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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 16, 2026 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 23-24, 28-30, 34-36, 40, 47-53 are rejected under 35 U.S.C. 103 as being unpatentable over Torii et al. (US PGPUB 2010/0125165 – “Torii”) in view of Dickhans (US PGPUB 2016/0058507 – “Dickhans”), Ludlow et al. (US PGPUB 2020/0369013 – “Ludlow”), Jenkins (US PGPUB 2018/0333044 – “Jenkins”), and Kizuka (US PGPUB 2019/0275288 – “Kizuka”).
Regarding Claim 23, Torii discloses:
An endoscope (Torii FIG. 1, endoscope system 10) comprising:
a handle (Torii FIG. 1, grip portion 22a and handle section 17);
an insertion tube (Torii FIG. 1, nasal endoscope 11 and flexible tube 22) including a proximal end (Torii FIG. 1, showing proximal end of nasal endoscope 11 connected to grip portion 22a) and a distal end (Torii FIG. 1 distal flexible tube 22 portion of nasal endoscope 11), the proximal end connected to and extending from the handle (Torii FIG. 1, showing proximal end of nasal endoscope 11 connected to grip portion 22a);
a bending section (Torii FIG. 1, steering section 21) including a proximal end (Torii FIG. 1, proximal end of steering section 21) connected to and extending from the distal end of the insertion tube (Torii FIG. 1, distal end of flexible tube 22) and a distal end (Torii FIG. 1, first distal portion 20) distal of the proximal end of the bending section (Torii FIG. 1, showing steering section 21 connecting flexible tube 22 to first distal portion 20);
a tip part assembly (Torii FIG. 1, distal portion 20 with a head assembly; Torii paragraph [0070], “endoscope 11 includes a first distal portion 20 with a head assembly, a steering section 21 and a flexible tube 22”) connected to and extending from the distal end of the bending section (Torii FIG. 1, showing distal portion 20 connected to and extending from the distal end of steering section 21);
a working channel tube (Examiner-annotated Torii FIG. 2 shown below, flexible synthetic resin; Torii paragraph [0086], “instrument channel 51 is formed from flexible synthetic resin.”) extending distally from the handle (Torii FIG. 1, grip portion 22a) to the tip part (Torii FIG. 1, distal portion 20) and located inside the insertion tube and the bending section (Torii paragraph [0083], “The distal opening 59 of the endoscope 11 is formed to communicate from the instrument channel 51 with the proximal opening 19 at the handle section 17Torii paragraph [0086], “instrument channel 51 is disposed in the steering section 21 of the endoscope 11 and extends through the flexible tube 22”), the working channel tube (Torii FIG. 2, flexible synthetic resin) defining at least a portion of a working channel (Torii FIG. 2, instrument channel 51) configured to allow for insertion of a retractable instrument into a body (Torii paragraph [0112], medical instrument is entered through the instrument channel 51 to carry out the treatment“) and/or for suction of fluids from the body through the working channel (Torii FIG. 15, suction device 119; Torii paragraph [0109], “suction device 119 sucks fluid through the distal opening 59 from the instrument channel 51 of the endoscope 11, for example mucus, blood or the like”); and
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steering wires (Torii FIG. 2 shown below, steering wires 50) extending from the handle (Torii FIG. 1, handle 17 with steering wheels 28) to the bending section and configured to steer the tip part assembly (Torii paragraph [0073], “Steering wires for steering are contained in a tube lumen in the first elongated tube 16, and are moved back and forth by rotating the steering wheels 28 for steering”).
Torii does not explicitly disclose the working channel tube comprising an inner layer, a tie layer, and an outer layer.
Dickhans is analogous art in the field of minimally invasive surgical instruments that teaches the working channel tube (Dickhans FIG. 3A, working channel tube that defines working channel 18) comprising an inner layer (Dickhans FIG. 3B, layer 30), a tie layer (Dickhans FIG. 3B, layer 28), and an outer layer (Dickhans FIG. 3B, layer 34).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Dickhans’ multilayer working tube for Torii’s single layer working tube. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of a working channel tube that has the ability to conduct electrical energy/signals (conductive layer 28) while protecting these electrical energy/signals from extending into the working channel and/or other radial areas of the endoscope (by using insulative layer 30 and insulating layer 34).
Torii in view of Dickhans does not explicitly teach:
the working channel tube comprising an extruded inner layer, a tie layer, an extruded outer layer comprising a thermoplastic polyurethane,
wherein the tie layer and the inner layer comprise different materials,
wherein a wall thickness of the inner layer is within a range of 0.01 to 0.10 mm,
wherein a wall thickness of the outer layer is within a range of 0.1 to 0.5 mm, and
wherein a ratio of the wall thickness of the outer layer to the wall thickness of the inner layer is at least 1.5.
