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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 16/139,625 and 62/565,736, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The disclosure of the prior-filed applications does not provide adequate support for the substrate layer being impermeable as recited in instant independent claims 1 and 20. Although the disclosure of the prior-filed applications discloses a particular substrate layer that is an impermeable substrate layer, e.g., polyurethane film material, this does not provide adequate support for the broader limitation of an “impermeable substrate layer”. The disclosure of the prior-filed applications also does not provide adequate support for dependent claims 6 and 24 which further define the impermeable substrate layer.
Claim Objections
Claims 1 and 23 are objected to because of the following informalities:
Regarding claim 1, the limitation “the ultrasound transducer interface pad” in line 3 of the claim should be changed to – the disposable ultrasound transducer interface pad—in order to have proper antecedent basis.
Regarding claim 23, the limitation “the release layer” in line 2 should be changed to –the removable release layer—in order to have proper antecedent basis.
Appropriate correction is required.
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, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9, 14-25 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen et al. (US 2010/0100009, April 22, 2010) in view of Desai et al (US 2017/0128042, May 11, 2017).
Regarding claim 1, Nielsen discloses a disposable ultrasound transducer interface pad configured to adhere to at least one of an operational portion of an ultrasound transducer or a skin surface of a patient (“The present invention provides a medical device having a substrate polymer surface carrying thereon a hydrophilic coating comprising a cross-linked hydrophilic polymer and p-toluenesulfonamide, and a method for the preparation thereof.” Abstract), the ultrasound transducer interface pad comprising:
an impermeable substrate layer having a first surface and a second surface opposite the first surface (“substrate polymer surfaces of polymers such as polyurethanes and copolymers thereof, or polyether block amides such as Pebax.TM. or other polymer materials including polyvinyl chloride, polyamide, silicone, styrene-ethylene/butylene-styrene block copolymers (SEBS), styrene-isoprene-styrene block copolymers (SIS), styrene-ethylene/propylene-styrene block copolymers (SEPS), ethylene-vinyl acetate copolymers (EVA), polyethylene (PE), metallocene-catalyzed polyethylene, and copolymers of ethylene and propylene or mixtures of such polymers” [0035]);
a first hydrophilic coating layer applied to the first surface of the impermeable substrate layer (“The surface on which the hydrophilic coating is applied may be the full surface of the substrate polymer surface or a part of the surface.” [0038]), the first hydrophilic coating layer activatable to provide an acoustic coupling interface between the ultrasound transducer and the patient (“Such hydrophilic coatings are highly lubricious when wet as the coatings take up a significant amount of water, which leaves a non-bonded layer of free water molecules at the surface of the coating. The non-bonding character of the surface water is believed to cause the low friction of the wet coating.” [0007]).
Nielsen fails to disclose an adhesive layer formed on the second surface of the impermeable substrate layer and configured to adhere to the operational portion of the ultrasound transducer or the skin surface of the patient.
However, Desai teaches, in the same field of endeavor, an adhesive layer formed on the second surface of the impermeable substrate layer and configured to adhere to the operational portion of the ultrasound transducer or the skin surface of the patient (“the probe contact layer 30 includes an adhesive 31 on at least one side of the contact layer 30. The adhesive 31 allows the ultrashield 10 to be affixed to the probe 14, such as the faceplate 12 of the probe 14 and optionally the housing 16. This creates an airless connection between the ultrashield 10 and the probe 14.” [0062], Fig. 4 and corresponding description).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Nielsen with an adhesive layer formed on the second surface of the impermeable substrate layer and configured to adhere to the operational portion of the ultrasound transducer or the skin surface of the patient as taught by Desai in order to create an airless connection between the device and a probe ([0062]).
Regarding claim 2, Nielsen further discloses wherein the impermeable substrate layer comprises a polyurethane film material (“the substrate polymer surface is polyurethane” [0043]).
Regarding claim 3, Nielsen modified by Desai discloses the limitations of claim 1 as stated above but is silent on wherein the impermeable substrate layer has a thickness of 0.025 millimeter (mm) to 1.00 mm. However, it would have been an obvious matter of design choice to provide an impermeable substrate layer with a thickness of 0.025 millimeter (mm) to 1.00 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04.
Regarding claim 4, Nielsen modified by Desai discloses the limitations of claim 3 as stated above but is silent on wherein the first hydrophilic coating layer has a thickness of 0.002 millimeter (mm) to 0.005 mm. However, it would have been an obvious matter of design choice to provide a first hydrophilic coating layer with a thickness of 0.002 millimeter (mm) to 0.005 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04.
