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 amendment filed 08/26/2026 has been entered. Claims 21-26 and 28-40 are pending in the application.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 6-10, and 12-14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bruns et al. (US 20200237368 A1).
Regarding claims 1, 6-7, 10, and 12-13, Bruns et al. discloses a surgical stapler (10/310), comprising: an elongate body defining a proximal portion and a distal portion (figs. 1-3 and 11-12) ; and a tool assembly (12/212/312) defining a longitudinal axis and comprising: a cartridge assembly (37/237) with a distal cartridge end ([0099-0102, 0112-0114, 0125-0128], figs. 3-12); an anvil assembly (18/218/318/1718, figs. 3-12 and 45) with a distal anvil end (319, see distal end figs. 1-8 and 11-12) and
a support bracket (1740) on the distal anvil end [0232-0234], the anvil assembly being pivotably coupled to the cartridge assembly such that the tool assembly is moveable between an open position and a clamped position ([0099-0102, 0112-0114, 0125-0128], figs. 1-12 and 45); and
a dissector tip (1730) positioned at the distal anvil end overlying the distal cartridge end (figs. 1-12 and 45) comprising: a tip beam (1722) including: a proximal portion fixedly secured to the support bracket (1740 [0234], fig. 45); and
a distal portion being deformable, relative to the longitudinal axis, to define at least two angled configurations (“tip locking mechanism operable to releasably retain anvil tip (1722) in the first and second discrete positions” [0234]) in which the dissector tip (1722) is retained for use during a surgical procedure, tip beam (1722) is manually bendable for the two angled configurations and the at least two angled configurations of the dissector tip for use during a surgical procedure wherein the at least two angled configurations comprise a first configuration with the dissector tip substantially aligned with the longitudinal axis, and a second configuration with the dissector tip defining an acute angle with the longitudinal axis ([0214, 0232-0237], figs. 1-12 and 45-48).
Bruns et al. states: “tip locking mechanism may comprise one or more detent features, protrusions, recesses, resilient members, interference features, and the like of various types that will be readily apparent to those of ordinary skill in the art in view of the teachings herein [0214]…tip locking mechanisms described below in connection with anvils (1318, 1418, 1518, 1618, 1718, 1818)” [0214].. tip locking mechanism operable to releasably retain anvil tip (1722) in the first and second discrete positions” [0234].
Regarding claims 8-9 and 14, Bruns et al. discloses the distal beam portion includes a material (metal) with a retaining property such that, after bending the distal beam portion to a desired configuration, the material retains the distal beam portion in the desired configuration, wherein the tip beam comprises a metallic material, and wherein the tip beam cover comprises a biocompatible material (elastomeric) with at least one of a polymeric material, metal, ceramic, or an elastomeric material [0208-0234].
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-5, 11, and 15-20 is/are rejected under 35 U.S.C. 103 as obvious over Bruns et al. (US 20200237368 A1) in view of KNODEL et al. (WO 2013151888 A1).