Ludlow is analogous art in the field of tubing construction that teaches:
the working channel tube (Ludlow FIG. 1, multilayer flexible tube 100) comprising an extruded inner layer (Ludlow FIG. 1, inner layer 102; Ludlow paragraph [0019], describing the inner layer as being extruded), a tie layer (Ludlow FIG. 1, tie layer 106), an extruded outer layer (Ludlow FIG. 1, outer layer 104; Ludlow paragraph [0029], describing the outer layer as being extruded) comprising a thermoplastic polyurethane (Ludlow paragraph [0063], “the outer layer includes a thermoplastic polyurethane”),
wherein the tie layer and the inner layer comprise different materials (Ludlow Abstract, “an inner layer including a melt processable fluoropolymer includes a terpolymer including a tetrafluoroethylene, a hexafluoropropylene, and a vinylidene fluoride (THV)…a tie layer including a polymeric blend of a terpolymer including a tetrafluoroethylene, a hexafluoropropylene, and a vinylidene fluoride (THV) with a poly vinylidene fluoride (PVDF), a polyamide, a polyetheramide block copolymer, or combination thereof”),
wherein a wall thickness of the inner layer is within a range of 0.01 to 0.10 mm (Ludlow paragraph [0039], “the inner layer 102 may have a thickness of less than…about 2 mils.” (0.05 mm)),
wherein a wall thickness of the outer layer is within a range of 0.1 to 0.5 mm (Ludlow paragraph [0039], “the outer layer 104 may have a thickness in a range of about 0.1 mils to about 500 mils” (0.00254mm to 12.7mm)), and
wherein a ratio of the wall thickness of the outer layer to the wall thickness of the inner layer is at least 1.5 (Ludlow paragraph [0039], “the outer layer 104 may have a greater thickness than the inner layer 102. In an example, the outer layer 104 may have a thickness in a range of about 0.1 mils to about 500 mils” (12.7mm)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to construct Torii’s working channel using the multilayer flexible tube taught by Torii in view of Dickhans. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a flexible endoscope having a working channel tube made of biocompatible material such as a melt processable fluoropolymer (see Ludlow paragraph [0006]).
Torii in view of Dickhans and Ludlow does not explicitly teach the inner layer material is a high-density polyethylene.
Jenkins is analogous art in the field of endoscopes teaches the inner layer material (Jenkins FIG. 1A, liner (not shown) of working channel 200) is a high-density polyethylene (Jenkins paragraph [0046], “working channel 200 may further comprise an inner liner (not shown) attached to the inner surface 212 of the shaft 202. The inner liner may be made of…HDPE”.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Jenkins’s HDPE liner with the working channel tube shown in Dickhans FIG. 3A/3B in the endoscope taught by Torii in view of Dickhans and Ludlow. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope with a working channel that has reduced friction for passing medical instruments through the working channel (see Jenkins paragraph [0046]).
Torii in view of Dickhans, Ludlow, and Jenkins does not explicitly teach a metal coil between the tie layer and an outer surface of the outer layer.
Kizuka is analogous art in the field of minimally invasive surgery that teaches a catheter (Kizuka Examiner-annotated FIG. 2 shown below, catheter shaft 3) wherein a metal coil (Kizuka FIG. 4 coil 7; Kizuka paragraph [0032], “the material of the wire 7a constituting the coil body 7, for example, a metal material such as tungsten or a Ni—Ti alloy may be used or a resin material such as reinforced plastic (PEEK) may be used”) between the tie layer (Kizuka FIG. 4, tie layer at inner edge of outer layer 5) and an outer surface of the outer layer (Kizuka FIG. 4, showing coil 7 embedded in outer layer 15 of catheter 10).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Kizuka’s coil-embedded outer layer for the outer layer disclosed by Torii in the endoscope taught by Torii in view of Dickhans, Ludlow, and Jenkins. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of an endoscope having coils in the outer layer that are unconstrained relative to the inner layer, thus allowing them to freely rotate along the longitudinal axis of the catheter (see paragraph [0035] of Kizuka”).
Regarding Claim 24, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 23, as described above.
