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 Amendment
The amendments filed on 03/25/2026 have been entered. Claims 36-55 remain pending in the application.
Terminal Disclaimer
The terminal disclaimer filed on 03/25/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Pat. No. 11,883,036 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 03/25/2026, with respect to the rejection(s) of claim(s) 36 and 52 under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of King further in view of Hayashi in order to teach the newly recited limitations.
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) 36-43, 48-50, and 52-54 are rejected under 35 U.S.C. 103 as being obvious over King et al. (US 2018/0153552) in view of Hayashi et al. (US 2018/0333156).
Regarding claim 36 and 48-49, King et al. discloses a reloadable clipping system for treating tissue (100, FIG 1), comprising: a clipping assembly (102) including a pair of clip arms (114, [0035], FIG 1), a capsule (108, 106) configured to receive proximal ends of the clip arms therein (FIG 1 shows the proximal ends of the clip arms received within 108), and a first deformable element (one of 152) extending proximally from a proximal end of the capsule (FIG 1), the first deformable element including a first hook extending from a proximal portion of the first deformable element (proximal protrusion at 158 which projects in an arced shape to engage with 168 is interpreted as a hook); and an applicator (104, [0034]) having a distal end (Distal end of 110 shown in FIG 1) including a distal portion configured to be engaged by the first hook when the first hook is crimped thereover in a locked configuration (The radial groove on the distal end of 110 formed in between 162 and 170 is engaged by the first hook in a locked configuration; See FIG 1 where the radially inward protrusion at the proximal end of 106 is received and locked within the groove of 110. The hook is at least configured to engage the distal portion if the hook were crimped i.e. if an external radially inward force were applied to the hook. As disclosed, this radial inward force originates from an elasticity of the deformable element, [0041]), the distal end of the applicator being configured so that, when a compressive force exerted on the first deformable element exceeds a predetermined threshold value, the first deformable element is deformed out of engagement with the distal end of the applicator ([0044] discloses the process of the distal end of applicator applying a force to the first deformable element such that it bends radially outward; “deflecting the arms 152 radially outward to disengaging the coupler 106 from the catheter 110”. [0049] the coupler 106 may be moved even further proximally relative to the catheter 110, causing the shoulder 170 of the catheter 110 to interface with the proximal edge 158 resulting in even further deflection of the arms 152. As described above, the coupler 106 may yield to release the catheter 110 therefrom), and the clipping assembly includes at least one further deformable element extending proximally from the proximal end of the capsule (A second one of the arms 152), the further deformable element including a further hook extending from a proximal portion of further deformable element (Identical to what is described above in relation to the first deformable element) and being configured to be crimped over the distal portion in a locked configuration (The radial groove on the distal end of 110 formed in between 162 and 170 is engaged by the further hook in a locked configuration) and the distal end of the applicator is configured so that, when the compressive force exerted on the further deformable element exceeds a predetermined threshold value, the further deformable element is deformed out of engagement with the distal end of the applicator [0044] discloses the process of the distal end of applicator applying a force to the first deformable element such that it bends radially outward; “deflecting the arms 152 radially outward to disengaging the coupler 106 from the catheter 110”. [0049] the coupler 106 may be moved even further proximally relative to the catheter 110, causing the shoulder 170 of the catheter 110 to interface with the proximal edge 158 resulting in even further deflection of the arms 152. As described above, the coupler 106 may yield to release the catheter 110 therefrom).
King et al. fails to explicitly state that the yielding and deflection of the first deformable element and the further deformable element comprises being plastically deformed without fracture.
