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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 31 March 2026 has been entered. Claim 1 is currently amended. Claim 6 was previously canceled, and claim 16 is new. Claims 1-5 and 7-16 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitations of claim 12 have been incorporated into amended independent claim 1, and the claim therefore no longer further limits the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-5 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Yuasa et al. (US PGPub No. 2020/0315437), hereinafter Yuasa, in view of Kamakura (WO 2017122546, see machine translation) and Manzo et al. (US PGPub No. 2020/0129226), hereinafter Manzo, and further in view of Zhou (CN 111419340, see machine translation).
Regarding claims 1 and 12, Yuasa teaches a medical electrotome (Fig. 1: treatment device 1) comprising:
an outer sheath tube (Fig. 2B: flexible sheath 20);
a traction rope movably inserted in the outer sheath tube and a handle assembly configured to drive the traction rope to move (Fig. 2B: control wire 5; par. 0027: “the control wire 5 is inserted into the flexible sheath 20 so as to move forward and backward (distally and proximally) in response to movement of the handle assembly 3”), wherein a proximal end of the snare ring is fixedly connected with a distal end of the traction rope (Fig. 2A: snare 6 connected to control wire 5; par. 0027: “a first treatment member is coupled to a distal end of the control wire 5. In the embodiment shown, the first treatment member is a snare 6”);
and a knife head assembly (Figs. 2A-2B), wherein the knife head assembly comprises a snare ring (Fig. 2A: loop section 6a of snare 6) and a cutting knife (Figs. 3A-3B: diathermic knife 7) that comprises a knife handle (Figs. 3A-3B: connection tube 8, protection member 10, spring 11) and a knife head (Figs. 3-5: tip of knife 7),
wherein the distal end of the snare ring is embedded and fixed in the knife handle, and the snare ring is embedded and engaged with the knife handle to form a fixed connection structure (Figs. 3A-3B and par. 0031: “The snare 6 and knife 7 are clamped together via a cylindrical connection tube 8, which stabilizes the junction between the treatment members”),
wherein the handle assembly comprises an operating handle (Figs. 1 and 2B: two lateral rings 3a) and a handle holder that is fixed with a proximal end of the outer sheath tube (Fig. 1: distal end of handle assembly 3 fixed with proximal end of sheath 20; pars. 0023-24: “The insertion portion 2 includes a flexible sheath 20 […] a handle assembly 3 operatively (and optionally, removably) coupled to a proximal end of the insertion portion 2”).
Yuasa teaches a crimp-style connection between the snare and the knife handle and does not explicitly teach wherein the connection portion between the snare ring and the knife handle comprises a first through-hole penetrating through the knife handle; and a distal end of the snare ring is integrally provided with a ring connection portion formed by bending, the ring connection portion comprises a first bent section, a second bent section and a third bent section that are connected sequentially, wherein the second bent section is inserted through the first through-hole, so that motion of the snare ring relative to the knife handle is limited in all three dimensions, and wherein the first through-hole is a straight through-hole. However, in a related electrosurgical art, Kamakura teaches a snare ring (Figs. 1-2: loop-shaped wire 2) connected to an electrosurgical knife (Figs. 1-2: tip 1) via a straight through-hole penetrating through the knife handle (Fig. 2 and page 2, lines 4-9: “the conductive tip 1 has an opening 11, and that a part of the conductive wire 2 is positioned within the opening 11, thereby connecting the conductive tip 1 and the conductive wire 2. This allows the conductive tip and the conductive wire 2 to be efficiently connected. More preferably, an opening 11 is provided on the proximal side of the tip 1, and a portion of the conductive wire 2 is positioned within the opening 11, thereby connecting the conductive tip 1 and the conductive wire 2”), wherein a distal end of the snare ring is integrally provided with a ring connection portion formed by bending, the ring connection portion comprises a first bent section, a second bent section and a third bent section that are connected sequentially, wherein the second bent section is inserted through the first through-hole (page 23, lines 14-15: “the wire 2 has a first bent portion 22 in the first wire portion 2A and a second bent portion 23 in the second wire portion 2B”), so that the distal end of the snare ring is embedded and fixed in the knife handle and motion of the snare ring relative to the knife handle is limited in all three dimensions (page 22, lines 13-15: “The tip 1 may be rotatable with respect to the conductive wire 2, may be movable along the long axis of the wire 2, or may be completely fixed”), and wherein the second bent section forms sharp right angles at both ends of the first through-hole with the first bent section and the third bent section (Figs. 4-5: sharp right angles in conductive wire 2 at both ends of the opening 11).
The substitution of one known element (bore-through connection as taught by Kamakura) for another (crimp connection as taught by Yuasa) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, since the substitution of the bore-through connection shown in Kamakura would have yielded the predictable result of a secure connection between the snare and the knife handle that does not require clamping or crimping.