Ludlow further teaches wherein the outer layer material comprises a Shore A hardness according to ASTM D2240-15 within a range of 60 to 100 (Ludlow paragraph [0035], “the outer layer is formed from a polymer having a shore A hardness of less than about 80”) and a wall thickness within a range of 0.10 to 0.50 mm (Ludlow paragraph [0039], “the outer layer 104 may have a thickness in a range of about 0.1 mils to about 500 mils” (.00254 – 12.7 mm)), wherein the inner layer material comprises a Shore D hardness according to ASTM D2240-15 less than 80 (Ludlow paragraph [0022], “the hardness of the inner layer is shore D of less than about 95”), wherein the inner layer is softer than the outer layer (see Shore Hardness Scale below, Shore A hardness between having values that include 60-100, and Shore D hardness having that include 0-80, and, such that an inner layer material having a Shore D hardness of 0-60 is softer than an outer layer having a Shore A hardness of 100. See also Brinell and Rockwell Hardness Conversion Chart, https://web.archive.org/web/20180717132122/https://www.engineersedge.com/hardness_conversion.htm, July 17, 2018.);
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and wherein the inner layer and the outer layer are coextruded. (Ludlow paragraph [0019] describes the inner layer as being extruded, and Ludlow paragraph [0029] describes the outer layer as being extruded. Examiner notes that the specification provides no teaching that coextrusion affects the structure of the inner and outer layers. As such, the feature of coextrusion is deemed a manufacturing design choice having no structural limitations.)
Regarding Claim 28, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 23, as described above.
Ludlow further teaches wherein the inner layer material has a Shore D hardness according to ASTM D2240-15 equal to or less than 80 (Ludlow paragraph [0022], “the hardness of the inner layer is shore D of less than about 95”).
Regarding Claim 29, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 28, as described above.
Jenkins further teaches wherein the Shore D hardness is equal to or less than 70 (Ludlow paragraph [0022], “the hardness of the inner layer is shore D of less than about 95”).
Regarding Claim 30, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 23, as described above.
Ludlow further teaches wherein the wall thickness of the inner layer is within a range of 0.03 to 0.07 mm (Ludlow paragraph [0039], “the inner layer 102 may have a thickness of less than…about 2 mils.” (0.05 mm)).
Regarding Claim 34, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 23, as described above.
Leong further teaches wherein the metal coil is intermediate the inner layer and the outer layer (Leong FIG. 1A, working channel 206; Leong paragraph [0048], “working channel 206 may include an inner and outer layer of polymer material with a polymer or metal coil layer provided therebetween in a generally helical or braided geometry.“).
Regarding Claim 35, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 23, as described above.
Ludlow further teaches wherein the outer layer material comprises a Shore A hardness according to ASTM D2240-15 within a range of 60 to 100 (Ludlow paragraph [0035], “the outer layer is formed from a polymer having a shore A hardness of less than about 80”), and wherein the inner layer material comprises a Shore D hardness according to ASTM D2240-15 less than 80 (Ludlow paragraph [0022], “the hardness of the inner layer is shore D of less than about 95”).
Regarding Claim 36, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 23, as described above.
Ludlow further teaches wherein the inner layer is softer than the outer layer (Ludlow further teaches wherein the outer layer material comprises a Shore A hardness according to ASTM D2240-15 within a range of 60 to 100 (Ludlow paragraph [0035], “the outer layer is formed from a polymer having a shore A hardness of less than about 80”) and a wall thickness within a range of 0.10 to 0.50 mm (Ludlow paragraph [0039], “the outer layer 104 may have a thickness in a range of about 0.1 mils to about 500 mils” (.00254 – 12.7 mm)), wherein the inner layer material comprises a Shore D hardness according to ASTM D2240-15 less than 80 (Ludlow paragraph [0022], “the hardness of the inner layer is shore D of less than about 95”)see Shore Hardness Scale below, Shore A hardness between having values that include 60-100, and Shore D hardness having that include 0-80, and, such that an inner layer material having a Shore D hardness of 0-60 is softer than an outer layer having a Shore A hardness of 100. See also Brinell and Rockwell Hardness Conversion Chart, https://web.archive.org/web/20180717132122/https://www.engineersedge.com/hardness_conversion.htm, July 17, 2018) and wherein the inner layer and the outer layer are coextruded. (Ludlow paragraph [0019] describes the inner layer as being extruded, and Ludlow paragraph [0029] describes the outer layer as being extruded. Examiner notes that the specification provides no teaching that coextrusion affects the structure of the inner and outer layers. As such, the feature of coextrusion is deemed a manufacturing design choice having no structural limitations.)
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Regarding Claim 40, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 23, as described above.
Torii further discloses a monitor or a display (Torii FIG. 1, display panel 15).
Regarding Claim 47, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 23, as described above.
Jenkins further teaches wherein the wall thickness of the outer layer of the working channel is within 0.3 to 0.5 mm (Jenkins FIG. 1B, shaft wall 210 of working channel 200; Jenkins paragraph [0044], “The thickness of the shaft wall 210 may…about 0.3 mm.”). Jenkins also teaches wherein the working channel tube comprises an inner diameter of 3.5 to 5.0 mm (Jenkins paragraph [0044], “working channel 200 can define a shaft having an outer diameter that is greater than…1.2 mm”; Therefore, since Jenkins teaches that the outer diameter of the working channel is greater than 1.2 mm (e.g., 4 mm), and the outer layer of the working channel is about 0.3 mm, then the inner diameter of Jenkins’ working channel can be 3.7 mm).
