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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/06/2026 has been entered.
Response to Amendment
As of the reply filed 3/6/2026, claims 1-5, 7-12, 15, 18-19, and 22-29 are pending. Claims 1-2, 4-5, 7-9, 15, and 23 have been amended. Claims 6, 13-14, 16-17, 20-21, and 25 are canceled. Claims 11-12 remain withdrawn from consideration. Claims 27-29 are new.
Response to Arguments
Applicant’s amendments to claims 1 and 9 have overcome the previously filed claim objections, therefore these objections are withdrawn.
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection relies on a new reference to teach the amended claim language, and a new combination of references to teach the claim language as a whole.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2 and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 recites “wherein the end effector has a thickness of less than 0.5 mm”, however there is insufficient support for this limitation in the present specification, which only states that “In examples, first component 120A and second component 120B can be approximately 0.23 mm (0.009 inches) thick” (see PP [0054] of the present specification). Although the specification further states that “first component 120A and second component 120B can be thicker near shaft 116 to provide more rigidity and thinner near distal tip 126 to provide more flexibility” (see PP [0054]), this statement also does not provide adequate support for the range claimed. Claim 2 recites a broader range which is unsupported by this line. It is recommended that claim 2 be amended to reflect the language found in PP [0054] of the present specification.
Claim 27 recites “wherein the first component and the second component are fixed relative to each other without a hinge connection between them”, however Species A as elected (see Figs. 1A-B, 2A-B, 3A-B, 4A-B, 5A-C, 6-7, 8A-B, 9A-B, 13-14, 15A-B, and 16, see also Applicant’s Response to Restriction filed 5/08/2024) does not include support for the first and second components being fixed “without a hinge connection between them”. Applicant points to PP [0052] and Figs. 1A-B in the Remarks filed 3/6/2026 to support the language of this new claim. PP [0052] recites the following:
PP [0052] Shaft 116 can comprise a flexible and rigid body that supports tissue-removal device 112. Shaft 116 can include internal lumens or passages to connect tissue-removal device 112 to a proximate end of shaft 116 where operator controls can be located. Tissue-removal device 112 can comprise a cutting device having first component 120A and second component 120B. connected at hinge 122. Tissue-removal device 112 can have base 124 at shaft 116 and distal tip 26. In examples, tissue-removal device 112 can be configured as a scissors or forceps such that first component 120A and second component 120B form jaws. However, as discussed herein, tissue-removal devices can comprise scraping, sawing, slicing, cauterizing, ablating devices and the like. Inner opposing edges of first component 120A and second component 120B can be engaged along interface 128 configured to spread apart to receive tissue, such as by pivoting at hinge 122. Edges of first component 120A and second component 120B can be sharpened at interface 128 to form blades. In other examples, first and second components 120A and 120B can be serrated or include saw teeth, or a mixture of blades, serrations and teeth. In yet other examples, tissue-removal device 112 can comprise a tissue slicing device wherein first and second components 120A and 120B are connected as a single sheet or piece and a cutting edge can be located in place of interface 128. In such a configuration, the tissue-removal device 112 can be configured to shave or scrape tissue via rotation, similar to examples described below. In examples, first component 120A and second component 120B can be portions of a single sheet or piece of material and one or both other edges (edges opposite interface 128 in FIG. 1A that define an outer perimeter of tissue-removal device 112) of first component 120A and 120B can be sharpened.
The underlined portion supports the first half of claim 27, but the bolded sections contrast with the limitation of claim 27 requiring the first and second components being fixed “without a hinge connection between them”. The negative language of this limitation is missing from the present specification. Additionally, Figs. 1A-B which were mentioned as providing support for claim 27, show hinge 122 disposed between the first and second components and thus do not provide explicit support for the lack of a hinge connection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 29 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schaller et al. (US Patent No. 8,470,043 B2).
