DETAILED ACTION
This office action is in response to the amendment filed 11/21/2025. As directed by the amendment, claims 1-3, 6-11, and 13-15 have been amended, no claims have been cancelled, and claims 16-17 have been newly added. Thus, claims 1-17 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
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 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.
Claims 1-3 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowenstein (2014/0261443) in view of Weckstrom (5,913,249).
Regarding claim 1, Lowenstein in fig 1 discloses a tracheal ventilation device comprising; a cannula tube (102) (endotracheal tube) (para [0033]), a filling hose (32) (fluid outlet lumen for inflating and pressurizing retaining cuff (100)) and an inflatable sleeve (100) (retaining cuff) disposed around the cannula tube (102), wherein the inflatable sleeve (100) is in fluid contact with the filling hose (32) (filling hose (32) in fluid communication with sleeve (100) for inflating and pressurizing sleeve (100))) (para [0035]), and wherein the filling hose (32) is connected to a monitoring assembly (10) including a pressure sensor module (44) (para [0036]).
Lowenstein does not disclose and wherein the inner surface of the filling hose is formed by a solid hydrophilic layer consisting of a hydrophilic material.
However, Weckstrom teaches a respiratory device including a tubular flow channel (1) for passing a gas flow to be measured (col 4, ln 41-43) and configured to connect to a measuring device (8) that measures a pressure to determine a flow (col 4, ln 60-64), and wherein an inner surface of the tubular flow channel (1) that in direct contact with the gas flow to be measured, is provided with a surface-active agent for reducing the contact angle of a water drop or a drop containing water to said surface in relation to the contact angle formed between a corresponding surface not treated with such agent and a corresponding drop (col 4, ln 49-56), and wherein said agent may a solid hydrophilic layer comprising a hydrophilic material (surface active agent for reducing the contact angle of a water drop or a drop containing water to said surface in relation to the contact angle formed between a corresponding surface not treated with such agent and a corresponding water drop (col 2, ln 18-22), and surface-active agent can be a polymer including a hydrophilic group, such as a negatively charged carboxylic or sulphonic acid group (col 3, ln 22-29), and because the surface active agent is configured to reduce the contact angle of a water drop and contains a hydrophilic group, the molecules of the surface active agent as a whole is considered to consist of a hydrophilic material, as the surface active agent as a whole acts as a hydrophilic material to reduce the contact angle of a water drop).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Lowenstein by providing the inner surface of the filling hose with a solid hydrophilic layer consisting of a hydrophilic material as taught by Weckstrom in order to reduce the contact angle of a water drop or a drop containing water to the inner surface of the filling hose to cause the condensed water drops to spread along the interior surface to flow out of the filling hose (Weckstrom, col 2, ln 42-52) which would increase the accuracy of the sensor (Weckstrom, col 5, ln 65-col 6, ln 2)
Regarding claim 2, the modified Lowenstein’s reference discloses the hydrophilic layer consists of a hydrophilic layer material (Weckstrom, col 3, ln 22-29) which, when measured using the sessile drop method and calculated using Young's equation with distilled water at 20°C, the hydrophilic material forms a contact angle theta < 80 (contact angle of water will be smaller than 30°, preferably smaller than 10°, and most advantageously about 0° (col 3, ln 14-18), and calculated using the sessile drop method (col 5, ln 63-col 5, ln 4).
Regarding claim 3, the modified Lowenstein’s reference discloses the hydrophilic layer covers the inner surface of an outer filling hose layer in a planar manner (hydrophilic coating is applied as a film-like coating onto the surface in question) and is firmly connected to the inner surface (the coating formed from the agent is immobilized on the surface) (Weckstrom, col 3, ln 6-11).
Regarding claim 11, Lowenstein in fig 1 discloses a tracheal ventilation device comprising; a cannula tube (102) (endotracheal tube) (para [0033]), a filling hose (32) (fluid outlet lumen for inflating and pressurizing retaining cuff (100)) and an inflatable sleeve (100) (retaining cuff) disposed around the cannula tube (102), wherein the sleeve (100) is in fluid contact with the filling hose (32) (filling hose (32) in fluid communication with sleeve (100) for inflating and pressurizing sleeve (100))) (para [0035]), and wherein the filling hose (32) is connected to a monitoring assembly (10) including a pressure sensor module (44) (para [0036]).
