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 .
Election/Restrictions
Applicant’s election without traverse of Group I and species D, which corresponds to Figures 10A and 10B, in reply filed 07/31/2025, is acknowledged. Claims 10-15 have been withdrawn because such claims are directed to a non-elected species. Claims 1-9 and 16-20 are examined below.
Response to Amendment
The amendment filed 11/24/2025 has been entered. Claims 1, 3, 5- 21 are currently pending, with claims 2 and 4 canceled, and claims 10-15 withdrawn as being directed to a non-elected species.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the each independent claims has been amended with a newly added limitation stating, “wherein the primary control valve and the one ore more seals are formed from a single elastomeric material, the single elastomeric material forming the primary control valve comprises a first shore value and the single elastomeric material forming the one ore more seals comprises a second shore value lower than the first shore value.” Such newly added limitation changes the scope the claims and requires a new ground of rejection. As such, the previous grounds of rejection identified in the non-final office action dated, 08/27/2025, have been withdrawn and new grounds of ground of rejection are presented below.
Please see section 35 U.S.C. §103 below for further explanation.
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 1, 5-7, 9, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US2020/0352415) hereinafter Harris, in view of Schaefert, Andreas. The Benefits of Two Shot Injection Molding. Simtec. April 20, 2021. hereinafter Schaefert, in view of John T. Rogers (US4860995) hereinafter Rogers.
Regarding Claim 1, Harris discloses a medical device (abstract), comprising:
a primary control valve (Fig. 1a, 8, 9 cleaning valve assembly 102, [0062] valve 10, to include inner cylindrical member 16) including a top (Fig. 8 near proximal end 12), a bottom (Fig. 8 near distal end 14), one or more orifices (Figs. 8-9 apertures 24, 26), and a lumen (Fig. 9 lumen 22) in fluid communication with at least one orifice (Figs. 8-9 apertures 24, 26) in the one or more orifices (Figs. 8-9 apertures 24, 26); and
one or more seals (Fig. 8-9 one-way seal 62, seals 32,34,36) positioned between the top (Fig. 8 proximal end 12) and bottom (Fig. 8 distal end 14) of the primary control valve (Fig. 1a, 8, 9 cleaning valve assembly 102, [0062] valve 10, to include inner cylindrical member 16) , wherein the primary control valve (Fig. 1a, 8, 9 cleaning valve assembly 102, [0062] valve 10, to include inner cylindrical member 16) and the one or more seals (Fig. 8-9 one-way seal 62, seals 32,34,36) comprise a unitary structure ([0013] “The inner member may be a single, unitary structure formed of a single material. The inner member may include a plurality of seals configured to form a slidable interference fit with a wall of an endoscope valve cylinder so that a fluid cannot pass between each of the plurality of seals and the wall of the endoscope valve cylinder.”).
wherein the one or more seals are formed from a single elastomeric material ([0067] “Inner cylindrical member 16 may have disposed on it a first distal seal 32, a second distal seal 34, and a third distal seal 36. Distal seals 32, 34, 36 may be made from elastomeric material.” [0069] “Inner cylindrical member 16 may also be fitted with a one-way seal 62, which may be disposed between first distal seal 32 and proximal seal 42. One-way seal 62 may be formed of an elastomeric material, and may be annularly shaped, having an inner surface and an outer surface.”).
Harris is silent at explicitly disclosing the inner cylindrical member – the primary control valve – is also made of the single elastomeric material and the single elastomeric material forming the primary control valve comprises a first Shore value and the single elastomeric material forming the one or more seals comprises a second Shore value lower than the first Shore value. Harris does teach that the inner cylindrical member – the primary control valve – is made of a material capable of being injected molded, 3D printed, and otherwise formed (Fig. 1a, 8, 9 cleaning valve assembly 102, [0062] valve 10, to include inner cylindrical member 16, [0064] “Inner cylindrical member 16 may be, for example, a valve stem. Inner cylindrical member 16 may be a single, unitary structure formed of a single, continuous piece of material … thermoplastic, plastic, or the like), or from any other suitable material. Depending on the material used, inner cylindrical member 16 may be machined, injection molded, extruded (via, e.g., 3D printing), or otherwise formed. Inner cylindrical member 16 may be formed of a clear thermoplastic so that certain portions of an interior of inner cylindrical member 16 are visible through external walls of inner cylindrical member.”).