Regarding Claim 48, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 23, as described above.
Jenkins further teaches wherein the wall thickness of the outer layer of the working channel is within 0.1 to 0.3 mm (Jenkins FIG. 1B, shaft wall 210 of working channel 200; Jenkins paragraph [0044], “The thickness of the shaft wall 210 may…about 0.3 mm.”). Jenkins also teaches wherein the working channel tube comprises an inner diameter of 2.0 to 3.5 mm (Jenkins paragraph [0044], “working channel 200 can define a shaft having an outer diameter that is greater than…1.2 mm”; Therefore, since Jenkins teaches that the outer diameter of the working channel is greater than 1.2 mm (e.g., 3 mm), and the outer layer of the working channel is about 0.3 mm, then the inner diameter of Jenkins’ working channel can be 2.7 mm).
Regarding Claim 49, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 23, as described above.
Ludlow further teaches a contact layer (Ludlow FIG. 1, inner surface of outer layer 104) between the outer layer (Ludlow FIG. 1, outer layer 104) and the tie layer (Ludlow FIG. 1, tie layer 106).
Regarding Claim 50, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 49, as described above.
Ludlow further teaches wherein the contact layer (Ludlow FIG. 1, inner surface of outer layer 104) and the outer layer (Ludlow FIG. 1, outer layer 104) are comprised of the thermoplastic polyurethane (Ludlow paragraph [0063], “the outer layer includes a thermoplastic polyurethane”).
Regarding Claim 51, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 49, as described above.
Ludlow further teaches the inner layer (Ludlow FIG. 1, inner layer 102), the tie layer (Ludlow FIG. 1, tie layer 106), and the contact layer (Ludlow FIG. 1,inner surface of outer layer 104) are co-extruded (see Ludlow paragraphs [0045], [0046], and [0047], which respectively describe tie layer, outer layer, and inner layer being extruded. Examiner notes that the specification provides no teaching that coextrusion affects the structure of the inner and outer layers. As such, the explicit feature of coextrusion is deemed a design choice having no patentable weight.).
Regarding Claim 52, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 49, as described above.
Torii further discloses wherein the working channel tube (Torii FIG. 2, channel 51) extends from the handle (Torii FIG. 1, handle section 17) through the insertion tube (Torii FIG. 1, insertion portion of nasal endoscope 11) and the bending section (Torii FIG. 1, steering section 21), wherein the metal coil (Torii FIG. 2, coil 44) extends at least through the bending section (Torii paragraph [0080], “flexible structure 47 constitutes the flexible tube 22 of the endoscope 11. The flexible structure 47 is a three layer structure and includes a helical coil 44”).
Kizuka further teaches wherein the metal coil is embedded in the outer layer (Kizuka FIG. 4, showing coil 7 embedded in outer layer 15 of catheter 10).
Regarding Claim 53, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 23, as described above.
Torii further discloses wherein the working channel tube (Torii FIG. 2, channel 51) extends from the handle (Torii FIG. 1, handle section 17) through the insertion tube (Torii FIG. 1, insertion portion of nasal endoscope 11) and the bending section (Torii FIG. 1, steering section 21), wherein the metal coil (Torii FIG. 2, coil 44) extends at least through the bending section (Torii paragraph [0080], “flexible structure 47 constitutes the flexible tube 22 of the endoscope 11. The flexible structure 47 is a three layer structure and includes a helical coil 44”).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Torii et al. (US PGPUB 2010/0125165 – “Torii”) in view of Dickhans (US PGPUB 2016/0058507 – “Dickhans”), Ludlow et al. (US PGPUB 2020/0369013 – “Ludlow”), Jenkins (US PGPUB 2018/0333044 – “Jenkins”), Kizuka (US PGPUB 2019/0275288 – “Kizuka”), and Okishige (US PGPUB 2007/0005019 – “Okishige”).
Regarding Claim 25, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 23, as described above.
Ludlow further teaches wherein the outer layer material comprises a Shore A hardness according to ASTM D2240-15 within a range of 60 to 100 (Ludlow paragraph [0035], “the outer layer is formed from a polymer having a shore A hardness of less than about 80”), wherein the inner layer is softer than the outer layer (see Shore Hardness Scale below, Shore A hardness between having values that include 60-100, and Shore D hardness having that include 0-80, and, such that an inner layer material having a Shore D hardness of 0-60 is softer than an outer layer having a Shore A hardness of 100. See also Brinell and Rockwell Hardness Conversion Chart, https://web.archive.org/web/20180717132122/https://www.engineersedge.com/hardness_conversion.htm, July 17, 2018);
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Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka does not explicitly teach wherein the outer layer material comprises barium sulfate.
