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
As of the reply filed 8/25/2025, claims 1-5, 7-13, 15, 18-19, and 22-26 are pending. Claims 1, 3, 7-10, 11-12, 15, and 18 have been amended. Claims 6, 14, 16-17, and 20-21 are canceled. Claims 11-12 are withdrawn from consideration. Claims 22-26 are new.
Response to Arguments
Applicant’s amendments to claims 1, 15, and 20-21 have overcome the previously filed drawing objections, therefore these objections are withdrawn.
Applicant’s cancellation of claim 14 has overcome the previously filed claim objection, therefore this objection is withdrawn.
Applicant’s amendments to claims 1 and 14 have overcome the previously filed 112 rejections, therefore these rejections are withdrawn.
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, in view of Applicant’s amendments to the claims.
Claim Objections
Claims 1 and 9 are objected to because of the following informalities:
Claim 1 was amended to recite “the first edge” and “the second edge”, however line 17 was later amended to recite “the first blade edge and the second blade edge”. It is recommended that the names of these features be standardized and that line 17 be amended to recite only “the first edge and the second edge” instead.
Claim 9 was amended to recite “configured to be slide axially” in line 8, which is grammatically incorrect. It is recommended that the claim be amended such that this limitation reads as it originally did- “the guide configured to be slid axially by a user…” instead.
Appropriate correction is required.
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.
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.
Claims 1, 4-5, 7-8, 13, 18-19, and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura et al. (US PGPub 2012/0197253 A1) over Piskun (US PGPub 2016/0374658 A1).
With respect to claim 1, Nishimura et al. discloses a surgical instrument (1 in Fig. 1) for removing biological tissue during a surgical procedure (see PP [0002], the device is configured to incise or resect body tissue), the instrument (1) comprising:
a tissue collection device (1 in Fig. 1) comprising:
an elongate shaft (2 in Figs. 1-2) extending along a central axis to define an axial direction (see Fig. 2); and
an end effector (5) connected to a distal portion of the elongate shaft (2), wherein the end effector (5) comprises;
a first component (10) having a first edge sharpened to form a blade (sharp blade 10c); and
a second component (11) having a second edge sharpened to form a blade (sharp blade 11c);
wherein the first edge and the second edge (10-11) comprise inner opposing edges (see inner edges 10c and 11c in Figs. 2-3) that engage at an interface (13) along the central axis and are sharp to cut tissue (10c and 11c are sharp blades configured to cut tissue);
wherein curvature of one or both of the elongate shaft (2) and end effector (5) is adjustable (curvature of shaft 2 is adjustable, see flexible coil pipe 2a) to position the first blade edge and the second blade edge (10c and 11c) along a tissue surface when the curvature of the one or both of the elongate shaft (2) and end effector (5) is adjusted (see MPEP 2112.01, flexible coil 2a enables this by allowing adjustment to the orientation of the end effector 5 and the shaft 2); and
an endoscope (PP [0049]: “The sheath 2 is laid in a treatment device guide channel (not illustrated) of the endoscope”) comprising:
a shaft comprising an internal lumen in which the elongate shaft (2) is located, wherein the shaft is elongated so as to be configured to extend through anatomy, wherein the end effector is configured to protrude from an end of the internal lumen (PP [0085]: “when the treatment section 5 is projected from the treatment device guide channel of the endoscope into the body cavity”).
However, Nishimura et al. fails to disclose an endoscope comprising:
a biasing device within the internal lumen and engaged with the end effector, the biasing device configured to alter the curvature of one or both of the elongate shaft and end effector; and
a handpiece connected to a proximal end of the shaft, the handpiece including an activation mechanism to advance and retract the biasing device along the tissue collection device.