Schaefert, in the same field of endeavor, teaches a material capable of being injected molded is Liquid Silicone Rubber (LSR), which is a high-performance thermoset elastomeric material (Schaefert – page 1 - whole document).
Therefore, It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Harris with the teachings of Schaefert to include the primary control valve and the one or more seals to be formed from a single elastomeric material for the benefit of the elastomeric material having “excellent physical, chemical, and heat resistance properties…” necessary to function in a medical device (Schaefert – page 9 under the Medical/Healthcare section).
Schaefert continues to teach the single elastomeric material forming the primary control valve comprises a first Shore value and the single elastomeric material forming the one or more seals comprises a second Shore value (Schaefert – pages 2-3 under section “Liquid Silicone Rubber 2-Shot Injection Molding”, “It is even possible to over-mold LSR onto LSR, with two separate durometers and colors. The benefit for manufacturing is the ability to integrate several functions, parts, and materials into one component – permanently fused.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Harris with the teachings of Schaefert to have the primary control valve and the one or more seals be formed from a single elastomeric material, wherein the single elastomeric material forming the primary control valve comprises a first Shore value and the single elastomeric material forming the one or more seals comprises a second Shore value for the benefit of having the “…ability to integrate several …parts…into one component [that is] permanently fused” together” (Schaefert - pages 2-3 under section “Liquid Silicone Rubber 2-Shot Injection Molding”).
But, Harris in view of Schaefert is silent at specifically disclosing whether the second Shore value of the one or more seals is lower than the first Shore value of the primary control valve.
However Rogers teaches the second Shore value of the one or more seals (Rogers – Fig. 4 portion 304 and surface 308) is lower than the first Shore value of the primary control valve (Rogers – Fig. 4 valve guide 306, [col. 5 line 37-col. 6 line2] “ Flange portion 304, which forms an annularly extending sealing surface 308, is comprised of a relatively soft or resilient material whereas guide 306, while it is also plastic or of a plastic-like material is relatively harder and less resilient than the material of flange 304. This allows sealing surface 308 to effect better sealing with the seating surface in the valve assembly while ensuring that valve guide 306 is sufficiently rigid and hard enough to resist bending or excessive wearing. Flange 304 and guide 306 can be formed separately and then simply bonded together along their intersecting surfaces.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Harris in view of Schaefert with the teachings of Rogers to have the second Shore value of the one or more seals is lower than the first Shore value of the primary control valve for the benefit of ensuring the primary control valve is rigid enough to withstand the applied force required for the valve to function properly - change positions - and still have the sealing surfaces of the one or more seals to actively seal and function appropriately along the side of a valve cylinder (Rogers - [col. 5 line 37-col. 6 line2]).
Regarding Claim 5, Harris in view of Schaefert in view of Rogers teaches the medical device of claim 1, further comprising a housing (Harris - Fig. 1a, 8, 9 cylindrical member 18) configured to couple with the primary control valve (Harris - Fig. 1a, 8, 9 cleaning valve assembly 102 via cylindrical member 16) and a valve well (Harris - Fig. 9 valve cylinder 39).
Regarding Claim 6, Harris in view of Schaefert in view of Rogers teaches the medical device of claim 5, wherein the housing (Harris - Fig. 1a, 8, 9 cylindrical member 18) is configured to provide a biasing force (Figs. 9-10, [0077] “Outer cylindrical member 18 may be biased to the uncompressed state of the first configuration…”) between the primary control valve (Harris - Fig. 1a, 8, 9 cleaning valve assembly 102 via cylindrical member 16) and the valve well (Harris - Fig. 9 valve cylinder 39).
Regarding Claim 7, Harris in view of Schaefert in view of Rogers teaches the medical device of claim 6, wherein the housing (Harris - Fig. 1a, 8, 9 cylindrical member 18) is formed from an elastomer (Harris - [0071] “Outer cylindrical member 18 may be formed of an elastomeric material such as, for example, silicone rubber, urethane rubber, natural rubber, nitrile rubber, butyl rubber, any combinations thereof, and/or any material exhibiting the appropriate material properties including elongation/recovery characteristics.”).