Lowenstein does not disclose a method for improving the pressure measurement in an inflatable sleeve of a tracheal ventilation device via a filling hose comprising the step of applying a hydrophilic layer the filling hose such that an inner wall of the filling hose is formed by the hydrophilic layer consisting of a hydrophilic material.
However, Weckstrom teaches a respiratory device including a tubular flow channel (1) for passing a gas flow to be measured (col 4, ln 41-43) and configured to connect to a measuring device (8) that measures a pressure to determine a flow (col 4, ln 60-64), and a surface active agent is applied to the inner wall of the tubular flow channel for reducing the contact angle of a water drop or a drop containing water to said surface in relation to the contact angle formed between a corresponding surface not treated with such agent and a corresponding drop (col 4, ln 49-56), and wherein said agent may a solid hydrophilic layer consisting of a hydrophilic material (surface active agent for reducing the contact angle of a water drop or a drop containing water to said surface in relation to the contact angle formed between a corresponding surface not treated with such agent and a corresponding water drop (col 2, ln 18-22), and surface-active agent can be a polymer including a hydrophilic group, such as a negatively charged carboxylic or sulphonic acid group (col 3, ln 22-29), and because the surface active agent is configured to reduce the contact angle of a water drop and contains a hydrophilic group, the molecules of the surface active agent as a whole is considered to consist of a hydrophilic material, as the surface active agent as a whole acts as a hydrophilic material to reduce the contact angle of a water drop).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of Lowenstein by providing the inner surface of the filling hose with a solid hydrophilic layer consisting of a hydrophilic material for improving pressure measurement in a sleeve of a tracheal ventilation device as taught by Weckstrom in order to reduce the contact angle of a water drop or a drop containing water to the inner surface of the filling hose to cause the condensed water drops to spread along the interior surface to flow out of the filling hose (Weckstrom, col 2, ln 42-52) which would increase the accuracy of the sensor (Weckstrom, col 5, ln 65-col 6, ln 2).
Claims 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowenstein and Weckstrom as applied to claim 1 above, and further in view of Maguire et al (2011/0027334).
Regarding claim 4, modified Lowenstein discloses a hydrophilic layer.
Modified Lowenstein does not disclose the hydrophilic layer is made of a hydrophilic polymer material which is selected from hydrophilic poly(lactams), polyurethanes, polyvinyl alcohol, polyvinyl ethers, maleic anhydride-based copolymers, polyesters, vinylamines, polyethylenimines, polyethylene oxides, polypropylene oxides, poly(carboxylic acids), polyamides, polyanhydrides, polyphosphazenes, polypeptides, polysaccharides, polyesters, oligonucleotides, polyvinylpyrrolidone, polyvinylpyrrolidone copolymer, polyvinylpolypyrrolidone, polylactides, polyglycolides and polycaprolactones.
However, Maguire teaches an endotracheal tube including a tube having a core layer (144) and an inner layer (143) (para [0039]), wherein the inner layer may be made from a biocompatible polymeric material, and wherein the material is a hydrophilic polymer material which is selected from hydrophilic polyurethanes, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene oxide, polyether, and combinations thereof (para [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lowenstein so that the hydrophilic layer is made of a hydrophilic polymer material which is selected from hydrophilic polyurethanes, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene oxide, polyether, and combinations thereof as taught by Maguire, as the use of suitable biocompatible materials such as hydrophilic polyurethanes, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene oxide, and polyether to be provided as an inner coating of a respiratory tube is known in the art, and it appears that the modified Lowenstein’s device would perform equally well to provide a hydrophilic coating to reduce the surface energy of water of the material of the hydrophilic coating is a hydrophilic polymer. See MPEP 2143(I)(A).
Regarding claim 5, modified Lowenstein discloses a hydrophilic layer.