Regarding claim 5, Nielsen modified by Desai discloses the limitations of claim 4 as stated above. Desai was relied on to teach the adhesive layer. Desai further teaches, in the same field of endeavor, wherein the adhesive layer has a thickness of 0.025 millimeter (mm) to 0.2 mm (“the adhesive 31 has a very fine thickness, such as 0.001 [0.0254 millimeters] to 0.005 inches [0.127 millimeters], more particularly 0.002 [0.0508 millimeters] to 0.003 [0.0762 millimeters] inches.” [0063]). It would have been an obvious matter of design choice to provide an adhesive layer with a thickness of 0.025 millimeter (mm) to 0.2 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04.
Regarding claim 6, Nielsen suggests wherein the impermeable substrate layer is configured to prevent particulates greater than 27 nanometers from penetrating the impermeable substrate layer according to ASTM F1671/F1671M-22 (“substrate polymer surfaces of polymers such as polyurethanes and copolymers thereof, or polyether block amides such as Pebax.TM. or other polymer materials including polyvinyl chloride, polyamide, silicone, styrene-ethylene/butylene-styrene block copolymers (SEBS), styrene-isoprene-styrene block copolymers (SIS), styrene-ethylene/propylene-styrene block copolymers (SEPS), ethylene-vinyl acetate copolymers (EVA), polyethylene (PE), metallocene-catalyzed polyethylene, and copolymers of ethylene and propylene or mixtures of such polymers” [0035]) but does not explicitly state as such. However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the impermeable substrate layer to prevent particulates greater than 27 nanometers from penetrating the impermeable substrate layer according to ASTM F1671/F1671M-22, because applicant has not disclosed that the particular impermeability range provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results (e.g. optimizing permeability) to one of ordinary skill in the art at the time of the invention. As such, the modification of coat weight would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Nielsen.
Regarding claim 7, Nielsen modified by Desai discloses the limitations of claim 1 as stated above but fails to disclose further comprising a release layer provided on the adhesive layer.
However, Desai further teaches, in the same field of endeavor, a release layer provided on the adhesive layer (packaging layer 50b, Fig. 15 and corresponding description).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Nielsen with a release layer provided on the adhesive layer as taught by Desai in order to protect the adhesive layer prior to use.
Regarding claim 8, Nielsen further discloses wherein the first hydrophilic coating layer is configured to be activatable by a liquid (“Such hydrophilic coatings are highly lubricious when wet as the coatings take up a significant amount of water” [0007]).
Regarding claim 9, Nielsen further discloses wherein the impermeable substrate layer comprises polyurethane (“the substrate polymer surface is polyurethane” [0043]. Nielsen is silent on the impermeable substrate layer having a thickness of 0.025 millimeter (mm) to 1.0 mm. However, it would have been an obvious matter of design choice to provide an impermeable substrate layer with a thickness of 0.025 millimeter (mm) to 1.00 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04.
Regarding claim 14, Nielsen further discloses wherein the first hydrophilic material comprises one of an ultraviolet (UV) light curable hydrophilic material or a heat curable hydrophilic material (“Such polymers may be achieved by copolymerising an acrylic substance like dimethylaminoethylmethacrylate with N-vinyl pyrrolidone, methacrylic acid, methacrylic esters, methyl vinyl ether etc. Such polymers are typically coated to the surface and ultimately radiation cured. A hydrophilic polymer useful for the coating may further be achieved by adding monomers of acrylic nature to the above-mentioned types of polymers. All the polymers can potentially be cross-linked by UV, electron beam or gamma irradiation.” [0039]; also see “It may be necessary or desirable to increase the temperature of the substrate polymer or the air surrounding the substrate polymer to speed up the evaporation process. Preferably, the evaporation process is facilitated by drying the substrate polymer with the coating solution at a temperature in the range of 25-100.degree. C. depending on the thermostability of the substrate polymer. Typically, the substrate polymer (e.g. a medical device) is dried in an oven.” [0093]).
Regarding claim 15, Nielsen further discloses wherein the first hydrophilic coating layer comprises polyvinylpyrrolidone/polyurethane or poly methacrylate (“Hydrophilic polymers containing active hydrogens capable of reacting with isocyanate groups may suitably be used in urethane type coatings. Such a coating is prepared by first coating an isocyanate compound onto the substrate polymer surface where such coating either adheres or covalently bonds to reactive groups at the surface. Secondly, a hydrophilic, reactive polymer is coated on top of such dried coating containing isocyanate groups. Said polymers may contain --OH, --SH, --NH--, --NH.sub.2 and --CONH.sub.2 groups. The polymers may be acrylic polymers and copolymers comprising acrylamide, hydroxyethyl acrylate, acrylic acid, polyethylene glycol methacrylate, polypropylene glycol methacrylate and the like. Furthermore, polyethylene glycols and polyvinyl pyrrolidone are useful for such hydrophilic coatings.” [0040]).
