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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 13th, 2026 has been entered.
Response to Amendment
Applicant’s amendments to the claims have overcome the claim objections and the 112(b) rejections previously set forth in the Non-Final Rejection mailed October 22nd, 2025.
Response to Arguments
Applicant’s arguments, see pages 9-10, filed March 13th, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102 have been fully considered and are persuasive in view of the amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art that teaches the newly disclosed claim limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites “liquid” in line 14 and it is unclear if this is the same liquid or a different liquid from that recited in line 2. For examination purposes, these are the same liquid and the limitation will be interpreted as “the liquid”.
Regarding claim 1, the claim recites “a first channel that is formed in the tubular portion to extend in an axial direction of the tubular portion, and has a distal end communicating with the first distal end opening and a proximal end communicating with the first connection port such that the liquid is ejectable from the first distal end opening” in lines 12-15 and it is unclear how this collection of features is configured “such that the liquid is ejectable from the first distal end opening” since lines 8-9 recite “a first connection port to which either of the liquid supply tool or the suction tool” which does not positively recite which of the liquid supply or suction tools are connected to the first connection point. For examination purposes, the limitation will be interpreted based on the liquid supply tool being connected to the first connection port until Applicant either amends or clarifies.
Regarding claim 1, the claim recites “a second channel that is formed in the tubular portion to extend in the axial direction, and has a distal end communicating with the second distal end opening and a proximal end communicating with the second connection port such that suction is provided at the second distal end opening when the suction tool is connected to the second connection port” in lines 20-24 and it is unclear how this collection of features is configured “such that suction is provided at the second distal end opening when the suction tool is connected to the second connection port” since lines 16-17 recite “a second connection port to which either of the liquid supply tool or the suction tool is connectable” which does not positively recite which of the liquid supply or suction tools are connected to the second connection point. For examination purposes, the limitation will be interpreted based on the suction tool being connected to the second connection port until Applicant either amends or clarifies.
Claims 2-11 are also rejected by virtue of their dependency on claim 1.
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.
Claims 1-4 & 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tang et al. (U.S. Pub. No. 20210113260, earliest effective filing date & cited in IDS), herein referred to as “Tang” in view of Tang et al. (U.S. Pub. No. 20220000344, earliest effective filing date), herein referred to as “Tang 2”.
Regarding claim 1, Tang discloses an endoscope ([0047]: As shown in FIG. 4A, dual-channel injection bipolar high frequency electrosurgical knife is inserted into the lesion tissue 40 through the value of the endoscope during surgery) comprising:
a suction source comprising a suction tool ([0043]: an infusion pump or a syringe may be connected to the 6% Luer taper 361 to inject liquid, such as normal saline; wherein a syringe is capable of providing suction);
a liquid supply source comprising a liquid supply tool configured to supply liquid ([0042]: The infusion pump is connected to the 6% Luer taper 351, normal saline or indicarmine is used to inject into submucosal to elevate the mucosal tissue and form a liquid cushion so called “water cushion” under the mucous membrane; [0049]: inject the normal saline or indicarmine into the lesion tissue 40 through the 6% Luer taper 351 to elevate the mucosal tissue);
an endoscopic treatment tool (Abstract: Dual-channel injection bipolar high frequency electrosurgical knife), comprising:
a tubular portion (protective tube 25);
a retractable rod (hollow tubular portion 111) configured to protrude from a distal end surface of the tubular portion ([0035]: hollow tubular portion 111 extends from the distal end to the proximal end of the bipolar high frequency electrosurgical knife) by a variable protrusion amount from the distal end surface in response to operations of an operation unit ([0035]: The active electrode 11 is used to cut tissue and inject liquid, and can be extended or retracted relative to the main part 20. The active electrode 11 is comprised of the hollow tubular portion 111 and the protrusion 112, and the distal end of hollow tubular portion 111 is provided with a protrusion 112);