Okishige is analogous art in the field of minimally invasive surgery that teaches wherein the outer layer material (Okishige FIG. 2, distal end 32 of catheter body 3, having a layer 5a which is an outer layer of material for lumen 31, which is analogous to a working channel) comprises barium sulfate (Okishige paragraph [0037], “ distal end 32 may be made radiopaque by incorporating the resin constituting the inner layer 5a or the outer layer 5b with 30 to 70 wt % of radiopaque metal powder, such as barium sulfate”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate Okishige’s barium sulfate into the Dickhans outer layer 34 in the endoscope taught by Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka. A person having ordinary skill in the art would be motivated to combine these
prior art elements according to known methods to yield the predictable result of an endoscope whose position while in situ is confirmed by an x-ray (see Dickhans paragraph [0037]).
Regarding Claim 26, Torii in view of Dickhans, Ludlow, Jenkins, Kizuka, and Okishige teaches the features of Claim 25, as described above.
Ludlow further teaches wherein the Shore A hardness is within a range of 85 to 100 (Ludlow paragraph [0035], “the outer layer is formed from a polymer having a shore A hardness of less than about 80”). Examiner notes that the specification does not state that the hardness range is critical, or even that an outer layer having hardness of 85 produces a different result/performance that an outer layer having a hardness of about 80. As such, Examiner interprets Ludlow as teaching this feature. See MPEP 2144.05(I) and MPEP 2144.05 (III)(A).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Torii et al. (US PGPUB 2010/0125165 – “Torii”) in view of Dickhans (US PGPUB 2016/0058507 – “Dickhans”), Ludlow et al. (US PGPUB 2020/0369013 – “Ludlow”), Jenkins (US PGPUB 2018/0333044 – “Jenkins”), Kizuka (US PGPUB 2019/0275288 – “Kizuka”), and Konstantin (US PGPUB 2010/0094086 – “Konstantin”).
Regarding Claim 37, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka the features of Claim 23, as described above.
Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka does not explicitly teach wherein the wall thickness of the inner layer is substantially constant along an entire length of the working channel tube, and wherein the wall thickness of the outer layer is substantially constant along an entire length of the working channel tube.
Konstantin is analogous art in the field of tubular construction that teaches wherein a wall thickness of the inner layer is substantially constant along an entire length of the working channel tube, and wherein a wall thickness of the outer layer is substantially constant along an entire length of the working channel tube (Konstantin paragraph [0096], “A two-layer tube of PVC having an outer layer (Shore hardness 90; thickness 0.1 mm), an inner layer (Shore hardness 55; thickness 0.8 mm) and having a wall thickness of 0.9 mm as well as an inner diameter of 10.5 mm.” Examiner interprets Konstantin as teaching a working channel having a single disclosed inner diameter (10.5mm) and an outer layer with a single disclosed thickness (0.1mm) and an inner layer with a single disclosed thickness (0.8mm). Thus, the thicknesses of the inner and outer layers are constant.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Konstantin’s soft tube for Ludlow’s tube in the endoscope taught by Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of an endoscope having a working channel that is less likely to damage an inserted instrument than a working channel with a hard inner layer.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Torii et al. (US PGPUB 2010/0125165 – “Torii”) in view of Dickhans (US PGPUB 2016/0058507 – “Dickhans”), Ludlow et al. (US PGPUB 2020/0369013 – “Ludlow”), Jenkins (US PGPUB 2018/0333044 – “Jenkins”), Kizuka (US PGPUB 2019/0275288 – “Kizuka”), and Chu et al. (US PGPUB 2003/0163119 – “Chu”).
Regarding Claim 38, Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka teaches the features of Claim 23, as described above.
Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka does not explicitly teach wherein a proximal portion of the working channel tube is everted.
Chu is analogous art in the field of minimally invasive surgery that teaches wherein a proximal portion is everted (Chu FIG. 1, everted/curled end 16-2 of tube 16).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Chu’s everted/curled end 16-2 in the endoscope taught by Torii in view of Dickhans, Ludlow, Jenkins, and Kizuka. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope having in insertion tube that is redundantly secured to a handle/hub using both an everted tube connection (Chu’s everted/curled end 16-2 wrapped around barb 41) and an outer securement (Chu’s everted/curled end 16-2 secured to sleeve assembly 18 by cap 17). A person having skill in the art would be motivated to combine these features in order to reduce the potential of the insertion portion disconnecting from the endoscopic handle during surgery.