Regarding Claim 9, Harris in view of Schaefert in view of Rogers teaches the medical device of claim 1, wherein the one or more seals (Harris - Fig. 8-9 one-way seal 62, seals 32,34,36) are overmolded (Harris - [0084] “In many embodiments, one or more of seals 132, 134, 136, 142 and/or one or more of seals 32, 34, 36, 42 may be formed via overmolding.”) onto the primary control valve (Harris - Fig. 1a, 8, 9 cleaning valve assembly 102, [0062] valve 10, to include inner cylindrical member 16) to form the unitary structure (Harris - [0013] “The inner member may be a single, unitary structure formed of a single material. The inner member may include a plurality of seals configured to form a slidable interference fit with a wall of an endoscope valve cylinder so that a fluid cannot pass between each of the plurality of seals and the wall of the endoscope valve cylinder.”).
Regarding Claim 16, Harris discloses a medical device (Fig. 1a cleaning valve assembly 102), comprising:
a primary control valve (Fig. 1a, 8, 9 cleaning valve assembly 102, [0062] valve 10, to include inner cylindrical member 16) including a top (Fig. 8 near proximal end 12), a bottom (Fig. 8 near distal end 14), one or more orifices (Figs. 8-9 apertures 24, 26), and a lumen (Fig. 9 lumen 22) in fluid communication with at least one orifice (Figs. 8-9 apertures 24, 26) in the one or more orifices (Figs. 8-9 apertures 24, 26); and
one or more seals (Fig. 8-9 one-way seal 62, seals 32,34,36) positioned between the top (Fig. 8 proximal end 12) and bottom (Fig. 8 distal end 14) of the primary control valve (Fig. 1a, 8, 9 cleaning valve assembly 102, [0062] valve 10, to include inner cylindrical member 16) , wherein the primary control valve (Fig. 1a, 8, 9 cleaning valve assembly 102, [0062] valve 10, to include inner cylindrical member 16) and the one or more seals (Fig. 8-9 one-way seal 62, seals 32,34,36) comprise a unitary structure ([0013] “The inner member may be a single, unitary structure formed of a single material. The inner member may include a plurality of seals configured to form a slidable interference fit with a wall of an endoscope valve cylinder so that a fluid cannot pass between each of the plurality of seals and the wall of the endoscope valve cylinder.”), and
a housing (Fig. 1a, 8, 9 cylindrical member 18) configured to couple with the primary control valve (Fig. 1a, 8, 9 cleaning valve assembly 102 via cylindrical member 16) and a valve well (Fig. 9 valve cylinder 39);
wherein the one or more seals are formed from a single elastomeric material ([0067] “Inner cylindrical member 16 may have disposed on it a first distal seal 32, a second distal seal 34, and a third distal seal 36. Distal seals 32, 34, 36 may be made from elastomeric material.” [0069] “Inner cylindrical member 16 may also be fitted with a one-way seal 62, which may be disposed between first distal seal 32 and proximal seal 42. One-way seal 62 may be formed of an elastomeric material, and may be annularly shaped, having an inner surface and an outer surface.”).
Harris is silent at explicitly disclosing the inner cylindrical member – the primary control valve – is also made of the single elastomeric material and the single elastomeric material forming the primary control valve comprises a first Shore value and the single elastomeric material forming the one or more seals comprises a second Shore value lower than the first Shore value. Harris does teach that the inner cylindrical member – the primary control valve – is made of a material capable of being injected molded, 3D printed, and otherwise formed (Fig. 1a, 8, 9 cleaning valve assembly 102, [0062] valve 10, to include inner cylindrical member 16, [0064] “Inner cylindrical member 16 may be, for example, a valve stem. Inner cylindrical member 16 may be a single, unitary structure formed of a single, continuous piece of material … thermoplastic, plastic, or the like), or from any other suitable material. Depending on the material used, inner cylindrical member 16 may be machined, injection molded, extruded (via, e.g., 3D printing), or otherwise formed. Inner cylindrical member 16 may be formed of a clear thermoplastic so that certain portions of an interior of inner cylindrical member 16 are visible through external walls of inner cylindrical member.”).