Regarding claims 15-16, 18, and 20, Bruns et al. discloses a tool assembly (12/312) for a surgical stapler (10/310), the tool assembly comprising: a cartridge assembly (37/237) with a distal cartridge end ([0099-0102, 0112-0114, 0125-0128], figs. 3-12); an anvil assembly (318/1718, figs. 3-12 and 45) comprising
a base portion (fig. 6 – proximal coupling end with pivot posts) and an anvil portion (elongate anvil body/18/218/318/1718, [0095-0102, 0232], figs. 1-8, 11, and 45) having an anvil distal end (319, see distal end figs. 1-8 and 11-12), the base portion coupled to the cartridge assembly such that the tool assembly is moveable from an open position to a clamped position ([0095-0102, 0112-0114, 0125-0128], figs. 3-12), and the anvil portion (elongate anvil body) secured to the base portion and including a plurality of staple deforming pockets [0232]; and
a dissector tip (1722 and/or 1740/1730) coupled to one of the distal cartridge end or the distal anvil end (coupled via 1730/1740), and overlying the other of the distal cartridge end or the distal anvil end (figs. 1-12 and 45), the dissector tip having a tapered distal surface ([0113-0116], tips shown tapered, “tapered distal tip (1722)” [0232], figs. 8-12 and 45) and comprising;
a tip beam (1722) with a proximal portion fixedly secured to the anvil assembly (1718/1740 [0234], fig. 45), with a deformable distal beam portion that is manually bendable to define at least one angled configuration, relative to a longitudinal axis extending through a anvil connection member (1730) and dissector tip (extends through 1730/1722), in which the tip beam is retained for use during a surgical procedure and the at least one angled configuration comprise a first configuration with the dissector tip substantially aligned with the longitudinal axis, and a second configuration with the dissector tip defining an acute angle with the longitudinal axis ([0214, 0232-0237], figs. 1-12 and 45-48).
Bruns et al. teaches having a tip beam cover at least partially surrounding the tip beam and movable therewith to the at least one angled configuration ([0171, 0192, 0208], figs. 23-35) and teaches having a C-clip (1746) and locking detents for the tip beam/shaft (1740) that is retained in different positions [0232-0234], figs. 45-48).
Bruns et al. teaches anvil tips (1222, 1322, 1422, 1522, 1622, 1722, 1822) … include rigid materials, elastically deformable materials, or combinations thereof…may be include a core or proximal base portion formed of a rigid material such as a metal, and an elastomeric body portion coupled to or otherwise overmolded about the rigid core or proximal base portion [0208].
Bruns et al. fails to explicitly disclose having a tip beam with a deformable distal beam portion that is manually bendable to define at least one angled configuration, relative to a longitudinal axis extending through the tool assembly, in which the tip beam is retained for use during a surgical procedure; and a tip beam cover at least partially surrounding the tip beam and movable therewith to the at least one angled configuration and having tapered distal surface.
KNODEL et al. teaches having a dissector tip (200) having a tapered distal surface (blunt, figs. 30-33) and comprising a tip beam (202) with a deformable distal beam portion that is manually bendable to define at least one angled configuration relative to a longitudinal axis (fig. 32) extending through the tool assembly (“flexible tip 200 initially may be straight, angled or form any other suitable shape” [0051-0053, 0065, 0075-], claims 1-6, 9-11, and 9-18, figs. 30-32) and teaches the tip beam cover envelops the tip beam and defines an atraumatic configuration with rounded edge surfaces and a distally-tapering width ([0051-0053, 0065, 0075-], claims 1-6, 9-11, and 9-18, figs. 30-32).
Given the teachings of Bruns et al. have a dissector tip with a tapered distal surface and a deformable distal beam portion that is manually bendable to define at least one angled configuration relative to a longitudinal axis and having the tip straight or angled as desired and tip beam cover at least partially surrounding the tip beam and movable therewith to the at least one angled configuration, it 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 to modify the tip beam with having a deformable distal beam portion that is manually bendable to define at least one angled configuration, relative to a longitudinal axis extending through the tool assembly, in which the tip beam is retained for use during a surgical procedure; and a tip beam cover at least partially surrounding the tip beam and movable therewith to the at least one angled configuration to have the tip proximal portion fixedly secured to the anvil assembly or cartridge assembly for grasping tissue as needed (from top/anvil or bottom/cartridge as needed/desired) indexed a selected number of degrees to have precise adjustment of the tip end for more precise adjustment of the tool/effector for different position needs and more precise action on a surgical area and/or for having a protective cover/softer cover purposes as taught by KNODEL et al. and since has been held adjustability, where needed, is not a patentable advance, and if an art-recognized need for adjustment the prior art would have been obvious. In re Stevens, 212 F.2d 197, 101 USPQ 284 (CCPA 1954).