Nielsen in silent on the first hydrophilic coating layer having a thickness of 2.0 microns to 5.0 microns. However, it would have been an obvious matter of design choice to provide a first hydrophilic coating layer having a thickness of 2.0 microns to 5.0 microns, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04.
Regarding claim 16, Nielsen modified by Desai discloses the limitations of claim 1 as stated above. Desai was relied on to teach the adhesive layer. Desai further teaches, in the same field of endeavor, further comprising a removable release layer coupled to the adhesive layer (packaging layer 50b, Fig. 15 and corresponding description), the removable release layer configured to be removed from the adhesive layer to expose the adhesive layer for adhering the disposable ultrasound transducer interface pad to the operational portion of the ultrasound transducer or the skin surface of the patient (“the probe contact layer 30 has an adhesive 31 which adheres the probe contact layer to the packaging layer 50b. In some embodiments, when the packaging layer 50b is removed for use, the same adhesive 31 is then used to adhere the ultrashield 10 to the probe 14.” [0099]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Nielsen with a removable release layer coupled to the adhesive layer, the removable release layer configured to be removed from the adhesive layer to expose the adhesive layer for adhering the disposable ultrasound transducer interface pad to the operational portion of the ultrasound transducer or the skin surface of the patient as taught by Desai in order to protect the adhesive layer prior to use. Regarding claim 17, Nielsen further discloses wherein the impermeable substrate layer is made of a flexible material (“substrate polymer surfaces of polymers such as polyurethanes” [0035]).
Regarding claim 18, Nielsen further discloses further comprising a second hydrophilic coating layer applied to the second surface of the impermeable substrate layer (“The surface on which the hydrophilic coating is applied may be the full surface of the substrate polymer surface or a part of the surface.” [0038]), the second hydrophilic coating layer activatable to provide an additional acoustic coupling interface between the ultrasound transducer and the patient (“Such hydrophilic coatings are highly lubricious when wet as the coatings take up a significant amount of water, which leaves a non-bonded layer of free water molecules at the surface of the coating. The non-bonding character of the surface water is believed to cause the low friction of the wet coating.” [0007]).
Regarding claim 19, Nielsen further discloses wherein the first hydrophilic coating layer forms a continuous layer on the first surface of the impermeable substrate layer (“The surface on which the hydrophilic coating is applied may be the full surface of the substrate polymer surface or a part of the surface.” [0038]).
Regarding claim 20, Nielsen discloses a disposable ultrasound transducer interface pad configured to adhere to at least one of an operational portion of an ultrasound transducer or a skin surface of a patient (“The present invention provides a medical device having a substrate polymer surface carrying thereon a hydrophilic coating comprising a cross-linked hydrophilic polymer and p-toluenesulfonamide, and a method for the preparation thereof.” Abstract), the ultrasound transducer interface pad comprising:
a flexible, impermeable substrate layer having a first surface and a second surface opposite the first surface (“substrate polymer surfaces of polymers such as polyurethanes and copolymers thereof, or polyether block amides such as Pebax.TM. or other polymer materials including polyvinyl chloride, polyamide, silicone, styrene-ethylene/butylene-styrene block copolymers (SEBS), styrene-isoprene-styrene block copolymers (SIS), styrene-ethylene/propylene-styrene block copolymers (SEPS), ethylene-vinyl acetate copolymers (EVA), polyethylene (PE), metallocene-catalyzed polyethylene, and copolymers of ethylene and propylene or mixtures of such polymers” [0035]);
a first hydrophilic coating layer applied to the first surface of the impermeable substrate layer (“The surface on which the hydrophilic coating is applied may be the full surface of the substrate polymer surface or a part of the surface.” [0038]), the first hydrophilic coating layer activatable to provide an acoustic coupling interface between the ultrasound transducer and the patient (“Such hydrophilic coatings are highly lubricious when wet as the coatings take up a significant amount of water, which leaves a non-bonded layer of free water molecules at the surface of the coating. The non-bonding character of the surface water is believed to cause the low friction of the wet coating.” [0007]).
Nielsen is silent on the impermeable substrate layer having a thickness ranging from 0.025 millimeter (mm) to 1.00 mm. However, it would have been an obvious matter of design choice to provide an impermeable substrate layer with a thickness of 0.025 millimeter (mm) to 1.00 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04.