Schaefert, in the same field of endeavor, teaches a material capable of being injected molded is Liquid Silicone Rubber (LSR), which is a high-performance thermoset elastomeric material (Schaefert – page 1 - whole document).
Therefore, It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Harris with the teachings of Schaefert to include the primary control valve and the one or more seals to be formed from a single elastomeric material for the benefit of the elastomeric material having “excellent physical, chemical, and heat resistance properties…” necessary to function in a medical device (Schaefert – page 9 under the Medical/Healthcare section).
Schaefert continues to teach the single elastomeric material forming the primary control valve comprises a first Shore value and the single elastomeric material forming the one or more seals comprises a second Shore value (Schaefert – pages 2-3 under section “Liquid Silicone Rubber 2-Shot Injection Molding”, “It is even possible to over-mold LSR onto LSR, with two separate durometers and colors. The benefit for manufacturing is the ability to integrate several functions, parts, and materials into one component – permanently fused.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Harris with the teachings of Schaefert to have the primary control valve and the one or more seals be formed from a single elastomeric material, wherein the single elastomeric material forming the primary control valve comprises a first Shore value and the single elastomeric material forming the one or more seals comprises a second Shore value for the benefit of having the “…ability to integrate several …parts…into one component [that is] permanently fused” together” (Schaefert - pages 2-3 under section “Liquid Silicone Rubber 2-Shot Injection Molding”).
But, Harris in view of Schaefert is silent at specifically disclosing whether the second Shore value of the one or more seals is lower than the first Shore value of the primary control valve.
However Rogers teaches the second Shore value of the one or more seals (Rogers – Fig. 4 portion 304 and surface 308) is lower than the first Shore value of the primary control valve (Rogers – Fig. 4 valve guide 306, [col. 5 line 37-col. 6 line2] “ Flange portion 304, which forms an annularly extending sealing surface 308, is comprised of a relatively soft or resilient material whereas guide 306, while it is also plastic or of a plastic-like material is relatively harder and less resilient than the material of flange 304. This allows sealing surface 308 to effect better sealing with the seating surface in the valve assembly while ensuring that valve guide 306 is sufficiently rigid and hard enough to resist bending or excessive wearing. Flange 304 and guide 306 can be formed separately and then simply bonded together along their intersecting surfaces.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Harris in view of Schaefert with the teachings of Rogers to have the second Shore value of the one or more seals is lower than the first Shore value of the primary control valve for the benefit of ensuring the primary control valve is rigid enough to withstand the applied force required for the valve to function properly - change positions - and still have the sealing surfaces of the one or more seals to actively seal and function appropriately along the side of a valve cylinder (Rogers - [col. 5 line 37-col. 6 line2]).
Regarding Claim 17, Harris in view of Schaefert in view of Rogers teaches the medical device of claim 16, wherein the housing (Harris - Fig. 1a, 8, 9 cylindrical member 18) is configured to provide a biasing force (Harris - Figs. 9-10, [0077] “Outer cylindrical member 18 may be biased to the uncompressed state of the first configuration…”) between the primary control valve (Harris - Fig. 1a, 8, 9 cleaning valve assembly 102 via cylindrical member 16) and the valve well (Harris - Fig. 9 valve cylinder 39).
Regarding Claim 18, Harris in view of Schaefert in view of Rogers teaches the medical device of claim 16, wherein the housing (Harris - Fig. 1a, 8, 9 cylindrical member 18) is formed from an elastomer (Harris - [0071] “Outer cylindrical member 18 may be formed of an elastomeric material such as, for example, silicone rubber, urethane rubber, natural rubber, nitrile rubber, butyl rubber, any combinations thereof, and/or any material exhibiting the appropriate material properties including elongation/recovery characteristics.”).
