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 .
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.
Claim 10-12 and 18 is 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.
Claim 10 recites, “wherein the minimum bending radius of the first tube body is r1, and the minimum bending radius of the second tube body is r2, meeting 1<r1/r2<=8” and it is unclear what units this bending radius is being measured in as no units are included in the limitation. For the purposes of examination, the units are interpreted to be in millimeters (mm) as all other units described in the specification are measured in millimeters (see at least Specification Para. [0057] and [0061]-[0064]).
Claim 11 is additionally rendered indefinite due to its dependency and further modification of claim 10.
Claim 12 recites, “wherein a length of the firs tube body is L1, and the length of the second tub body is L2, meeting 0<L2/L1<=1” and it is unclear what units these lengths is being measured in as no units are included in the limitation. For the purposes of examination, the units are interpreted to be in millimeters (mm) as all other units described in the specification are measured in millimeters (see Specification Para. [0063]-[0064]).
Claim 18 recites, “wherein the first tube body comprises one spiral harness layer” and it is unclear if this “spiral harness layer” is intended to refer back to and further modify the “spiral harness layer” previously defined in claim 1, from which claim 18 ultimately depends, or whether this limitation seeks to introduce a separate “spiral harness layer” in addition to the one previously introduced in claim 1. For the purposes of examination, this limitation is interpreted to refer to and further modify the “spiral harness layer” previous introduced in claim 1.
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.
Claim(s) 1-2, 5-6, 8-9 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wei (WO 2022127749 A1) in view of Bardsley (US 2021/0275337 A1), further in view of Hsu (US 2021/0045626 A1).
Regarding claim 1, Wei discloses:
A torque transmission tube (see Fig. 10), comprising:
a first tube body (spring tube 1111, see Fig. 10), having a first channel (see Fig. 2 showing wherein riveting tube 160 extends through a lumen of the spring tube, this lumen defining a “first channel”; see also Para. [0068]) and corresponding first and second ends in an extending direction of the first channel (see Figs. 1 and 10 showing a proximal and distal end of the spring tube);
wherein the first tube body comprises a at least one strand of wire (spring tube comprises metal wires wrapped around the surface thereof; see Para. [0073] and [0075]; see also Fig. 10), each strand of wire spirally winds from the first end to the second end (see Fig. 10 and Para. [0073]-[0075]), the plurality of strands of wires spirally wind to form at least one spiral wire harness layer (see Fig. 10 showing a spiral wire harness formed around the spring tube by the spiral metal wire(s)), the at least one spiral wire harness layer surrounds to form the first channel (see Fig. 10);
a second tube body (steel tube 1112, see Fig. 10), having a second channel (see Figs. 1-2 and Para. [0068]; riveting tube 160 extends through the entire length of the elongate body; the lumen within the steel tube portion defining a “second channel”) and corresponding third and fourth ends in an extension direction of the second channel (see Fig. 10 showing a proximal and distal end of the steel tube), wherein the third end is connected with the second end (see Fig. 10 showing the proximal end of the steel tube (i.e., “third end”) connected to the distal end of the spring tube (i.e., “second end”); see also Para. [0075]), and the second channel is communicated with the first channel (see Figs. 1-2 and 10 showing the channel extends through the entire length of the elongate tubular body);
However, Wei does not expressly disclose wherein the first tube body comprises a plurality of strands of wires; and
wherein a minimum bending radius of the second tube body is smaller than a minimum bending radius of the first tube body.
In the same field of endeavor, namely elongate tubular bodies for surgical instruments formed from a coiled wire, Bardsley teaches a torque transmission tube (pusher shaft 50, see Figs. 1-2) having a first tube body (filar tube 60, see Fig. 3A , 5 and 8C; see also Para. [0051]) comprised of a plurality of helically-extending wire strands (see Para. [0051]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the spring tube of Wei to be comprised of a plurality of helical wires (as opposed to a single wire) as disclosed by Bardsley to, in this case, provide increased axial strength and rigidity to the spring tube.