However, Hayashi et al. teaches in the same field of endeavor a clipping system (100, FIG 5A) having a pair of clip arms (110, 120) associated with a first deformable element (142) at the proximal end (FIG 5B), a further deformable element (another of 142, [0086]) and an applicator (20, [0101]) having a distal end (50) with a distal portion (52) configured to be engaged by a first hook (140, FIG 3A) of the first deformable element (FIG 3A, [0084] discloses the engagement) and a further hook of the further deformable element (another of 140 of a respective projection arm 142) and wherein, when a compressive force exerted on the first deformable element and the further deformable element exceeds a predetermined threshold (by retracting wire 20 as shown in FIG 9B, [0133]), the first deformable element and further deformable element is plastically deformed out of engagement with the distal end of the applicator (FIG 9B) without fracture of the first deformable element or the further deformable element ([0133] discloses 140 is plastically deformed and as shown in FIG 9B remains intact, therefore it achieves the plastic deformation without fracture). Hayashi further discloses the first deformable element and further deformable element can be plastically deformed or may be elastically deformed ([0133]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of King such that the deflecting and yielding of first deformable element and further deformable element results in plastic deformation without fracture, as taught by Hayashi et al., for the purpose of utilizing a technique commonly known in the art for allowing the first and further deformable elements to sufficiently flex away from the distal end of the applicator to achieve the predictable result of releasing the clipping assembly.
Regarding claim 37 and 39, King/ Hayashi et al. disclose the invention substantially as claimed, as set forth above for claim 36. King further discloses the distal portion includes a first ramped portion (See annotated FIG below) tapering to a distal end of the distal portion (Left end as viewed in the annotated FIG) and a necked portion (see annotated FIG below) extending proximally from the first ramped portion and the distal portion includes a second ramped portion (See annotated FIG below) flaring proximally outward from a proximal end of the necked portion (As shown in the FIG below).
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Regarding claim 38, King/ Hayashi et al. disclose the invention substantially as claimed, as set forth above for claim 37. King further discloses a proximal end of the first ramped portion includes a lip (See annotated FIG above) defined via a recess extending between an interior surface of the first ramped portion and an exterior surface of the necked portion (The pocket formed between the first ramped portion and the necked portion is interpreted as a recess), the lip configured to engage the first hook when the first hook is crimped thereover in the locked configuration ([0041], FIG 1).
Regarding claim 40, King/ Hayashi et al. disclose the invention substantially as claimed, as set forth above for claim 39. King further discloses the first and second ramped surfaces define substantially conically shaped portion of the distal end of the applicator (Although only shown in cross section in FIG 1, the first and second ramped surfaces extend radially around the longitudinal axis of the system and therefore form conically shaped portions of the applicator) while the neck portion extends along a cylindrical portion of the distal end of the applicator (The neck portion has a constant diameter thereby forming a cylindrical portion).
Regarding claim 41, King/ Hayashi et al. disclose the invention substantially as claimed, as set forth above for claim 36. King further discloses the distal end of the applicator includes a bushing (The distal end 160 shown in FIG 1 is interpreted as a bushing) and the distal portion of the distal end of the applicator is formed on the bushing (The neck is formed in this region as shown in FIG 1), the distal portion configured to be engaged by the first hook when the first hook is crimped thereover in the locked configuration (FIG 1, [0041]]).
Regarding claim 43, King/ Hayashi et al. disclose the invention substantially as claimed, as set forth above for claim 36. King further discloses a cartridge (Paragraph [0045] discloses the clip and applicator may be stored in a cartridge) including a space sized and shaped to house the clipping assembly therein (Paragraph [0045] discloses the clip can be stored in the tissue receiving configuration), and a longitudinal slot sized and shaped to receive the distal end of the applicator therein (Paragraph [0045] discloses a proximal opening for receiving the distal end of the applicator, for coupling to the clip).
Regarding claim 50, King/ Hayashi et al. disclose the invention substantially as claimed, as set forth above for claim 36. King further discloses the proximal ends of the clip arms are connected to one another via a yoke (102, [0035]) coupleable with an enlarged distal end (122) of a control member (112, [0037]) extending through an elongated flexible member of the applicator (Not shown, [0042]).
