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 .
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.
Claim Objections
Claim 7 objected to because of the following informalities: “that a gas or a liquid in the hollow space is not easily leaked out to the exterior is formed in the first layer and the second layer” should likely read “that a gas or a liquid in the hollow space is not easily leaked out to the exterior”. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katsuhiko (JP2016073562A) in view of Bloomfield (20150344635).
With regards to claim 1, Katsuhiko discloses a mammary prosthesis (1), comprising: a first layer made of silicone rubber (2, abstract), the first layer (2) inside which a hollow space is formed (6); and a second layer arranged on an outer side of the first layer (3), the second layer being harder than the first layer (abstract), the second layer being configured by containing silicone rubber (3, abstract), but fails to disclose that the first layer is configured by containing a mixture of silicone rubber and at least two types of thickeners whose viscosities are different from each other.
Bloomfield discloses a method of creating viscoelastic silicone rubbers. Bloomfield teaches type of silicone rubber made by mixing silicone rubber and at least two types of thickeners whose viscosities are different from each other ([0274], blended and softened with 0.5 wt % Oleic acid, and Crosslinked using 0.57 wt % VX Peroxide). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Katsuhiko’s mammary prosthesis to include that the first layer is configured by containing a mixture of silicone rubber and at least two types of thickeners whose viscosities are different from each other, as taught by Bloomfield, in order to create a viscoelastic silicone rubber ([0277]).
Claim(s) 2, 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katsuhiko (JP2016073562A) in view of Bloomfield (20150344635) as applied to claim 1 above, and further in view of Pace (CA2301445A1) and Reynolds (20040010311).
With regards to claim 2, Katsuhiko as modified by Bloomfield discloses the mammary prosthesis according to claim 1, but fails to disclose that it is comprising: a colored layer arranged on an outer side of the second layer, the colored layer being configured by containing a colorant; and a cover layer arranged on an outer side of the colored layer, the cover layer being capable of suppressing peeling of the colored layer.
Pace also discloses a mammary prosthesis (FIG 2) with a first layer formed of silicone rubber (10) with a hollow space inside (25). Pace teaches a colored layer (17) formed on the outside of the silicone rubber layer (10, FIG 2), the colored layer being configured by containing a colorant (to add color). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Katsuhiko’s mammary prosthesis to include a colored layer arranged on an outer side of the second layer, the colored layer being configured by containing a colorant, as taught by Pace, in order to look like a human breast (abstract).
Katsuhiko as modified by Bloomfield and Pace fails to disclose a cover layer arranged on an outer side of the colored layer, the cover layer being capable of suppressing peeling of the colored layer. Reynolds also discloses a mammary prosthesis (FIG 6) with an inner layer (21), an outer layer (22), nipple (7), and areola (10), where the nipple and areola are colored ([0026]). Reynolds teaches a cover layer arranged on an outer side of the colored layer ([0042]), the cover layer being capable of suppressing peeling of the colored layer ([0042], where the film envelope is capable of suppressing peeling). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Katsuhiko’s mammary prosthesis to include a cover layer arranged on an outer side of the colored layer, the cover layer being capable of suppressing peeling of the colored layer, as taught by Reynolds, in order to keep the nipple and areola portion adhered ([0042]).
With regards to claim 3, Katsuhiko as modified by Bloomfield, Pace, and Reynolds discloses the mammary prosthesis according to claim 2, wherein the colored layer (Pace 17) has a nipple region (Pace 15, 16, FIG 2) in which a nipple is displayed (Pace 16, FIG 2), and the nipple region (Pace 15, 16, FIG 2) and other regions of the colored layer (Pace 17) are positioned in the same plane (Pace pg 5 line 3, “the thickness of the fabric 17 closely corresponds to the thickness of the areola disc 15 such as to provide a smooth transition”).
Claim(s) 4, 8, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katsuhiko (JP2016073562A) in view of Bloomfield (20150344635), Pace (CA2301445A1), and Reynolds (20040010311), and further in view of Kudo (JP2000054202A).