The recitation of “wherein, in the process of connecting the cutting knife with the snare ring, the snare ring is inserted into the first through-hole first, then the ring connection portion of the distal end of the snare ring is bent into the first bent section, the second bent section and the third bent section sequentially” is regarded as a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. 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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
Kamakura does not explicitly teach two grooves arranged symmetrically and extending in a length direction of the knife handle in communication with two ends of the first through-hole, wherein the first bent section and the third bent section are limited in the two grooves respectively, and wherein each groove of the two grooves is a groove opened on the surface of the knife handle. However, given that open grooves for the first and third bent sections would provide only redundant functionality for this particular structure (namely, limiting the movement of the snare ring relative to the knife handle, which is already fixed), it would have been an obvious matter of design choice to make the limiting structures in whatever form or shape was desired or expedient, since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
The combination further does not explicitly teach wherein the second bent section is in a transition fit with the first through-hole. However, in a related electrosurgical art, Manzo teaches using friction from sharp bend angles as a means to retain a looped structure in place (Fig. 5A and par. 0048: “Path 748A is substantially co-planar with guide channel 746 and includes multiple sharp bends. Contact between cable loop 750 and the surface of jaw 742A at the bends in path 748A creates friction that prevents or resists sliding of cable 750, each bend increasing the frictional force that acts to retain cable loop 750 against pullout”), which Manzo teaches as an alternative to crimping for fixation against unwanted movement (par. 0047: “reliably attaching a crimp to some cable materials, e.g., non-conductive cable materials can present challenges. To avoid crimping, the cable loop may terminate through a high-friction pathway in jaw 742 or 744, so that friction prevents cables 751, 752, 753, and 754 from slipping relative to jaws 742 or 744”). In light of Manzo’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the knife handle of the combined reference such that the first through-hole provides friction (that is, a transition fit) with the second bent section of the snare ring, since Manzo teaches that friction from sharp bend angles can be used as an alternative to crimping (as taught by Yuasa) for fixation against unwanted movement of the combined reference’s looped structure, i.e., the snare ring.
Yuasa is silent with respect to a locking assembly configured to achieve mechanical locking and unlocking between the operation handle and the handle holder via rotation. However, in an analogous art, Zhou teaches a handle assembly for an electrosurgical blade with a locking assembly (Figs. 1-2 and par. 0040: “A locking element is provided in the through hole 112”) configured to achieve mechanical locking and unlocking between the operation handle and the handle holder via rotation (par. 0017: “When locking and positioning are required, the rotating rod is rotated so that the long side of the locking section is perpendicular to the extension direction of the opening groove. The locking section presses against the opening groove on the pull rod, causing the sidewall of the opening groove to expand outward and press against the inner sidewall of the sliding groove. This causes the pull rod and the rotating handle to fit tightly together, thus locking the pull rod and the rotating handle relative to each other and preventing axial sliding within the sliding groove”), which allows for adjustment and locking of surgical instrument length without requiring the user to constantly monitor and adjust the length (par. 0017: “this adjustable and locking handle assembly also enables the adjustment and locking of the extension length of surgical instruments, such as the electrosurgical cutter in an electrosurgical unit, the wire cutting ring in a snare, and the basket body in a stone retrieval basket, without requiring the user to constantly monitor and adjust the length, facilitating the operation of the aforementioned medical devices”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the handle assembly of the combined reference by providing a locking assembly that achieves mechanical locking and unlocking between the operation handle and the handle holder via rotation, as taught by Zhou, in order to allow for adjustment and locking of the surgical instrument’s length without requiring the user to constantly monitor and adjust the length, as taught by Zhou.
Regarding claim 2, the combination teaches the medical electrotome of claim 1 as described previously. Yuasa further teaches wherein the snare ring is formed by multiple strands of braided wires made of stainless steel, or multiple strands of braided wires made of nickel and titanium, or multiple strands of braided wires made of a composite material of stainless steel, nickel and titanium, or a single wire made of stainless steel, or a single wire made of nickel and titanium (par. 0052: “The diathermic snare may be formed of stainless steel, for example. […] The snare wire can be a stranded wire (comprising a plurality of elemental wires stranded together) or a monofilament wire”). Examiner notes that because these claim limitations are stated as alternatives, the claim is considered to be met when only one of the limitations is met.
Regarding claim 3, the combination teaches the medical electrotome of claim 1 as described previously. Yuasa further teaches wherein the snare ring and the knife handle are fixed together by welding or bonding (par. 0029: “a second treatment member coupled to a distal end of the first treatment member. Throughout this disclosure, unless indicated otherwise, members can be directly coupled to each other via conventional means, such as brazing, soldering, welding, or clamping” and par. 0031: “the insertion portion 2 of the treatment device 1 includes a snare 6 as the first treatment member and a knife 7 as the second treatment member”).