In the same field of endeavor, namely flexible elongate shaft bodies for surgical instruments, Hsu teaches a torque transmission tube (shaft 220, see Fig. 22A) having a deflectable first tube body (proximal section 240, see Fig. 22A and Para. [0123]) and a deflectable second tube body (distal section 250, see Fig. 22A and Para. [0123]); wherein a minimum bending radius of the second tube body is smaller than a minimum bending radius of the first tube body (see Para. [0127] and [0147]) which allows the distal portion of the torque transmission tube to be more flexible than the proximal section which allows the distal tip to more easily navigate through tortuous anatomy to reach a target site while allowing the proximal section to be more rigid and stronger.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the torque transmission tube of Wei to cause the distal steel tube portion thereof to comprise a smaller bend radius compared to the more proximal spring tube portion as disclosed by Hsu to, in this case, allow the distal portion of the torque transmission tube (i.e., the portion carrying the surgical instrument 140) to be more flexible to more easily manipulate and navigate the surgical device 140 to a target site while having the more proximal portion of the torque transmission tube be more rigid to provide increased support while maintaining a degree of flexibility.
Regarding claim 2, the combination of Wei, Bardsley and Hsu disclose the invention of claim 1, Wei, as modified by Bardsley, further discloses wherein the first tube body comprises one spiral wire harness layer (see Wei Fig. 10; spiral wire harness formed by the wire extending helically around the spring tube), the plurality of strands of wires are arranged around the first channel and extend in a same direction to form the one spiral wire harness layer (see Wei Fig. 10 and Bardsley Figs. 3A, 5 and 8C showing wherein the wires extend in the same direction along the length of the respective torque transmission tube(s)).
Regarding claim 5, the combination of Wei, Bardsley and Hsu disclose the invention of claim 1, Wei further discloses a connecting piece provided between the first tube body and the second tube body (see Examiner’s Diagram of Fig. 10 below showing a joint portion between the spring tube and steel tube constituting a “connecting piece”; see also Para. [0075] mentioning wherein these two tube portions are welded together; the weld portion being the “connecting piece” as shown in Examiner’s Diagram of Fig. 10 below), and the second end is connected with the third end through the connecting piece (see Examiner’s Diagram of Fig. 10 below; see also Para. [0075]).
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Examiner’s Diagram of Fig. 10
Regarding claim 6, the combination of Wei, Bardsley and Hsu disclose the invention of claim 1, Wei further discloses wherein the wire comprises a first connector located at the first end (see Examiner’s Diagram of Fig. 1 below showing an enlarged view of the proximal portion of the device in which a “first connector” is located at the proximal end of the spring tube withing the handle portion) and a second connector located at the second end (see Examiner’s Diagram of Fig. 10 above showing a “second connector” located at the distal end of the spring tube and connecting to the steel tube; see also Para. [0075] mentioning wherein the tube portions are connected together by a weld which would further constitute the “second connector”), the first connectors of the plurality of strands of wires are connected with each other (all elements along the length of the spring tube are connected to one-another; see Figs. 1 and 10), and the second connectors of the plurality of strands of wires are connected with each other (all elements along the length of the spring tube are connected to one-another; see Figs. 1 and 10).
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Examiner’s Diagram of Fig. 1 (Enlarged Proximal Portion of Spring Tube Within Handle Portion)
Regarding claim 8, the combination of Wei, Bardsley and Hsu disclose the invention of claim 1, Wei, as modified by Bardsley, further discloses wherein there are n strands of wires (see Bardsley Para. [0051] mentioning wherein there may be 6, 8, 12 or 18 wires forming the torque transmission tube, as incorporated into the spring tube of Wei).
However, Wei does not expressly disclose a diameter of the spring tube (see Para. [0062] mentioning wherein the diameter of the device can be set as required) and thus does not expressly disclose wherein a diameter of the wires is d mm, meeting: n/d>1.
Bardsley further discloses wherein a diameter of the coiled tube can be within a range of 0.011 inches to 0.0145 inches (see Para. [0056]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to cause the diameter of the spring tube of Wei to have a diameter within the range of 0.011 to 0.0145 inches as disclosed by Bardsley since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Wei would not operate differently with the claimed diameter. The device of Wei is configured to treat polyps but Wei is silent in regards to any express constant dimensions pertaining to the size of the device. Therefore, one of ordinary skill in the art would have looked to the prior art for references dimensions to be used in creating the device of Wei for a specific procedure. Bardsley's device is dimensioned to be navigated through the vasculature, which is a location in which polyps may form. Therefore, one of ordinary skill in the art would have expected the device of Wei to function properly with the dimensions disclosed by Bardsley should the device of Wei be used to treat polyps within the vasculature. Further, it has been held that selecting relative dimensions for a specific task or procedure is obvious to one of ordinary skill in the art absent express contradictory criticality pertaining to the claimed dimensions (see In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955)). Upon incorporation of the known diameter of Bardsley into the device of Wei, the conditions “n/d >=1” are met for any diameter value “d” and wire number “n” disclosed by Bardsley, as incorporated into the device of Wei.
