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 1-9 are pending and examined below. Claims 10-17 is/are withdrawn.
Election/Restrictions
Applicant's election with traverse of Claims 1-9 in the reply filed on 06/22/2026 is acknowledged. The traversal is on the ground(s) that different classifications or search strategies does not identify a serious search or examination burden. This is not found persuasive because claims 1-9 is directed towards a medical device and 10-17 is directed towards a method of implantation which would require different search strategies and/or classification.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "the formula" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the atomic valency" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the number of water" in line 6. There is insufficient antecedent basis for this limitation in the claim.
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) 1-5, 7, & 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Danscher (US 20200046879 A1) in view of Trogolo et al. (US 6866859 B2) hereinafter, Trogolo.
Regarding claim 1, Danscher teaches a medical device configured as a breast prosthesis for implantation into a host, comprising
a silicone elastomer (silicone implants, ¶0018, Danscher) having a capsular contracture reducing or inhibiting agent incorporated therein (prevent or reduce capsular contracture, abstract & ¶0011, Danscher),
and being present in said elastomer (embedded in the wall of the implant and applied to the surface of the implant, ¶0019-0020, Danscher) in a therapeutically effective amount sufficient to inhibit capsular contracture (preventing capsular contracture, ¶0022, Danscher) when said device is implanted in said host (gold particle is to be implanted in the proximity of an implant and implants that are used are selected from abreast, ¶0018).
Danscher does not teach said capsular contracture reducing or inhibiting agent comprising ceramic particles. However, Trogolo teaches an article including a surface having a coating thereon, in which the coating includes a base coat (abstract, Trogolo) wherein
said capsular contracture reducing or inhibiting agent comprising ceramic particles (ceramic component is dispersed in one or both of the base coat and top-coat, abstract, 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 Danscher by incorporating the teaching above as taught by Trogolo in order to impart anti-microbial properties to articles having biocompatible coatings (col. 5 lines 12-13, Trogolo).
Regarding claim 2, Danscher does not teach wherein said ceramic particles comprise an aluminosilicate. However, Trogolo discloses
wherein said ceramic particles comprise an aluminosilicate represented by the formula XM2/nO
·
Al2O3
·
YSiO2
·
ZH2O wherein M represents an ion-exchangeable ion, n represents the atomic valency of the (metal) ion, X and Y represent coefficients of metal oxide and silica respectively, and Z represents the number of water of crystallization (aluminosilicate and 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 Danscher by incorporating the teachings above as taught by Trogolo in order to impart anti-microbial properties to articles having biocompatible coatings (col. 5 lines 12-13, Trogolo).
Regarding claim 3, Danscher does not teach wherein said ceramic particles are a zeolite. However, Trogolo discloses
wherein said ceramic particles are a zeolite (ceramic component is a zeolite, abstract, 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 Danscher by incorporating the teaching above as taught by Trogolo in order to impart anti-microbial properties to articles having biocompatible coatings (col. 5 lines 12-13, Trogolo).
Regarding claim 4, Danscher teaches
wherein said ceramic particles comprise one or more metal ions (gold ions, ¶0022, Danscher).
Regarding claim 5, Danscher teaches
wherein said breast prostheses (Fig. 1) comprises an outer surface, and wherein said capsular contracture reducing or inhibiting agent is incorporated into said outer surface (gold particles either embedded in or onto the surface of the implant, ¶0026, Danscher).
Regarding claim 7, Danscher teaches
wherein said breast prostheses is implanted submuscularly (¶0006, Danscher).
Regarding claim 9, Danscher teaches
wherein said breast prostheses is a tissue expander (breast implant in the body therefore it expands the tissue, Fig. 1, ¶0028, Danscher).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Danscher in view of Trogolo and further in view of Schrank et al. (EP 2982386 A1) hereinafter, Schrank.
Regarding claim 6, Danscher 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 Danscher and Trogolo by incorporating the teachings above as taught by Schrank in order to reduce fibrosis and the formation of scars (¶0048, Schrank).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Danscher in view of Trogolo and further in view of Hunter (US 20100074934 A1).
Regarding claim 8, Danscher does not teach wherein said breast prostheses is implanted subglandularly. However, Hunter teaches implants are associated with a combination of paclitaxel or derivatives and dipyridamole or derivatives in order to inhibit fibrosis (abstract, Hunter)
wherein said breast prostheses is implanted subglandularly (subglandular implants, ¶0358, Hunter).
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 Danscher and Trogolo by incorporating the teaching above as taught by Hunter in order to create a space between the glandular tissue and the pectoralis major muscle that extends down to the inframammary crease for the implant (¶0358, Hunter).
Conclusion
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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