With respect to claim 29, Schaller et al. discloses a surgical instrument (see Figs. 22-25) for removing biological tissue during a surgical procedure (col. 1, lines 13-15: “may be utilized in a minimally invasive, e.g. endoscopic, surgical procedure to cut and remove tissue”), the instrument comprising:
a tissue collection device (see Figs. 22-25) comprising:
an elongate shaft (128) extending along a central axis to define an axial direction (128 extends along 129 in Fig. 22); and
an end effector (124) connected to a distal portion of the elongate shaft (128), wherein the end effector (124) comprises;
a first component (130 in Figs. 23-24) having a first edge sharpened to form a blade (col. 12, lines 47-49: “the tool 146 includes a first blade 130 and a second blade 148, in a two or opposing dual blade configuration”); and
a second component (148) having a second edge sharpened to form a blade (col. 12, lines 47-49: “the tool 146 includes a first blade 130 and a second blade 148, in a two or opposing dual blade configuration”);
wherein the first edge (edge of 130) and the second edge (edge of 148) comprise inner opposing edges (inner edges of 130 and 148, these edges are opposing due to their radial placement, see Fig. 23 where 130 and 148 as a whole oppose one another, their inner opposing edges also oppose one another) that engage at an interface (140) along the central axis and are sharp to cut tissue (see col. 12, lines 47-49 as cited above, the blade edges are sharp to cut tissue);
wherein curvature of the end effector (124) is adjustable (see curve adjusting in Figs. 23-24, both the blades 130 and 148 are adjusted and the overall curvature is adjusted via the curve of shaft 128) to position the first edge (edge of 130) and the second edge (edge of 148) along a tissue surface when the curvature of the end effector (124) is adjusted (col. 12 last paragraph to col. 13 first paragraph: “Referring to FIG. 24, the slip fit connection between the blades 130 and 148 and the pushing member 128 enhances the cutting tool's ability to translate over the curved portions of the distal end portion 34 of guide member 30. As the distal end portion 126 of pushing member 128 translates over the distal end portion 34 of the guide member 30, the proximal end portion 160 of blade 148, located on the inside of the curve, moves proximally away from collar 142 and the proximal end portion 132 of blade 130, located on the outside of the curve, moves distally until it engages collar 142”, this curvature adjustment enables placement of the edges along a tissue surface); and
wherein the end effector (124) comprises a thin sheet-like body (see thin structure of 130 in Figs. 22 and 23) having a thickness dimension (see thickness in Fig. 23), a length dimension along the central axis (see length in Fig. 23), and a transverse width dimension perpendicular to the central axis (see width in Fig. 22), wherein the thickness dimension is smaller than both the length dimension and the transverse width dimension (see Figs. 22-23, 130 and 148 of end effector 124 are each thinner than they are long or wide).
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, 15, 18-19, 23-24, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller et al. (US Patent No. 8,470,043) in view of Nishimura et al. (US PGPub 2012/0197253 A1) and Piskun (US PGPub 2016/0374658 A1).
With respect to claim 1, Schaller et al. discloses a surgical instrument (see Figs. 22-25) for removing biological tissue during a surgical procedure (col. 1, lines 13-15: “may be utilized in a minimally invasive, e.g. endoscopic, surgical procedure to cut and remove tissue”), the instrument comprising:
a tissue collection device (see Figs. 22-25) comprising:
an elongate shaft (128) extending along a central axis to define an axial direction (128 extends along 129 in Fig. 22); and
an end effector (124) connected to a distal portion of the elongate shaft (128), wherein the end effector (124) comprises;
a first component (130 in Figs. 23-24) having a first edge sharpened to form a blade (col. 12, lines 47-49: “the tool 146 includes a first blade 130 and a second blade 148, in a two or opposing dual blade configuration”); and
a second component (148) having a second edge sharpened to form a blade (col. 12, lines 47-49: “the tool 146 includes a first blade 130 and a second blade 148, in a two or opposing dual blade configuration”);
wherein the first edge (edge of 130) and the second edge (edge of 148) comprise inner opposing edges (inner edges of 130 and 148, these edges are opposing due to their radial placement, see Fig. 23 where 130 and 148 as a whole oppose one another, their inner opposing edges also oppose one another) that engage at an interface (140) along the central axis and are sharp to cut tissue (see col. 12, lines 47-49 as cited above, the blade edges are sharp to cut tissue);
wherein curvature of the end effector (124) is adjustable (see curve adjusting in Figs. 23-24, both the blades 130 and 148 are adjusted and the overall curvature is adjusted via the curve of shaft 128) to position the first edge (edge of 130) and the second edge (edge of 148) along a tissue surface when the curvature of the end effector (124) is adjusted (col. 12 last paragraph to col. 13 first paragraph: “Referring to FIG. 24, the slip fit connection between the blades 130 and 148 and the pushing member 128 enhances the cutting tool's ability to translate over the curved portions of the distal end portion 34 of guide member 30. As the distal end portion 126 of pushing member 128 translates over the distal end portion 34 of the guide member 30, the proximal end portion 160 of blade 148, located on the inside of the curve, moves proximally away from collar 142 and the proximal end portion 132 of blade 130, located on the outside of the curve, moves distally until it engages collar 142”, this curvature adjustment enables placement of the edges along a tissue surface); and
wherein the end effector (124) comprises a thin sheet-like body (see thin structure of 130 in Figs. 22 and 23) having a thickness dimension (see thickness in Fig. 23), a length dimension along the central axis (see length in Fig. 23), and a transverse width dimension perpendicular to the central axis (see width in Fig. 22), wherein the thickness dimension is smaller than both the length dimension and the transverse width dimension (see Figs. 22-23, 130 and 148 of end effector 124 are each thinner than they are long or wide).