Regarding claim 52 and 54, King discloses a clip device (100, FIG 1, [0034]), comprising: a pair of clip arms (114), each of the clip arms extending from a proximal end (118) to a distal end (116); a capsule (108, 106) configured to receive proximal ends of the clips arms therein (FIG 1, [0034-0035, 0040]); and a first deformable element (one of 152) extending proximally from a proximal end of the capsule (FIG 1), the first deformable element including a first hook extending from a proximal portion of the first deformable element (proximal protrusion at 158 which projects in an arced shape to engage with 168 is interpreted as a hook) to be crimped over a distal portion of a distal end of an applicator (104, [0034]; The radial groove on the distal end of 110 formed in between 162 and 170 is engaged by the first hook in a locked configuration; See FIG 1 where the radially inward protrusion at the proximal end of 106 is received and locked within the groove of 110. The hook is at least configured to engage the distal portion if the hook were crimped i.e. if an external radially inward force were applied to the hook. As disclosed, this radial inward force originates from an elasticity of the deformable element, [0041]) so that, when a compressive force exerted on the first deformable element exceeds a predetermined threshold value, the first deformable element is deformed out of engagement with the distal end of the applicator ([0044] discloses the process of the distal end of applicator applying a force to the first deformable element such that it bends radially outward; “deflecting the arms 152 radially outward to disengaging the coupler 106 from the catheter 110”. [0049] the coupler 106 may be moved even further proximally relative to the catheter 110, causing the shoulder 170 of the catheter 110 to interface with the proximal edge 158 resulting in even further deflection of the arms 152. As described above, the coupler 106 may yield to release the catheter 110 therefrom), and the clipping assembly includes at least one further deformable element extending proximally from the proximal end of the capsule (A second one of the arms 152), the further deformable element including a further hook extending from a proximal portion of further deformable element (Identical to what is described above in relation to the first deformable element) and being configured to be crimped over the distal portion in a locked configuration (The radial groove on the distal end of 110 formed in between 162 and 170 is engaged by the further hook in a locked configuration) and the distal end of the applicator is configured so that, when the compressive force exerted on the further deformable element exceeds a predetermined threshold value, the further deformable element is deformed out of engagement with the distal end of the applicator [0044] discloses the process of the distal end of applicator applying a force to the first deformable element such that it bends radially outward; “deflecting the arms 152 radially outward to disengaging the coupler 106 from the catheter 110”. [0049] the coupler 106 may be moved even further proximally relative to the catheter 110, causing the shoulder 170 of the catheter 110 to interface with the proximal edge 158 resulting in even further deflection of the arms 152. As described above, the coupler 106 may yield to release the catheter 110 therefrom).
King et al. fails to explicitly state that the yielding and deflection of the first deformable element and the further deformable element comprises being plastically deformed without fracture.
However, Hayashi et al. teaches in the same field of endeavor a clipping system (100, FIG 5A) having a pair of clip arms (110, 120) associated with a first deformable element (142) at the proximal end (FIG 5B), a further deformable element (another of 142, [0086]) and an applicator (20, [0101]) having a distal end (50) with a distal portion (52) configured to be engaged by a first hook (140, FIG 3A) of the first deformable element (FIG 3A, [0084] discloses the engagement) and a further hook of the further deformable element (another of 140 of a respective projection arm 142) and wherein, when a compressive force exerted on the first deformable element and the further deformable element exceeds a predetermined threshold (by retracting wire 20 as shown in FIG 9B, [0133]), the first deformable element and further deformable element is plastically deformed out of engagement with the distal end of the applicator (FIG 9B) without fracture of the first deformable element or the further deformable element ([0133] discloses 140 is plastically deformed and as shown in FIG 9B remains intact, therefore it achieves the plastic deformation without fracture). Hayashi further discloses the first deformable element and further deformable element can be plastically deformed or may be elastically deformed ([0133]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of King such that the deflecting and yielding of first deformable element and further deformable element results in plastic deformation without fracture, as taught by Hayashi et al., for the purpose of utilizing a technique commonly known in the art for allowing the first and further deformable elements to sufficiently flex away from the distal end of the applicator to achieve the predictable result of releasing the clipping assembly.