Claims 41, 44, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Torii et al. (US PGPUB 2010/0125165 – “Torii”) in view of Kizuka (US PGPUB 2019/0275288 – “Kizuka”), Ludlow et al. (US PGPUB 2020/0369013 – “Ludlow”), and Beisel (US Patent 5,947.940 – “Beisel”).
Regarding Claim 41, Torii discloses:
An endoscope (Torii FIG. 1, endoscope system 10) comprising:
a handle (Torii FIG. 1, handle section 17);
an insertion tube (Torii FIG. 1, nasal endoscope 11 and flexible tube 22) including a proximal end (Torii FIG. 1, showing proximal end of nasal endoscope 11) and a distal end (Torii FIG. 1, showing a distal end of nasal endoscope 11 that connects to flexible tube 22), the proximal end connected to the handle (Torii FIG. 1, showing proximal end of nasal endoscope 11 connected to grip portion 22a);
a bending section (Torii FIG. 1, steering section 21) including a proximal end (Torii FIG. 1, proximal end of steering section 21) connected to the distal end of the insertion tube (Torii FIG. 1, distal end of flexible tube 22) and a distal end (Torii FIG. 1, first distal portion 20) distal of the proximal end of the bending section (Torii FIG. 1, showing steering section 21 connecting flexible tube 22 to first distal portion 20);
a tip part assembly (Torii FIG. 1, distal portion 20 with a head assembly; Torii paragraph [0070], “endoscope 11 includes a first distal portion 20 with a head assembly, a steering section 21 and a flexible tube 22”) connected to and extending from the distal end of the bending section (Torii FIG. 1, showing distal portion 20 connected to and extending from the distal end of steering section 21);
a working channel tube (Examiner-annotated Torii FIG. 2 shown below, flexible synthetic resin; Torii paragraph [0086], “instrument channel 51 is formed from flexible synthetic resin.”) extending distally from the handle (Torii FIG. 1, grip portion 22a) to the tip part (Torii FIG. 1, distal portion 20) and located inside the insertion tube and the bending section (Torii paragraph [0083], “The distal opening 59 of the endoscope 11 is formed to communicate from the instrument channel 51 with the proximal opening 19 at the handle section 17; Torii paragraph [0086], “instrument channel 51 is disposed in the steering section 21 of the endoscope 11 and extends through the flexible tube 22”), the working channel tube (Torii FIG. 2, flexible synthetic resin) defining at least a portion of a working channel (Torii FIG. 2, instrument channel 51) configured to allow for insertion of a retractable instrument into a body (Torii paragraph [0112], medical instrument is entered through the instrument channel 51 to carry out the treatment“) and/or for suction of fluids from the body through the working channel (Torii FIG. 15, suction device 119; Torii paragraph [0109], “suction device 119 sucks fluid through the distal opening 59 from the instrument channel 51 of the endoscope 11, for example mucus, blood or the like”); and
steering wires (Torii FIG. 2, steering wires 50) extending from the handle to the bending section and configured to steer the tip part assembly (Torii paragraph [0073], “Steering wires for steering are contained in a tube lumen in the first elongated tube 16, and are moved back and forth by rotating the steering wheels 28 for steering”).
Torii does not explicitly disclose a metal coil between the tie layer and an outer surface of the outer layer.
Kizuka is analogous art in the field of minimally invasive surgery that teaches a catheter (Kizuka Examiner-annotated FIG. 2 shown below, catheter shaft 3) having a metal coil (Kizuka FIG. 4 coil 7; Kizuka paragraph [0032], “the material of the wire 7a constituting the coil body 7, for example, a metal material such as tungsten or a Ni—Ti alloy may be used or a resin material such as reinforced plastic (PEEK) may be used”) between the tie layer (Kizuka FIG. 4, tie layer at inner edge of outer layer 5) and an outer surface of the outer layer (Kizuka FIG. 4, showing coil 7 embedded in outer layer 15 of catheter 10).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Kizuka’s coil-embedded outer layer for the outer layer disclosed by Torii in the endoscope disclosed by Torii. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of an endoscope having coils in the outer layer that are unconstrained relative to the inner layer, thus allowing them to freely rotate along the longitudinal axis of the catheter (see paragraph [0035] of Kizuka”).
Torii in view of Kizuka does not explicitly teach:
the working channel tube comprising an extruded inner layer of an inner layer material, a tie layer, an extruded outer layer of an outer layer material different from the inner layer material,
wherein the outer layer material is a thermoplastic polyurethane with a wall thickness within a range of 0.10 to 0.50 mm,
wherein the inner layer material is a high-density polyethylene with a Shore D hardness according to ASTM D2240-15 less than 80 and a wall thickness within a range of 0.01 to 0.10 mm,
wherein a ratio of the wall thickness of the outer layer to the wall thickness of the inner layer greater than 1.5, and
wherein the inner layer and the outer layer are coextruded.