However, Schaller et al. fails to explicitly disclose an endoscope comprising:
a shaft comprising an internal lumen in which the elongate shaft 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;
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), Nishimura teaches a system (see Fig. 1) comprising a tool (10) including an elongate shaft (11) and an end effector (14A-B) and further comprising an endoscope (1), the endoscope comprising a shaft (shaft of 1) comprising an internal lumen (2) in which the elongate shaft (11) is located, wherein the shaft (shaft of 1) is elongated so as to be configured to extend through anatomy, wherein the end effector (14A-B) is configured to protrude from an end of the internal lumen (2, see Fig. 1 where the tool 10 extends past the internal lumen to protrude).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Schaller et al. device according to the teachings of Nishimura to include an endoscope arranged about the elongate shaft as claimed. One of ordinary skill in the art would have been motivated to perform this modification as it is a simple combination of prior art elements according to known methods that would have yielded predictable results. One of ordinary skill in the art could have added the endoscope of Nishimura to the Schaller et al. system as each element merely performs the same function as it does separately, the combination as proposed simply incorporating the endoscope of Nishimura as a delivery and visualization guide sheath for the tool of the Schaller et al. reference. Such a modification would have yielded predictable results, as Schaller et al. teaches that the disclosed devices “are particularly well suited for performing endoscopic discectomy procedures” (col. 6, lines 34-36) and that “the tissue manipulation tools may be utilized in minimally invasive procedures that are conducted through an access port” (col. 6, lines 37-39), suggesting that the tool disclosed therein is suitable for combination with an endoscope for minimally invasive access and that the combination as proposed would not alter the main operating principle of the Schaller et al. device.
However, Schaller et al. as modified by Nishimura further fails to disclose 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 combination as proposed to incorporate the biasing device and handpiece 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 Schaller 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 and further with the tool of Schaller et al. disposed therethrough, since Piskun contemplates 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]). The modification as proposed would not alter the main operating principle of the Schaller et al. device, but would simply provide a method of controlling the bend of the flexible shaft (128 bends in Figs. 23-24) of the Schaller et al. reference.
Regarding claim 4, Schaller et al. as modified by Nishimura and Piskun further discloses wherein the end effector (124 in Figs. 23-24 of Schaller et al.) is biased to a straight configuration at rest (see Fig. 23) and not subject to external forces (in Fig. 23, shaft 128 is straight and the blade edges 130 and 148 are in a straight configuration as they extend for at least a portion of their length parallel to the shaft 128).
Regarding claim 5, Schaller et al. as modified by Nishimura and Piskun wherein the end effector (124 in Figs. 23-24 of Schaller et al.) is biased to a curved configuration at rest (see Fig. 24) and not subject to external forces (in Fig. 24, shaft 128 is curved and biases the end effector 124, see Fig. 22 for reference, to a curved configuration where blade edges 130 and 148 are not symmetrically opposing one another).
