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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/26/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7, 10-12 and 14-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Status
The drawing objections, 35 U.S.C. 112(a) and 35 U.S.C. 112(b) rejections have been overcome.
Claims 1-7, 10-12, 14-15 and 17-22 are examined below.
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.
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) 1-5, 7, 14-15 and 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mosharrafa (US 2016/0082235 A1) in view of Yu (US 2012/0245685 A1).
Regarding claim 1, Mosharrafa teaches a tissue expander (100, tissue expander, fig. 1B) comprising:
an expandable shell (200, shell) having an anterior portion (fig. 2A) and a posterior portion (fig. 2A);
wherein at least a portion of the posterior portion of the tissue expander comprises a laminate structure (120, extension portion, fig. 2B),
the laminate structure extending from a perimeter of the posterior portion of the tissue expander (fig. 2B).
Mosharrafa fails to teach a fluid collection component comprising an open cell matrix foam. However, Yu teaches an artificial breast implant that includes a fluid collection component comprising an open cell matrix foam (70, open cell foam layer, fig. 7), the fluid collection component coupled to the expandable shell (it is an outside layer of the shell) and configured to absorb extracellular fluid adjacent the tissue expander upon implantation (The phrase “the fluid collection component . . . configured to absorb extracellular fluid adjacent the tissue expander upon implantation ” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the open cell foam layer is considered to be capable of absorbing extracellular fluid adjacent the tissue expander upon implantation.), wherein the laminate structures includes the fluid collection component (the open cell foam layer is on the outside of the extension portion, creating an additional layer to the laminate). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the tissue expander of Mosharrafa to include a fluid collection component comprising an open cell matrix foam as taught by Yu in order to minimize the occurrence of capsular contracture (abstract, Yu).
Regarding claim 2, Mosharrafa further teaches a base coupled to the posterior portion of the expandable shell (120, extension portion, fig. 2B).
Regarding claim 3, Mosharrafa further teaches at least a portion of the base extends radially beyond a periphery of the expandable shell (fig. 1B).
Regarding claim 4, Mosharrafa as modified by Yu discloses the invention substantially as claimed and as discussed above with respect to claim 2, and additionally teaches the fluid collection component is carried by the base (it is layered on the base).
Regarding claim 5, Mosharrafa further teaches the base comprises a circumferential flange (fig. 1B).
Regarding claim 7, Mosharrafa as modified by Yu discloses the invention substantially as claimed and as discussed above with respect to claim 2, and additionally the base comprises a layered structure (fig. 2B) having a tear-resistant portion (¶ [0052]) and the fluid collection component (layered on the extension).
Regarding claim 14, Mosharrafa further teaches the at least a portion of the posterior portion of the tissue expander comprises a tear-resistant material (¶ [0052]).
Regarding claim 15, Mosharrafa further teaches the laminate structure forms a ring around the posterior portion of the tissue expander (fig. 1B).
Regarding claim 17, Mosharrafa teaches a method for expanding a soft tissue in a body of a living subject (¶ [0007]), the method comprising:
forming a subdermal cavity at a site where the soft tissue is to be expanded (¶ [0075]); and
implanting a tissue expander in the subdermal cavity (¶ [0087]), the tissue expander comprising an expandable shell (200, shell, fig. 2A) having an anterior portion (fig. 2A), and a posterior portion (fig. 2A), wherein at least a portion of the posterior portion of the tissue expander comprises a laminate structure (120, extension portion, fig. 2B) extending from a perimeter of the posterior portion of the tissue expander (fig. 2B).
Mosharrafa fails to teach a fluid collection component comprising an open cell matrix foam. However, Yu teaches an artificial breast implant that includes the posterior portion of the tissue expander comprises a fluid collection component comprising an open cell matrix foam (70, open cell foam layer, fig. 7), the fluid collection component configured to absorb extracellular fluid adjacent the tissue expander upon implantation (The phrase “the fluid collection component . . . configured to absorb extracellular fluid adjacent the tissue expander upon implantation ” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the open cell foam layer is considered to be capable of absorbing extracellular fluid adjacent the tissue expander upon implantation.), wherein the laminate structure includes the fluid collection component (the open cell foam layer is on the outside of the extension portion, creating an additional layer to the laminate). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the tissue expander of Mosharrafa to include a fluid collection component comprising an open cell matrix foam as taught by Yu in order to minimize the occurrence of capsular contracture (abstract, Yu).