Regarding claims 42 and 53, King/Hayashi et al. discloses the invention substantially as claimed, as set forth above for claim 36 and 52. The device as modified further discloses the first deformable element is formed of a material configured to permit elastic deformation thereof without fracture during a loading of the clipping assembly when the first deformable element is slid proximally along an exterior surface of the distal portion until the first hook snaps over the distal portion to couple the capsule to the distal end of the applicator ([0041] “The arms 152 deflect away from one another as the engaging features 162 at the distal end 160 are being inserted therebetween. Once the engaging features 162 are received within the grooves 154, however, the arms 152 snap inward under their natural bias so that the grooves 154 and the engaging features 162 engage one another, coupling the catheter 110 to the coupler 106”).
King is silent regarding the material of the first deformable element, specifically the first deformable element being formed of a metal material.
However, Hayashi et al. teaches the first deformable element (140) is configured to plastically deform without fracture during a loading of the clipping assembly when the first deformable element is slid proximally along an exterior surface of the distal portion until the first hook snaps over the distal portion to couple the capsule to the distal end of the applicator (FIG 5B, [0093, 0118-0121]), and wherein the first deformable element is made of a metal material ([0075], wherein 130 is formed of a metal material and 142 is an element of 130).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the first deformable element of King to be formed of a metal material, for the purpose of having desired rigidity and flexibility characteristics such that it can elastically deform without breaking, while also being formed of a material commonly known in the art for being biocompatible.
Claims 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2018/0153552), in view of Hayashi et al. (US 2018/0333156), further in view of Kimura et al. (US 2007/0112359).
Regarding claim 44-45, King/Hayashi discloses the invention substantially as claimed, as set forth above for claim 43.
King is silent regarding specific features of the cartridge, specifically wherein the longitudinal slot includes a crimping feature configured to engage a deformable portion of the first deformable element, so that, when the first deformable element is moved proximally past the crimping feature the first hook of the first deformable element is crimped over the distal portion in the locked configuration and the crimping feature includes a ramped surface tapering toward a distal end so that the ramped surface exerts a radially inward and a distal force to the first hook so that a tip of the first hook is received within a cavity defined in the distal portion.
However, Kimura discloses a cartridge (70, FIGs 12-19) for housing a clip (60) in the open configuration (FIG 13A shows clip 60 within the cartridge in the open configuration) and a longitudinal slot (78, 79, 80, FIGs 12A-12B, paragraphs [0112-0119]) for receiving an applicator (20, FIGs 17-19, paragraph [0132]), wherein the longitudinal slot includes a crimping feature (Tapered surface 7 8c, FIG 12B, paragraph [0115]) configured to engage a deformable portion of the first deformable element, so that, when the first deformable element is moved proximally past the crimping feature the first hook of the first deformable element is crimped over the distal portion in the locked configuration (The limitations “configured to engage a deformable portion of the first deformable element, so that, when the first deformable element is moved proximally past the crimping feature the first hook of the first deformable element is crimped over the distal portion in the locked configuration” recites functional language indicating an intended use of the device. The prior art device need only be configured to perform such a function. Crimping feature 78c is at least configured to engage 63h of the clip as the clip is moved proximally therepast such that the diameter is reduced, paragraph [0116]. Therefore, the surface 78c would be at least capable of engaging a deformable portion of the first deformable element when the first deformable element is moved proximally therepast so that the first deformable element is crimped over the distal portion in the locked configuration because the shape of the cartridge is the same as that of the present invention which is disclosed as being capable of achieving said function) and wherein the crimping feature includes a ramped surface tapering toward a distal end so that the ramped surface exerts a radially inward and a distal force to the first hook so that a tip of the first hook is received within a cavity defined in the distal portion (The tapered shape of the surface would exert a radially inward force capable of achieving the effect of pushing the tip of the hook inward).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of King et al. to comprise the cartridge taught by Kimura including the crimping feature as claimed, for the purpose of providing a housing for the clip in a sterile packaging such that the applicator can be easily attached to the clip without contaminating the clip (Kimura: paragraph [0123 – 0124]).
Regarding claim 46, King/ Hayashi discloses the invention substantially as claimed, as set forth above for claim 43.