With regards to claim 4, Katsuhiko as modified by Bloomfield, Pace, and Reynolds discloses the mammary prosthesis according to claim 2, but fails to disclose that it is comprising: a reflection suppression layer arranged on an outer side of the cover layer, the reflection suppression layer being capable of suppressing reflection of light of the cover layer or the colored layer.
Kudo discloses a mammary prosthesis (FIG 1). Kudo teaches a reflection suppression layer arranged on an outer side of the cover layer ([0012], where matte suppresses reflection, and the matte surface is on the front, i.e. the outer side), the reflection suppression layer being capable of suppressing reflection of light of the cover layer or the colored layer ([0012], the matte layer is capable of suppressing reflection of light). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Katsuhiko’s mammary prosthesis to include a reflection suppression layer arranged on an outer side of the cover layer, the reflection suppression layer being capable of suppressing reflection of light of the cover layer or the colored layer, as taught by Kudo, in order to give a texture close to that of skin ([0012]).
With regards to claim 8, Katsuhiko discloses a mammary prosthesis (1), comprising: a silicone rubber layer configured by containing silicone rubber (2, abstract), the silicone rubber layer (2, abstract) inside which a hollow space is formed (6); a nipple portion provided (2A) in part of the silicone rubber layer (2, abstract) on an opposite side of the hollow space (6, FIG 2), but fails to disclose that the nipple portion being configured by containing a mixture of silicone rubber and at least two types of thickeners whose viscosities are different from each other; a colored layer arranged on an outer side of the silicone rubber layer and on an outer side of the nipple portion, the colored layer being configured by containing a colorant; a cover layer arranged on an outer side of the colored layer, the cover layer being capable of suppressing peeling of the colored layer; and a reflection suppression layer arranged on an outer side of the cover layer, the reflection suppression layer being capable of suppressing reflection of light of the cover layer or the colored layer.
Bloomfield discloses a method of create viscoelastic silicone rubbers. Bloomfield teaches type of silicone rubber made by mixing silicone rubber and at least two types of thickeners whose viscosities are different from each other ([0274], blended and softened with 0.5 wt % Oleic acid, and Crosslinked using 0.57 wt % VX Peroxide). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Katsuhiko’s mammary prosthesis to include disclose that the nipple portion being configured by containing a mixture of silicone rubber and at least two types of thickeners whose viscosities are different from each other, as taught by Bloomfield, in order to create a viscoelastic silicone rubber ([0277]).
Katsuhiko as modified by Bloomfield fails to disclose a colored layer arranged on an outer side of the silicone rubber layer and on an outer side of the nipple portion, the colored layer being configured by containing a colorant. Pace also discloses a mammary prosthesis (FIG 2) with a first layer formed of silicone rubber (10) with a hollow space inside (25). Pace teaches a colored layer (17) formed on the outside of the silicone rubber layer (10, FIG 2), the colored layer being configured by containing a colorant (it is inherent that a colorant must be used to add color). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Katsuhiko’s mammary prosthesis to include a colored layer arranged on an outer side of the second layer, the colored layer being configured by containing a colorant, as taught by Pace, in order to look like a human breast (abstract).
Katsuhiko as modified by Bloomfield and Pace fails to disclose a cover layer arranged on an outer side of the colored layer, the cover layer being capable of suppressing peeling of the colored layer. Reynolds also discloses a mammary prosthesis (FIG 6) with an inner layer (21), an outer layer (22), nipple (7), and areola (10), where the nipple and areola are colored ([0026]). Reynolds teaches a cover layer arranged on an outer side of the colored layer ([0042]), the cover layer being capable of suppressing peeling of the colored layer ([0042], where the film envelope is capable of suppressing peeling). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Katsuhiko’s mammary prosthesis to include a cover layer arranged on an outer side of the colored layer, the cover layer being capable of suppressing peeling of the colored layer, as taught by Reynolds, in order to keep the nipple and areola portion adhered ([0042]).