Modified Lowenstein does not disclose the hydrophilic layer is made of a hydrophilic polymer material which is selected from hydrophilic homo- and copolymers of acrylic acid, salts of homo- and copolymers of methacrylic acid, salts of homo- and copolymers of maleic acid, salts of homo- and copolymers of fumaric acid, salts of homo- and copolymers of monomers comprising sulphonic acid groups, homo- and copolymers of monomers comprising quaternary ammonium salts and mixtures and/or derivatives thereof.
However, Maguire teaches an endotracheal tube including a tube having a core layer (144) and an inner layer (143) (para [0039]), wherein the inner layer may be made from a biocompatible polymeric material, and wherein the material is a hydrophilic polymer material which is selected from hydrophilic homo- and copolymers of acrylic acid and salts of homo- and copolymers of methacrylic acid (acrylates and methacrylates having hydrophilic esterifying groups, acrylic acid, and combinations thereof) (para [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lowenstein so that the hydrophilic layer is made of a hydrophilic polymer material which is selected from hydrophilic homo- and copolymers of acrylic acid and salts of homo- and copolymers of methacrylic acid as taught by Maguire, as the use of suitable biocompatible materials such hydrophilic homo- and copolymers of acrylic acid and salts of homo- and copolymers of methacrylic acid to be provided as an inner coating of a respiratory tube is known in the art, and it appears that the modified Lowenstein’s device would perform equally well to provide a hydrophilic coating to reduce the surface energy of water of the material of the hydrophilic coating is a hydrophilic polymer. See MPEP 2143(I)(A).
Claim 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowenstein and Weckstrom as applied to claim 1 above, and further in view of Maguire et al, with Balbierz et al (5,599,291) provided as evidence.
Regarding claim 5, modified Lowenstein discloses a hydrophilic layer.
Modified Lowenstein does not disclose the hydrophilic layer is made of a water-swellable material that is transitionable between a dry state and a water-swollen state.
However, Maguire teaches an endotracheal tube including a tube having a core layer (144) and an inner layer (143) (para [0039]), wherein the inner layer may be made from a biocompatible polymeric material, and wherein the material can be polyethylene oxide, sodium, potassium and calcium alginates, agar, gelatin, polyvinylpyrrolidone, hydroxypropyl cellulose, and combinations thereof (para [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lowenstein so that the hydrophilic layer is made of a hydrophilic polymer material which is selected from polyethylene oxide, sodium, potassium and calcium alginates, agar, gelatin, polyvinylpyrrolidone, hydroxypropyl cellulose or combinations thereof as taught by Maguire, as the use of suitable biocompatible materials such polyethylene oxide, sodium, potassium and calcium alginates, agar, gelatin, polyvinylpyrrolidone, hydroxypropyl cellulose, and combinations thereof to be provided as an inner coating of a respiratory tube is known in the art, and it appears that the modified Lowenstein’s device would perform equally well to provide a hydrophilic coating to reduce the surface energy of water of the material of the hydrophilic coating is a hydrophilic polymer. See MPEP 2143(I)(A). The now-modified Lowenstein’s hydrophilic coating is considered to be a water-swellable coating that is transitionable between a dry state and a water-swollen state, as the hydrophilic coating can be made from hydrophilic polymeric materials such as polyethylene oxide, sodium, potassium and calcium alginates, agar, gelatin, polyvinylpyrrolidone, hydroxypropyl cellulose or combinations thereof (Maguire, para [0021]), and as evidenced by Balbierz et al (5,599,291), the materials for a hydrophilic coating such as polyethylene oxide, sodium, potassium and calcium alginates, agar, gelatin, polyvinylpyrrolidone, or hydroxypropyl cellulose are water-swelling polymers that are transitionable between a dry state and a water-swollen state, as they allow swelling of a certain percent after hydration (Balbierz, col 6, ln 6-17).
Claims 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowenstein, Weckstrom, Maguire et al, and Balbierz et al as applied to claim 6 above, and further in view of Nelson et al (2008/0236593).
Regarding claim 7, modified Lowenstein discloses a hydrophilic layer comprising a water-swellable material (Maguire, para [0021], Balbierz, col 6, ln 6-17) capable of being in a dry state when no water contacts the hydrophilic layer (Balbierz, col 6, ln 6-17).
