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 .
This Office Action is in response to the amendments dated October 24, 2025.
Claims 23-26, 28-30, 34-38, 40-41, and 44-53 are pending.
Claim Objections
Claims 28-29, 37, and 41 are objected to because of the following informalities:
Claim 28 is objected to for depending on cancelled Claim 27.
Claim 29 is objected to for depending on Claim 28.
Claim 37 is objected to for the double typographical error “wall wall” in line 3.
Claim 41 is objected to for the typographical error “an an” in line 13, which Examiner believes should be “and an”.
Appropriate correction by Applicant is required.
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.
Claims 23-26, 28-30, 34-35, 40, 47-51, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Torii et al. (US PGPUB 2010/0125165 – “Torii”) in view of Ludlow et al. (US PGPUB 2020/0369013 – “Ludlow”) and Jenkins (US PGPUB 2018/0333044 – “Jenkins”).
Regarding Claim 23, 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) extending from the handle;
a bending section (Torii FIG. 1, steering section 21) extending from the insertion tube;
a tip part assembly (Torii FIG. 1, distal portion 20 with a head assembly) extending from the bending section;
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”); and
a working channel tube (Torii FIG. 2, flexible structure 47), the working channel tube defining at least a portion of a working channel (Torii FIG. 2, instrument channel 51) extending from the handle through the insertion tube and the bending section 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
a metal coil between the tie layer and an outer surface of the outer layer (Torii FIG. 5, showing helical coil 68 between outer layer 70 and the inner layer that defines working channel 72)
Torii does not explicitly disclose:
the working channel tube comprising an extruded inner layer comprising a high-density polyethylene, 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 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…a tie layer including a polymeric blend of a terpolymer”),
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 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 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 Ludlow do not explicitly teach the inner layer material is a high-density polyethylene.
Jenkins 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 in the endoscope taught by Torii in view of 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]).
Regarding Claim 24, Torii in view of Ludlow and Jenkins 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”), 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 manufacturing design choice having no patentable weight.)
Regarding Claim 25, Torii in view of Ludlow and Jenkins 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”).
Regarding Claim 26, Torii in view of Ludlow and Jenkins 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).
Regarding Claim 28, Torii in view of Ludlow and Jenkins teaches the features of Claim 27, 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 Ludlow and Jenkins 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 Ludlow and Jenkins 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 Ludlow and Jenkins teaches the features of Claim 23, 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 35, Torii in view of Ludlow and Jenkins 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 40, Torii in view of Ludlow and Jenkins 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 Ludlow and Jenkins teaches the features of Claim 23, as described above.
wherein the working channel tube comprises an inner diameter of 3.5 to 5.0 mm and the wall thickness of the outer layer is within 0.3 to 0.5 mm.
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 Ludlow and Jenkins 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 Ludlow and Jenkins 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 and the tie layer.
Regarding Claim 50, Torii in view of Ludlow and Jenkins teaches the features of Claim 49, as described above.
Ludlow further teaches wherein the contact layer and the outer layer are comprised of the thermoplastic polyurethane (Ludlow paragraph [0063], “the outer layer includes a thermoplastic polyurethane”).
Regarding Claim 51, Torii in view of Ludlow and Jenkins teaches the features of Claim 49, as described above.
Ludlow 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 (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.).
Regarding Claim 53, Torii in view of Ludlow and Jenkins 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 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Torii et al. (US PGPUB 2010/0125165 – “Torii”) in view of Ludlow et al. (US PGPUB 2020/0369013 – “Ludlow”), Jenkins (US PGPUB 2018/0333044 – “Jenkins”), and Konstantin (US PGPUB 2010/0094086 – “Konstantin”).
Regarding Claim 36, Torii in view of Ludlow and Jenkins teaches the features of Claim 23, as described above.
Torii in view of Ludlow and Jenkins does not explicitly teach wherein the inner layer is softer than the outer layer.
Konstantin 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 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 a working channel that is less likely to damage an inserted instrument than a working channel with a hard inner layer.
Regarding Claim 37, Torii in view of Ludlow and Jenkins teaches the features of Claim 23, as described above.
Torii in view of Ludlow and Jenkins 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 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 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 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 Ludlow et al. (US PGPUB 2020/0369013 – “Ludlow”), Jenkins (US PGPUB 2018/0333044 – “Jenkins”), and Chu et al. (US PGPUB 2003/0163119 – “Chu”).
Regarding Claim 38, Torii in view of Ludlow and Jenkins teaches the features of Claim 23, as described above.
