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.
Response to Arguments
Applicant’s arguments, filed 5/1/26, with respect to the rejection(s) of claim(s) 1-4, 6, 7-8 under 35 U.S.C. 103 have been fully considered and are not persuasive. The applicant argues that Maxwell fails to disclose or suggest the specific cohesive strength or volume ratios claimed in the application, and that Maxwell lacks the recognition that these parameters can improve rupture stability. Examiner maintains that while Maxwell does not disclose specific cohesive strength or volume ratios, Maxwell does disclose gels with different cohesive strengths and the relative structure. Further, Youn teaches increasing the viscosity and degree of cross-linking to strengthen the cohesive gel as needed to prevent wrinkling and Becker teaches the claimed volume ratios. Therefore, to modify Maxwell as claimed would have been obvious to one having ordinary skill in the art (see rejection below for details).
Applicant’s arguments, filed 5/1/26, with respect to the rejection(s) of claim(s) 5, 9, 10 under 35 U.S.C. 103 have been fully considered and are persuasive. Examiner agrees that Williams discloses a mechanical “load” rather than a “cohesive strength” of the gel. Examiner also acknowledges that estimating the volume ratio of 50% from Figure 4 of Maxwell was improper. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Maxwell (2007/0135916), Youn (2022/0409354), Becker (2017/0348089), and Mojaradi (2013/0325119).
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maxwell (2007/0135916) in view of Youn (2022/0409354) and Becker (2022/0409354)).
Regarding claim 1, Maxwell discloses a breast implant (FIG 3 or 4) comprising: a filler including two or more types of silicone 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); wherein an 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]), 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]), but fails to disclose wherein the silicone gel disposed in the side portion has a cohesive strength of specifically 23 to 40 N, and wherein the side portion occupies 20 to 50 vol% based on a total volume of the inside of the silicone shell.
Youn discloses a silicone breast implant filled with a cohesive gel and a method of increasing viscosity and cross-linking to strengthen the cohesive gel ([0012]). Youn teaches that as the degree of cross-linking of the silicone gel disposed in the side portion is increased, it becomes hard and thick ([0012]). Therefore, 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 the degree of cohesiveness in the side portion of Maxwell’s breast implant by increasing the viscosity and degree of cross-linking to strengthen the cohesive gel as needed, as taught by Youn, in order to prevent wrinkling ([0012], [0127], FIG 18). Further, there is no evidence of record that establishes that a gel cohesiveness of 23-40N would result in a difference in the function of Youn’s silicone breast implant. A person having ordinary skill in the art, being faced with modifying Youn’s silicone breast implant, would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended being given the claimed gel cohesivity. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the cohesiveness “may” be within the claimed range, and offering other acceptable ranges (10-40N, specification at pg 8, lines 10-15) and therefore there appears to be no criticality places on the range as claimed such that it produces an unexpected result.
Maxwell as modified by Youn fails to disclose wherein the side portion occupies 20 to 50 vol% based on a total volume of the inside of the silicone 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 20 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).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maxwell (2007/0135916) in view of Youn (2022/0409354) and Mojaradi (2013/0325119).
Regarding claim 7, Maxwell discloses a breast implant (FIG 3 or 4) comprising: a filler including two or more types of silicone 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); 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]); 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]), but fails to disclose wherein the silicone gel disposed in the lower portion has a cohesive strength of 23 to 40 N, and wherein the lower portion occupies 20 to 50 vol% based on a total volume of the inside of the silicone shell.
Youn discloses a silicone breast implant filled with a cohesive gel and a method of increasing viscosity and cross-linking to strengthen the cohesive gel ([0012]). Youn teaches that as the degree of cross-linking of the silicone gel disposed in the side portion is increased, it becomes hard and thick ([0012]). 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 the degree of cohesiveness in the lower portion of Maxwell’s breast implant by increasing the viscosity and degree of cross-linking to strengthen the cohesive gel as needed, as taught by Youn, in order to prevent wrinkling ([0012], [0127], FIG 18). Further, there is no evidence of record that establishes that a gel cohesiveness of 23-40N would result in a difference in the function of Youn’s silicone breast implant. A person having ordinary skill in the art, being faced with modifying Youn’s silicone breast implant, would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended being given the claimed gel cohesivity. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the cohesiveness “may” be within the claimed range, and offering other acceptable ranges (10-40N, specification at pg 8, lines 10-15) and therefore there appears to be no criticality places on the range as claimed such that it produces an unexpected result.
Maxwell as modified by Youn fails to disclose wherein the lower portion occupies 20 to 50 vol% based on a total volume of the inside of the silicone shell. Mojaradi discloses a breast implant (FIG 2) filled with gels of different levels of cohesiveness ([0019]). Mojaradi teaches that lower portion occupies an equal volume to the upper cavity, 50% ([0005], the prosthetic cavity is split into two equal upper and lower volumes).
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 Mojaradi to include that the lower portion occupies 20 and 50 vol% based on the total volume of the inside of the silicon shell, as taught by Mojaradi, in order to have different compartments with the required cohesiveness ([0030]).
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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