Regarding claim 9, the combination of Wei, Bardsley and Hsu disclose the invention of claim 8, Wei, as modified by Bardsley further discloses wherein the torque transmission tube meets 2<=n<=16 (see Bardsley Para. [0051] mentioning wherein the number of wire strands “n” may be 6, 8 or 12, as incorporated into the device of Wei) and 0<d<=2 (see Bardsley Para. [0056] mentioning a diameter range of 0.011 to 0.0145 inches which falls within the claimed range).
Regarding claim 15, the combination of Wei, Bardsley and Hsu disclose the invention of claim 1, Wei further discloses wherein the wire has a cross section perpendicular to a spiral extension direction of the wire (see Fig. 10); the cross section is circular (see Fig. 10 showing the wire would around the spring tube is circular, thus having a circular cross-section).
Regarding claim 16, the combination of Wei, Bardsley and Hsu disclose the invention of claim 1, Wei further discloses wherein materials of the first tube body and second tube body are both metal (Para. [0044] mentioning wherein the spring tube may be a metal tube; see also Para. [0072] mentioning wherein the steel tube is formed from stainless steel).
Claim(s) 3-4 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wei (WO 2022127749 A1) in view of Bardsley (US 2021/0275337 A1), further in view of Hsu (US 2021/0045626 A1), further in view of Massimini (US 2023/0218314 A1).
Regarding claim 3, the combination of Wei, Bardsley and Hsu disclose all of the limitations of the invention of claim 1.
However, Wei does not expressly disclose wherein the first tube body comprises a plurality of spiral wire harness layers, the plurality spiral wire harness layers are stacked along a radial direction of the first tube body, and each spiral wire harness layer comprises at least one strand of wire.
In the same field of endeavor, namely torque transmission shafts for surgical devices comprising at least one coiled wire, Massimini teaches a torque transmission shaft (drive coil 20, see Figs. 1-3B) comprising a plurality of wire harnesses stacked along a radial direction of the torque transmission shaft (see Fig. 3B showing wherein the drive coil comprises a first coil layer 54 and a second coil layer 58; see also Para. [0061]); each wire harness comprising at least on strand of wire (see Para. [0061]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known wire coil arrangement for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)) to have obtained the predictable result of having the wire of the spring tube of Wei be formed as a double-coil layer as disclosed by Massimini. Since Massimini expressly discloses wherein a coil-layer of a torque transmission tube can be either a single layer of double-layer coil (see Para. [0061]), one of ordinary skill in the art would view the two configuration as interchangeable and would have expected the device of Wei to therefore function equally well with either a single wire layer of double wire layer, as disclosed by Massimini.
Regarding claim 4, the combination of Wei, Bardsley, Hsu and Massimini disclose all of the limitations of the invention of claim 3, Wei, as modified by Massimini, further discloses wherein the wires of at least two adjacent spiral wire harness layers have different spiral extension directions (see Massimini Para. [0061] wherein the inner and outer wire layers can be wound in different directions).
Regarding claim 7, the combination of Wei, Bardsley and Hsu disclose all of the limitations of the invention of claim 1, Wei further discloses wherein the extending direction of the first channel is an axial direction of the first tube body (see Fig. 10).
However, Wei does not expressly disclose wherein under an axial tensile force of 10 N, an axial tensile displacement of the first tube body does not exceed 5mm; and under an axial pressure of 60 N, an axial compression displacement of the first tube body does not exceed 40 mm.
In the same field of endeavor, namely elongate torque transmission tubes for surgical devices, Massimini teaches a torque transmission tube (drive coil 20, see Fig. 1 and 2); wherein under an axial tensile force of 10 N, an axial tensile displacement of the torque transmission tube does not exceed 5mm (see Para. [0007] and [0071] mentioning wherein the drive coil comprises a tensile stiffness of between 0 to 5N/mm; therefore, should 10N be allied, the tensile axial displacement would have a maximum value of 2mm); and under an axial pressure of 60 N, an axial compression displacement of the torque transmission tube does not exceed 40 mm (see Para. [0007] and [0071] mentioning wherein the drive coil comprises an axial stiffness of between 0 and 10N/mm; therefore, should 60N be applied, the compressive axial displacement would have a maximum value of 6mm).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the spring tube of Wei to comprise an axial stiffness such that wherein under an axial tensile force of 10 N, an axial tensile displacement of the spring tube does not exceed 5mm; and under an axial pressure of 60 N, an axial compression displacement of the spring tube does not exceed 40 mm as applicant appears to have placed no criticality on the claimed range (see Specification Para. [0057]; there does not appear to be any criticality to the range claimed in the specification) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wei (WO 2022127749 A1) in view of Bardsley (US 2021/0275337 A1), further in view of Hsu (US 2021/0045626 A1), further in view of Le (US 2013/0331689 A1).