Nielsen is also silent on the first hydrophilic coating layer having a thickness ranging between 0.002 mm and 0.005 mm. However, it would have been an obvious matter of design choice to provide a first hydrophilic coating layer with a thickness of 0.002 mm to 0.005 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04.
Nielsen fails to disclose an adhesive layer applied to the second surface of the impermeable substrate layer and configured to adhere to the operational portion of the ultrasound transducer or the skin surface of the patient, the adhesive layer having a thickness ranging from 0.025 mm to 0.2 mm.
However, Desai teaches, in the same field of endeavor, an adhesive layer applied to the second surface of the impermeable substrate layer and configured to adhere to the operational portion of the ultrasound transducer or the skin surface of the patient (“the probe contact layer 30 includes an adhesive 31 on at least one side of the contact layer 30. The adhesive 31 allows the ultrashield 10 to be affixed to the probe 14, such as the faceplate 12 of the probe 14 and optionally the housing 16. This creates an airless connection between the ultrashield 10 and the probe 14.” [0062], Fig. 4 and corresponding description). the adhesive layer having a thickness of 0.025 mm to 0.2 mm (“the adhesive 31 has a very fine thickness, such as 0.001 [0.0254 millimeters] to 0.005 inches [0.127 millimeters], more particularly 0.002 [0.0508 millimeters] to 0.003 [0.0762 millimeters] inches.” [0063]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Nielsen with an adhesive layer applied to the second surface of the impermeable substrate layer and configured to adhere to the operational portion of the ultrasound transducer or the skin surface of the patient as taught by Desai in order to create an airless connection between the device and a probe ([0062]). Further, it would have been an obvious matter of design choice to provide an adhesive layer with a thickness of 0.025 millimeter (mm) to 0.2 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04.
Regarding claim 21, Nielsen further discloses further comprising a second hydrophilic coating layer applied to the second surface of the impermeable substrate layer (“The surface on which the hydrophilic coating is applied may be the full surface of the substrate polymer surface or a part of the surface.” [0038]), the second hydrophilic coating layer activatable to provide an additional acoustic coupling interface between the ultrasound transducer and the patient (“Such hydrophilic coatings are highly lubricious when wet as the coatings take up a significant amount of water, which leaves a non-bonded layer of free water molecules at the surface of the coating. The non-bonding character of the surface water is believed to cause the low friction of the wet coating.” [0007]).
Regarding claim 22, Nielsen further discloses wherein the first hydrophilic material comprises one of an ultraviolet (UV) light curable hydrophilic material or a heat curable hydrophilic material (“Such polymers may be achieved by copolymerising an acrylic substance like dimethylaminoethylmethacrylate with N-vinyl pyrrolidone, methacrylic acid, methacrylic esters, methyl vinyl ether etc. Such polymers are typically coated to the surface and ultimately radiation cured. A hydrophilic polymer useful for the coating may further be achieved by adding monomers of acrylic nature to the above-mentioned types of polymers. All the polymers can potentially be cross-linked by UV, electron beam or gamma irradiation.” [0039]; also see “It may be necessary or desirable to increase the temperature of the substrate polymer or the air surrounding the substrate polymer to speed up the evaporation process. Preferably, the evaporation process is facilitated by drying the substrate polymer with the coating solution at a temperature in the range of 25-100.degree. C. depending on the thermostability of the substrate polymer. Typically, the substrate polymer (e.g. a medical device) is dried in an oven.” [0093]).
Regarding claim 23, Nielsen modified by Desai discloses the limitations of claim 20 as stated above. Desai was relied on to teach the adhesive layer. Desai further teaches, in the same field of endeavor, further comprising a removable release layer coupled to the adhesive layer (packaging layer 50b, Fig. 15 and corresponding description), the release layer configured to be removed from the adhesive layer to expose the adhesive layer for adhering the disposable ultrasound transducer interface pad to the operational portion of the ultrasound transducer or the skin surface of the patient (“the probe contact layer 30 has an adhesive 31 which adheres the probe contact layer to the packaging layer 50b. In some embodiments, when the packaging layer 50b is removed for use, the same adhesive 31 is then used to adhere the ultrashield 10 to the probe 14.” [0099]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Nielsen with a removable release layer coupled to the adhesive layer, the release layer configured to be removed from the adhesive layer to expose the adhesive layer for adhering the disposable ultrasound transducer interface pad to the operational portion of the ultrasound transducer or the skin surface of the patient as taught by Desai in order to protect the adhesive layer prior to use.