Regarding Claim 20, Harris in view of Schaefert in view of Rogers teaches the medical device of claim 16, wherein the one or more seals (Harris - Fig. 8-9 one-way seal 62, seals 32,34,36) are overmolded (Harris - [0084] “In many embodiments, one or more of seals 132, 134, 136, 142 and/or one or more of seals 32, 34, 36, 42 may be formed via overmolding.”) onto the primary control valve (Harris - Fig. 1a, 8, 9 cleaning valve assembly 102, [0062] valve 10, to include inner cylindrical member 16) to form the unitary structure (Harris - [0013] “The inner member may be a single, unitary structure formed of a single material. The inner member may include a plurality of seals configured to form a slidable interference fit with a wall of an endoscope valve cylinder so that a fluid cannot pass between each of the plurality of seals and the wall of the endoscope valve cylinder.”). .
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Harris in view of Schaefert in view of Rogers in view of Yasuyuki Sato (US2006/0041190) hereinafter Sato.
Regarding Claim 3, Harris in view of Schaefert in view of Rogers teaches the medical device of claim 1, but is silent wherein the elastomer comprises nitrile rubber.
However Sato, in the same field of endeavor, teaches wherein the elastomer of the sealing member comprises nitrile rubber (Sato – [0036] “An elastic material made of the sealing member 30 may be one of various rubber materials, for example, silicone rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber, epichlorhydrin rubber, polyurethane rubber, fluorocarbon rubber, natural rubber, or one or combination of two or more materials such as styrene, polyolefin, polyvinyl chloride, polyurethane, polyamid, polybutadiene, transpolyisoprene, fluorocarbon rubber, chlorinated polyethylene. However, among all, it is preferable that the core member 31 of the sealing member 30 is mainly made of silicone rubber. With this configuration, elasticity of the sealing member 30 particularly increases, and airtightness between the cylinder 12 and the piston 20 is securely maintained.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Harris in view of Schaefert in view of Rogers with the teachings of Sato to include wherein the elastomer comprises nitrile rubber for the benefit of increasing elasticity of the sealing member while maintaining airtightness between the valve stem and the vale cylinder (Sato –[0036]).
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Harris in view of Scheafert in view of Rogers in view of Millman et al. (US2007/0005002) hereinafter Millman.
Regarding Claim 8, Harris in view of Scheafert in view of Rogers teaches the medical device of claim 1, Harris teaches “the valve may have a single elastomeric component, or spring cap, which may combine and simplify the functionality of a number of components (e.g., a boot, spring, spring housing, and stem cap)” (Harris – abstract) but Harris in view of Scheafert in view of Rogers is silent as to explicitly further comprising a variable rate spring.
However Millman, the same field of endeavor, teaches a variable rate spring. (Millman - [0231-0233] “In which case, the touch sensitive handle may include one or more springs 306A-306C to provide differing spring constants or a single spring 306 with a progressive rate spring constant as the positions of the grips 350A-350B change. An explanation as to how the touch sensitive handle 325 functions was previously describe with reference to FIG. 3C. By using the grip of the touch sensitive handle 325 to control the IAB robotic surgical instrument, the rotational motion of the handle may be used for further movement or control of the instrument. The position of the grips 350A-350B can vary over a range of positions in order to control suction, blowing and irrigation of a surgical site such as from a fully released or fully open position to a fully squeezed or fully closed position. FIGS. 16B-16D illustrate different positions of the grips 350A-350B of the touch sensitive handle 325 when squeezed by a hand H of the operator O to control the IAB robotic surgical tool at a surgical site. FIG. 16B illustrates a fully open grip position without any squeezing by the hand H. FIG. 16C illustrates the hand H squeezing the grips 350A-350B to a half-way closed position. To provide force feedback to a user, a first spring rate may be used over a range of positions, such as from the fully open to the half-way closed position. FIG. 16D illustrates the hand H squeezing the grips 350A-350B to a fully closed position. To provide force feedback to a user, a second spring rate somewhat greater than the first may be used over a range of positions, such as from the half-way closed position to the fully closed position.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Harris in view of Scheafert in view of Rogers with the spring disclosed in Harris to be a variable rate spring disposed about a portion of the primary control valve similar to the variable spring taught in Millman for the benefit of giving feedback to the user as well maintaining control of the rate of fluid within the valve (Millman - [0231-0233]).
Regarding Claim 19, Harris in view of Scheafert in view of Rogers teaches the medical device of claim 16, Harris teaches “the valve may have a single elastomeric component, or spring cap, which may combine and simplify the functionality of a number of components (e.g., a boot, spring, spring housing, and stem cap)” (Harris – abstract) but is silent as to explicitly further comprising a variable rate spring.
