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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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) 1-4, 7-8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maxwell et al. (2007/0135916).
Regarding claim 1, Maxwell discloses a breast implant (FIG 3 or 4) comprising: a filler including two or more types of gels having different cohesive strengths (Fig. 3 or 4 and [0027] or [0028], wherein the illustrated gel filler having varying cohesiveness is considered two or more “types” of gels as claimed); and a silicone shell surrounding the filler ([0023] and [0027] or [0028], Fig. 3 or 4). Maxwell fails to explicitly disclose the two or more types of gels are silicone gels. However, Maxwell teaches that the typical permanent breast prothesis is pre-filled with silicone gel ([0005]). 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 used silicone gels for Maxwell’s two or more types of gels, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of design choice. In re Leshin, 125 USPQ 46.
Regarding claim 2, Maxwell discloses the breast implant of claim 1, wherein an inside of the silicone shell is divided into two or more areas (FIG 3 or 4), and the two or more types of silicone gels having different cohesive strengths are disposed in the two or more areas, respectively ([0027] or [0028]).
Regarding claim 3, Maxwell discloses the breast implant of claim 1, wherein the inside of the silicone shell is divided into a side portion and a middle portion (FIG 3, where the side portion is the posterior portion and the middle portion is the anterior portion [0027]), and two types of silicone gels having different cohesive strengths are disposed in the side portion and the middle portion, respectively ([0027).
Regarding claim 4, Maxwell discloses the breast implant of claim 3, wherein the silicone gel disposed in the side portion has higher cohesive strength than the silicone gel disposed in the middle portion (FIG 3, [0027]).
Regarding claim 7, Maxwell discloses the breast implant of claim 1, wherein the inside of the silicone shell is divided into an upper portion and a lower portion (FIG 4), and two types of silicone gels having different cohesive strengths are disposed in the upper portion and the lower portion, respectively (FIG 4, [0028]).
Regarding claim 8, Maxwell discloses the breast implant of claim 7, wherein the silicone gel disposed in the lower portion has higher cohesive strength than the silicone gel disposed in the upper portion (FIG 4, [0028]).
Regarding claim 10, Maxwell discloses the breast implant of claim 7, but fails to explicitly disclose wherein the lower portion occupies 10 to 50 vol% based on the total volume of the inside of the silicon shell. However, Fig. 4 illustrates the lower portion occupies about 50 vol% based on the total volume of the inside of the silicon shell, which overlaps the claimed range. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the lower portion of Maxwell’s implant occupying 10 and 50 vol% based on the total volume of the inside of the silicon shell, 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 pgs. 3 and 8 of the instant specification indicating the lower portion “may” occupy the claimed range).
Claim(s) 5,9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maxwell et al. (20070135916) as applied to claims 3 and 7 above, and further in view of Williams (20210046212).
Regarding claim 5, Maxwell fails to disclose wherein the silicone gel disposed in the side portion has a cohesive strength of 10 to 40 N. Williams also discloses a breast implant ([0580]) and teaches the breast implant is formed to withstand a load of at least 15N, which falls within the claimed range of 10 to 40N ([0580]). 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 provided the side portion silicone gel of Maxwell with a cohesive strength of 10-40N in order for the implant to be able to withstand the force applied on it both during rest and during exercise ([0580]).
Regarding claim 9, Maxwell discloses the breast implant of claim 7, but fails to disclose wherein the silicone gel disposed in the lower portion has a cohesive strength of 10 to 40 N. Williams also discloses a breast implant ([0580]) and teaches the breast implant can withstand a load of at least 15N, which falls within the claimed range of 10 to 40N ([0580]). 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 provided the side portion silicone gel of Maxwell with a cohesive strength of 10-40N in order for the implant to be able to withstand the force applied on it both during rest and during exercise ([0580]).
14. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Maxwell et al. (2007/0135916) as applied to claim 3 above, and further in view of Becker (2017/0348089).
Regarding claim 6, Maxwell discloses the breast implant of claim 3, but fails to disclose wherein the side portion occupies 10 to 50 vol% based on the total volume of the inside of the silicon shell.
Becker teaches a breast implant wherein the side potion (124) occupies 25 to 75 vol% based on the total volume of the inside of the silicon shell ([0038], “the volume of the inner shell 124 may be between 25 and 75 % of the volume of the outer shell 102”).
It would have been obvious to one having ordinary skill in the art before the effecting filing date of the claimed invention to have modified Maxwell in view of Becker to include that the side portion occupies 25 and 75 vol% based on the total volume of the inside of the silicon shell, as taught by Becker, in order to have adjustable volume and sizing of the implant ([0039]). 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 side portion occupation from between 25 and 75 vol% to between 10 to 50 vol% 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 pgs. 3 and 8 of the instant specification indicating the side portion “may” occupy the claimed range).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774