Regarding claim 10, the combination of Wei, Bardsley and Hsu disclose the invention of claim 1, Wei, as modified by Hsu, further discloses wherein the minimum bending radius of the first tube body is r1 (bend radius of the proximal section 240 of Hsu, as incorporated into the device of Wei; see Hsu Para. [0127]) and the minimum bending radius of the second tube body is r2 (bend radius of the proximal distal section 250 of Hsu, as incorporated into the device of Wei; see Hsu Para. [0127]).
However, Hsu does not expressly disclose precise units for the bending radius and thus does not expressly disclose wherein 1<r1/r2 <8.
In the same field of endeavor, namely flexible elongate torque transmission shafts for surgical devices, Le teaches a torque transmission tube (probe 1, see Fig. 1) comprising a first tube body (midsection of probe shaft 180; see Para. [0174] and Fig. 1 and 3) having a first bend radius (r1) (see Para. [0174]) and a second tube body (distal section of probe shaft 180, see Para. [0174] and Fig. 3) having a second bend radius (r2) (see Para. [0174]); wherein 1<r1/r2 <8 (see Para. [0174]; taking exemplary values for r1 to be 30 mm and r2 to be 15 mm, this would have r1/r2 = 2).
Since none of either Wei or Hsu disclosed expressly amounts/values for the bend radii of the portions of the torque transmission shaft, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to relevant prior art for known bend radius values used in similar device and thus to have modified the spring tube of Wei to comprise a bend radius of 30mm while simultaneously modifying the steel tube comprises a bend radius of 15mm, as disclosed to be known bend radius values for analogous device by Le to, in this case, provide known bend radius values for the deflectable portions of the torque transmission shaft of Wei, as modified by Hsu. With these values, the condition of 1<r1/r2 <8 is met since 30mm/15mm = 2.
Regarding claim 11, the combination of Wei, Bardsley, Hsu and Le disclose the invention of claim 10, Wei, as modified by Le, further discloses wherein the torque transmission tube further meets 20mm <=r1<=40mm (see Le Para. [0174] taking r1 to be 30mm) and 5mm<=r2<=20mm (see Le Para. [0174] taking r2 to be 15mm).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wei (WO 2022127749 A1) in view of Bardsley (US 2021/0275337 A1), further in view of Hsu (US 2021/0045626 A1), further in view of Strauss (US 2012/0116350 A1).
Regarding claim 12, the combination of Wei, Bardsley and Hsu disclose all of the limitations of the invention of claim 1.
However, Wei does not expressly disclose relative lengths of the first tube body and second tube body and thus does not expressly disclose wherein a length of the first tube body is L1 and a length of the second tube body is L2, meeting 0<L2/L1<=1.
In the same field of endeavor, namely flexible torque transmission shafts for surgical devices, Strauss teaches a torque transmission tube (catheter 100, see Fig. 1) having a first tube body (proximal section 116, see Fig. 1) comprising a first length (L1) (see Fig. 1 and Para. [0056]) and a second tube body (distal section 118, see Fig. 1) comprising a second length (L2) (see Fig. 1 and Para. [0056]); wherein 0<L2/L1<=1 (see Para. [0056] reciting relative dimensions between the two sections; taken at any of the value ranges, this would cause 0<L2/L1<=1 since L2 is larger than L1 while both values being positive).
Since Wei does not expressly disclose length dimensions for either the spring tube or steel tube, it would have been obvious to one of ordinary skill in the art to have looked to analogous prior art device for known torque transmission shaft lengths used in similar device and thus to have modified the spring tube and steel tube of Wei to comprise lengths of between 20-220cm and 2-50cm respectively as disclosed by Strauss as applicant appears to have placed no criticality on the claimed range (see Specification Para. [0064] mentioning wherein this claimed range facilitates use with various types of endoscopes but serves no specific critical function and is thus viewed as generic to all devices configured to be used with endoscopes) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (see Specification Para. [0064] mentioning the length range for the torque transmission tube as being between 1550-3000mm). In the resulting combination, the condition of wherein 0<L2/L1<=1 is met at any of the value ranges disclosed by Strauss, since L2 is larger than L1 while both values are positive.