Katsuhiko as modified by Bloomfield, Pace, and Reynolds fail to disclose a reflection suppression layer arranged on an outer side of the cover layer, the reflection suppression layer being capable of suppressing reflection of light of the cover layer or the colored layer. Kudo also discloses a mammary prosthesis (FIG 1). Kudo teaches a reflection suppression layer arranged on an outer side of the cover layer ([0012], where matte suppresses reflection, and the matte surface is on the front, i.e. the outer side), the reflection suppression layer being capable of suppressing reflection of light of the cover layer or the colored layer ([0012], the matte layer is capable of suppressing reflection of light). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Katsuhiko’s mammary prosthesis to include a reflection suppression layer arranged on an outer side of the cover layer, the reflection suppression layer being capable of suppressing reflection of light of the cover layer or the colored layer, as taught by Kudo, in order to give a texture close to that of skin ([0012]).
With regards to claim 9, Katsuhiko discloses an artificial nipple (2A), comprising: a main body layer (2, abstract), but fails to disclose that the main body layer is configured by containing a mixture of silicone rubber and at least two types of thickeners whose viscosities are different from each other; a colored layer arranged on an outer side of the main body layer, the colored layer being configured by containing a colorant; a cover layer arranged on an outer side of the colored layer, the cover layer being capable of suppressing peeling of the colored layer; and a reflection suppression layer arranged on an outer side of the cover layer, the reflection suppression layer being capable of suppressing reflection of light of the cover layer or the colored layer.
Bloomfield discloses a method of create viscoelastic silicone rubbers. Bloomfield teaches type of silicone rubber made by mixing silicone rubber and at least two types of thickeners whose viscosities are different from each other ([0274], blended and softened with 0.5 wt % Oleic acid, and Crosslinked using 0.57 wt % VX Peroxide). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Katsuhiko’s mammary prosthesis to include disclose that the main body layer is configured by containing a mixture of silicone rubber and at least two types of thickeners whose viscosities are different from each other, as taught by Bloomfield, in order to create a viscoelastic silicone rubber ([0277]).
Katsuhiko as modified by Bloomfield fails to disclose a colored layer arranged on an outer side of the main body layer, the colored layer being configured by containing a colorant. Pace also discloses a mammary prosthesis (FIG 2) with a first layer formed of silicone rubber (10) with a hollow space inside (25). Pace teaches a colored layer (17) formed on the outside of the silicone rubber layer (10, FIG 2), the colored layer being configured by containing a colorant (it is inherent that a colorant must be used to add color). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Katsuhiko’s mammary prosthesis to include a colored layer arranged on an outer side of the main body layer, the colored layer being configured by containing a colorant, as taught by Pace, in order to look like a human breast (abstract).
Katsuhiko as modified by Bloomfield and Pace fails to disclose a cover layer arranged on an outer side of the colored layer, the cover layer being capable of suppressing peeling of the colored layer. Reynolds also discloses a mammary prosthesis (FIG 6) with an inner layer (21), an outer layer (22), nipple (7), and areola (10), where the nipple and areola are colored ([0026]). Reynolds teaches a cover layer arranged on an outer side of the colored layer ([0042]), the cover layer being capable of suppressing peeling of the colored layer ([0042], where the film envelope is capable of suppressing peeling). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Katsuhiko’s mammary prosthesis to include a cover layer arranged on an outer side of the colored layer, the cover layer being capable of suppressing peeling of the colored layer, as taught by Reynolds, in order to keep the nipple and areola portion adhered ([0042]).