Regarding claim 4, the combination teaches the medical electrotome of claim 1 as described previously. Yuasa further teaches wherein the cutting knife is formed integrally with itself (Figs. 3A-3B: knife 7 formed integrally with itself).
Regarding claim 5, the combination teaches the medical electrotome of claim 1 as described previously. Yuasa further teaches wherein the knife head is of a mushroom-head type, a doornail type, a triangular type, an L-type or a linear type (Figs. 6A-6C; par. 0049: “FIGS. 6A-6C depict diathermic knives having various shapes. For example, the distal end of the knife can be blunt and/or hemispherical (FIG. 6A), hooked (FIG. 6B), or triangular (FIG. 6C)”).
Regarding claims 13-15, the combination teaches the medical electrotome of claim 1 as described previously. Zhou further teaches wherein the handle holder comprises an open slot extending axially in a sliding direction of the operating handle (Fig. 4: open slot 121), wherein the locking assembly comprises a rotating rod inserted in a second through-hole of the operating handle and comprising an end disposed in the open slot of the handle holder (Figs. 2-4: rotating rod 131 inserted in through-hole 112),
wherein the end of the rotating rod comprises two first opposite planar sides and two second opposite planar sides, and wherein a length of each of the two first opposite planar sides is longer than a length of each of the two second opposite planar sides (Fig. 3: planar sides 131a and 131b; par. 0042: “the locking section 131 has a set of relatively parallel and planar long side surface 131a and short side surface 131b. The length of the short side surface 131b is less than the length of the long side surface 131a”),
wherein the locking assembly is configured such that: when the two second opposite planar sides of the rotating rod are oriented in a width direction of the open slot, the operating handle can move axially in relation to the handle holder (Figs. 5-6 and par. 0046: “Since the distance b between the two long sides 131a is less than the width c of the opening groove 121 at this time, it does not prevent the pull rod 120 from sliding arbitrarily in the sliding groove 111, thereby realizing the adjustment of the extension length of the pull rod 120”); and when the two first opposite sides of the rotating rod are oriented in the width direction of the open slot, the operating handle is locked in place with the handle holder (Figs. 7-8 and par. 0047: “Since the distance a between the two short sides 131b is greater than the width c of the opening groove 121 at this time, the locking section 131 presses the side wall of the opening groove 121 outward. The side wall of the opening groove 121 is opened and pressed against the inner side wall of the sliding groove 111, thereby hindering the sliding of the pull rod 120 in the sliding groove 111, and realizing the effect of locking the pull rod 120 in the rotating handle 110 by the locking member”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the handle assembly of the combined reference with an open slot, second through-hole, and rotating rod with unequal planar sides as taught by Zhou, for the same reasons set forth previously in the rejection of claim 1.
Regarding claim 16, the combination teaches the medical electrotome of claim 1 as described previously. Kamakura further teaches wherein motion of the snare ring relative to the knife handle is prevented in all three dimensions (page 22, lines 13-15: “The tip 1 may be rotatable with respect to the conductive wire 2, may be movable along the long axis of the wire 2, or may be completely fixed;” since it is disclosed in contrast to configurations allowing motion in multiple dimensions, examiner interprets the fixed condition as preventing motion in all three dimensions).
Claims 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Yuasa in view of Kamakura, Manzo, and Zhou, and further in view of Hörlle et al. (US PGPub No. 2015/0320491), hereinafter Hörlle.
Regarding claim 7, Yuasa in view of Kamakura, Manzo, and Zhou teaches the electrotome of claim 1 as described previously. Yuasa further teaches comprising an injection unit (par. 0033: “The protection member 10 may also include an aperture 10e for passage of any fluid injected via the accessory port 4”), an electroresection unit (par. 0049: “The first or second treatment member may be a diathermic knife, in which cutting is performed by applying high-frequency current”), and a margin electroresection unit (Fig. 8C-8E and par. 0075: “FIG. 8C shows the distal portion of the flexible sheath 20 when the treatment device 1 is in the snare mode. The loop section 6a of the snare 6 is positioned around the isolated target tissue portion T. After positioning the distal loop in a desired position around the base of the isolated target tissue portion T, electrical current is applied via the snare 6 to the base portion as the snare 6 is retracted in order to collapse the snare 6 and finish resecting the target tissue portion T”), but the combination does not explicitly teach an electrocoagulation unit.
However, in related electrosurgical art, Hörlle teaches an electrotome (Fig. 1: bipolar electrosurgical instrument 100) with an electrocoagulation unit (Fig. 4: coagulation electrodes 1 and 2). To provide the electrotome of the combined reference with an electrocoagulation unit, as taught by Hörlle, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods (attaching electrodes to a catheter-type device) with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art, i.e., one skilled in the art would have recognized that adding the electrocoagulation unit of Hörlle to the electrotome of the combined reference would allow the electrotome to perform both cutting and coagulation in a single instrument.