a first connection port (6% luer taper 351) to which either of the liquid supply tool or the suction tool is connectable (infusion pump; [0042]: The infusion pump is connected to the 6% Luer taper 351, normal saline or indicarmine is used to inject into submucosal to elevate the mucosal tissue and form a liquid cushion so called “water cushion” under the mucous membrane);
a first distal end opening that is formed in a distal end surface of the retractable rod ([0049]: place the active electrode 11 at the marked point and inserted into the submucosal of the lesion tissue 40. Then, inject the normal saline or indicarmine into the lesion tissue 40 through the 6% Luer taper 351 to elevate the mucosal tissue; [0052]: As shown in FIGS. 1 and 4G, if there is tissue hemorrhage during the cutting process, the hemorrhage site 50 can also be flushed with normal saline injected by the 6% Luer taper 351; while the distal opening does not have a label, see Fig. 4G for the fluid path & first distal end opening);
a first channel (first liquid passageway 29a) that is formed in the tubular portion to extend in an axial direction of the tubular portion, and has a distal end communicating with the first distal end opening and a proximal end communicating with the first connection port such that liquid is ejectable from the first distal end opening ([0039]: The first channel 27 can restrains the hollow tubular portion 111 of the active electrode 11, and the proximal end of the hollow tubular portion 111 connects to the insulation coated screw 22 through the connector 21, thereby providing the first liquid passageway 29a; [0049]: place the active electrode 11 at the marked point and inserted into the submucosal of the lesion tissue 40. Then, inject the normal saline or indicarmine into the lesion tissue 40 through the 6% Luer taper 351 to elevate the mucosal tissue; [0052]: As shown in FIGS. 1 and 4G, if there is tissue hemorrhage during the cutting process, the hemorrhage site 50 can also be flushed with normal saline injected by the 6% Luer taper 351);
a second connection port (6% luer taper 361) to which either of the liquid supply tool or the suction tool is connectable ([0043]: an infusion pump or a syringe may be connected to the 6% Luer taper 361 to inject liquid, such as normal saline);
a second distal end opening that is formed in the distal end surface of the tubular portion ([0039]: the gap between the hollow tubular portion 111 of the active electrode 11 and the insulating part 12); and
a second channel (second liquid passageway 29b) that is formed in the tubular portion to extend in the axial direction, and has a distal end communicating with the second distal end opening and a proximal end communicating with the second connection port ([0039]: an interstitial passageway between the insulation sheath 25 and the seal 23, forming the second liquid passageway 29b liquid flows through the interstitial passage to the proximal end of the insulating part 12, and then flows into the gap between the hollow tubular portion 111 of the active electrode 11 and the insulating part 12, so that can clean the active electrode 11 and the insulating part 12, and can also flush the hemorrhage site; [0043]: an infusion pump or a syringe may be connected to the 6% Luer taper 361 to inject liquid, such as normal saline. Liquid enters the second liquid passageway 29b through the 6% Luer taper and then flows through the gap between the hollow tubular portion 111 of the active electrode 11 and the insulating part 12, thereby reaches the active electrode 11 and clean the mucous tissue on the active electrode 11 and insulating part 12 at the same time).
While Tang discloses the use of a syringe ([0043]) which is known to be capable of suction, Tang fails to explicitly disclose a suction source comprising a suction tool configured to supply suction;
such that suction is provided at the second distal end opening when the suction tool is connected to the second connection port.
However, Tang 2 discloses an endoscope ([0011]: an endoscope), comprising:
a suction source comprising a suction tool configured to supply suction (vacuum source; [0028]: a vacuum device is connected at the Luer taper through a channel of the spiral tube 223 to suck the tissue into the puncturing needle for sampling);
such that suction is provided at the second distal end opening when the suction tool is connected to the second connection port ([0028]: a vacuum device is connected at the Luer taper through a channel of the spiral tube 223 to suck the tissue into the puncturing needle for sampling; wherein the second distal end opening is the puncturing needle & the Luer taper is the second connection port).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the endoscope and endoscopic treatment tool of Tang to include a suction source and the suction functionalities of the second connection port and the second channel, as taught by Tang 2, for the purpose of enabling suction of tissue into the puncturing needle for sampling (Tang 2: [0028]). Wherein in this combination the endoscope and lumen arrangement is still that of Tang but the positive recitation of a suction source is taught by Tang 2.