Regarding claim 13, the combination of Wei, Bardsley and Hsu disclose all of the limitations of the invention of claim 1.
However, Wei does not expressly disclose a length of the device and thus does not expressly disclose wherein a length of the torque transmission tube is L3, meeting 1550mm <=L3 <=3000mm.
In the same field of endeavor, namely torque transmission tubes for surgical devices, Strauss teaches a torque transmission tube (catheter 100, see Fig. 1) having a first tube body (proximal section 116, see Fig. 1) and a second tube body (distal section 118, see Fig. 1); wherein the total length (L3) of the torque transmission tube is between 1550mm and 3000mm (see Para. [0056]).
Since Wei does not expressly disclose length dimensions for either the spring tube or steel tube, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the total length of the torque transmission tube of Wei to be between 1550mm and 3000mm as applicant appears to have placed no criticality on the claimed range (see Specification Para. [0064] mentioning wherein this claimed range facilitates use with various types of endoscopes but serves no specific critical function and is thus viewed as generic to all devices configured to be used with endoscopes) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 14, the combination of Wei, Bardsley and Hsu disclose all of the limitations of the invention of claim 1.
However, Wei does not expressly disclose a length of the device and thus does not expressly disclose wherein a lead S of a spiral wire formed by a spiral extension of the wire is 3-30mm.
In the same field of endeavor, namely flexible torque transmission shafts for surgical devices, Strauss teaches a torque transmission tube (catheter 100, see Fig. 1) having a first tube body (proximal section 116, see Fig. 1) comprising a first length (L1) (see Fig. 1 and Para. [0056]) and a second tube body (distal section 118, see Fig. 1) comprising a second length (L2) (see Fig. 1 and Para. [0056]); wherein a length S of a portion of the first tube body is between 3-30 mm (see Para. [0056] mentioning wherein the total length of the first tube body may be between 20cm to 220cm, thus comprising a length along a portion thereof of between 3-30mm).
Since Wei does not expressly disclose length dimensions for either the spring tube or steel tube, it would have been obvious to one of ordinary skill in the art to have looked to analogous prior art device for known torque transmission shaft lengths used in similar device and thus to have modified the spring tube of Wei to comprise lengths of between 20-220cm as disclosed by Strauss as applicant appears to have placed no criticality on the claimed range (see Specification Para. [0064] mentioning wherein this claimed range facilitates use with various types of endoscopes but serves no specific critical function and is thus viewed as generic to all devices configured to be used with endoscopes) and since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Wei would not operate differently with the claimed spring tube length since Strauss discloses wherein this disclosed length facilitates use of the device within an anatomical space.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akahane (US 2008/0242924 A1) in view of Wei (WO 2022127749 A1), further in view of Bardsley (US 2021/0275337 A1), further in view of Hsu (US 2021/0045626 A1).
Regarding claim 17, Akahane discloses:
A surgical instrument (see Fig. 1), applied to an endoscope (see Fig. 5), the surgical instrument comprising:
A torque transmission tube (torque transmitting sleeve 21, see Figs. 1 and 3-4);
an operating handle (proximal handle portion, see Fig. 1), provided at a first end of the torque transmission tube (see Fig. 1); and an executing piece (mounting part 10, see Fig. 1), provided at the fourth end of the torque transmitting tube (see Fig. 1);
wherein the operating handle is used for driving the torque transmission tube to rotate so as to transmit a torque to the executing piece (see Para. [0031]).
However, while Akahane discloses a torque transmission tube (torque sleeve 21, see Fig. 3), Akahane does not expressly disclose the torque transmission tube according to claim 1.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known outer sheath for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)) to have obtained the predictable result of incorporating the torque transmission tube of Wei in-place of the outer resin tube of the torque transmission sleeve of Akahane. As the outer sleeve (20b) of the torque transmission sleeve is just a resin tube whose purpose is to protect the inner mesh layers from the external environment (see Para. [0013] and [0028]), one of ordinary skill in the art would have expected the device of Akahane to function equally well with either the current resin tube or the torque transmission tube of Wei, since both tubes are fully capable of protecting internal components from the external environment and are configured to serve the same core function.
