp arms pivoting in any particular direction relative to the pivot pin, and such features should not be read into the claims. Therefore, applicants’ argument is not persuasive as it fails to highlight what claimed features of a pivot pina re not being taught by pin 323 of Zhu.
Lastly, Applicant argues that Zhu fails to teach locking noses as claimed. Applicant again summarizes the operation of Zhu but fails to specifically point out what features of the claims are not being met. Applicants’ conclusion that “the structural arrangement disclosed and taught by Zhu for maintaining the elastic clips of the clamp in a closed state after claiming the tissue differs from the configuration of the pivot pin and the locking noses recited in claim 1” is not sufficient without distinctly pointing out which claim limitations are not being met. Examiner notes that the claim does not require any direct engagement between the pivot pin and locking noses. 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).
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 4, 9, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu (US 2014/0171973).
Regarding claim 1, Zhu discloses a medical device for causing hemostasis of blood vessel (FIG 1, particularly the embodiment of FIG 23-24. [0117] disclose the differences of this embodiment. Any elements not discussed as being different are understood to function the same as in previous embodiments) comprising: a handle (20, FIGs 1-2, [0067, 0068, 0070]); a sheath device (30), which is attached to the handle (FIG 1, [0068-0069]); a clamp device (10) comprising a clamp housing (12) defining a longitudinal direction (See longitudinal axis in FIG 23) with a clamp base (Proximal end of 12 which is fitted into 312) in particular in the form of a sleeve provided on the distal end of the sheath device (See narrowed diameter of 12 in FIGs 19a-20a, where the sleeve is provided on the distal end of the sheath device as shown in the connected state of FIG 20b, 20d) and at least two, in particular exactly two clamp arms (Two arms of clip 11, FIG 4), said clamp housing defining an interior space (Hollow lumen of 12 shown in FIG 23); a control wire (321) extending through the sheath device (FIGs 5-6, [0070]) and reversibly movable in the distal and proximal direction ([0071] “before the certain pull force is achieved, the elastic clips 11 of the clamp 10 could be pushed or pulled by the shaft 321”); and an actuator (22) coupled to the proximal end of the control wire (0070]) and actuable to reversibly move the control wire in the distal and proximal direction ([0070-0071]); wherein the clamp arms are each coupled to the distal end of the control wire (See coupled connection in FIG 5) and wherein the clamp device is actuable to open and close the clamp arms by a movement of the control wire such that a movement of the control wire in a proximal direction is translated into a closing movement of the clamp arms ([0071 and 0010]) and a movement of the control wire in the distal direction is translated into an opening movement of the clamp arms ([0097] “When the slider and shaft 321 are pushed, the elastic chips 11 move to the far end of the tightening tube 12, the second bending portion which is straightened by the tightening tube 12 returns back to its original curved state, and the outer portions of two elastic clips 11 are separated to open the clamp 10”); wherein the clamp arms are coupled to the distal end of the control wire via a pivot pin (323, FIG 4 shows coupling to distal end of 321) extending through corresponding through-holes (117) provided in the proximal end sections of the clamp arms (FIG 14, [0088]) and being held releasably at the distal end of the control wire (The clamp arms are releasably connected to the control wire 321 via connector 322, [0070]), where the pivot pin protrudes laterally on both sides from the clamp arms and the distal end of the control wire (FIGs 4 and 5), and two locking noses (See annotated FIG 23 below) provided on the clamp housing (12) extending into the interior space of the clamp housing (FIG 23), wherein the locking noses are designed in such a way that they allow the pivot pin to pass them in the proximal direction but prevent passing of the pivot pin in the distal direction in order to lock the clamp arms in a closed state ([0117] references “joint stick 328”. However, this is understood to be a typo for “joint stick 323” i.e. the pivot pin. FIGs 23-24 show the clip is withdrawn proximally such that the pivot pin can pass in a proximal direction, but prevented from being advanced distally after passing. After being released from concave 3228, the curved base of the clip expands to engage the inner wall of the clamp housing, therefore restricting axial movement, [0117-0118], and thus preventing passing of the pivot pin in the distal direction in order to lock the clamp arms in a closed state).
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Regarding claim 4, Zhu discloses the pivot pin is of tubular shape (FIG 14, [0089]).
Regarding claim 9, Zhu discloses the clamp housing comprises a central passage opening (Proximal opening to the lumen of the tubular section of 12) and two bearing arms (1211, FIG 19a) extending in the distal direction from the clamp base (FIG 19a), so that the interior space of the clamp housing is defined by the central passage opening and the space between the bearing arms (FIG 19a-20a show the interior space is defined by the central passage opening and the arms).