In the same field of minimally invasive procedures (abstract), Piskun teaches a surgical assembly comprising a tool (125 in Fig. 1) and a biasing device (110) within a lumen (see 110 within 105) engaged with the end effector (125), the biasing device (110) configured to alter the curvature of the tool (125, PP [0107]: “The channel 110 can, for example, be in operable contact with an independently manipulable-and-articulable tool, the channel having an elevator component for moving a bendable section. Thus, the length of the channel in some embodiments is sufficient so it can extend out the proximal end of the outer tube 105 for manipulation by the user. The tool channels are bendable or articulable at a distal end so they angle away from the longitudinal axis and toward the target tissue 190”, PP [0108]: “As can be appreciated, the tool 120,125 can be flexible, at least at a distal end such that when the tool channel 110 bends in a manner described above, it also bends the tool which is positioned therein”) and a handpiece configured to connect to a proximal end of a shaft (PP [0107]: “the tool channel 110 can have a mechanism such as an elevator component or a control wire attached to a distal end which can be pulled by the user or pulled by an actuator to move the tool channel to the bent position”), the handpiece including an activation mechanism to advance and retract the biasing device along the tissue collection device (see PP [0107]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Nishimura et al. device to incorporate the biasing device as taught by Piskun. One of ordinary skill in the art would have been motivated to perform this modification because it would have constituted the use of a known technique (the use of an articulating guide sheath to control articulation of a tool inserted therethrough) to improve a known device (the tool of Nishimura et al.) in such a way as to yield predictable results, since the combination as proposed would yield the biasing channel of Piskun (110 in Fig. 1) within the endoscope as disclosed by Nishimura et al. and further with the tool of Nishimura et al. disposed therethrough, since Piskun states that “the tool 120,125 can include a grasper, a forceps, a snare, a scissor, a knife, a dissector, a clamp, an endoscopic stapler, a tissue loop, a clip applier, a suture-delivering instrument, or an energy-based tissue coagulator or cutter” (PP [0108]).
Regarding claim 4, Nishimura et al. as modified by Piskun further discloses wherein one or both of the elongate shaft (2 in Fig. 2) and end effector (5) are biased to a straight configuration (see Fig. 2, 2 and 5 are both straight).
Regarding claim 5, Nishimura et al. as modified by Piskun further discloses wherein one or both of the elongate shaft (2 in Fig. 2) and end effector (5) are biased to a curved configuration (see MPEP 2112.01, when navigating torturous vasculature the coil pipe 2a would be biased to a curved configuration by the surrounding tissue of the patient’s body).
Regarding claim 7, Nishimura et al. as modified by Piskun further discloses wherein the biasing device (110 in Fig. 1 of Piskun) induces the end effector (5 in Fig. 1 of Nishimura et al., see also 125 in Fig. 1 of Piskun) to being straight (see MPEP 2112.01, PP [0107]: “the tool channel 110 can have a mechanism such as an elevator component or a control wire attached to a distal end which can be pulled by the user or pulled by an actuator to move the tool channel to the bent position”, since the biasing member 110 can be actuated to affect the bend of the end effector it can also induce it to be straight).
Regarding claim 8, Nishimura et al. as modified by Piskun further discloses wherein the biasing device (110 in Fig. 1 of Piskun) induces the end effector (5 in Fig. 1 of Nishimura et al., see also 125 in Fig. 1 of Piskun) to being curved (see MPEP 2112.01, PP [0107]: “the tool channel 110 can have a mechanism such as an elevator component or a control wire attached to a distal end which can be pulled by the user or pulled by an actuator to move the tool channel to the bent position”).
Regarding claim 13, Nishimura et al. as modified by Piskun further discloses wherein means for controlling curvature (this does not fall under 112(f) because the claim later states that the structure is a pre-curve) of one or both of the elongate shaft (2 in Fig. 2) and end effector (5) comprises a pre-curve introduced into one or both of the elongate shaft (2) and end effector (5, the end effector 5 has rounded edges and can be considered to have a pre-curve).
Regarding claim 18, Nishimura et al. as modified by Piskun further discloses wherein the biasing device (110 in Fig. 1 of Piskun) is configured to slide along the end effector (5 in Fig. 1 of Nishimura et al., see also tool 125 in Fig. 1 of Piskun) to increase a radial distance between a tip of the end effector and the central axis (see PP [0107], movement of 110 adjusts the bend of the end effector therefore changing the radial distance).
Regarding claim 19, Nishimura et al. as modified by Piskun further discloses wherein the device (110 in Fig. 1 of Piskun) to adjust curvature of the end effector (5 in Fig. 1) comprises a steerable or pre-curved guide slidably connected to the end effector (110 is a steerable guide, see PP [0107]).