King et al. is silent regarding specific features of the cartridge, specifically wherein the longitudinal slot includes a stop along a portion thereof configured to engage a portion of the distal end of the applicator to prevent the distal end of the applicator from moving distally therebeyond.
However, Kimura discloses a cartridge (70, FIGs 12-19) for housing a clip (60) in the open configuration (FIG 13A shows clip 60 within the cartridge in the open configuration) and a longitudinal slot (78, 79, 80, FIGs 12A-12B, paragraphs [0112-0119]) for receiving an applicator (20, FIGs 17-19, paragraph [0132]), wherein the longitudinal slot includes a stop (81, FIG 12B, paragraph [0124]) along a portion thereof (FIG 12 shows stop 81 is within longitudinal slot 80) configured to engage a portion of the distal end of the applicator to prevent the distal end of the applicator from moving distally therebeyond (Distal end tip contact portion 81 prevents further insertion of the distal end of applicator 20, paragraph [0124]. Therefore, the stop is interpreted as being at least configured to engage a distal end of the applicator and prevent further distal movement).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of King et al. to comprise the cartridge taught by Kimura including the stop as claimed, for the purpose of providing a housing for the clip in a sterile packaging such that the applicator can be easily attached to the clip without contaminating the clip (Kimura: paragraph [0123 -0124)).
Claim 47 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2018/0153552), in view of Hayashi et al. (US 2018/0333156), further in view of Terada (US 2013/0072946).
Regarding claims 47 and 55, King et al./Hayashi discloses the invention substantially as claimed, as set forth above for claim 36 and 52.
King et al. is silent regarding the first hook hooks extending along a substantially J-shape so that a tip of the first hook extends toward distal direction.
However, Terada teaches a reloadable clip device (100, FIGs 1-3, paragraph [0082]) wherein connecting elements (43, paragraph [0154]) including hooks (73) connecting the proximal end of a capsule (29) to the distal end of an applicator (23, FIG17, paragraph [(0148-0154) wherein the hook extends along a substantially J-shape so that a tip of the hook extends toward a distal direction (FIGs 19, 27, and 38A-38B show the shape of hook 73 is that of a J-shape wherein the tip of the hook extends towards a distal direction) and are deformable engaged in a locked position with a groove (Abutment of the hook tip against 143, FIG 19, 27, and 38A-39B, [0148, 0154, 0166, and 0207-0209]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the radially inward projecting tip of the hook of King et al. such that it extends toward a distal direction, as taught by Terada, for the purpose of substituting commonly known means for attaching a clip capsule to the distal end of an applicator and substitution of one for the other would have resulted in the predictable result of allowing for the connection to be sufficiently rigid while also being detachable. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2018/0153552), in view of Hayashi et al. (US 2018/0333156), further in view of Litscher et al. (US 2005/0107809).
Regarding claim 51, King et al./Hayashi discloses the invention substantially as claimed, as set forth above for claim 50.
King et al. is silent regarding the yoke including a proximal portion and a distal portion connected to one another at a point configured to separate when a predetermined force is exerted thereon.
However, Litscher et al. discloses a clip (90, FIGs 1-1A) releasably connected to an applicator (100) wherein proximal ends of clip arms (208) are connected to one another via a yoke (206,204, FIG 1A) coupleable with an enlarge distal end (140) of a control member (118, FIG 5 and 9-10) wherein the yoke includes a proximal portion (204) and a distal portion (206, FIGs 9-10) connected to one another at a point configured to separate when a predetermined force is exerted thereon (204 and 206 are connected via separable engagement between 216 and 214, paragraph [0069]. Proximal and distal portions are configured to separate when a predetermined force is exerted on the connection between them, paragraph [0069)).
Therefore, it would have been obvious to one of ordinal skill in the art at the time of filing to modify the connection between the enlarged distal end of the control member and the yoke of King et al. with the connection taught by Litscher et al., for the purpose of substituting a mechanism commonly known in the art for achieving the predictable result of forming a releasable connection between the control member and the yoke such that the clip can be controllably detached from the applicator.
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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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
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