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 .
Response to Amendment
Applicant’s amendment to the claims filed February 17, 2026 has been entered. Claim 13 is currently amended. Claims 1-12 and 14 have been canceled. Claims 13 and 15-17 are pending and under examination
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.
Claims 13 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Schuessler (US 7,628,604) in view of Kia et al. (US 2003/0030177) and any one of Amick (US 2021/0251777), Malice et al. (US 6,443,986), or Rasmussen (US 5,925,282).
Regarding claim 13, Schuessler teaches a method of making a silicone elastomer breast prosthesis (Abstract; col. 1, lines 13-16; col. 5, lines 65-67; col. 6, lines 45-48; col. 7, lines 38-44), comprising the steps of: (a) placing a bag/liner that includes a polymeric film into a mold that is complementary in shape to the breast prosthesis, the polymeric bag including at least one interior surface that has a complementary texture that is complementary to a desired texture (col. 1, lines 13-16; col. 2, lines 11-18; col. 2, lines 51-59; col. 3, lines 46-52; col. 5, line 61-col. 6, line 8 – the bag/liner is made of the same materials as disclosed in the instant specification and is understood to be sufficiently flexible; col. 6, lines 27-30; col. 6, lines 36-55; col. 7, lines 28-38 – the bag/liner of polymeric material may be reused by placing it into the mold again; Figure 1 – the bag/liner has a shape that matches the configuration of hemispherical top mold (10) (col. 4, lines 27-33) and bottom mold (20)); (b) injecting an uncured silicone elastomer into the bag (col. 1, lines 13-16; col. 2, lines 11-18; col. 2, lines 51-59; col. 3, lines 46-52; col.. 5, line 61-col. 6, line 8; col. 6, lines 27-30; col. 6, lines 36-55); (c) curing the uncured silicone elastomer while the uncured silicone elastomer is in the bag so as to form a cured silicone elastomer shape (col. 3, line 39-54; col. 4, lines 16-27; col. 5, lines 61-67; col. 6, line 36-col. 7, line 13); and (d) removing the bag from the silicone elastomer shape so as to expose the breast prosthesis, wherein the breast prosthesis includes at least one surface having the desired texture (col. 2, lines 59-63; col. 7, lines 15-37).
Schuessler do not teach the bag includes at least two layers of a polymeric film that are heat sealed together.
However, Kia et al. teach an analogous method of providing a textured surface to an article wherein, instead of applying a coating/liner/bag to the surface of a mold in an additional step, the process is simplified by applying a pre-made textured film to the surface of the mold (paragraphs [0002], [0005]-[0010] and [0026]-[0028]) and each of Amick (paragraph [0024]; sealing is explicitly recited and heat-sealing is understood to be at least prima facie obvious in this context to one having ordinary skill in the art), Malice et al. (col. 3, lines 22-42; col. 6, lines 51-54), and Rasmussen (Abstract; col. 1, lines 40-47; col. 3, lines 50-col. 4, line 42) analogously teach and suggest that films/bags configured to the shape of a breast prosthesis and mold and that are suitable for injecting material between the layers of the films/bags for forming the breast prosthesis are suitably provided as two layers of films that are sealed/heat-sealed together.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Schuessler with the teaching of Kia et al. and any one of Amick, Malice et al., or Rasmussen and to have replaced the textured liner/bag of Schuessler with a textured liner/bag including at least two layers of a polymeric film that are heat sealed together, as suggested by Kia et al. and any one of Amick, Malice et al., or Rasmussen for the purpose, as suggested by the references, of providing the texture to the breast prosthesis of Schuessler in a simplified manner. Kia et al. suggest replacing the liner and method of making the liner of Schuessler with a pre-made liner/bag/film and the additional references provide teaching as to how the film would be constructed for the production of a breast prosthesis in the analogous art (e.g. by heat sealing films together at a seam). In combination, each and every limitation of the claim is taught and suggested by the prior art.
As to claim 15, Schuessler discloses applying a vacuum and heat to the elastomer for curing (col. 1, lines 20-23; col. 5, lines 61-68; col. 6, lines 36-58; col. 7, lines 3-9).
As to claim 16, Schuessler teaches the breast prosthesis has a shell shape (Abstract; col. 1, lines 45-54; col. 3, lines 34-52; col. 4, lines 28-35; col. 5, lines 44-48; col. 6, lines 36-52; Figure 1 (10)).