Ludlow is analogous art in the field of tubing construction that teaches:
the working channel tube (Ludlow FIG. 1, multilayer flexible tube 100) comprising an extruded inner layer (Ludlow FIG. 1, inner layer 102; Ludlow paragraph [0019], describing the inner layer as being extruded) of an inner layer material, a tie layer (Ludlow FIG. 1, tie layer 106), an extruded outer layer of an outer layer material different from the inner layer material (Ludlow Abstract, “an outer layer including a melt processable polymer having a shore hardness less than a shore hardness of the inner layer”).
wherein the outer layer material is a thermoplastic polyurethane (Ludlow paragraph [0029], “the outer layer includes a thermoplastic polyurethane”) and a wall thickness within a range of 0.10 to 0.50 mm (Ludlow paragraph [0039], “the outer layer 104 may have a thickness in a range of about 0.1 mils to about 500 mils” (.00254 – 12.7 mm)),
wherein the inner layer material has a Shore D hardness according to ASTM D2240-15 less than 80 (Ludlow paragraph [0022], “the hardness of the inner layer is shore D of less than about 95”) and a wall thickness within a range of 0.01 to 0.10 mm (Ludlow paragraph [0039], “the inner layer 102 may have a thickness of less than…about 2 mils.” (0.05 mm)), and
wherein a ratio of the wall thickness of the outer layer to the wall thickness of the inner layer greater than 1.5 (the ratio of 500 mils to 2 mils from Ludlow is 250:1), and
wherein the inner layer and the outer layer are coextruded. (Examiner notes that the specification provides no teaching that coextrusion affects the structure of the inner and outer layers. As such, this feature is deemed a design choice having no patentable weight.)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to construct Torii’s working channel using the multilayer flexible tube taught by Ludlow in the endoscope taught by Torii in view of Kizuka. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a flexible endoscope having a working channel tube made of biocompatible material such as a melt processable fluoropolymer (see Ludlow paragraph [0006].
Torii in view of Kizuka and Ludlow does not explicitly teach wherein the outer layer material is a thermoplastic polyurethane with a Shore A hardness according to ASTM D2240-15 within a range of 85 to 100.
Beisel is analogous art in the field of tubular construction that teaches wherein the outer layer material (Beisel FIG. 6, outer layer 12 of catheter 10) is a thermoplastic polyurethane with a Shore A hardness according to ASTM D2240-15 within a range of 85 to 100 (Beisel col. 13 lines 47-65, “An example of a design for a 19 ga. epidural catheter in accordance with the invention is shown in FIGS. 6 and 7…results in a remarkable smooth, transparent coil 14 which, after passing through an oven at about 170 degrees C. in 10 seconds, can be corona discharge treated and semi-pressure extrusion coated to a final O.D. of 0.98 mm (0.039") with an outer tubular layer 12 of 95 Shore A Tecothane, an aromatic polyurethane”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Beisel’s polyurethane to construct the outer layer of the working channel tube taught by Ludlow in the endoscope taught by Torii in view of Kizuka and Ludlow. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a working channel that has maximized longitudinal strength (see Beisel col. 10 lines 32-33).
Regarding Claim 44, Torii in view of Kizuka, Ludlow, and Beisel teaches the features of Claim 41, as described above.
Torii further discloses wherein the metal coil is intermediate the inner layer and the outer layer (Torii FIG. 6, showing helical coil 68 between covering layer 70 and inner layer that defines working channel 72).
Regarding Claim 46, Torii in view of Kizuka, Ludlow, and Beisel teaches the features of Claim 41, as described above.
Torii further discloses a monitor or a display (Torii FIG. 1, display panel 15).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Torii et al. (US PGPUB 2010/0125165 – “Torii”) in view of Kizuka (US PGPUB 2019/0275288 – “Kizuka”), Ludlow et al. (US PGPUB 2020/0369013 – “Ludlow”), Beisel (US Patent 5,947.940 – “Beisel”), and Konstantin (US PGPUB 2010/0094086 – “Konstantin”).
Regarding Claim 45, Torii in view of Kizuka, Ludlow, and Beisel teaches the features of Claim 41, as described above.
Torii in view of Kizuka, Ludlow, and Beisel does not explicitly teach wherein the inner layer is softer than the outer layer.
