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 .
Claim Amendments
The amendments dated Aug 13, 2026 are sufficient to overcome the previous claim objections and 112(b) rejections.
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.
Claim(s) 1, 7, 10, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vetter et al. [US 2023/0127245 A1, hereinafter “Vetter”] in view of Hanson et al. [US 20160354584 A1, hereinafter “Hanson”] and Cui et al. [US 2009/0326558 A1, hereinafter “Cui”].
Re. claim 1, Vetter discloses a manufacturing method for an integrated [“single homogeneous piece of material,” Par. 0033] gripper [grasping tool, Par. 0003, or Par. 0033, in the embodiment where the “beaks” are “blunt for use as clamps”] configured to clamp targets [“for use as clamps,” Par. 0033] for hemostasis or closure (the intended use of the gripper, however, a hemostatic clamp is disclosed in Par. 0002) , the manufacturing method comprising:
providing a tubular base material [a “single hollow tube” is provided, Par. 0033];
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forming a plurality of gripping heads [“beaks,” Par. 0026; see Annotated Fig. 2 above] facing each other [Fig. 2] by cutting the base material using a laser [“an entire work element 13 may be formed of a single homogeneous piece of material—such as from a single hollow tube that is (for example) laser-cut to form all of the structures shown in FIGS. 2 and 3,” Par. 0033];
forming a plurality of columns [here, four, where each column comprises one of the slits 466] of first shrinkage slits [466, Annotated Fig. 2 below] in a first direction [along the length/axis of the cutter in Fig. 2, see Fig. 2] of the base material by cutting the base material using the laser [Par. 0033], the first shrinkage slits all extending in a second direction of the base material [Annotated Fig. 2 below], and each column of the first shrinkage slits corresponding to one of the gripping heads in the first direction [in this case, each “column” of slits corresponds to a head, specifically two per head];
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forming at least two gripping arms having first ends connected to each other and second ends separated from each other [Annotated Fig. 2] by cutting the base material in the first direction using the laser [Par. 0033], each of the gripping arms comprising one column of the first shrinkage slits and one of the gripping heads [as defined],
wherein the clamping jaw structure is configured to clamp and close the targets[“hemostatic clamps, staplers, clip appliers and combinations of clamps and clip appliers,” Par. 0002].
The invention of Vetter differs from the claimed invention in the following ways: (1), Vetter fails to teach each column comprising a plurality of slits distributed in a first direction (because there is only one slit per column), and (2) Vetter fails to teach the gripping heads being bent inward to form the clamping jaw structure.
Re. (1), Hanson discloses, in a laser cut tubular medical device [Par. 0052], columns of slits [“slots” 22] are formed by a plurality of slits distributed in a first direction [“slots 22 can be arranged along the length of…tubular member 20 to achieve desired properties… adjacent slots 22, may be equally spaced along the length of tubular member 20….” Par. 0050]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Vetter by adding, to each of the above columns of Vetter, one or more additional slits above or below (with respect to the first direction) the existing slit such that each column comprises a plurality of slits distributed in a first direction, as taught by Hanson, because this help “achieve desired properties” [Hanson Par. 0050] such as enhanced flexibility [Hanson Par. 0049].
Re. (2), Vetter discloses “Additional features such as scissors blades or clamp faces may be attached to opposing beak structures and crimped, glued and/or laser-welded in place” [par 0033], but fails to disclose bending the heads inward. However, Cui discloses bending gripping heads inwards to form a clamping jaw structure [“single elongated plate is bent….Further, the end portions are bent so as to be opposed to each other, thereby forming the claw portions 22, 22 to two open ends,” Par. 0033. The two heads, here mapped to 22, are bent inwards, see Fig. 2, to form the clamping jaw structure.] configured to clamp a target [Figs 8B-C]. Note that, given the clamping feature, an open target placed between the arms would also be capable of being closed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Vitter by adding the step of bending the heads inwards to form a clamping jaw structure, as taught by Cui, in order to precisely hold an object between the two claw portions [Cui Par. 0081].