As to claim 17, Schuessler teaches the method set forth above. Schuessler does not explicitly teach the recited sequence of injecting the elastomer into the bag before placing the bag into the mold. However, Schuessler teaches that a previously produced liner may be reused and that this liner may or may not be placed into the mold to form the prosthesis (col. 7, lines 15-38). Therefore, the elastomer could be placed in the liner before the combined material is then placed in the mold for rotational molding of the shell or the liner could be placed in the mold first and then the elastomer could be added to the liner. With one of two options available, it would have been prima facie obvious to pick one or the other. Further, some of the secondary references further suggest the sequence as claimed (e.g. Malice et al. col. 3, lines 64-col. 4, line 9; col. 6, lines 15-41; Rasmussen: col. 3, lines 50-col. 4, line 42). It would have been prima facie obvious to fill the bag of Schuessler prior to placing it in the mold, as suggested by Malice or Rasmussen, for the purpose, as suggested by Malice et al. or Rasmussen, of facilitating the shaping, formation, and curing of the prosthesis.
Claims 13 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Schuessler (US 2011/0257743) in view of any one of Amick (US 2021/0251777), Malice et al. (US 6,443,986), or Rasmussen (US 5,925,282).
Regarding claim 13, Schuessler teaches a method of making a silicone elastomer breast prosthesis (Abstract; paragraphs [0004], [0014], [0046]-[0048] and [0060]), comprising the steps of: (a) placing a bag/liner that includes a flexible polymeric film into a mold that is complementary in shape to the breast prosthesis, the polymeric bag including at least one interior surface that has a complementary texture that is complementary to a desired texture (Figure 7 (130); paragraphs [0046]-[0048]); (b) injecting an uncured silicone elastomer into the bag (paragraphs [0004], [0014], [0046]-[0048] and [0060]; Figure 7 (132)); (c) curing the uncured silicone elastomer while the uncured silicone elastomer is in the bag so as to form a cured silicone elastomer shape (paragraphs [0004], [0014], [0046]-[0048] and [0060]); and (d) removing the bag from the silicone elastomer shape so as to expose the breast prosthesis, wherein the breast prosthesis includes at least one surface having the desired texture (paragraphs [0046]-[0048]).
Schuessler do not teach the bag/liner includes at least two layers of a polymeric film that are heat sealed together.
However each of Amick (paragraph [0024]; sealing is explicitly recited and heat-sealing is understood to be at least prima facie obvious in this context to one having ordinary skill in the art), Malice et al. (col. 3, lines 22-42; col. 6, lines 51-54), and Rasmussen (Abstract; col. 1, lines 40-47; col. 3, lines 50-col. 4, line 42) analogously teach and suggest that films/bags/liners configured to the shape of a breast prosthesis and mold and that are suitable for injecting material between the layers of the films/bags for forming the breast prosthesis are suitably provided as two layers of films that are sealed/heat-sealed together.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Schuessler with any one of Amick, Malice et al., or Rasmussen and to have utilized two heat sealed polymer layers as the bag/liner of Schuessler, as suggested by any one of Amick, Malice et al., or Rasmussen for the purpose, as suggested by the references, of providing a liner having a shape and configuration known to be suitable and effective in the breast prosthesis molding art. In combination, each and every limitation of the claim is taught and suggested by the prior art.
As to claim 15, Schuessler teaches and suggests heat curing (paragraphs [0004], [0005], [0037] and [0039]).
As to claim 16, Schuessler teaches the prosthesis has a shell shape (Abstract; Figures 2, 3 and 7; paragraph [0010]).
As to claim 17, Schuessler teaches the method set forth above. Schuessler does not explicitly teach the recited sequence of injecting the elastomer into the bag before placing the bag into the mold. However, Schuessler teaches that a previously produced liner may be reused and that this liner may or may not be placed into the mold to form the prosthesis (col. 7, lines 15-38). Therefore, the elastomer could be placed in the liner before the combined material is then placed in the mold for rotational molding of the shell or the liner could be placed in the mold first and then the elastomer could be added to the liner. With one of two options available, it would have been prima facie obvious to pick one or the other. Further, some of the secondary references further suggest the sequence as claimed (e.g. Malice et al. col. 3, lines 64-col. 4, line 9; col. 6, lines 15-41; Rasmussen: col. 3, lines 50-col. 4, line 42). It would have been prima facie obvious to fill the bag of Schuessler prior to placing it in the mold, as suggested by Malice or Rasmussen, for the purpose, as suggested by Malice et al. or Rasmussen, of facilitating the shaping, formation, and curing of the prosthesis.
Response to Arguments
Applicant’s arguments filed February 17, 2026 have been fully considered, but are moot in view of the new grounds of rejection necessitated by the amendment to the claims. The amendment has overcome the section 112b rejections. As such, those rejections have been withdrawn.
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 Jeff Wollschlager whose telephone number is (571)272-8937. The examiner can normally be reached M-F 7:00-3:30.
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/JEFFREY M WOLLSCHLAGER/Primary Examiner, Art Unit 1742