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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 7 are rejected under 35 U.S.C. 102(a)(1) as being disclosed by Yamauchi (JP 2016073562 A) "Yamauchi", via attached translation (MAMMARY PROSTHESIS).
Regarding Claim 1, Yamauchi discloses an artificial breast (artificial breast 1, par [0027], Fig.
1), comprising: a first layer (soft layer 4, par. [0029], Fig. 1) configured by containing silicone gel (pars. [0020], [0029], Fig. 1);
a second layer (second silicone rubber layer 3, par. [0028], Fig. 1) configured by containing silicone rubber and arranged partly on an outer side of the first layer, the second layer being harder than the first layer (pars. [0028], [0029], Fig. 1);
a third layer (first silicone rubber layer 2, par. [0027], Fig. 1) configured by containing silicone
rubber and arranged on the outer side of the first layer and the second layer, the third layer being harder than the first layer and the second layer (pars. [0027], [0028], Fig. 1);
and a fourth layer (third silicone rubber layer 5, par. [0031], Fig. 1) configured by containing
silicone rubber and arranged partly on an outer side of the third layer, the fourth layer having the same hardness as the third layer (par. [0031], Fig. 1),
wherein a curing speed of the silicone rubber of the third layer is slower than a curing speed
of the silicone rubber of the second layer (pars. [0062], [0065], [0078], Fig. 1).
Regarding Claim 7, Yamauchi discloses the artificial breast according to claim 1 (artificial breast 1, par [0027], Fig. 1), wherein the first layer is configured by containing the silicone gel without any space (par. [0029], Fig. 1).
Claim(s) 9 is rejected under 35 U.S.C. 102(a)(1) as being disclosed by Smith (US 20110120616 A1) "Smith".
Regarding Claim 9, Smith discloses a silicone rubber body (resilient skin, par. [0010], See
Annotated Fig. 5, below), comprising: a silicone rubber layer (outer side 16, pars. [0010] and [0057], See Annotated Fig. 5, below) configured by containing silicone rubber;
a colored layer (outer layer 18, par. [0060], See Annotated Fig. 5, below) arranged on an outer side of the silicone rubber layer, the colored layer being configured by containing a colorant (par. [0062]);
a cover layer (See Annotated Fig. 5, below) arranged on an outer side of the colored layer,
the cover layer being capable of suppressing peeling of the colored layer (par. [0062]);
and a reflection suppression layer (See Annotated Fig. 5, below) 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 (par. [0062]).
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Yamauchi (JP 2016073562 A) "Yamauchi" in view of Smith (US 20110120616 A1) "Smith", via attached translation (MAMMARY PROSTHESIS).
Regarding Claim 2, Yamauchi does not disclose colored layers containing a colorant and a
cover layer. However, Smith, in the same field of art, teaches a breast prosthesis (prosthesis 10, par. [0055], Fig. 12) comprising:
a colored layer (outer layer 18, par. [0062], See Annotated Fig. 5, above) arranged on the outer side of the third layer (second outer side 16, pars. [0057], [0062], See Annotated Fig. 5, above), the colored layer being configured by containing a colorant (par. [0065]);
and a cover layer (See Annotated Fig. 5, above) arranged on an outer side of the colored
layer, the cover layer being capable of suppressing peeling of the colored layer (par. [0062]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Yamauchi to include colored layers containing a colorant and a cover layer, as taught by Smith, in order to provide a more realistic areola area as well as veins or freckles, which will provide a more suitable and comfortable look for patients (Smith, pars. [0003], [0037], [0062]).
Regarding Claim 3, Yamauchi does not disclose a colored layer with a nipple region. However, Smith, in the same field of art, teaches a breast prosthesis (prosthesis 10, par. [0055], Fig. 12), wherein the colored layer has a nipple region (nipple protrusion 36, par. [0067], Fig. 10) in which a nipple is displayed, and the nipple region and other regions of the colored layer are positioned in the same plane (pars. [0062], [0067], Fig. 10). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Yamauchi to include a colored layer with a nipple region, as taught by Smith, in order to provide a more realistic areola area, which will provide a more suitable and comfortable look for patients (Smith, pars. [0003], [0037], [0062]).
Regarding Claim 4, Yamauchi does not disclose a reflection suppression layer on the outer side of the cover layer. However, Smith, in the same field of art, teaches a breast prosthesis (prosthesis 10, par. [0055], Fig. 12) comprising: a reflection suppression layer (See Annotated Fig. 5, above) 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 (par. [0062]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Yamauchi to include a reflection suppression layer on the outer side of the cover layer, as taught by Smith, in order to provide a better resemblance to a natural breast (Smith, par. [0057]).
Regarding Claim 5, Yamauchi does not disclose a thin film layer on the outer side of the fourth layer capable of blocking a substance. However, Smith, in the same field of art, teaches a breast prosthesis (prosthesis 10, par. [0055], Fig. 12) comprising: a thin film layer (cover 28, par. [0065], Fig. 7) arranged on an outer side of the fourth layer, the thin film layer being capable of blocking a substance, with the thin film layer being transparent (pars. [0065], [0080], Figs. 7 and 13). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Yamauchi to include a thin film layer on the outer side of the fourth layer capable of blocking a substance, as taught by Smith, in order to conform to the body of the wearer while being secured to the prosthesis, which will maximize comfort for the wearer (Smith, pars. [0065], [0066]).
Regarding Claim 6, Yamauchi does not disclose an adhesive layer with varying attachment to the outermost side. However, Smith, in the same field of art, teaches a breast prosthesis (prosthesis 10, par. [0055], Fig. 12) comprising: an adhesive layer (resilient bonding layers 52 and 56, par. [0082], Fig. 13) arranged attachably to and detachably from a layer which is arranged on the outermost side, the adhesive layer being configured by containing an adhesive material (par. [0082], Fig. 13). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Yamauchi to include an adhesive layer with varying attachment to the outermost side, as taught by Smith, in order to have a temporary adhesive bond to the user’s skin, which helps to secure the prosthetic on the skin of the user by preventing sliding (Smith, par. [0082]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamauchi (JP 2016073562 A) "Yamauchi" in view of Laghi et al (US 20120010705 A1) "Laghi", via attached translation (MAMMARY PROSTHESIS).
Regarding Claim 8, Yamauchi does not disclose a third layer arranged to cover the entire first
layer. However, Laghi, in the same field of art, teaches a breast prosthesis (lightweight breast prosthesis 1, par. [0021], Fig. 1) wherein the third layer (cover layers 3 and 4, par. [0004], Fig. 2) is arranged to cover the entire first layer (inner core 2, par [0004], Fig. 2). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Yamauchi to include a third layer arranged to cover the entire first layer, as taught by Laghi, in order to help provide a more realistic feel for the prosthesis, as the silicone gel in deeper layers will not be as consistent with natural human tissue (Laghi, par. [0016]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700