Re. claim 7, Vetter Fig. 1 is silent regarding the claimed notches, but, in the embodiment of Fig. 7A, discloses forming a notch [Annotated Fig. 7A] extending in the first direction of the base material by cutting opposed ends of the gripping arms using the laser [“In this embodiment, a method of forming the forceps or clamp includes a laser cut extension 525 of the general beak shape on both beaks,” Par. 0040], (“to form an avoidance structure”: this is the intended use or result of the above notches. The notches inherently perform this function, because the material that was removed creates a space where contact is avoided). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Vetter by using the step of Fig. 7A to create notches/an avoidance structure because this allows the method to form a surgical forceps or clamp [Par. 0040].
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Re. claim 10, Vetter discloses forming a separation base by cutting an end of the base material facing away from the gripping arms using the laser [428, Figs. 2-3, which has various cuts including 292B and those around 427], the separation base and the gripping arms being connected into an entirety [Fig. 3] with a first tearing portion [469] disposed between the separation base and the gripping arms.
Re. claim 16, Vetter discloses an integrated gripper [Par. 0033], and given the manufacturing method taught by Vetter as modified by Hanson and Cui, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the integrated gripper of Vetter to produce an integrated gripper manufactured by the manufacturing method according to claim 1 for the reasons set forth with respect to claim 1 above.
Claim(s) 2, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vetter in view of Hanson, Cui, and Harlev et al. [US 20170312420 A1, hereinafter “Harlev”].
Re. claim 2, Vetter discloses a manufacturing method for an integrated [“single homogeneous piece of material,” Par. 0033] gripper [grasping tool, Par. 0003, or Par. 0033, in the embodiment where the “beaks” are “blunt for use as clamps”] configured to clamp targets [“for use as clamps,” Par. 0033] for hemostasis or closure (the intended use of the gripper, however, a hemostatic clamp is disclosed in Par. 0002), the manufacturing method comprising:
providing a tubular base material [a “single hollow tube” is provided, Par. 0033];
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forming a plurality of gripping heads [“beaks,” Par. 0026; see Annotated Fig. 2 above] by cutting the base material using a laser [“an entire work element 13 may be formed of a single homogeneous piece of material—such as from a single hollow tube that is (for example) laser-cut to form all of the structures shown in FIGS. 2 and 3,” Par. 0033];
forming a plurality of columns [here, four, where each column comprises one of the slits 466] of first shrinkage slits [466, Annotated Fig. 2 below] in a first direction [along the length/axis of the cutter in Fig. 2, see Fig. 2] of the base material by cutting the base material through the laser [Par. 0033], the first shrinkage slits all extending in a second direction of the base material [Annotated Fig. 2 below], and each column of the first shrinkage slits corresponding to one of the gripping heads in the first direction [in this case, each “column” of slits corresponds to a head, specifically two per head];
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forming at least two gripping arms having first ends connected to each other and second ends separated from each other [Annotated Fig. 2] by cutting the base material in the first direction through the laser [Par. 0033], each of the gripping arms comprising one column of the first shrinkage slits and one of the gripping heads [as defined]; and wherein the clamping jaw structure is configured to clamp and close the targets[“hemostatic clamps, staplers, clip appliers and combinations of clamps and clip appliers,” Par. 0002].
The invention of Vetter differs from the claimed invention in the following ways: (1), Vetter fails to teach each column comprising a plurality of slits distributed in a first direction (because there is only one slit per column), (2) Vetter fails to teach the gripping heads being bent inward to form the clamping jaw structure, and (3) Vetter discloses starting with a tubular material rather than providing a sheet-like base and bending it into a tubular shape.
Re. (1), Hanson discloses, in a laser cut tubular medical device [Par. 0052], columns of slits [“slots” 22] are formed by a plurality of slits distributed in a first direction [“slots 22 can be arranged along the length of…tubular member 20 to achieve desired properties… adjacent slots 22, may be equally spaced along the length of tubular member 20….” Par. 0050]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Vetter by adding, to each of the above columns of Vetter, one or more additional slits above or below (with respect to the first direction) the existing slit such that each column comprises a plurality of slits distributed in a first direction, as taught by Hanson, because this help “achieve desired properties” [Hanson Par. 0050] such as enhanced flexibility [Hanson Par. 0049].
