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 . Claims 1-3, & 5-9 are pending and examined below.
Response to Arguments
Applicant's arguments filed 08/04/2026 have been fully considered but they are not persuasive.
Applicant argues that the amendments to the independent claim overcome the rejections of record (pages 4-7) and that the dependent claims rise and fall with the same arguments (pages 7-8).
Applicant's arguments are moot due to the additional reference applied to the newly added limitations, as detailed in the rejection below.
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, 3, 5, and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 20100074934 A1) in view of Chudzik et al. (US 20060287410 A1) hereinafter, Chudzik.
Regarding claim 1, Hunter teaches
a medical device configured as a breast prosthesis for implantation into a host (breast implant, ¶0358, Hunter), comprising
a silicone elastomer having a capsular contracture reducing or inhibiting agent incorporated therein (agent is incorporated into the saline, gel or silicone within the implant, ¶0360, Hunter),
said capsular contracture reducing or inhibiting agent and being present in said elastomer in a therapeutically effective amount sufficient to inhibit capsular contracture when said device is implanted in said host (agent is incorporated into the saline, gel or silicone within the implant, ¶0360, and inhibiting or reducing the overgrowth of granulation tissue, which can lead to encapsulation of the device, ¶0353, Hunter).
Hunter does not teach said capsular contracture reducing or inhibiting agent comprising ceramic particles. However, Chudzik teaches macromer composition that can be used to coat and/or fill voids within or upon the surface of device that is implanted into a portion of the body (¶0032, Chudzik) wherein
said capsular contracture reducing or inhibiting agent comprising ceramic particles (glass ceramic, ¶0105, Chudzik), and
wherein the ceramic particles are devoid of antimicrobial metal ions (glass ceramic, therefore devoid of antimicrobial metal ions, ¶0105, Chudzik).
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 teachings of Hunter by incorporating the teaching above as taught by Chudzik in order to augment tissue growth or function (¶0011, Chudzik).
Regarding claim 3, Hunter does not teach wherein said ceramic particles are a zeolite. However, Chudzik teaches
wherein said ceramic particles are a zeolite (¶0107, Chudzik).
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 teachings of Hunter by incorporating the teaching above as taught by Chudzik in order to augment tissue growth or function (¶0011, Chudzik).
Regarding claim 5, Hunter teaches
wherein said breast prostheses comprises an outer surface (outer surface, ¶0360, Hunter), and wherein
said capsular contracture reducing or inhibiting agent is incorporated into said outer surface (incorporation of a combination onto a breast implant (e.g., as a coating applied to the outer surface of the implant and or incorporated into, and released from, the outer polymeric membrane of the implant), ¶0360, Hunter).
Regarding claim 7, Hunter teaches
wherein said breast prostheses is implanted submuscularly (breast implants are placed subpectorally, ¶0360, Hunter).
Regarding claim 8, Hunter teaches
wherein said breast prostheses is implanted subglandularly (breast implants are placed subglandularly, ¶0360, Hunter).
Regarding claim 9, Hunter teaches
wherein said breast prostheses is a tissue expander (breast tissue expanders, ¶0362, Hunter).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter in view of Chudzik and further in view of Trogolo et al. (US 6866859 B2) hereinafter, Trogolo.
Regarding claim 2, Hunter in view of Chudzik discloses an aluminosilicate (¶0105, Chudzik) but does not teach wherein said ceramic particles comprise an aluminosilicate represented by a formula XM2/nO·Al2O3·YSiO2·ZH20. However, Trogolo teaches an article including a surface having a coating (abstract, Trogolo)
wherein said ceramic particles comprise an aluminosilicate represented by a formula XM2/nO·Al2O3·YSiO2·ZH20 wherein M represents an ion-exchangeable ion, n represents an atomic valency of the ion, X and Y represent coefficients of metal oxide and silica respectively, and Z represents a number of water of crystallization (chemical formula, col. 2 lines 1-10, Trogolo).
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 teachings of Hunter and Chudzik by incorporating the teaching above as taught by Trogolo as that is the three-dimensional skeletal structure of the formula for aluminosilicate (col. 2 lines 1-2, Trogolo).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter in view of Chudzik and further in view of Schrank et al. (EP 2982386 A1) hereinafter, Schrank.
Regarding claim 6, Hunter does not teach wherein said breast prostheses comprises multiple layers of said silicone elastomer. However, Schrank teaches a breast implant comprising a flexible shell (abstract, Schrank)
wherein said breast prostheses comprises multiple layers of said silicone elastomer (¶0015, Schrank), including an outer layer (top layer, ¶0017, Schrank), and wherein
said capsular contracture reducing or inhibiting agent is incorporated into at least said outer layer (shell may be coated with an NO-releasing material, ¶0016, Schrank).
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 teachings of Hunter and Chudzik by incorporating the teachings above as taught by Schrank in order to reduce fibrosis and the formation of scars (¶0048, Schrank).
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.
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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