Katsuhiko as modified by Bloomfield, Pace, and Reynolds fail to disclose a reflection suppression layer arranged on an outer side of the cover layer, the reflection suppression layer being capable of suppressing reflection of light of the cover layer or the colored layer. Kudo also discloses a mammary prosthesis (FIG 1). Kudo teaches a reflection suppression layer arranged on an outer side of the cover layer ([0012], where matte suppresses reflection, and the matte surface is on the front, i.e. the outer side), the reflection suppression layer being capable of suppressing reflection of light of the cover layer or the colored layer ([0012], the matte layer is capable of suppressing reflection of light). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Katsuhiko’s mammary prosthesis to include a reflection suppression layer arranged on an outer side of the cover layer, the reflection suppression layer being capable of suppressing reflection of light of the cover layer or the colored layer, as taught by Kudo, to give a texture close to that of skin ([0012]).
Claim(s) 5, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katsuhiko (JP2016073562A) in view of Bloomfield (20150344635) as applied to claim 1 above, and further in view of Reynolds (20040010311) and Stadler (20150314493).
With regards to claim 5, Katsuhiko as modified by Bloomfield discloses the mammary prosthesis according to claim 1, but fails to disclose that it is comprising: a thin film layer arranged on an outer side of the second layer, the thin film layer being capable of blocking a substance, with the thin film layer being transparent.
Reynolds discloses a mammary prosthesis (FIG 6) with an inner layer (21), an outer layer (22), nipple (7), and areola (10), where the nipple and areola are colored ([0026]). Reynolds teaches a thin film layer arranged on an outer side of the second layer ([0042]), the thin film layer being capable of blocking a substance ([0042], where the film envelope has the capability of blocking a substance). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Katsuhiko’s mammary prosthesis to include a thin film layer arranged on an outer side of the second layer, the thin film layer being capable of blocking a substance, as taught by Reynolds, in order to keep the nipple and areola portion adhered ([0042]).
Katsuhiko as modified by Reynolds fails to disclose that the thin film layer is transparent. Stadler discloses a mammary prosthesis (FIG) with a thin covering (18, [0004]). Stadler teaches that the thin film layer is transparent ([0004]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Katsuhiko’s mammary prosthesis to include that the thin film layer is transparent, as taught by Stadler, in order to provide an attractive appearance ([0004]).
With regards to claim 6, Katsuhiko as modified by Bloomfield, Reynolds, and Stadler discloses the mammary prosthesis according to claim 5, comprising: an adhesive layer (8) arranged attachably to and detachably ([0048] of attached English translation) from a layer which is arranged on the outermost side (FIG 4), the adhesive layer being configured by containing an adhesive material ([0050] of attached English translation).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katsuhiko (JP2016073562A) in view of Bloomfield (20150344635) as applied to claim 1 above, and further in view of Pace (CA2301445A1) and Landuyt (US6149632A).
With regards to claim 7, Katsuhiko as modified by Bloomfield discloses the mammary prosthesis according to claim 1, but fails to disclose a through hole passing through the first layer and the second layer and providing communication between an exterior and the hollow space, the through hole having such a size that a gas or a liquid in the hollow space is not easily leaked out to the exterior is formed in the first layer and the second layer.
Pace also discloses a mammary prosthesis (FIG 2) with a first layer formed of silicone rubber (10) with a hollow space inside (25). Pace teaches a through hole (34) passing through the first layer and the second layer and providing communication between an exterior and the hollow space (FIG 2), the through hole (34). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Katsuhiko’s mammary prosthesis to include a through hole passing through the first layer and the second layer and providing communication between an exterior and the hollow space, as taught by Pace in order to allow communication between the interior and exterior of the prosthesis (pg 5 line 18).
Katsuhiko as modified by Pace fails to disclose that the through hole has such a size that a gas or a liquid in the hollow space is not easily leaked out to the exterior. Landuyt also discloses a cylindrical housing (1) with a through hole (16) passing through a first layer (13) and second layer (14). Landuyt teaches that the through hole (16) has such a size that a gas or a liquid in the hollow space is not easily leaked out to the exterior (col 3, line 18). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Katsuhiko’s mammary prosthesis to include that the through hole has such a size that a gas or a liquid in the hollow space is not easily leaked out to the exterior, as taught by Landuyt, in order to have an effective seal (col 3, line 26).
Conclusion
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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