Modified Lowenstein does not disclose the when the water-swellable material is in the dry state, the hydrophilic layer has a layer thickness in the range from 0.1 to 5 um.
However, Nelson teaches a medical device comprising an endotracheal tube (16), wherein a hydrophilic coating may be applied to an inner surface of the device, and wherein the hydrophilic layer can have a layer thickness in the range from 0.002 mm to 2.5 mm thickness (2 um to 2500 um thickness).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lowenstein so that, when the water-swellable material is in the dry state, the hydrophilic layer has a layer thickness in the range from 0.1 to 5 um as taught by Nelson, as the feature of providing a hydrophilic layer with a thickness in a range of 2 um to 2500 um is known in the art, and because the claimed range of 0.1 to 5 um overlaps with the range of 2 um to 2500 um disclosed in the prior art, a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 8, modified Lowenstein discloses a hydrophilic layer comprising a water-swellable material (Maguire, para [0021], Balbierz, col 6, ln 6-17) that is transitionable to a water-swollen state (Balbierz, col 6, ln 6-17).
The now-modified Lowenstein’s device does not disclose that when the water-swellable material is in the water-swollen state, the hydrophilic layer has a layer thickness in the range from 10 to 200 um.
However, Nelson teaches a medical device comprising an endotracheal tube (16), wherein a hydrophilic coating may be applied to an inner surface of the device, and wherein the hydrophilic layer can have a layer thickness in the range from 0.002 mm to 2.5 mm thickness (2 um to 2500 um thickness).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lowenstein so that, in a water-swollen state, the hydrophilic layer has a layer thickness in the range from 10 to 200 um as taught by Nelson, as the feature of providing a hydrophilic layer with a thickness in a range of 2 um to 2500 um is known in the art, and because the claimed range of 10 to 200 um overlaps with the range of 2 um to 2500 um disclosed in the prior art, a prima facie case of obviousness exists. See MPEP 2144.05(I).
Claims 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowenstein, Weckstrom, Maguire et al, and Balbierz et al as applied to claim 6 above, and further in view of Hoftman et al (2017/0043111).
Regarding claim 9, modified Lowenstein discloses a hydrophilic layer comprising a water-swellable material (Maguire, para [0021], Balbierz, col 6, ln 6-17) capable of being in a dry state when no water contacts the hydrophilic layer (Balbierz, col 6, ln 6-17).
Modified Lowenstein does not disclose that when the water-swellable material is in the dry state, the filling hose has an inner diameter of less than 1.0 mm.
However, Hoftman in figs 1-3 teaches a tracheal ventilation device including a cannula tube (12) (shaft), an inflatable sleeve (22) (tracheal balloon cuff) disposed around the cannula tube (12) (para [0055]), and a filling hose (34) (inflation lumen) in fluid communication with the inflatable sleeve (22), and wherein the filling hose (34) has an inner diameter (ID) of 0.75 mm (para [0053]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the filling hose of modified Lowenstein so that, in the dry state, the filling hose has an inner diameter of less than 1.0 mm, as the feature of providing a filling hose with an inner diameter with an inner diameter of 0.75 mm is known in the art, and because the claimed range of less than 1 mm overlaps with an inner diameter of 0.75 mm disclosed in the prior art, a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 10, modified Lowenstein discloses a hydrophilic layer comprising a water-swellable material (Maguire, para [0021], Balbierz, col 6, ln 6-17) capable of being in a water-swellable state when water contacts the hydrophilic layer (Balbierz, col 6, ln 6-17).
Modified Lowenstein does not disclose that when the water-swellable material is in the water-swollen state, the filling hose has an inner diameter of more than 0.3 mm.
However, Hoftman in figs 1-3 teaches a tracheal ventilation device including a cannula tube (12) (shaft), an inflatable sleeve (22) (tracheal balloon cuff) disposed around the cannula tube (12) (para [0055]), and a filling hose (34) (inflation lumen) in fluid communication with the inflatable sleeve (22), and wherein the filling hose (34) has an inner diameter (ID) of 0.75 mm (para [0053]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the filling hose of modified Lowenstein so that, in the dry state, the filling hose has an inner diameter of more than 0.3 mm, as the feature of providing a filling hose with an inner diameter of 0.75 mm is known in the art, and because the claimed range of more than 0.3 mm overlaps with an inner diameter of 0.75 mm disclosed in the prior art, a prima facie case of obviousness exists. See MPEP 2144.05(I).