Regarding claims 17 and 19, Bruns et al. discloses the distal beam portion includes a material (metal) with a retaining property such that, after bending the distal beam portion to a desired configuration, the material retains the distal beam portion in the desired configuration, wherein the tip beam comprises a metallic material, and wherein the tip beam cover comprises a biocompatible material (elastomeric) with at least one of a polymeric material, metal, ceramic, or an elastomeric material [0208-0234]. KNODEL et al. also teaches the distal beam portion includes a material (bendable core 202) with a retaining property such that, after bending the distal beam portion to a desired configuration, the material retains the distal beam portion in the desired configuration, wherein the tip beam comprises a metallic material, and wherein the tip beam cover comprises a biocompatible material with at least one of a polymeric material, metal, ceramic, or an elastomeric material [0052].
Regarding claims 2-5 and 11, Bruns et al. teaches having a tip beam cover at least partially surrounding the tip beam and movable therewith to the at least one angled configuration ([0171, 0192, 0208], figs. 23-35) and teaches having a C-clip (1746) and locking detents for the tip beam/shaft (1740) that is retained in different positions [0232-0234], figs. 45-48).
Bruns et al. fails to explicitly disclose having the dissector tip further comprises a tip beam cover at least partially surrounding the tip beam, wherein the tip beam cover defines a vertical thickness that decreases toward a distal direction with respect to the longitudinal axis, wherein the tip beam cover further defines a lateral width that decreases toward the distal direction, wherein the tip beam cover envelops the tip beam and defines an atraumatic configuration with rounded edge surfaces and a distally-tapering width.
KNODEL et al. teaches the dissector tip further comprises a tip beam cover (204) at least partially surrounding the tip beam ([0052[, fig. 32), wherein the tip beam cover defines a vertical thickness that decreases toward a distal direction with respect to the longitudinal axis (figs. 30-33), wherein the tip beam cover further defines a lateral width that decreases toward the distal direction, wherein the tip beam cover envelops the tip beam and defines an atraumatic configuration with rounded edge surfaces and a distally-tapering width.
Given the teachings of Bruns et al. have a dissector tip with a tapered distal surface and a deformable distal beam portion that is manually bendable to define at least one angled configuration relative to a longitudinal axis and having the tip straight or angled as desired and tip beam cover at least partially surrounding the tip beam and movable therewith to the at least one angled configuration, it 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 to modify the dissector tip further comprises a tip beam cover at least partially surrounding the tip beam, wherein the tip beam cover defines a vertical thickness that decreases toward a distal direction with respect to the longitudinal axis, wherein the tip beam cover further defines a lateral width that decreases toward the distal direction, wherein the tip beam cover envelops the tip beam and defines an atraumatic configuration with rounded edge surfaces and a distally-tapering width for having smooth intro feature for less damage to tissue (gentler) and a protective cover/softer cover purposes as taught by KNODEL et al.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as obvious over KNODEL et al. (WO 2013151888 A1) in view of Harris et al. (US 20190000481 A1) and further in view of Bruns et al. (US 20200237368 A1).
Regarding claims 1, 6-7, 10, 12-13, 18, and 20, KNODEL et al. discloses a tool assembly (4) for a surgical stapler (1), the tool assembly comprising: a cartridge assembly (14); an anvil assembly (12) comprising a base portion (78, figs. 11-12) and an anvil portion (12), the base portion coupled to the cartridge assembly such that the tool assembly is moveable from an open position to a clamped position (figs. 1-4, 14-15, 21-22, and 30-32), and the anvil portion secured to the base portion and including a plurality of staple deforming pockets [0042]; and
a dissector tip (200) having a tapered distal surface (blunt, figs. 30-33) and comprising a tip beam (202) with a proximal portion and a distal portion with the proximal portion fixedly secured to the cartridge assembly (via molding or “mechanically attached”, directly attached to anvil [0052] with a deformable distal beam portion that is manually bendable to define at least one angled configuration relative to a longitudinal axis (fig. 32) extending through the tool assembly, wherein the deformable distal beam portion is manually bendable to define the first configuration and the second configuration, the at least one angled configuration comprises a first configuration with the dissector tip aligned with the longitudinal axis, and a second configuration with the dissector tip defining an acute angle with the longitudinal axis (“flexible tip 200 initially may be straight, angled or form any other suitable shape” [0051-0053, 0065, 0075-], claims 1-6, 9-11, and 9-18, figs. 30-32).