Regarding claim 23, Nishimura et al. as modified by Piskun further discloses wherein the inner opposing edges (10c and 11c in Fig. 2) extend parallel to the central axis (see Fig. 2, the inner edges extend distally in a direction parallel at least in part to the central axis).
Regarding claim 24, Nishimura et al. as modified by Piskun further discloses wherein a distal tip of the end effector (5 in Fig. 2) formed by the first component and the second component (10 and 11) is blunt (see Fig. 2, only 10c-d and 11c-d are sharpened, therefore the distal ends of 10 and 11 as seen in Fig. 2 can be considered to be a blunt distal tip).
Regarding claim 25, Nishimura et al. as modified by Piskun further discloses wherein the interface (13 in Fig. 2 of Nishimura et al.) of the inner opposing edges of the first edge and the second edge (10c and 11c) extends along a length (13 has a length therefore it extends along a length).
Regarding claim 26, Nishimura et al. as modified by Piskun further discloses wherein the first and second components (10 and 11 in Fig. 2 of Nishimura et al.) are configured to spread apart from each other to cut tissue when pushed against the tissue surface (see Fig. 3).
Claims 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura et al. (US PGPub 2012/0197253 A1) and Piskun (US PGPub 2016/0374658 A1), as applied to claim 1 above, and further in view of Ouchi (US PGPub 2002/0123667 A1).
Regarding claim 2, Nishimura et al. as modified by Piskun further discloses wherein the end effector (5 in Fig. 2 of Nishimura et al.) comprises a flexible sheet body (scissors 10 and 11 are relatively thin and could be bent under certain circumstances therefore they can be considered a flexible sheet body), the flexible sheet body being disposed transverse to the central axis of the elongate shaft (the body of 5 can be moved relative to the central axis of elongate shaft 2 when the coiled portion 2a is bent, therefore it can be disposed transverse to the axis of the elongate shaft 2).
However, Nishimura et al. fails to disclose wherein the end effector comprises a flexible sheet metal body, since the Nishimura et al. reference is silent on the material of the scissors 10 and 11.
In the same field of electrosurgical end effectors (abstract), Ouchi teaches a device (100 in Fig. 1) comprising an end effector (106) consisting of a first and second component (110 and 112), wherein the end effector comprises a flexible sheet metal body (PP [0012]: “The shafts and/or the end effectors may be made of metal in order to increase the durability of the forceps”, the end effector is thin and therefore can be considered to be a sheet, and is capable of being bent therefore it can be considered to be relatively flexible).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Nishimura et al. and Piskun combination to further incorporate the teachings of Ouchi and include wherein the end effector comprises a flexible sheet metal body. One of ordinary skill in the art would have been motivated to perform this modification “to increase the durability of the [end effector]” (PP [0012]). Such a modification would yield predictable results since the Ouchi device also concerns itself with electrically conductive jaw members (PP [0009]).
Regarding claim 15, Nishimura et al. as modified by Piskun further discloses wherein the end effector (5 in Fig. 3A) comprises:
a first sheet body having the first blade edge (10 with 10c); and
a second sheet body having the second blade edge (11 with 11c).
However, Nishimura et al. is silent on the material of the end effector and fails to disclose first and second sheet metal bodies.
In the same field of electrosurgical end effectors (abstract), Ouchi teaches a device (100 in Fig. 1) comprising an end effector (106) consisting of a first and second component (110 and 112), wherein the end effector comprises a flexible sheet metal body (PP [0012]: “The shafts and/or the end effectors may be made of metal in order to increase the durability of the forceps”, the end effector is thin and therefore can be considered to be a sheet, and is capable of being bent therefore it can be considered to be relatively flexible).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Nishimura et al. and Piskun combination to further incorporate the teachings of Ouchi and include wherein the end effector comprises a flexible sheet metal body. One of ordinary skill in the art would have been motivated to perform this modification “to increase the durability of the [end effector]” (PP [0012]). Such a modification would yield predictable results since the Ouchi device also concerns itself with electrically conductive jaw members (PP [0009]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Nishimura et al. (US PGPub 2012/0197253 A1) and Piskun (US PGPub 2016/0374658 A1), as applied to claim 1 above, and further in view of Wayne et al. (US PGPub 2002/0026189 A1).