Claim 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowenstein and Weckstrom as applied to claim 11 above, and further in view of Kliment et al (4,729,914).
Regarding claim 12, modified Lowenstein discloses the hydrophilic layer is applied to the inner wall of the filling hose.
Modified Lowenstein does not disclose that the hydrophilic layer is applied to the inner wall of the filling hose directly during production of the tracheal ventilation device or not until a later time after production of the tracheal ventilation device and prior to its use.
However, Kliment teaches a method of applying a hydrophilic layer to medical devices (col 1, ln 12-18), wherein a hydrophilic layer is applied to the device during production of the device by dissolving N-vinylpyrrolidone monomers in a solvent containing a polymerization initiator and the solution heated to mildly elevated temperatures (col 4, ln 4-24), applying a prepolymer to a substrate (col 3, ln 21-37) applying the N-vinylpyrollidone copolymer to the substrate, and then drying to evaporate the solvent (col 4, ln 4-18).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of modified Lowenstein so that the hydrophilic layer is applied to the inner wall of the filling hose directly during production of the tracheal ventilation device, or not until a later time after production of the tracheal ventilation device and prior to its use wherein the application of the hydrophilic layer involves the steps of dissolving the hydrophilic monomer in a solvent containing a polymerization initiator and the solution heated to mildly elevated temperatures, applying a prepolymer to a substrate applying the hydrophilic copolymer to the substrate, and then drying to evaporate the solvent as taught by Kliment in order to provide a chemical union which firmly binds the hydrophilic layer to the substrate and prevent leaching of ingredients from the coating into an aqueous media (Kliment, col 4, ln 18-29).
Regarding claim 13, modified Lowenstein discloses a hydrophilic layer.
Modified Lowenstein does not disclose the hydrophilic layer is applied by introducing a hydrophilic coating material in a flowable form into the lumen of the filling hose.
However, Kliment teaches a method of applying a hydrophilic layer to medical devices (col 1, ln 12-18), wherein a hydrophilic coating material is provided in a flowable form by dissolving N-vinylpyrrolidone monomers in a solvent containing a polymerization initiator and the solution heated to mildly elevated temperatures (col 4, ln 4-24), applying a prepolymer to a substrate (col 3, ln 21-37) applying the N-vinylpyrollidone copolymer to the substrate, and then drying to evaporate the solvent (col 4, ln 4-18).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of modified Lowenstein so that the hydrophilic layer is applied by introducing a hydrophilic coating material in a flowable form into the lumen of the filling hose wherein the application of the hydrophilic layer involves the steps of dissolving the hydrophilic monomer in a solvent containing a polymerization initiator and the solution heated to mildly elevated temperatures, applying a prepolymer to a substrate applying the hydrophilic copolymer to the substrate, and then drying to evaporate the solvent as taught by Kliment in order to provide a chemical union which firmly binds the hydrophilic layer to the substrate and prevent leaching of ingredients from the coating into an aqueous media (Kliment, col 4, ln 18-29).
Regarding claim 14, the modified Lowenstein’s reference discloses the coating material is introduced into the filling hose in liquid form, in dissolved form, in suspended form or in powder form (coating material formed by dissolving N-vinylpyrrolidone monomers in a solvent containing a polymerization initiator, and therefore the coating material is in a liquid form as solvent can be liquids such as methyl alcohol or tetrahydrofuran, and is in a dissolved form as the monomers are dissolved in the solvent) (Kliment, col 4, ln 14-34).
Regarding claim 15, the modified Lowenstein’s reference discloses the coating material introduced into the filling hose is converted into a solid coating on the inner wall of the outer hose layer by spontaneous curing, by drying, by using elevated temperature and/or by irradiation with light (prepolymer is overcoated with the coating material of the N-vinylpyrrolidone copolymer, and subjected to air drying to evaporate the solvent and remains an outer film of the N-vinylpyrrolidone copolymer) (col 4, ln 4-18).