KNODEL et al. fails to explicitly disclose the tip proximal portion fixedly secured to the anvil assembly, the distal portion being deformable to a longitudinal axis of the tool assembly to define at least two angled configurations of the dissector tip for use during a surgical procedure wherein the at least two angled configurations comprise a first configuration with the dissector tip substantially aligned with the longitudinal axis, and a second configuration with the dissector tip defining an acute angle with the longitudinal axis and the tip beam with a deformable distal beam portion that is manually bendable to define at least one angled configuration, relative to a longitudinal axis extending through the tool assembly, in which the tip beam is retained for use during a surgical procedure; and a tip beam cover at least partially surrounding the tip beam and movable therewith to the at least one angled configuration and having tapered distal surface.
Harris et al. teaches an anvil assembly (318) with a dissector tip (319/519/3219 and/or 70314, figs. 108-111) having a proximal portion fixedly secured to the anvil assembly or cartridge assembly and with the distal portion being deformable to a longitudinal axis of the tool assembly to define at least two angled configurations (non-deflected position to a deflected position and other positions “ad hoc customization of the bend angle” figs. 11-17, 26E-29 and 59-66) of the dissector tip for use during a surgical procedure and teaches having protrusion (3231) to pivot tip (3219) into bent positions ([2010, 0270] and also teaches having a tapered distal surface (3519, figs. 28-29) and having a malleable/bendable tips wherein the at least two angled configurations comprises a first configuration with the dissector tip substantially aligned with the longitudinal axis, and a second configuration with the dissector tip defining an acute angle (figs. 11-17, 26E-29 and 59-66 show acute angles) with the longitudinal axis (30312/30422, 30522 [0367-0381, 0458-0460, 0499], claims 1 and 13, figs. 59-66).
Harris et al. states: “allows for ad hoc customization of the bend angle [0373] ... malleable member (30422) is configured to increase the rigidity of placement tip (30414) and allow an operator to customize the shape of placement tip (30414) by producing different angles of placement tip (30414). For example, FIG. 63A may refer to a pre-customized standard angle alpha (α31), while FIG. 63B may refer to a post-customized angle beta (β31) [0375]… allow an operator to customize the shape of the placement tip by producing different placement tip angles” ([0499] and claim 13).
Bruns et al. teaches a surgical stapler (10/310), comprising a dissector tip (1730) positioned at the distal anvil end overlying the distal cartridge end (figs. 1-12 and 45) comprising: a tip beam (1722) including: a proximal portion fixedly secured to the support bracket (1740 [0234], fig. 45); and a distal portion being deformable, relative to the longitudinal axis, to define at least two angled configurations (“tip locking mechanism operable to releasably retain anvil tip (1722) in the first and second discrete positions” [0234]) in which the dissector tip (1722) is retained for use during a surgical procedure, tip beam (1722) is manually bendable for the two angled configurations and the at least two angled configurations of the dissector tip for use during a surgical procedure wherein the at least two angled configurations comprise a first configuration with the dissector tip substantially aligned with the longitudinal axis, and a second configuration with the dissector tip defining an acute angle with the longitudinal axis ([0214, 0232-0237], figs. 1-12 and 45-48).