Regarding claim 7, Schaller et al. as modified by Nishimura and Piskun further discloses wherein the biasing device (110 in Fig. 1 of Piskun) induces the end effector (124 in Figs. 23-24 of Schaller et al.) to being straight (Piskun PP [0107]: “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. Such bendability can be achieved by providing tool channels (guides) 110 of shape memory material with a shape memorized bent position as shown in FIG. 1. When contained within the lumen of the outer tube 105 for insertion, the tool channels 110 would have a substantially straightened position, and when advanced from the distal end of the outer tube 105, would return to the bent position of FIG. 1. Other materials could also be utilized. In alternate embodiments, 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. These different ways to achieve bendability (articulation) of the tool channels can be used for the various embodiments of the systems described herein”, by controlling the bend of 110 the end effector can be induced into a straight position).
Regarding claim 8, Schaller et al. as modified by Nishimura and Piskun further discloses wherein the biasing device (110 in Fig. 1 of Piskun) induces the end effector (124 in Figs. 23-24 of Schaller et al.) to being curved (Piskun PP [0107]: “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. Such bendability can be achieved by providing tool channels (guides) 110 of shape memory material with a shape memorized bent position as shown in FIG. When contained within the lumen of the outer tube 105 for insertion, the tool channels 110 would have a substantially straightened position, and when advanced from the distal end of the outer tube 105, would return to the bent position of FIG. 11.. Other materials could also be utilized. In alternate embodiments, 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. These different ways to achieve bendability (articulation) of the tool channels can be used for the various embodiments of the systems described herein”, 110 can bend via shape memory material or a control wire to induce the end effector into a curved position).
Regarding claim 15, Schaller et al. as modified by Nishimura and Piskun further discloses wherein the end effector (124 in Fig. 22 of Schaller et al., see also Figs. 23-24 for double-blade embodiment) comprises:
a first sheet body (130, see Fig. 22, 130 has a thin flat body) having the first blade edge (col. 12, lines 47-49: “the tool 146 includes a first blade 130 and a second blade 148, in a two or opposing dual blade configuration”); and
a second sheet body (148) having the second blade edge (col. 12, lines 47-49: “the tool 146 includes a first blade 130 and a second blade 148, in a two or opposing dual blade configuration”).
However, the combination as proposed fails to disclose wherein the first sheet body and the second sheet body are fabricated from a metal shape memory alloy.
In an alternate embodiment, Schaller et al. further discloses a tissue manipulation tool (160 in Figs. 27-29) including a blade (168) comprising a sheet body (see angled view in Fig. 27, 168 is a thin sheet blade), wherein the sheet body blade (168) is fabricated from a metal shape memory alloy (col. 19, lines 56-end: “Preferably, the blade 168 is constructed from a flexible, superelastic material such as nitinol or other similar alloys”).
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 combination as proposed according to the additional teachings of Schaller et al. to include wherein the blades comprise a shape memory sheet metal body as claimed. One of ordinary skill would have been motivated to perform this modification because it is a combination of elements that would have yielded predictable results, as the embodiment in Figs. 27-29 of Schaller et al. includes a flexible blade that is substantially similar to the flexible blade of the embodiment of Figs. 23-24 such that the modification as proposed would not alter the main operating principle of the primary embodiment of the Schaller et al. reference, which is also concerned with a flexible blade for excising tissue.
Regarding claim 18, Schaller et al. as modified by Nishimura and Piskun further discloses wherein the biasing device (110 in Fig. 1 of Piskun) is configured to slide along the end effector (124 in Fig. 22 of Schaller et al., see also Figs. 23-24 for double-blade embodiment) to increase a radial distance between a tip of the end effector and the central axis (Piskun PP [0107]: “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. Such bendability can be achieved by providing tool channels (guides) 110 of shape memory material with a shape memorized bent position as shown in FIG. When contained within the lumen of the outer tube 105 for insertion, the tool channels 110 would have a substantially straightened position, and when advanced from the distal end of the outer tube 105, would return to the bent position of FIG. 11.. Other materials could also be utilized. In alternate embodiments, 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. These different ways to achieve bendability (articulation) of the tool channels can be used for the various embodiments of the systems described herein”, see Figs. 23-24 of Schaller et al., a biasing device such as 110 of Piskun would bend the blades 130 and 148 of Schaller et al. and increase their radial distance from the central axis).