Regarding claim 8, the combination teaches the electrotome of claim 7 as described previously. Yuasa further teaches the outer sheath tube (Fig. 2B: flexible sheath 20), a protective tube fixed to a distal end of the outer sheath tube (Figs. 4A-4C: protection member 10, flexible sheath 20; par. 0035: “the proximal protruding portion 10b can be removably press fit into the distal end of the flexible sheath 20 so that the flexible sheath 20 stretches around the proximal protruding portion 10b. As used herein, the term “press fit” refers to an interference fit in which two parts are fastened by friction after the parts are pushed together”), said handle holder (Fig. 1: distal end of handle assembly 3 fixed with proximal end of sheath 20), a catheter movably inserted in the handle holder and fixed with the proximal end of the traction rope (Fig. 2B: plug 12 fixed with proximal end of control wire 5; par. 0025: “The two lateral rings 3a are slidably connected to the remainder of the handle assembly 3 and are operatively connected to a control wire 5 via a plug 12”), a gas-liquid connector arranged on the handle holder, and a gas-liquid channel arranged in the gas-liquid connector (Fig. 2B: accessory port 4 and channel therein; par. 0026: “The treatment device 1 also includes an accessory port 4 that allows coupling of the treatment device 1 to other instruments. For example, the accessory port 4 can be connected to a pump or syringe (not shown) in order to administer saline and/or other medicaments to the treatment site. When a fluid such as saline is administered, the fluid passes through the lumen of the flexible sheath 20 to the distal end of the flexible sheath 20, and is ejected from the distal end of the flexible sheath 20 while it is positioned at the treatment site”). The combined reference is considered to meet the limitation of the injection unit as claimed because all the listed structures are taught by Yuasa.
Regarding claim 9, the combination teaches the electrotome of claim 8 as described previously. Yuasa further teaches a connecting tube arranged inside the outer sheath tube (Figs. 2A-2B: connection of control wire 5 and snare 6; pars. 0027-0028: “a first treatment member is coupled to a distal end of the control wire 5. In the embodiment shown, the first treatment member is a snare 6 […] When the control wire 5 is pulled backward (proximally), the loop section 6a of the snare 6 is retracted into the flexible sheath 20 and is stored within the flexible sheath 20”), said operating handle in sliding fit with the handle holder in an extension direction of the outer sheath tube (Fig. 1: lateral rings 3a and Figs. 5A-5C: lateral rings sliding with forces FA, FB in extension direction of the outer sheath tube), and an energized connector arranged on the operating handle and connected with the catheter (par. 0060: “The treatment members may be electrically coupled to the power source via the handle assembly 3, which may include a conductive member integrated within the handle assembly 3 via electrical cabling that electrically couples the handle assembly 3 with the power source”). Yuasa teaches the catheter, the handle holder, the outer sheath tube, the traction rope, the snare ring, and the cutting knife as laid out previously in the rejections of claims 1, 6, and 8. The combined reference is considered to meet the limitation of the margin electroresection unit as claimed because all the listed structures are taught by Yuasa.
Regarding claim 10, the combination teaches the electrotome of claim 9 as described previously. Yuasa teaches the energized connector, the operating handle, the catheter, the gas-liquid connector, the handle holder, the gas-liquid channel, the outer sheath tube, the traction rope, the connecting tube, the snare ring, the cutting knife, and the protective tube as laid out previously in the rejections of claims 1, 6, and 8-9. Hörlle further teaches wherein the electrocoagulation unit comprises electrocoagulation electrodes (Fig. 4: coagulation electrodes 1 and 2) fixed in an outer sheath tube (Fig. 4: coagulation electrodes 1,2 within guide sheath 200), and it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the electrocoagulation electrodes of Hörlle in the electrocoagulation unit of the combined reference, for the same reasons laid out previously in the rejection of claim 7.
Regarding claim 11, the combination teaches the electrotome of claim 10 as described previously. Yuasa teaches the energized connector, the operating handle, the catheter, the handle holder, the outer sheath tube, the traction rope, the connecting tube, the snare ring and the cutting knife as laid out previously in the rejections of claims 1, 6, and 8-10. The combined reference is considered to meet the limitation of the margin electroresection unit as claimed because all the listed structures are taught by Yuasa.
Response to Arguments
Applicant’s arguments, filed 31 March 2026, with respect to the rejection(s) of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kamakura. As described previously, Kamakura teaches fixing a snare ring in a knife handle so that the motion of the snare ring relative to the knife handle is limited in all three dimensions.
Conclusion
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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