Bruns et al. states: “tip locking mechanism may comprise one or more detent features, protrusions, recesses, resilient members, interference features, and the like of various types that will be readily apparent to those of ordinary skill in the art in view of the teachings herein [0214]…tip locking mechanisms described below in connection with anvils (1318, 1418, 1518, 1618, 1718, 1818)” [0214].. tip locking mechanism operable to releasably retain anvil tip (1722) in the first and second discrete positions” [0234].
Given the teachings of Kondo et al. to have a dissector tip with a tapered distal surface and a deformable distal beam portion that is manually bendable to define at least one angled configuration relative to a longitudinal axis and having the tip straight or angled as desired, it 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 to modify the tip proximal portion to be fixedly secured to the anvil assembly, the distal portion being deformable to a longitudinal axis of the tool assembly to define at least two angled configurations of the dissector tip for use during a surgical procedure wherein the at least two angled configurations comprise a first configuration with the dissector tip substantially aligned with the longitudinal axis, and a second configuration with the dissector tip defining an acute angle with the longitudinal axis and the tip beam with a deformable distal beam portion that is manually bendable to define at least one angled configuration, relative to a longitudinal axis extending through the tool assembly, in which the tip beam is retained for use during a surgical procedure; and a tip beam cover at least partially surrounding the tip beam and movable therewith to the at least one angled configuration and having tapered distal surface to have the tip proximal portion fixedly secured to the anvil assembly or cartridge assembly for grasping tissue as needed (from top/anvil or bottom/cartridge as needed/desired) indexed a selected number of degrees to have precise adjustment of the tip end for more precise adjustment of the tool/effector for different position needs and more precise action on a surgical area and/or for tissue adjustment purposes as taught by Harris et al. and Bruns et al. and since has been held adjustability, where needed, is not a patentable advance, and if an art-recognized need for adjustment the prior art would have been obvious. In re Stevens, 212 F.2d 197, 101 USPQ 284 (CCPA 1954).
Regarding claims 2-5, 11, and 16, KNODEL et al. discloses the dissector tip further comprises a tip beam cover (204) at least partially surrounding the tip beam ([0052[, fig. 32), wherein the tip beam cover defines a vertical thickness that decreases toward a distal direction with respect to the longitudinal axis (figs. 30-33), wherein the tip beam cover further defines a lateral width that decreases toward the distal direction, wherein the tip beam cover envelops the tip beam and defines an atraumatic configuration with rounded edge surfaces and a distally-tapering width.
Regarding claims 8-9, 14, 17, and 19, KNODEL et al. discloses the distal beam portion includes a material (bendable core 202) with a retaining property such that, after bending the distal beam portion to a desired configuration, the material retains the distal beam portion in the desired configuration, wherein the tip beam comprises a metallic material, and wherein the tip beam cover comprises a biocompatible material with at least one of a polymeric material, metal, ceramic, or an elastomeric material [0052]. Harris et al. also teaches having a distal beam portion includes a material with a retaining property such that, after bending the distal beam portion to a desired configuration ([0367-0381, 0458-0460, 0499], claims 1 and 13, figs. 59-66), the material retains the distal beam portion in the desired configuration wherein the tip beam comprises a metallic material, and wherein the tip beam cover comprises a biocompatible material with at least one of a polymeric material, metal, ceramic, or an elastomeric material [0380]. Bruns et al. also teaches the distal beam portion includes a material (metal) with a retaining property such that, after bending the distal beam portion to a desired configuration, the material retains the distal beam portion in the desired configuration, wherein the tip beam comprises a metallic material, and wherein the tip beam cover comprises a biocompatible material (elastomeric) with at least one of a polymeric material, metal, ceramic, or an elastomeric material [0208-0234].
Conclusion
Additional prior art considered pertinent: KR 101209589 B1 – ANVIL TIP BENDABLE IN MIDDLE, see form 892.
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 ROBERT LONG whose telephone number is (571)270-3864. The examiner can normally be reached M-F, 9am-5pm, 8-9pm (EST).
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/ROBERT F LONG/Primary Examiner, Art Unit 3731
