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 .
Response to Amendment
The amendments filed on May, 14th, 2026 have been entered. For this application examiner
acknowledges claims, 1-7 are pending examination.
Response to Arguments
Applicant’s arguments, see remarks, filed 5/14/2026, with respect to the rejection(s) of claim(s) 1-7 under 35 U.S have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yamauchi, Spence, and Smith.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Yamauchi (JP 2016073562 A) "Yamauchi" in view of Spence (US 4019209 A) "Spence", 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), but fails to disclose the third layer covering the entire first layer.
However, Spence, in the same field of art, teaches an artificial breast (gel 10, par. (1) Description, Fig. 1) wherein the third layer (layers 21 and 31, par. (4) Description, Fig. 2) is arranged to cover the entire first layer (gel 10, pars. (1) and (4), 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 Spence, in order to decrease the surface stickiness of the core of the implant and to provide enough elasticity or stretch to keep the implant intact when enduring external forces (Spence, par. (9) Description).
Regarding Claim 7, Yamauchi further 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) 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Yamauchi (JP 2016073562 A) "Yamauchi" in view of Spence (US 4019209 A) "Spence" in further view of Smith (US 20110120616 A1) "Smith", via attached translation (MAMMARY PROSTHESIS).
Regarding Claim 2, Yamauchi in view of Spence 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, below) arranged on the outer side of the third layer (second outer side 16, pars. [0057], [0062], See Annotated Fig. 5, below), the colored layer being configured by containing a colorant (par. [0065]);
and 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]). 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 in view of Spence 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 in view of Spence 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 in view of Spence 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 in view of Spence 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, 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]). 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 in view of Spence 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 in view of Spence 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 in view of Spence 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 in view of Spence 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 in view of Spence 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]).
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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
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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