Regarding claim 3, Nishimura et al. as modified by Piskun further discloses wherein the end effector (5 in Fig. 2 of Nishimura et al.) comprises an electric blade (PP [0074]: “The blades 10c and 11c of the pair of scissor elements 10 and 11 are electrically conductive. Almost entire surface of the treatment section 5 including the stopper 14 but not the blades 10c and 11c is nonconductive”) comprising:
a flexible insulating body (7) comprising the elongate shaft (7 is an insulating body on top of shaft 2, and is part of shaft 2); and
a flexible conducting wire (3) extending along the flexible insulating body (7) and the end effector (5) to define a cutting edge;
wherein the flexible conducting wire (3) is connectable to an energization source (265 in Fig. 3C).
However, Nishimura et al. and Piskun fail to disclose wherein the handpiece includes a control feature for operating the energization source.
In the same field of electrosurgical end effectors (abstract), Wayne et al. teaches an electrosurgical device (Figs. 1-3) comprising a handpiece including a control feature for operating the energization source (PP [0009]: “The support and operating button might be physically located on the handle so when the electrosurgical instrument is grasped by the handle the operating button is positioned for control by the surgeon's finger of electrosurgical energy delivery”, see also PP [0011]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Nishimura et al. and Piskun combination to further incorporate the teachings of Wayne et al. and explicitly include wherein the handpiece includes a control feature for operating the energization source. One of ordinary skill in the art would have been motivated to perform this modification because it involves the use of a known feature (a control feature for selectively controlling the energization of an electrosurgical device) to improve a similar device (the electrosurgical scissors of Nishimura et al.) in a way that would have yielded predictable results. Furthermore, the combination as proposed would still yield “the handpiece… [including] a control feature”, since claim 1 only requires “a handpiece connected to a proximal end of the shaft” and does not specifically recite any other structural features of the handpiece. Although the control feature as taught by Wayne et al. would not be part of the handpiece and biasing member as taught by Piskun, the handpiece of Wayne et al. can still be considered to be part of the Piskun handpiece since the proposed combination would yield the handpiece of Wayne et al. adjacent the handpiece of Piskun on the proximal end of the assembly.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura et al. (US PGPub 2012/0197253 A1) and Piskun (US PGPub 2016/0374658 A1), as applied to claim 1 above, and further in view of Marczyk et al. (US PGPub 2010/0179540 A1).
Regarding claim 9, Nishimura et al. as modified by Piskun further discloses wherein the biasing device (110 in Fig. 1 of Piskun) comprise a brace (body of 110) slidable along the end effector (5 in Fig. 1 of Nishimura et al., the body of 110 is slidable relative to tool 125 therefore it would be slidable along the end effector of Nishimura et al. when combined), the brace (body of 110) comprising:
a first flexible and elongate extension (PP [0107]: “the tool channel 110 can have a mechanism such as… a control wire attached to a distal end which can be pulled by the user or pulled by an actuator to move the tool channel to the bent position”) extending alongside the elongate shaft in the axial direction within the internal lumen (the combination as proposed would yield 110 within the endoscope as disclosed by Nishimura et al. with the elongate shaft 2 of the Nishimura et al. device within the channel 110); and
a guide (distal end of channel 110) connected to the first extension (core wire in PP [0107]) and extending flat across the end effector (5 in Fig. 1 of Nishimura et al., see MPEP 2112.01, the combination as proposed would be capable of being arranged in this way with the distal end of 110 extending across the end effector of Nishimura et al.), the guide (distal end of channel 110) configured to be slide axially by a user to push the end effector (5 in Fig. 1 of Nishimura et al.) to control the curvature via the actuation mechanism (PP [0108]: “The bendability of the channel 110 for moving a bendable section, often a distal end of the channel 110, manipulates, i.e., bends, the tool 120,125 positioned therein”).
However, Nishimura et al. as modified by Piskun fails to disclose a second flexible and elongate extension extending alongside the elongate shaft in the axial direction within the internal lumen, since Piskun only teaches a single control wire (see PP [0107]).