Konstantin is analogous art in the field of tubular construction that teaches wherein the inner layer is softer than the outer layer (Konstantin paragraph [0010] “the invention relates to a medico-technical flexible polymer tube made of thermoplastic material, the polymer tube including at least two layers which have a different Shore hardness; Konstantin paragraphs [0096]-[0098], “multi-layer eversion tube for an endoscope are manufactured of PVC by extrusion: two-layer tube of PVC having an outer layer (Shore hardness 90), an inner layer (Shore hardness 55)”.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Konstantin’s soft inner layer for Ludlow’s hard inner layer in the endoscope taught by Torii in view of Kizuka, Ludlow, and Beisel. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of an endoscope having a working channel that is less likely to damage an inserted instrument than a working channel with a hard inner layer.
Response to Arguments
Applicant’s arguments, see page 7, filed April 16, 2026, with respect to the objection to Claims 28-29, 37, and 41 have been fully considered and are persuasive in view of the current amendments thereto. The objection to Claims 28-29, 37, and 41 has been withdrawn.
Applicant’s arguments, see pages 7-12, filed April 16, 2026, with respect to the rejection(s) of Claims 23 and 36 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Dickhans (US PGPUB 2016/0058507 – “Dickhans”).
Applicant’s arguments against the rejection of Claim 23 are listed as First Denial through Fourth Denial, to which Examiner now responds:
1) First Denial. Applicant asserts that flexible structure 47 shown in FIG. 2 of Torii et al. (US PGPUB 2010/0125165 – “Torii”) is not a working channel tube, but rather is the endoscope tube 11 shown in Torii FIG. 1. Examiner respectfully disagrees. Although Examiner believes that Torii’s flexible structure 47 is analogous to the claimed working channel tube, the present Office Action clarifies that the flexible synthetic resin shown in Examiner-annotated FIG. 2 of Torii specifically teaches a working channel tube, as described above. Furthermore, newly-cited Dickhans (US PGPUB 2016/0058507 – “Dickhans”) clearly teaches a three layer working channel tube in Dickhans FIG. 3A, as described above.
2) Second Denial. Applicant again asserts that Torii’s flexible structure 47 is not a working channel tube, and thus the helical coil 68 in Torii FIG. 5 is not within a working channel tube. Examiner respectfully disagrees. Although Examiner believes that Torii’s flexible structure 47 is analogous to the claimed working channel tube, the present Office Action cites analogous art Kizuka (US PGPUB 2019/0275288 – “Kizuka”) as teaching a helical coil to be combined with Torii’s flexible synthetic resin that forms the working channel tube, and/or Dickhans’ three layer working channel tube, as described above.
3) Third Denial. Applicant asserts that a PHOSITA would not be motivated to combine Jenkins’ HDPE inner layer with the flexible tube taught by Ludlow. The feature of a working channel tube having an HDPE inner layer is rejected by using Jenkins’ HDPT inner layer with the multi-layered working channel tube taught by Dickhans’ FIG. 3A/3B, and thus this argument is moot. Applicant further argues that a PHOSITA would not be motivated to use a fluoropolymer, as discussed in the background paragraph [0006] of Ludlow, in a flexible endoscope. Examiner points out that Ludlow is not cited for teaching a standard rigid fluoropolymer, but rather a “melt processable fluoropolymer” which is a terpolymer including a tetrafluoroethylene, a hexafluoropropylene, and a vinylidene fluoride (THV), and is highly flexible (see Ludlow paragraph [0023], which describes the inner layer being made of melt processable fluoropolymer having a flexural modulus of less than 10,000 psi – equivalent to 0.06895 GPa (GigaPascals), which is 40X more flexible than a standard garden hose made of butyl rubber (having a flexural modulus of 0.3-3.4 GPa – see attached Chart of Young’s Modulus of Polymers & Plastics,
https://matmake.com/imgs/share/youngs-modulus-of-polymers-and-plastics-share.png, 2026). Applicant’s argument that HDPE is less expensive that other materials is conclusory and unsupported.
4) Fourth Denial. Applicant further argues that the materials used in Ludlow and Jenkins are incompatible, since HDPE has low surface energy and polyurethane is prone to degradation. Examiner notes again that Ludlow teaches melt processable fluoropolymer, not standard fluoropolymer.
Applicant’s arguments against the rejection of Claim 36 are found on page 12. Applicant’s arguments are focused against Konstantin (US PGPUB 2010/0094086 – “Konstantin”), which is no longer cited in the rejection of Claim 36, and thus is moot.
Finally, Applicant’s argument that combining four references requires impermissible hindsight is not persuasive. That is, and in response to applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991). As such, Applicant’s assertion is conclusory and unsupported in the record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include, but are not limited to:
Leong et al. (US PGPUB 2019/0350440 – “Leong”), which teaches in Leong FIG. 2A a working channel 206, which as described in Leong paragraph [0048] “ may include an inner and outer layer of polymer material with a polymer or metal coil layer provided therebetween in a generally helical or braided geometry”.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
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