Regarding claim 24, Nielsen suggests wherein the impermeable substrate layer is configured to prevent particulates greater than 27 nanometers from penetrating the impermeable substrate layer according to ASTM F1671/F1671M-22 (“substrate polymer surfaces of polymers such as polyurethanes and copolymers thereof, or polyether block amides such as Pebax.TM. or other polymer materials including polyvinyl chloride, polyamide, silicone, styrene-ethylene/butylene-styrene block copolymers (SEBS), styrene-isoprene-styrene block copolymers (SIS), styrene-ethylene/propylene-styrene block copolymers (SEPS), ethylene-vinyl acetate copolymers (EVA), polyethylene (PE), metallocene-catalyzed polyethylene, and copolymers of ethylene and propylene or mixtures of such polymers” [0035]) but does not explicitly state as such. However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the impermeable substrate layer to prevent particulates greater than 27 nanometers from penetrating the impermeable substrate layer according to ASTM F1671/F1671M-22, because applicant has not disclosed that the particular impermeability range provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results (e.g. optimizing permeability) to one of ordinary skill in the art at the time of the invention. As such, the modification of coat weight would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Nielsen.
Regarding claim 25, Nielsen further discloses wherein the first hydrophilic coating layer forms a continuous layer on the first surface of the impermeable substrate layer (“The surface on which the hydrophilic coating is applied may be the full surface of the substrate polymer surface or a part of the surface.” [0038]).
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen in view of Desai as applied to claim 1 above and further in view of Berard-Andersen et al. (US 2015/0018686, January 15, 2015, hereinafter “Berard”).
Regarding claim 10, Nielsen modified by Desai discloses the limitations of claim 1 as stated above. Desai was relied on to teach the adhesive layer. Nielsen modified by Desai fails to disclose wherein the adhesive layer comprises a silicone adhesive material.
However, Berard teaches, in the same field of endeavor, wherein the adhesive layer comprises a silicone adhesive material (“The tape may include a first adhesive surface for adhesion of the silicone gel to the skin and a second adhesive surface for adhesion of the silicone gel to the ultrasound probe. The first and second adhesive surfaces are preferably surfaces of the silicone gel. There may be two silicone gel layers respectively providing the first and second adhesive surfaces. Two similar silicone gel layers may be used, or alternatively the layers may be of different types with properties optimised for best adhesion to the probe and to the skin, respectively.” [0010]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Nielsen modified by Desai with wherein the adhesive layer comprises a silicone adhesive material as taught by Berard in order to provide an adhesive layer with improved adhesion to typical ultrasound probe materials ([0008] of Berard).
Regarding claim 11, Nielsen modified by Desai and Berard discloses the limitations of claim 10 as stated above. Berard was relied on to teach the silicone adhesive material. Nielsen modified by Berard fails to disclose wherein the silicone adhesive material has a thickness ranging from 0.025 millimeter (mm) to 0.2 mm. Instead, Berard teaches, in the same field of endeavor, wherein the silicone adhesive material has a thickness of 0.25 mm ([0015]).
However, it would have been an obvious matter of design choice to provide the silicone adhesive material having a thickness ranging from 0.025 millimeter (mm) to 0.2 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04.
Regarding claim 12, Nielsen modified by Desai and Berard discloses the limitations of claim 10 as stated above. Berard was relied on to teach the silicone adhesive material. Nielsen modified by Berard does not explicitly teach wherein the silicone adhesive material has a coat weight in a range of 100 grams per square meter (gsm) to 200 gsm. However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the silicone gel adhesive coating taught by Berard to have a coat weight in a range of 100 grams per square meter (gsm) to 200 gsm, because applicant has not disclosed that the claimed coat weight range provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results (e.g. optimizing tackiness of the adhesive layer) to one of ordinary skill in the art at the time of the invention. As such, the modification of coat weight would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Nielsen in view of Berard.
Regarding claim 13, Nielsen modified by Desai and Berard discloses the limitations of claim 10 as stated above. Berard is silent on wherein the silicone adhesive material has an adhesion of between 0.2 Newtons (N) per 25 millimeters (mm) and 0.8 N per 25 mm. However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the silicone gel adhesive coating taught by Berard to have an adhesion of between 0.2 Newtons (N) per 25 millimeters (mm) and 0.8 N per 25 mm, because applicant has not disclosed that the claimed coat weight range provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. Furthermore, it has been held before that "it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05.II.A), one of ordinary skill in the art could have made the modification with known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results (e.g. optimizing tackiness of the adhesive layer) to one of ordinary skill in the art at the time of the invention. As such, the modification of coat weight would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Nielsen in view of Berard.
Conclusion
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/A.A./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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