In the same field of flexible endoscopic instruments (abstract), Marczyk et al. teaches an instrument (see Fig. 8) comprising a flexible shaft (12) wherein the flexible shaft comprises first and second flexible elongate extensions (94a-b) extending alongside the shaft (12) in the axial direction for articulating the end effector (see Figs. 8-9).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the Nishimura et al. and Piskun combination to incorporate the teachings of Marczyk et al. and include a second flexible elongate extension. One of ordinary skill in the art would have been motivated to perform this modification since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)), and Piskun already contemplates a single elongate extension.
Regarding claim 10, Nishimura et al. as modified by Piskun further discloses wherein the biasing device (110 in Fig. 1 of Piskun) comprises a steering device (body of 110) configured to pull the end effector (5 in Fig. 1 of Nishimura et al.) in one or more directions (the combination as proposed would produce 110 surrounding the device of Nishimura et al., therefore the body of 110 would be able to pull the end effector in multiple directions), the steering device (body of 110) comprising:
a first pull wire (PP [0107]: “the tool channel 110 can have a mechanism such as… a control wire attached to a distal end which can be pulled by the user or pulled by an actuator to move the tool channel to the bent position”) extending alongside the elongate shaft () within the internal lumen and connected to the end effector (the combination as proposed would yield 110 within the endoscope as disclosed by Nishimura et al. with the elongate shaft 2 of the Nishimura et al. device within the channel 110);
wherein the activation mechanism is connected to the first pull wire to adjust tension in the first pull wire (PP [0107]: “the tool channel 110 can have a mechanism such as… a control wire attached to a distal end which can be pulled by the user or pulled by an actuator to move the tool channel to the bent position”).
However, Nishimura et al. as modified by Piskun fails to disclose a second pull wire, independent of the first pull wire, extending alongside the elongate shaft within the internal lumen and connected to the end effector, and wherein the activation mechanism is connected to the first pull wire and the second pull wire.
In the same field of flexible endoscopic instruments (abstract), Marczyk et al. teaches an instrument (see Fig. 8) comprising a flexible shaft (12) wherein the flexible shaft comprises first and second pull wires (94a-b) extending alongside the shaft (12) in the axial direction for articulating the end effector (see Figs. 8-9).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the Nishimura et al. and Piskun combination to incorporate the teachings of Marczyk et al. and include a second pull wire for articulating the end effector. One of ordinary skill in the art would have been motivated to perform this modification since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)), and Piskun already contemplates a single pull wire.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Nishimura et al. (US PGPub 2012/0197253 A1) and Piskun (US PGPub 2016/0374658 A1), as applied to claim 1 above, and further in view of Kappel et al. (US PGPub 2013/0172828 A1).
Regarding claim 22, Nishimura et al. as modified by Piskun fails to disclose a passage extending alongside the shaft of the endoscope and configured to open proximate the end effector;
wherein the passage is connectable to a source of adhesion suppressant; and
wherein the handpiece includes a control feature for dispensing adhesion suppressant from the passage.
In the same field of endoscopic surgical procedures (abstract), Kappel et al. teaches an endoscope comprising a plurality of passages (see Fig. 1) extending along the shaft of the endoscope (20) and configured to open proximate an end effector within the endoscope (see 90 in Fig. 2B). Kappel et al. further teaches wherein the passage is connectable to a source of adhesion suppressant (see MPEP 2112.01, this is functional language, irrigation channel 50 can be considered to be configured to connect to a source of adhesion suppressant) and a control feature at the proximal end of the endoscope for dispensing adhesion suppressant from the passage (50, PP [0042]: “Irrigation channel 50 may be configured to facilitate fluid flow (including a vacuum) from the proximal end of medical device 10 to the distal end of medical device 10. In some embodiments, a proximal end of irrigation channel 50 may be attached to a source of fluid, and a distal end of irrigation channel 50 may include a nozzle to alter fluid flow. In some embodiments, fluid may flow from the proximal end of medical device 10 to the work site through irrigation channel 50”, PP [0054]: “jet device 150 can cause laser energy or high pressure fluid from port 160 towards platen 170 to cut tissue received therebetween”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Nishimura et al. and Piskun combination to further incorporate the teachings of Kappel et al. and include the adhesion suppressant passage and control feature as claimed. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted applying a known technique (an endoscope with an irrigation channel comprising a control feature) to a similar device (the endoscope mentioned by Nishimura et al.) to yield predictable results.
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 Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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