Regarding claim 18, Mosharrafa further teaches positioning the tissue expander within the subdermal cavity such that the posterior portion of the tissue expander contacts an inferior portion of the subdermal cavity (figs. 10A-10C) and extracellular fluid from the inferior portion of the subdermal cavity is absorbed into the fluid collection component (The phrase “extracellular fluid from the inferior portion of the subdermal cavity is absorbed into the fluid collection component” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the open cell foam layer is considered to be capable of absorbing extracellular fluid from the inferior portion of the subdermal cavity).
Regarding claim 19, Mosharrafa further teaches inserting the tissue expander in the subdermal cavity (¶ [0087]) and suturing a portion of a perimeter thereof to an inferior portion of the subdermal cavity (¶ [0087]).
Regarding claim 20, Mosharrafa further teaches permitting expansion of the expandable shell upon implantation of the tissue expander so as to expand the soft tissue (¶ [0087]).
Regarding claim 21, Mosharrafa further teaches expanding the expandable shell by filling the expandable shell with a fluid (¶ [0033]).
Regarding claim 22, Mosharrafa teaches a method of reducing an amount of extracellular fluid adjacent a tissue expander upon implantation of the tissue expander, the method comprising positioning the tissue expander (¶ [0087]) having a posterior portion (fig. 2A), wherein at least a portion of the posterior portion of the tissue expander comprises a laminate structure (120, extension portion, fig. 2B) extending from a perimeter of the posterior portion of the tissue expander (fig. 2B).
Mosharrafa fails to teach a fluid collection component comprising an open cell matrix foam. However, Yu teaches an artificial breast implant that includes fluid collection component comprising an open cell matrix foam (70, open cell foam layer, fig. 7), the fluid collection component configured to absorb extracellular fluid within a subdermal cavity (The phrase “the fluid collection component configured to absorb extracellular fluid within a subdermal cavity” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the open cell foam layer is considered to be capable of absorbing extracellular fluid from the subdermal cavity) such that the posterior portion contacts an inferior portion of the subdermal cavity to permit the extracellular fluid from the inferior portion of the subdermal cavity to be absorbed into the fluid collection component (figs. 10A-10C), the laminate structure includes the fluid collection component (the silicone open cell foam layer is on the outside of the extension portion, creating an additional layer to the laminate). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the tissue expander of Mosharrafa to include a fluid collection component comprising an open cell matrix foam as taught by Yu in order to minimize the occurrence of capsular contracture (abstract, Yu).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mosharrafa in view of Yu as applied to claim 2 above, and further in view of Davila (US 2016/0262835 A1).
Regarding claim 6, Mosharrafa in view of Yu fails to teach the base comprises a plurality of suture tabs. However, Davila discloses a tissue expander that includes the base comprises a plurality of suture tabs (114, fixation tabs, figs. 1a-1b). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the extension portion of Mosharrafa and Yu to include suture tabs as taught by Davila in order to aid the surgeon in securing the expander to the chest wall to maintain its position during expansion (¶ [0023], Davila).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mosharrafa in view of Yu as applied to claim 1 above, and further in view of Rocco (US 2021/0161645 A1).
Regarding claim 10, Mosharrafa in view of Yu fails to teach the fluid collection component comprises hydrogel particles. However, Rocco discloses a composited for the repair and reconstruction of soft tissue (i.e. breast tissue) that includes hydrogel particles configured to retain fluid (¶ [0251]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the fluid collection component of Mosharrafa and Yu to include hydrogel particles as taught by Rocco in order to allow adequate extracellular matrix deposition (¶ [0250, Rocco).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mosharrafa in view of Yu as applied to claim 1 above, and further in view of Schuessler (US 2018/0280131 A1).
Regarding claim 11, Mosharrafa and Yu fail to teach the fluid collection component comprises salt particles. However, Schuessler teaches a breast implant with an open cell matrix foam that includes salt particles (¶ [0041] and ¶ [0053]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the open cell matrix foam of Mosharrafa and Yu to include salt particles as taught by Schuessler in order to achieve a particular rate of expansion and/or target characteristics of the device (¶ [0041], Schuessler).
Regarding claim 12, Mosharrafa as modified by Yu discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches the fluid collection component comprises an expandable elastomeric matrix (70, open cell foam layer, fig. 7).
Mosharrafa in view of Yu fails to teach granules of solute embedded within the open cell matrix foam. However, Schuessler further teaches granules of a solute embedded within the open cell matrix foam (¶ [0043]), wherein the matrix defines boundaries of a plurality of chambers within the matrix (¶ [0044]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the open cell matrix foam of Mosharrafa and Yu to include granules of solute embedded within as taught by Schuessler in order to achieve a particular rate of expansion and/or target characteristics of the device (¶ [0041], Schuessler).
Conclusion
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/T.M.D./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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