However Millman, the same field of endeavor, teaches a variable rate spring. (Millman - [0231-0233] “In which case, the touch sensitive handle may include one or more springs 306A-306C to provide differing spring constants or a single spring 306 with a progressive rate spring constant as the positions of the grips 350A-350B change. An explanation as to how the touch sensitive handle 325 functions was previously describe with reference to FIG. 3C. By using the grip of the touch sensitive handle 325 to control the IAB robotic surgical instrument, the rotational motion of the handle may be used for further movement or control of the instrument. The position of the grips 350A-350B can vary over a range of positions in order to control suction, blowing and irrigation of a surgical site such as from a fully released or fully open position to a fully squeezed or fully closed position. FIGS. 16B-16D illustrate different positions of the grips 350A-350B of the touch sensitive handle 325 when squeezed by a hand H of the operator O to control the IAB robotic surgical tool at a surgical site. FIG. 16B illustrates a fully open grip position without any squeezing by the hand H. FIG. 16C illustrates the hand H squeezing the grips 350A-350B to a half-way closed position. To provide force feedback to a user, a first spring rate may be used over a range of positions, such as from the fully open to the half-way closed position. FIG. 16D illustrates the hand H squeezing the grips 350A-350B to a fully closed position. To provide force feedback to a user, a second spring rate somewhat greater than the first may be used over a range of positions, such as from the half-way closed position to the fully closed position.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Harris in view of Scheafert in view of Rogers with the spring disclosed in Harris to be a variable rate spring disposed about a portion of the primary control valve similar to the variable spring taught in Millman for the benefit of giving feedback to the user as well maintaining control of the rate of fluid within the valve (Millman - [0231-0233]).
Claims 1 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Harris in view of Schaefert in view of Rogers.
Regarding Claim 1, Harris discloses a medical device (abstract), comprising:
a primary control valve (Figs. 13-14 valve 200 to include proximal portion 224 and distal portion 202) including a top (Figs 13-14 near proximal opening 236), a bottom (Figs 13-14 near distal end 242), one or more orifices (Figs. 8-9 proximal opening 236 and distal aperture 240), and a lumen (Figs. 13-14 lumen 232) in fluid communication with at least one orifice (Figs. 8-9 proximal opening 236 and distal aperture 240) in the one or more orifices (Figs. 8-9 proximal opening 236 and distal aperture 240); and
one or more seals (Figs 13-14, seals 286, 214,214) positioned between the top ((Figs 13-14 near proximal opening 236) and bottom (Figs 13-14 near distal end 242) of the primary control valve (Figs. 13-14 valve 200 to include proximal portion 224 and distal portion 202), wherein the primary control valve (Figs. 13-14 valve 200 to include proximal portion 224 and distal portion 202) and the one or more seals (Figs 13-14, seals 286, 214,214) comprise a unitary structure (Figs. 13-14, proximal portion 224 and distal portion 202 are a unitary structure, [0088], [0013] “The inner member may be a single, unitary structure formed of a single material. The inner member may include a plurality of seals configured to form a slidable interference fit with a wall of an endoscope valve cylinder so that a fluid cannot pass between each of the plurality of seals and the wall of the endoscope valve cylinder.”).
wherein the one or more seals are formed from a single elastomeric material ([0088] “A body of distal member 202 may be a single, unitary structure formed of a single, continuous material. Distal member 202 may be fitted with a first distal seal 212 and a second distal seal 214, each of which may have any of the properties of distal seals 32, 34, 36, or proximal seal 42, described above,…” [0067] “Inner cylindrical member 16 may have disposed on it a first distal seal 32, a second distal seal 34, and a third distal seal 36. Distal seals 32, 34, 36 may be made from elastomeric material.” [0069] “Inner cylindrical member 16 may also be fitted with a one-way seal 62, which may be disposed between first distal seal 32 and proximal seal 42. One-way seal 62 may be formed of an elastomeric material, and may be annularly shaped, having an inner surface and an outer surface.”).