Re. (2), Vetter discloses “Additional features such as scissors blades or clamp faces may be attached to opposing beak structures and crimped, glued and/or laser-welded in place” [par 0033], but fails to disclose bending the heads inward. However, Cui discloses bending gripping heads inwards to form a clamping jaw structure [“single elongated plate is bent….Further, the end portions are bent so as to be opposed to each other, thereby forming the claw portions 22, 22 to two open ends,” Par. 0033. The two heads, here mapped to 22, are bent inwards, see Fig. 2, to form the clamping jaw structure.] configured to clamp a target [Figs 8B-C]. Note that, given the clamping feature, an open target placed between the arms would also be capable of being closed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Vitter by adding the step of bending the heads inwards to form a clamping jaw structure, as taught by Cui, in order to precisely hold an object between the two claw portions [Cui Par. 0081].
Re. (3): providing a sheet-like base material; bending the base material around the first direction and fixing the bent base material to have a tubular shape: Vetter discloses removing material from a tubular shape. However, Harlev teaches, in a method of forming a medical device by removing material, providing a sheet-like base material “a flat sheet of material,” Par. 0049], performing laser cutting on the sheet, and then bending the base material [Par. 0049] around a first direction and fixing it [Par. 0246] to have a tubular shape [“various features … can be formed in the substantially flat sheet [e.g. through laser cutting] prior to …the substantially flat sheet is formed into the tube 233,” Par. 0328]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Vetter by forming the heads, columns, and arms in a sheet-like base material and then bending the base material around the first direction and fixing it to form a tube, as taught by Harlev, instead of cutting into a tubular base material, because “[a]s compared to forming features on a curved material, it should be appreciated that forming [features] on the substantially planar sheet can reduce manufacturing complexity and, also or instead, facilitate controlling spacing and size tolerances” [Harlev Par 0328].
Re. claim 18, Vetter Fig. 1 is silent regarding the claimed notches, but, in the embodiment of Fig. 7A, discloses forming a notch [Annotated Fig. 7A] extending in the first direction of the base material by cutting opposed ends of the gripping arms using the laser [“In this embodiment, a method of forming the forceps or clamp includes a laser cut extension 525 of the general beak shape on both beaks,” Par. 0040], (“to form an avoidance structure”: this is the intended use or result of the above notches. The notches inherently perform this function, because the material that was removed creates a space where contact is avoided). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Vetter by using the step of Fig. 7A to create notches/an avoidance structure because this allows the method to form a surgical forceps or clamp [Par. 0040].
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Re. claim 19, Vetter discloses forming a separation base by cutting an end of the base material facing away from the gripping arms using the laser [428, Figs. 2-3, which has various cuts including 292B and those around 427], the separation base and the gripping arms being connected into an entirety [Fig. 3] with a first tearing portion [469] disposed between the separation base and the gripping arms.
Allowable Subject Matter
Claims 3-6, 11-15, and 17, 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.
Claims 8 and 9 are allowable.
Vetter fails to teach or suggest the following:
Re. claims 3 and 17: a plurality of second shrinkage slits by cutting the base material in the second direction at side end surfaces on two sides of each column of the first shrinkage slits, wherein the second shrinkage slits on a same side are arranged in the first direction; two ends of each of the first shrinkage slits extends between two adjacent second shrinkage slits in the first direction; and an overlapping region between the first shrinkage slits and the second shrinkage slits forms a twist deformable section.
Re. claim 8: forming an engaging slot by cutting the first ends connected to each other of the gripping arms through the laser, the engaging slot being configured to lock the gripping arm.
Re. claim 11: two tearing portions distributed in the second direction of the base material.
Re. claim 12, forming separation grooves recessed towards the gripping arms by cutting two sides of the first tearing portion using the laser, the first tearing portion being located at a recess.
Re. claim 13, forming a suspended suspension portion and cantilevers located on two sides of the suspension portion by cutting the separation base using the laser, the suspension portion being aligned with the first tearing portion.
Re. claim 15, forming a stopper by cutting the separation base using the laser; and pressing and deforming the stopper towards an interior of the separation base, to cause the stopper to protrude towards the interior of the separation base.
Response to Arguments
Applicant's arguments filed 8/13/26 have been fully considered but they are not persuasive. Applicant argues that Vetter fails to teach the gripper configured to clamp targets, and the clamping jaw structure configured to clamp and close the targets. The examiner respectfully submits that Vetter does teach such configuration, as set forth above.
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 ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-Th 9 am to 3 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