Regarding claim 18, the combination of Akahane, Wei, Bardsley and Hsu disclose the invention of claim 17, Wei further discloses wherein the first tube body comprises one spiral wire harness layer (see Fig. 10 showing a spiral wire harness layer formed around the spring tube by the helical metal wire(s)), the plurality of strands of wires are arranged around the first channel and extend in a same direction to form the one spiral wire harness layer (see Fig. 10).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akahane (US 2008/0242924 A1) in view of Wei (WO 2022127749 A1), in view of Bardsley (US 2021/0275337 A1), further in view of Hsu (US 2021/0045626 A1), further in view of Massimini (US 2023/0218314 A1).
Regarding claim 19, the combination of Akahane, Wei, Bardsley and Hsu disclose all of the limitations of the invention of claim 17.
However, Wei does not expressly disclose wherein the first tube body comprises a plurality of spiral wire harness layers, the plurality spiral wire harness layers are stacked along a radial direction of the first tube body, and each spiral wire harness layer comprises at least one strand of wire.
In the same field of endeavor, namely torque transmission shafts for surgical devices comprising at least one coiled wire, Massimini teaches a torque transmission shaft (drive coil 20, see Figs. 1-3B) comprising a plurality of wire harnesses stacked along a radial direction of the torque transmission shaft (see Fig. 3B showing wherein the drive coil comprises a first coil layer 54 and a second coil layer 58; see also Para. [0061]); each wire harness comprising at least on strand of wire (see Para. [0061]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known wire coil arrangement for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)) to have obtained the predictable result of having the wire of the spring tube of Wei be formed as a double-coil layer as disclosed by Massimini. Since Massimini expressly discloses wherein a coil-layer of a torque transmission tube can be either a single layer of double-layer coil (see Para. [0061]), one of ordinary skill in the art would view the two configuration as interchangeable and would have expected the device of Wei to therefore function equally well with either a single wire layer of double wire layer, as disclosed by Massimini.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akahane (US 2008/0242924 A1) in view of Wei (WO 2022127749 A1), in view of Bardsley (US 2021/0275337 A1), further in view of Hsu (US 2021/0045626 A1), further in view of Palmer (US 5782748 A).
Regarding claim 20, the combination of Akahane, Wei, Bardsley, and Hsu disclose all of the limitations of the invention of claim 17, Akahane further discloses:
wherein the executing piece comprises:
a clamping seat (mounting part 10, see Fig. 1), provided at the fourth end of the torque transmission tube (see Fig. 1);
a clamping part (forceps 12, see Fig. 2), connected with the clamping seat (see Fig. 2); and
a pulling part (operating wire 22, see Fig. 1 and Para. [0023]), movably provided in the first channel and the second channel of the torque transmission tube (see Fig. 1 and Para. [0023]), and connected between the operating handle and the clamping part (see Para. [0023]);
wherein, the operating handle is further used for driving the pulling part to move along an extending direction of the pulling part, so as to drive the clamping part to move (see Para. [0023]).
However, Akahane does not expressly disclose wherein the clamping seat and the clamping part are configured to detach and separate from the torque transmission tube and the pulling part upon actuation of the end effector jaws.
In the same field of endeavor, namely surgical forceps devices, Palmer teaches a surgical forceps (see Figs. 1-2) comprising a torque transmission tube (coil 20, see Figs. 1-2); a proximal handle (handle 10, see Fig. 1) a pulling part (pull wire 22, see Figs. 1-9); a clamping seat (coupling device 70, see Fig. 2) and a clamping part (jaws 52/54, see Fig. 2); wherein upon actuation of the clamping part by the pulling part, the clamping part and clamping seat may be detached from the torque transmission tube and pulling part (see Col. 5, Lines 18-60) which would allow the jaws to be left in-place for a follow-up procedure.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Akahane to allow the mounting part and forceps to be detachable from the torque transmission tube and operating wire as disclosed by Palmer to, in this case, allow the distal end effector jaw portion to remain in-place during withdrawal of the proximal handle portion for a follow-up procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 20200405128 A1 to Kaffes, US 20120172663 A1 to Parretta, US 20210275136 A1 to Stigall, US 20120100729 A1 to Edidin all disclose bending radii values for torque transmission shafts for surgical instruments. Additionally, US 6273860 B1 to Kostylev, US 6461310 B1 to Palmer, US 20200315716 A1 to Penny, US 20190387959 A1 to Yi, US 5531664 A to Adachi, US 5002041 A to Chikama, US 20040230212 A1 to Wulfman, US 20020017515 A1 to Obata, US 20180296068 A1 to Stevens, US 6443909 B1 to Ouchi, and US 20170340862 A1 to Calabrese all disclose torque transmission shafts having at least two co-axial coil layers
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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