Claim 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowenstein in view of Weckstrom and Hoftman et al.
Regarding claim 16, Lowenstein in fig 1 discloses a tracheal ventilation device comprising; a cannula tube (102) (endotracheal tube) (para [0033]), a filling hose (32) (fluid outlet lumen for inflating and pressurizing retaining cuff (100)) comprising a solid outer filling hose layer (wall of filling hose (32)), and an inflatable sleeve (100) (retaining cuff) disposed around the cannula tube (102), wherein the inflatable sleeve (100) is in fluid contact with the filling hose (32) (filling hose (32) in fluid communication with sleeve (100) for inflating and pressurizing sleeve (100))) (para [0035]), and wherein the filling hose (32) is connected to a monitoring assembly (10) including a pressure sensor module (44) (para [0036]).
Lowenstein does not disclose the outer filling hose layer having an inner diameter of less than 1.0 mm.
However, Hoftman in figs 1-3 teaches a tracheal ventilation device including a cannula tube (12) (shaft), an inflatable sleeve (22) (tracheal balloon cuff) disposed around the cannula tube (12) (para [0055]), and a filling hose (34) (inflation lumen) in fluid communication with the inflatable sleeve (22), and wherein the filling hose (34) has an inner diameter (ID) of 0.75 mm (para [0053]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the filling hose of modified Lowenstein so that the filling hose has an inner diameter of less than 1.0 mm, as the feature of providing a filling hose with an inner diameter with an inner diameter of 0.75 mm is known in the art, and because the claimed range of less than 1 mm overlaps with an inner diameter of 0.75 mm disclosed in the prior art, a prima facie case of obviousness exists. See MPEP 2144.05(I). The now-modified Lowenstein’s device discloses that the outer filling hose layer having an inner diameter of less than 1.0 mm, as Lowenstein discloses that the filling hose (32) shown to have an outer filling hose layer comprising the wall of the hose (32), and Hoftman teaches that an inner diameter of an inflation lumen for an endotracheal tube can have a diameter of less than 1.0 mm (0.75 mm) (Hoftman, para [0053]).
The now-modified Lowenstein’s device does not disclose a solid hydrophilic layer provided on an inner side of the outer filling hose layer, the solid hydrophilic layer defining an inner surface of the filling hose.
However, Weckstrom teaches a respiratory device including a tubular flow channel (1) for passing a gas flow to be measured (col 4, ln 41-43) and configured to connect to a measuring device (8) that measures a pressure to determine a flow (col 4, ln 60-64), and wherein an inner surface of the tubular flow channel (1) that in direct contact with the gas flow to be measured is provided with a surface-active agent for reducing the contact angle of a water drop or a drop containing water to said surface in relation to the contact angle formed between a corresponding surface not treated with such agent and a corresponding drop (col 4, ln 49-56) (surface-active agent can be a polymer including a hydrophilic group, such as a negatively charged carboxylic or sulphonic acid group) (col 3, ln 22-29).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Lowenstein by providing a solid hydrophilic layer provided on an inner side of the outer filling hose layer, the solid hydrophilic layer defining an inner surface of the filling hose as taught by Weckstrom in order to reduce the contact angle of a water drop or a drop containing water to the inner surface of the filling hose to cause the condensed water drops to spread along the interior surface to flow out of the filling hose (Weckstrom, col 2, ln 42-52) which would increase the accuracy of the sensor (Weckstrom, col 5, ln 65-col 6, ln 2)
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowenstein, Weckstrom and Hoftman et al as discussed in claim 16 above, and further in view of Samuelson (6,165,166).
Regarding claim 17, modified Lowenstein discloses a filling hose comprising an outer filling hose layer and a solid hydrophilic layer.
Modified Lowenstein does not disclose a connecting layer provided between the outer filling hose layer and the solid hydrophilic layer, the connecting layer having a layer thickness in a range from 10 nm to 10 um.