Regarding claim 2, Tang discloses further comprising:
a tube (core rod 31, connector 21 & insulation coated screw 22) that communicates with a through passage formed in the retractable rod ([0039]: The first channel 27 can restrains the hollow tubular portion 111 of the active electrode 11, and the proximal end of the hollow tubular portion 111 connects to the insulation coated screw 22 through the connector 21, thereby providing the first liquid passageway 29a; see Figs. 1-2 & 7B), wherein
the first distal end opening is an opening of the through passage formed in the distal end surface of the retractable rod ([0039]: The first channel 27 can restrains the hollow tubular portion 111 of the active electrode 11, and the proximal end of the hollow tubular portion 111 connects to the insulation coated screw 22 through the connector 21, thereby providing the first liquid passageway 29a; see Figs. 1-2 & 7B), and
the first channel includes the through passage and the tube ([0039]: The first channel 27 can restrains the hollow tubular portion 111 of the active electrode 11, and the proximal end of the hollow tubular portion 111 connects to the insulation coated screw 22 through the connector 21, thereby providing the first liquid passageway 29a; see Figs. 1-2 & 7B).
Regarding claim 3, Tang discloses wherein
a proximal end of the retractable rod is disposed in a distal end of the tube to allow the through passage to communicate with the tube ([0039]: The first channel 27 can restrains the hollow tubular portion 111 of the active electrode 11, and the proximal end of the hollow tubular portion 111 connects to the insulation coated screw 22 through the connector 21, thereby providing the first liquid passageway 29a), and
in response to the tube moving forward and backward in the axial direction within the tubular portion in response to the operations of the operation unit, the retractable rod is configured to move forward and backward in the axial direction, and the protrusion amount of the retractable rod from the distal end surface of the tubular portion changes ([0044]: As shown in FIGS. 1 and 2, when pushing the slider 33 to move distally along the core rod 31, the slider 33 pushes the active electrode 11 to protrude distally through the connection sheath 32 … When pulling the slider 33 to move proximally along the core rod 31, the active electrode 11 is driven to recover proximally).
Regarding claim 4, Tang discloses wherein
in a front view of the distal end surface of the tubular portion, the retractable rod is located in a central region of the distal end surface of the tubular portion ([0039]: As shown in Fig. 7B, the first liquid passageway 29a and the second liquid passageway 29b are provided in the insulation sheath 25 as coaxial position; see Also Fig. 4G), and the second distal end opening is located in a peripheral region of the distal end surface of the tubular portion located outside the central region ([0039]: the gap between the hollow tubular portion 111 of the active electrode 11 and the insulating part 12; see Figs. 4E & 4F).
Regarding claim 7, Tang discloses wherein
the tubular portion includes a support passage that slidably supports the retractable rod in the axial direction ([0039]: an interstitial passageway between the insulation sheath 25 and the seal 23), and
the support passage forms a part of the second channel ([0039]: There is an interstitial passageway between the insulation sheath 25 and the seal 23, forming the second liquid passageway 29b liquid flows through the interstitial passage to the proximal end of the insulating part 12, and then flows into the gap between the hollow tubular portion 111 of the active electrode 11 and the insulating part 12, so that can clean the active electrode 11 and the insulating part 12, and can also flush the hemorrhage site).
Regarding claim 8, Tang discloses wherein
the tubular portion includes
a sheath (insulation sheath 25); and
a cap (insulating part 12) attached to the sheath to close a distal end opening of the sheath (see Fig. 2),
the support passage is a third through passage that penetrates the cap ([0039]: the gap between the hollow tubular portion 111 of the active electrode 11 and the insulating part 12), and has an opening on a proximal end side communicating with the sheath and an opening on a distal end side formed in a distal end surface of the cap ([0039]: There is an interstitial passageway between the insulation sheath 25 and the seal 23, forming the second liquid passageway 29b liquid flows through the interstitial passage to the proximal end of the insulating part 12, and then flows into the gap between the hollow tubular portion 111 of the active electrode 11 and the insulating part 12, so that can clean the active electrode 11 and the insulating part 12, and can also flush the hemorrhage site), and
the third through passage forms a part of the second channel ([0039]: There is an interstitial passageway between the insulation sheath 25 and the seal 23, forming the second liquid passageway 29b liquid flows through the interstitial passage to the proximal end of the insulating part 12, and then flows into the gap between the hollow tubular portion 111 of the active electrode 11 and the insulating part 12, so that can clean the active electrode 11 and the insulating part 12, and can also flush the hemorrhage site).
