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
Claims 5 and 6 are objected to because of the following informalities:
In claim 5, line 1, “the reinforcing material”, should be “the one or more reinforcing material layers”.
In claim 6, line 1, “the reinforcing material layer”, should be “the one or more reinforcing material layers”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 3-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chitre et al. (US20110270391).
Regarding claim 1, Chitre discloses artificial implant (10) comprising: a silicone shell (22, see paragraphs [0078] - [0079]); and a filler (saline 14) filled in the shell (see Fig. 1) wherein at least a portion of the shell (22) is a rupture-resistant portion including two or more silicone layers (36 and 38) and one or more reinforcing material layers (40) interposed therebetween (see Fig. 1 and [0078]).
Regarding claim 3, Chitre further discloses wherein the shell further includes a barrier film layer (26, see Fig. 1).
Regarding claim 4, Chitre further discloses wherein the rupture-resistant portion (36, 38, 40) is provided in a side portion (see Fig. 1).
Regarding claim 5, Chitre further discloses the one or more reinforcing material layers (40) is made up of polyurethane or nylon (see paragraph [0080]).
Regarding claim 6, Chitre further discloses wherein the one or more reinforcing material layers (40) has at least one mesh structure (see paragraph [0080], reinforcement layer 40 may comprise a mesh or fabric).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chitre as applied to claim 1 above, and further in view of Schuessler et al. (US20190175332).
Regarding claim 2, Chitre fails to disclose wherein a portion of the shell, which is not the rupture-resistant portion, has a thickness of 0.40 to 0.80mm, and the rupture-resistant portion has a thickness of 0.40 to 1.20 mm.
Schuessler also discloses an artificial implant (20) with a flexible outer shell (22) that defines an internal cavity to be filled with fluid (24) and teaches the flexible shell to have varied wall thicknesses for different portions of the shell that vary from 0.254-0.456 mm in a non-rupture-resistant portion (see Figs 5-6 and paragraph [0033], non-reinforced shell wall thickness is at least 0.254 mm and desirably about 0.456 mm) to 0.51-1.52 mm in a ruptured resistant portion (see Figs 5-6 and paragraph [0032], the thickness of reinforced area B is between about 0.51-1.52 mm). 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 the rupture-resistant portion of Chitre’s shell to have a thickness between about 0.51-1.52 mm as taught by Schuessler in order to allow for the implant to maintain the breast natural shape after implantation (see paragraphs [0007] and 0008]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the rupture-resistant portion from between about 0.51-1.52 mm as taught by Schuessler to be between 0.40 to 1.20 mm as claimed since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pg. 2 of the instant specification indicating the rupture resistant portion “may” have a thickness in the claimed range).
It is noted that it is not required that the shell have a portion that is not the rupture resistant portion because the limitation “at least a portion of the shell is a rupture-resistance portion” encompasses a shell in which all portions are rupture resistance portions.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chitre.
Chitre further discloses the rupture-resistant portion (36, 38, 40) consists of two layers of silicone elastomer (36 and 38 are formed of silicone) to one reinforcing material layer (40) of fabric or mesh ([0079-0081], thereby having a weight that is mostly silicone. it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the rupture-resistant portion to have the silicone and reinforcing material in a weight ratio of 55 to 95:5 to 45
as claimed since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pg. 2 of the instant specification indicating the rupture resistant portion “may” have a weight ratio in the claimed range).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chitre as applied to claim 1 above, and further in view of Williams et al. (US20200390933).
Regarding claim 8, Chitre further discloses the rupture resistant portion may partially comprise polyurethane but fails to disclose wherein the rupture-resistant portion has a tensile strength of 25 N or more.
Williams discloses polymer mesh breast implants and teaches the polymer mesh breast implant being formed to withstand loads of at least 60 N generated by the native tissue (see paragraph [0579]; in which 60 N is more than 25 N as claimed). 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 the rupture resistant-portion of Chitre to have a tensile strength of at least 60 N, as taught by Williams, in which 60 N is more than 25 N as claimed, in order to support the mechanical forces acting on the breast during normal activities at the time of implantation (see paragraph [0579]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chitre as applied to claim 1 above, and further in view of Szycher et al. (US5254662).
Regarding claim 9, Chitre fails to disclose wherein the rupture-resistant portion has an elongation rate of 300 to 500%.
Szycher discloses a polyurethane that can be used in mammary prostheses (see col 3, lines 30-37) and teaches the polyurethane has an ultimate elongation rate of 450% (which is within the range of 300-500%; see col. 6, line 40). 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 the rupture-resistant portion of Chitre to have an elongation rate of 450%, as taught by Szycher, which is within the claimed range of 300-500%, in order to prevent hardening of native tissue surrounding the implant and long-term biodegradation (see col 2, lines 8-14).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN ZHI-DE YAO whose telephone number is (571)272-5449. The examiner can normally be reached Monday - Friday 8:00 am to 5:00 pm.
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/JUSTIN ZHI-DE YAO/Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774