However, Samuelson in fig 1 teaches a medical catheter including an outer layer (16) (col 5, ln 54-60), an inner coating layer (12) (core layer) (col 6, ln 24-38), and a connecting layer (14) (intermediate tie layer) provided between the outer layer (16) and the inner coating layer (12) (col 5, ln 54-60), the connecting layer (14) configured to provide a strong connection between the core layer (12) and the outer layer (16) (col 3, ln 65-col 4, ln 6), and having a layer thickness in a range from 0.003 mm to 0.03 mm (3 um to 30 um) (col 8, ln 39--50).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Lowenstein by providing a connecting layer provided between the outer filling hose layer and the solid hydrophilic layer, the connecting layer having a layer thickness in a range from 0.003 mm to 0.03 mm (3 um to 30 um) as taught by Samuelson in order to provide a strong connection between the outer filling hose layer and the solid hydrophilic layer (Samuelson, col 3, ln 65-col 4, ln 6). The now-modified Lowenstein’s device is considered to have a layer thickness in a range from 10 nm to 10 um, because the claimed layer thickness in a range from 10 nm to 10 um overlaps with a layer thickness of 3 um to 30 um disclosed in the prior art (i.e. between 3 um and 10 um), and therefore, a prima facie case of obviousness exists. See MPEP 2144.05(I).
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
Applicant argues on page 7, first full paragraph-page 8, third full paragraph of applicant’s remarks, that Wekstrom does not disclose “a solid hydrophilic layer consisting of a hydrophilic material” as recited in claim 1 because Weckstrom discloses that the surface-active agent must include molecules from both a hydrophobic group and a hydrophilic group. However, Weckstrom does not disclose a heterogenous mixture of hydrophilic and hydrophobic molecules, but that a molecule of the surface-active agent can comprise a hydrophilic group and a hydrophobic group, such as dioctyl sodium sulfosuccinate (col 3, ln 22-28). Weckstrom discloses that the surface-active agent is configured to reduce the contact angle of a water drop or a drop containing water to said surface in relation to the contact angle formed between a corresponding surface not treated with such agent and a corresponding water drop (col 2, ln 18-22). Therefore, because the surface-active agent is configured to reduce the contact angle of a water drop and contains a hydrophilic group, the molecules of the surface-active agent as a whole is considered to consist of a hydrophilic material, as the surface-active agent as a whole acts as a hydrophilic material to reduce the contact angle of a water drop. Although not relied upon in the current rejection, Maguire et al (2011/0027334) teaches an endotracheal tube including a tube having a core layer (144) and an inner layer (143) (para [0039]), wherein the inner layer may be made from a biocompatible polymeric material, and wherein the material is a hydrophilic polymer material which is selected from hydrophilic polyurethanes, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene oxide, polyether, and combinations thereof (para [0021]), and therefore, a hydrophilic layers consisting of a hydrophilic material such as hydrophilic polyurethanes, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene oxide, polyether, and combinations thereof as taught by Maguire, as the use of suitable biocompatible materials such as hydrophilic polyurethanes, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene oxide, and polyether are known in the art, and therefore, would not be patentable over the prior art of record. Therefore, the rejection is maintained.
Applicant argues on page 8, fourth full paragraph of applicant’s remarks, that Hoftman’s inflation lumens are not capable of including a solid hydrophilic layer consisting of a hydrophilic material, as Hoftman discloses that a lubricant coating is disposed in the tracheal lumen (28) or bronchial lumen (30), but a lubricant coating is not disposed within the inflation lumen (32). However, Hoftman is relied upon to teach that a filling hose having an inner diameter of less than 1.0 (e.g. 0.75 mm) (Hoftman, para [0053]) is known in the art to be a suitable inner diameter for a filling hose, and therefore, although modified Lowenstein does not specifically disclose the inner diameter of the filling house, because Hoftman teaches that it is known in the art to provide a hose having an inner diameter less than 1.0 mm, as the feature of providing a filling hose with an inner diameter with an inner diameter of 0.75 mm is known in the art to be of a suitable diameter to allow the filling hose to inflate a cuff of an endotracheal tube. Therefore, the rejection is 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 DOUGLAS Y SUL whose telephone number is (571)270-5260. The examiner can normally be reached Monday-Friday 9 am-5:30 pm EST.
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, TIMOTHY STANIS can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DOUGLAS Y SUL/Examiner, Art Unit 3785