Regarding claim 9, Tang discloses wherein
at least a part of the first channel passes through the second channel ([0039]: As shown in Fig. 7B, the first liquid passageway 29a and the second liquid passageway 29b are provided in the insulation sheath 25 as coaxial position), and
a seal (seal 23) securing airtightness of the second channel inside the tubular portion is disposed on an outer periphery of a portion of the first channel passing through the second channel ([0041]: The seal 23 is covered on the outer surface of the connector 21 and the insulation coated screw 22 by heat shrink, welding, adhesive bonding or other. The concavo-convex structure of the connector 21 allows the seal 23 to better cover the surface for better sealing, which makes the electrosurgical knife product to withstand 30 atm pressure. The size of the channel formed by the seal 23 is smaller than the first channel 27 ensuring that liquid can successfully pass through the second liquid passageway 29b).
Regarding claim 10, Tang discloses further comprising:
a contact portion (connection cable 34) to which a high-frequency power supply for allowing a high-frequency current to flow is connectable ([0048]: The connection cable 34 of the present invention is connected to an external high-frequency generator); and
a wire (connector 21) having conductivity disposed in the tubular portion ([0040]: a connector 21, which have conductive function; see Fig. 2), wherein
the retractable rod has conductivity (active electrode 11; [0035]: The active electrode 11 is used to cut tissue … active electrode 11 may be a metal material such as stainless steel, titanium, tungsten, or the material which has conductivity), and
the wire has a distal end electrically connected to the retractable rod, and a proximal end electrically connected to the contact portion ([0040]: The proximal end of the connector 21 is connected to the insulation coated screw 22. The insulation coated screw 22 including the conductive screw and the insulating coating on the surface. The material of the insulating coating is polymer material. The proximal end of the insulation coated screw 22 is connected with the connection cable 34 and connected at the distal end with the connector 21 which having conductive function, thereby achieving the conductive function of the active electrode 11).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Tang in view of Tang 2 as applied to claim 1 above, and further in view of Okada (U.S. Pub. No. 20040210284, previously cited), herein referred to as “Okada”.
Regarding claim 5, Tang in view of Tang 2 fails to disclose wherein
a plurality of the second distal end openings are formed in the distal end surface of the tubular portion, and
the plurality of the second distal end openings are located side by side at an equal pitch around the retractable rod in the front view.
However, Okada discloses wherein
a plurality of the second distal end openings (two openings 19) are formed in the distal end surface of the tubular portion ([0061]: insulating tip 8 are provided with the two openings 19; see Fig. 1B), and
the plurality of the second distal end openings are located side by side at an equal pitch around the retractable rod in the front view ([0061]: insulating tip 8 are provided with the two openings 19; see Fig. 1B).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the endoscopic treatment tool of Tang in view of Tang 2 to have a plurality of the second end distal openings and locations, as taught by Okada, for the purpose of cleaning the bleeding region. Accordingly, the bleeding region can be cleaned to expose the bleeding point without changing the surgical instrument before blood is coagulated and stanched by means of the distal flat portion of the platelike electrode portion. Thus, intra-operative bleeding can be stopped quickly and securely (Okada: [0061]).
Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a plurality of the second distal end openings are formed in the distal end surface of the tubular portion, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to the plurality of the second distal end openings are located side by side at an equal pitch around the rod-shaped member in the front view, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 6, Tang discloses wherein the tubular portion includes
a sheath (insulation sheath 25); and
a cap (insulating part 12) attached to the sheath to close a distal end opening of the sheath (see Fig. 2), wherein the cap includes
a first through passage that slidably supports the retractable rod in the axial direction, has an opening on a proximal end side communicating with the sheath and an opening on a distal end side formed in the distal end surface of the cap, and penetrates the cap ([0039]: There is an interstitial passageway between the insulation sheath 25 and the seal 23, forming the second liquid passageway 29b liquid flows through the interstitial passage to the proximal end of the insulating part 12, and then flows into the gap between the hollow tubular portion 111 of the active electrode 11 and the insulating part 12, so that can clean the active electrode 11 and the insulating part 12, and can also flush the hemorrhage site; [0044]: When pulling the slider 33 to move proximally along the core rod 31, the active electrode 11 is driven to recover proximally. When the protrusion 112 of the active electrode 11 touch the insulating part 12, since the size of the protrusion 112 is larger than the hollow tube of the insulating part 12, and stairs formed by differences in size limited the active electrode 11 to be pulled toward the proximal end, thereby acting as a restriction);
But Tang in view of Tang 2 fails to disclose a second through passage that is formed to extend in the axial direction around the first through passage and penetrates the cap,
the second through passage forms a part of the second channel, and
an opening on a distal end side of the second through passage is the second distal end opening, and is formed in the distal end surface of the cap.
However, Okada discloses a second through passage (lumens of two openings 19) that is formed to extend in the axial direction around the first through passage and penetrates the cap ([0051]: As shown in FIG. 1B, a slide aperture 18 is formed axially in the stopper member 6 and the insulating tip 8. The rod-shaped electrode portion 12 of the knife element 11 is passed through the slide aperture 18. Further, a pair of liquid feed openings 19 are arranged around the slide aperture 18; see openings 19 in insulating tip 8 in Fig. 1B),
the second through passage forms a part of the second channel ([0051]: The openings 19 communicate with the internal space 2a of the sheath 2), and
an opening (opening 19) on a distal end side of the second through passage is the second distal end opening, and is formed in the distal end surface of the cap ([0051]: As shown in FIG. 1B, a slide aperture 18 is formed axially in the stopper member 6 and the insulating tip 8. The rod-shaped electrode portion 12 of the knife element 11 is passed through the slide aperture 18. Further, a pair of liquid feed openings 19 are arranged around the slide aperture 18; see openings 19 in insulating tip 8 in Fig. 1B).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the endoscopic treatment tool of Tang in view of Tang 2 to have a second through passage and opening, as taught by Okada, for the purpose of cleaning the bleeding region. Accordingly, the bleeding region can be cleaned to expose the bleeding point without changing the surgical instrument before blood is coagulated and stanched by means of the distal flat portion of the platelike electrode portion. Thus, intra-operative bleeding can be stopped quickly and securely (Okada: [0061]).
Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a second through passage that is formed to extend in the axial direction around the first through passage and penetrates the cap-shaped member, the second through passage forms a part of the second channel, and an opening on the distal end side of the second through passage is the second distal end opening, and is formed in a distal end surface of the cap-shaped member, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tang in view of Tang 2 as applied to claim 1 above, and further in view of Yamamoto et al. (U.S. Pat. No. 9526562), herein referred to as “Yamamoto”.
Regarding claim 11, Tang in view of Tang 2 fails to disclose wherein when the retractable rod is fully retracted, at least a portion of the second distal end opening is unblocked.
However, Yamamoto discloses wherein when the retractable rod is fully retracted, at least a portion of the second distal end opening is unblocked (Col. 8, lines 51-55: as shown in FIG. 9, by making the size of the accommodating portion 6d close to the outer diameter of the distal-end expanded portion 3b, the grooves 6b may be protruded radially farther outward than the inner surface of the accommodating portion 6d). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the endoscopic treatment tool of Tang in view of Tang 2 to have at last a portion of the second distal end opening to be unblocked, as taught by Yamamoto, for the purpose of enabling the liquid to be dispensed mainly from the flow channels formed by the grooves, the liquid can be released in the form of a converged narrow flow (Yamamoto: Col. 8, lines 55-58).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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