Harris is silent at explicitly disclosing the inner cylindrical member – the primary control valve – is also made of the single elastomeric material and the single elastomeric material forming the primary control valve comprises a first Shore value and the single elastomeric material forming the one or more seals comprises a second Shore value lower than the first Shore value. Harris does teach that the inner cylindrical member – the primary control valve – is made of a material capable of being injected molded, 3D printed, and otherwise formed (Harris - Figs. 13-14 valve 200 to include proximal portion 224 and distal portion 202, [0088] “Distal member 202 may be formed of any of the materials described above with respect to inner cylindrical member 16.” [0064] “Inner cylindrical member 16 may be, for example, a valve stem. Inner cylindrical member 16 may be a single, unitary structure formed of a single, continuous piece of material … thermoplastic, plastic, or the like), or from any other suitable material. Depending on the material used, inner cylindrical member 16 may be machined, injection molded, extruded (via, e.g., 3D printing), or otherwise formed. Inner cylindrical member 16 may be formed of a clear thermoplastic so that certain portions of an interior of inner cylindrical member 16 are visible through external walls of inner cylindrical member.”).
Schaefert, in the same field of endeavor, teaches a material capable of being injected molded is Liquid Silicone Rubber (LSR), which is a high-performance thermoset elastomeric material (Schaefert – page 1 - whole document).
Therefore, It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Harris with the teachings of Schaefert to include the primary control valve and the one or more seals to be formed from a single elastomeric material for the benefit of the elastomeric material having “excellent physical, chemical, and heat resistance properties…” necessary to function in a medical device (Schaefert – page 9 under the Medical/Healthcare section).
Schaefert continues to teach the single elastomeric material forming the primary control valve comprises a first Shore value and the single elastomeric material forming the one or more seals comprises a second Shore value (Schaefert – pages 2-3 under section “Liquid Silicone Rubber 2-Shot Injection Molding”, “It is even possible to over-mold LSR onto LSR, with two separate durometers and colors. The benefit for manufacturing is the ability to integrate several functions, parts, and materials into one component – permanently fused.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Harris with the teachings of Schaefert to have the primary control valve and the one or more seals be formed from a single elastomeric material, wherein the single elastomeric material forming the primary control valve comprises a first Shore value and the single elastomeric material forming the one or more seals comprises a second Shore value for the benefit of having the “…ability to integrate several …parts…into one component [that is] permanently fused” together” (Schaefert - pages 2-3 under section “Liquid Silicone Rubber 2-Shot Injection Molding”).
But, Harris in view of Schaefert is silent at specifically disclosing whether the second Shore value of the one or more seals is lower than the first Shore value of the primary control valve.
However Rogers teaches the second Shore value of the one or more seals (Rogers – Fig. 4 portion 304 and surface 308) is lower than the first Shore value of the primary control valve (Rogers – Fig. 4 valve guide 306, [col. 5 line 37-col. 6 line2] “ Flange portion 304, which forms an annularly extending sealing surface 308, is comprised of a relatively soft or resilient material whereas guide 306, while it is also plastic or of a plastic-like material is relatively harder and less resilient than the material of flange 304. This allows sealing surface 308 to effect better sealing with the seating surface in the valve assembly while ensuring that valve guide 306 is sufficiently rigid and hard enough to resist bending or excessive wearing. Flange 304 and guide 306 can be formed separately and then simply bonded together along their intersecting surfaces.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Harris in view of Scheafert with the teachings of Rogers to have the second Shore value of the one or more seals is lower than the first Shore value of the primary control valve for the benefit of ensuring the primary control valve is rigid enough to withstand the applied force required for the valve to function properly - change positions - and still have the sealing surfaces of the one or more seals to actively seal and function appropriately along the side of a valve cylinder (Rogers - [col. 5 line 37-col. 6 line2]).
Claim 21, Harris in view of Scheafert in view of Rogers teaches the medical device of claim 1, wherein the lumen (Harris - Figs. 13-14 lumen 232) extends to the top (Harris - Figs 13-14 near proximal opening 236) of the primary control valve (Figs. 13-14 valve 200 to include proximal portion 224 and distal portion 202).
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 MEGAN E MONAHAN whose telephone number is (571)272-7330. The examiner can normally be reached Monday - Friday, 8am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN ELIZABETH MONAHAN/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795