Torii in view of Ludlow and Jenkins does not explicitly teach wherein a proximal portion of the working channel tube is everted.
Chu 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 Ludlow and Jenkins. 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 Ludlow et al. (US PGPUB 2020/0369013 – “Ludlow”).
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) extending from the handle;
a bending section (Torii FIG. 1, steering section 21) extending from the insertion tube;
a tip part assembly (Torii FIG. 1, distal portion 20 with a head assembly) extending from the bending section;
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”); and
a working channel tube (Torii FIG. 2, flexible structure 47), the working channel tube defining at least a portion of a working channel (Torii FIG. 2, instrument channel 51) extending from the handle through the insertion tube 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”).
Torii does not explicitly disclose:
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, and a metal coil between the tie layer and an outer surface of the outer layer,
wherein the outer layer material is a thermoplastic polyurethane with a Shore A hardness according to ASTM D2240-15 within a range of 60 to 100 and 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 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”), and a metal coil between the tie layer and an outer surface of the outer layer (Torii FIG. 5, showing helical coil 68 between covering layer 70 and inner layer that defines working channel 72),
wherein the outer layer material is a thermoplastic polyurethane (Ludlow paragraph [0029], “the outer layer includes a thermoplastic polyurethane”) with 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 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. 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].
Regarding Claim 44, Torii in view of Ludlow 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 Ludlow 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 Ludlow et al. (US PGPUB 2020/0369013 – “Ludlow”) and Konstantin (US PGPUB 2010/0094086 – “Konstantin”).
Regarding Claim 45, Torii in view of Ludlow teaches the features of Claim 41, as described above.
Torii in view of Ludlow do not explicitly teach wherein the inner layer is softer than the outer layer.
Konstantin 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 Ludlow. 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 52 is rejected under 35 U.S.C. 103 as being unpatentable over Torii et al. (US PGPUB 2010/0125165 – “Torii”) in view of Ludlow et al. (US PGPUB 2020/0369013 – “Ludlow”), Jenkins (US PGPUB 2018/0333044 – “Jenkins”), and Kizuka (US PGPUB 2019/0275288 – “Kizuka”).
Regarding Claim 52, Torii in view of Ludlow and Jenkins 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”).
Torii in view of Ludlow and Jenkins do not explicitly teach wherein the metal coil is embedded in the outer layer.
Kizuka 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).
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 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”).
Response to Arguments
Applicant’s arguments, see page 6, filed on October 24, 2025, with respect to the drawing objections have been fully considered and are persuasive in view of the present claim amendments. The objection to the drawings has been withdrawn.
Applicant’s arguments, see page 6, filed on October 24, 2025, with respect to the objections to Claims 23, 30, and 39 have been fully considered and are persuasive in view of the present claim amendments. The objections to Claims 23, 30, and 39 have been withdrawn.
Applicant’s arguments, see page 6, filed on October 24, 2025, with respect to the rejections of Claims 38-39 under 35 U.S.C. 112(b) have been fully considered and are persuasive in view of the present claim amendments. The rejections of Claims 38-39 under 35 U.S.C. 112(b) have been withdrawn.
Regarding Applicant's arguments, filed on October 24, 2025, against the rejections of Claims 23 and 41 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Specifically, Applicant argues on page 7 that amended Claims 23 and 41 now include the features of a metal coil between a tie layer and an outer surface of the outer layer of the tube, in addition to thickness ranges and ratios between thicknesses of the layers. These features are all addressed/rejected in the 35 U.S.C. 103 rejections of Claims 23 and 41 presented above
Pages 7-8 then discuss features being presently claimed.
Pages 8-9 then traverse the 35 U.S.C. 103 rejections of Claims 23 and 41 by arguing that Torii does not claim a coil that extends over the bending section. Examiner respectfully points out that this is not what is claimed in Claims 23 and 41. Rather, Claims 23 and 41 claim a coil that is between a tie layer and an outer layer of a working channel tube, which includes all of the insertion tube plus a bending section that make up a working channel tube. As described in the rejections above, Torii FIG. 5 shows showing helical coil 68 between outer layer 70 and the inner layer that defines working channel 72, which extends though the working channel tube.
On page 10, Applicant argues that Ludlow does not teach a coil. However, Ludlow is never cited as teaching a coil, thus the argument is moot.
For reasons stated herein, the rejection of Claim 23 and 41, as well as Claims 24-26, 28-30, 34-38, 40, and 44-53 under 35 U.S.C. 103 are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
01/06/26