Regarding claim 19, Schaller et al. as modified by Nishimura and Piskun further discloses wherein the device to adjust curvature (110 in Fig. 1 of Piskun, this limitation is being interpreted to mean the biasing device since claim 1 does not provide antecedent basis for “a device to adjust curvature” but merely states “the biasing device configured to alter the curvature…”) of the end effector (124 in Fig. 22 of Schaller et al., see also Figs. 23-24 for double-blade embodiment) comprises a steerable or pre-curved guide slidably connected to the end effector (Piskun PP [0107]: “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. Such bendability can be achieved by providing tool channels (guides) 110 of shape memory material with a shape memorized bent position as shown in FIG. When contained within the lumen of the outer tube 105 for insertion, the tool channels 110 would have a substantially straightened position, and when advanced from the distal end of the outer tube 105, would return to the bent position of FIG. 11. Other materials could also be utilized. In alternate embodiments, 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. These different ways to achieve bendability (articulation) of the tool channels can be used for the various embodiments of the systems described herein”, see Figs. 23-24 of Schaller et al., the biasing device 110 is either pre-curved with shape memory material or can be bent via a control wire and actuator, in the combination as proposed the end effector 124 of Schaller et al. is within the channel of biasing device 110 of Piskun such that they are slidably connected to one another).
Regarding claim 23, Schaller et al. as modified by Nishimura and Piskun further discloses wherein the inner opposing edges (edges of 130 and 148 in Figs. 23-24) extend parallel to the central axis (see Fig. 23, a portion of the edges of 130 and 148 are parallel to the central axis), and wherein the thin sheet-like body (body of 130 and 148, see the sheet of 130 in a three-quarter view in Fig. 22) is deformable to flex transversely to the central axis (see Figs. 23-24, 130 flexes and deforms in a direction perpendicular to 126, which is transverse to the central axis along 126 and 128).
Regarding claim 24, Schaller et al. as modified by Nishimura and Piskun further discloses wherein a distal tip of the end effector (124 in Fig. 22 of Schaller et al., see also Figs. 23-24) formed by the first component and the second component (130 and 148) is blunt (first collar 140 as shown in Fig. 22 and shown unmarked in Figs. 23-24 is a flat, blunt structure).
Regarding claim 26, Schaller et al. as modified by Nishimura and Piskun further discloses wherein the first and second components (130 and 148 in Figs. 23-24 of Schaller et al.) are configured to spread apart from each other (see Fig. 24, 130 bends away from 148) to cut tissue when pushed against the tissue surface (col. 12, lines 47-49: “the tool 146 includes a first blade 130 and a second blade 148, in a two or opposing dual blade configuration”).
Regarding claim 27, Schaller et al. as modified by Nishimura and Piskun further discloses wherein the first component and the second component (130 and 148 in Figs. 23-24 of Schaller et al.) comprise portions of a single continuous sheet of material (col. 12, lines 47-49: “the tool 146 includes a first blade 130 and a second blade 148, in a two or opposing dual blade configuration”, MPEP 2113: “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, see also In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), the two flat blades 130 and 148 are structurally the same as two portions of a single continuous sheet of material), wherein the first component and the second component (130 and 148) are fixed relative to each other without a hinge connection between them (130 and 148 are fixed via first collar 140, see Fig. 22 for numbering reference, there is no hinge connection in Figs. 130-148).
Regarding claim 28, Schaller et al. as modified by Nishimura and Piskun further discloses wherein the first component and the second component (130 and 148 in Figs. 23-24 of Schaller et al.) are each resilient to return to an undeflected state after being deflected by external force (see Figs. 23-24, 130 and 148 are flexible and can return to an undeflected state).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Schaller et al. (US Patent No. 8,470,043) in view of 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 Fogarty et al. (US PGPub 2002/0059938 A1) and Wayne et al. (US PGPub 2002/0026189 A1).
Regarding claim 3, Schaller et al. as modified by Nishimura and Piskun fails to disclose wherein the end effector comprises an electric blade comprising:
a flexible insulating body comprising the elongate shaft; and
a flexible conducting wire extending along the flexible insulating body and the end effector to define a cutting edge;
wherein the flexible conducting wire is connectable to an energization source; and
wherein the handpiece includes a control feature for operating the energization source.