Regarding claim 10, Zhu discloses a disengaging arrangement is provided which allows disconnecting the clamp arms from the control wire when the clamp arms are locked in the closed state and the control wire is further pulled in the proximal direction (FIGs 23-24, [0117-0118]).
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) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu (US 2014/0171973) in view of Kimura (US 2005/0059985).
Regarding claims 2-3, Zhu discloses the invention substantially as claimed, as set forth above for claim 1. Zhu further discloses each locking nose has on its distal side an inclined surface with respect to the longitudinal direction of the clamping house (See FIG 23 wherein the distal surface of the nose is angled) and on its proximal side, another inclined surface
Zhu is silent regarding the inclination angle of the inclined surface is at minimum 30° and/or at maximum 60°, preferably 45° with respect to the longitudinal direction of the clamp housing, and that each locking nose has on its proximal side a surface extending perpendicular to the longitudinal direction.
However, Kimura teaches in the same filed of endeavor of hemostasis clip devices (Abstract) a locking projection (3b, FIG 1C), having on one side, an inclined surface (3f) of 30° ([0137]) and on an opposed side, a surface extending perpendicular to the longitudinal direction (FIGs 1A and 1C show a face vertical), whereby allowing hook section 12 to travel in over direction, over the inclined surface, but prevent passing in the opposed direction ([0147-0148]).
Therefore, it would have been obvious to one of ordinary skill int eh art at the time of filing to modify the locking noses of Zhu such that the inclined distal surface is angled at 30° and the proximal side surface is perpendicular to the longitudinal direction, as taught by Kimura, for the purpose of facilitating the gradual sliding over the locking nose in the proximal direction, and providing a more secure locking face to prevent movement in the distal direction.
Claim(s) 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu (US 2014/0171973) in view of Estevez (US 2019/0090882).
Regarding claims 5 and 7, Zhu discloses the invention substantially as claimed, as set forth above for claim 1.
Zhu is silent regarding the clamp housing having on its inner surface two sliding grooves extending in the longitudinal direction and arranged opposite each other in such a way that each end section of the pivot pin engages into one sliding groove wherein the sliding grooves have a rectangular cross-section.
However, Estevez teaches in the same field of endeavor of hemostatic clip assemblies (Abstract) a tubular housing (110, FIG 1 and 3) housing a portion of the clip assembly (FIG 5) having a sliding groove (116, [0032], FIG 3) extending in the longitudinal direction (FIG 3) in such a way that an end section of a pin (122) engages into the sliding groove ([0032]) and wherein the sliding groove has a rectangular cross-section (FIG 3). Estevez further teaches that the benefit of providing the sliding groove engaged with the pin is to prevent rotation of the clip relative to the tubular housing.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the inner surface of the clamp housing to comprise who rectangular shaped sliding grooves extending in the longitudinal direction and arranged opposite each other in such a way that each end section of the pivot pin engages into one sliding groove, as taught by Estevez, for the purpose of guiding the clip in a straight path through the clamp housing such that undesired rotation is preventing and the desired orientation can be reliably achieved.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu (US 2014/0171973).
Regarding claim 19, Zhu discloses the invention substantially as claimed, as set forth above for claim 1. Zhu further discloses the clamp arms are coupled to the distal end of the control wire (FIG 23, coupled via the connection of 321 to 322 and further to the base of the clamp arms) in a pivotal manner around a common pivot axis defined by the pivot pin (The arms are pivotable about the pivot pin, which defines an axis).
Zhu is silent regarding clamp arms being provided as separate elements.
However, Zhu teaches in the alternative embodiments that the clamp arms can be provided as separate elements (FIG 4-9 wherein clamp arms are separate elements 11), instead of the unitary structure disclosed in the embodiment of FIGs 23-24, [0117].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the unitary clamp arms of FIG 23-24 to be two separate clamp arms attached at eh pivot pin, as taught by the alternative embodiment, for the purpose of achieving the predictable results of forming the clamp arms in commonly known manner which would be releasably attached to the control wire and would not alter the function or operation of the device apart from the form of the arms.
Allowable Subject Matter
Claims 6, 8, 11-18 are 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.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 6, the prior art of record fails to teach or render obvious the particular arrangement of the locking noses within sliding grooves. Although the prior art teaches the used of sliding grooves to maintaining the rotational orientation of the clip, and the prior art teaches the use of locking noses, there is no teaching which would suggest how to combine the placement of these two elements in the claimed manner. Regarding claim 11, the prior art of record fails to teach or render obvious the limitations of the coupling head as required by the claim.
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 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.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771