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 tissue excision devices (abstract), Fogarty et al. teaches an end effector (200 in Fig. 3C) comprising an electric blade (250 and 260) comprising:
a flexible insulating elongate shaft (PP [0283]: “The flexible plastic tubing serves to electrically insulate the device from electrocautery and provide a clean pathway for the metal tubing to get to the tissue volume 22”); and
a flexible conducting wire (270 and 210 in Fig. 3C, PP [0135]: “proximal portion 210 is flexible enough”) extending along the flexible insulating elongate shaft (see PP [0283], the entire device extends through a portion of the flexible insulating elongate shaft including the flexible conducting wire) and the end effector (270 and 210 extend along a portion of the end effector 200) to define a cutting edge (PP [0138]: “When so energized, the distal portion 220 of the locating element becomes an active electrode that can cut through and optionally cauterize tissue as is well known to those of skill in the art”, the wire 270 and 210 convey electrical current to enable cutting through tissue, thus defining a cutting edge);
wherein the flexible conducting wire (270 and 210) is connectable to an energization source (265).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed further to include the electrical conduction features as claimed. One of ordinary skill in the art would have been motivated to perform this modification in order to “cut through and optionally cauterize tissue” and to “assist in advancing” the end effector through tissue (PP [0138] of Fogarty et al.), which would beneficially enhance the efficiency of the tissue removal procedure. The modification as proposed furthermore would not alter the main operating principle of the Schaller et al. device, since it is contemplated for use “in any number of surgical procedures to cut or otherwise disrupt and remove tissue from a patient” (col. 6, lines 32-34) and the combination as proposed would simply and predictably yield the cutting device as presented with the energization features of Fogarty et al. which would enhance the device’s cutting ability and offer the ability to selectively cauterize during or after the excision of tissue to promote hemostasis.
However, Schaller et al. as modified by Nishimura, Piskun, and Fogarty et al. fails 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 combination as proposed 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 combination as proposed) in a way that would have yielded predictable results, modifying the actuator of Piskin (see PP [0107]) to simply and predictably include the control feature for selectively controlling the energization functionality as taught by the Fogarty et al. reference.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller et al. (US Patent No. 8,470,043), 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, Schaller et al. as modified by Nishimura et al. and Piskun further discloses wherein the biasing device (110 in Fig. 1 of Piskun) comprises a brace (body of 110) slidable along the end effector (see Figs. 23-24 of Schaller et al., the body of 110 is slidable relative to tool 125 therefore it would be slidable along the end effector of Schaller et al. when combined), the brace (body of 110) comprising:
a first flexible and elongate extension (Piskun 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 of the Schaller 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 (see Figs. 23-24 of Schaller 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 Schaller et al.), wherein the guide comprises a slotted body having a slot open on one side to receive the end effector therethrough (see lumen through channel 110 which receives tool 125 and is configured to receive the end effector of Schaller et al.), wherein the guide is configured to ride along an external surface of the end effector (see Figs. 23-24 of Schaller et al.) without fully encircling the end effector (channel 110 of Piskun is separately advanceable compared to tool 125, and is configured to ride along a portion of the surface of tool 125 without fully encircling it, as tool 125 can extend beyond the distal end of channel 110, when combined tool 125 is replaced with the end effector of Schaller et al. such that it does is configured to ride along its external surface without fully encircling the end effector as the end effector extends distally beyond the end of channel 110), the guide (distal end of channel 110) configured to be slid axially by a user to push the end effector (see Figs. 23-24 of Schaller et al.) to control the curvature via the actuation mechanism (Piskun 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, Schaller et al. as modified by Nishimura et al. and 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 combination as proposed 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, Schaller et al. as modified by Nishimura et al. and 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 (see Figs. 23-24 of Schaller et al.) in one or more directions (the combination as proposed would produce 110 surrounding the device of Schaller 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 (128 in Figs. 23-24 of Schaller et al., in the combination as proposed the pull wire extends along channel 110 and 128 of Schaller et al. extends within the lumen of 110 along the pull wire) 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 of the Schaller 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, Schaller et al. as modified by Nishimura et al. and 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 combination as proposed 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 Schaller et al. (US Patent No. 8,470,043) in view of 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, Schaller et al. as modified by Nishimura and 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 combination as proposed 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. and shown in Piskin) to yield predictable results.
Conclusion
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
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