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 Arguments
Applicant’s arguments with respect to claim(s) 1-12 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
Drawing objections and 35 U.S.C. 112(b) rejections are overcome. Claim 13 is canceled. Claims 1-12 and 14-22 are examined below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 22.
In the remarks dated 12/02/2025 applicant states corrected drawings are submitted. However, they are not found within the response.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9, 11 and 12 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 9, there is no support for a fluid collection component comprising an open cell matrix foam configured to wick the extracellular fluid. Paragraph [0052] of the specification points diffusion as the method of absorption. Wicking is performed via capillary action whereas open cell matrix foam retains fluid through absorption and being water permeable. This is different from wicking.
Regarding claim 11, there is no support for a fluid collection component comprising salt particles configured to wick the extracellular fluid. Paragraph [0050] of the specification points to an osmotic gradient (i.e. diffusion) as the method of absorption. Wicking is performed via capillary action whereas salt particles retain fluid through diffusion. Further, as stated in the remarks by the applicant on page 7, “diffusion and wicking are two different processes.”
Regarding claim 12, there is no support for a fluid collection component comprising an expandable elastomeric matrix and granules of solute configured to wick the extracellular fluid. Paragraphs [0053-0054] of the specification points to an osmotic gradient (i.e. diffusion) as the method of absorption. Wicking is performed via capillary action whereas an expandable elastomeric matrix and granules of solute retain fluid through diffusion. Further, as stated in the remarks by the applicant on page 7, “diffusion and wicking are two different processes.”
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 and 14-21 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites “the posterior portion comprises a fluid collection component” in lines 4-5. It is unclear if this is the posterior portion of the shell claimed in line 4 of claim 17 or the posterior portion of the tissue expander claimed in lines 6-7 of claim 17. Dependent claims 18-21 are likewise rejected.
Claim 18 recited “the posterior portion” in lines 2. It is unclear if this is the posterior portion of the shell in line 4 of claim 17 or the posterior portion of the tissue expander in lines 6-7 of claim 17.
Claim Rejections - 35 USC § 102
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 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) 1-5, 7-8 and 14-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mosharrafa (US 2016/0082235 A1) as evidenced by Payne (US 5,348,547 A).
Regarding claim 1, Mosharrafa discloses 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); and
a fluid collection component coupled to the expandable shell (135, reinforcement material, fig. 1B) and configured to absorb extracellular fluid adjacent the tissue expander upon implantation. The phrase “a 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 reinforcement material is a Dacron mesh and is considered to be capable of absorbing extracellular fluid adjacent the tissue expander upon implantation. Dacron has absorbent properties as evidenced by Payne (col 9 lines 29-49).
wherein at least a portion of the posterior portion of the tissue expander comprises a laminate structure including the fluid collection component (fig. 2B, ¶ [0053]),
the laminate structure extending from a perimeter of the posterior portion of the tissue expander (fig. 2A) and configured to wick the extracellular fluid from tissue adjacent the tissue expander. The phrase “the laminate structure . . . configured to wick the extracellular fluid from tissue adjacent the tissue expander” 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 reinforcement material is a part of the laminate structure and is considered to be capable of wicking extracellular fluid from tissue adjacent he tissue expander. Dacron is the reinforcement material and has wicking properties as evidenced by Payne (col 9 lines 29-49).
Regarding claim 2, Mosharrafa further discloses a base coupled to the posterior portion of the expandable shell (120, extension portion, fig. 2A).
Regarding claim 3, Mosharrafa further discloses at least a portion of the base extends radially beyond a periphery of the expandable shell (fig. 1B).
Regarding claim 4, Mosharrafa further discloses the fluid collection component is carried by the base (fig. 1B).
Regarding claim 5, Mosharrafa further discloses the base comprises a circumferential flange (fig. 1B).
Regarding claim 7, Mosharrafa further discloses the base comprises a layered structure (fig. 2B) having a tear-resistant portion and the fluid collection component (¶ [0052-0053]).
Regarding claim 8, Mosharrafa further discloses the fluid collection component comprises a fibrous mesh (Dacron, ¶ [0052]).
Regarding claim 14, Mosharrafa further discloses the at least a portion of the posterior portion of the tissue expander comprises a tear-resistant material (¶ [0053).
Regarding claim 15, Mosharrafa further discloses the laminate structure forms a ring around the posterior portion of the tissue expander (fig. 1B).
Regarding claim 16, Mosharrafa further discloses the ring is configured to wick the extracellular fluid from tissue adjacent the tissue expander. The phrase “the ring is configured to wick the extracellular fluid from tissue adjacent the tissue expander” 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 reinforcement material is Dacron mesh and a part of the ring and is considered to be capable of wicking the extracellular fluid from tissue adjacent the tissue expander. Dacron has wicking properties as evidenced by Payne (col 9 lines 29-49).
Regarding claim 17, Mosharrafa discloses 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]),
an expandable shell (200, shell) having an anterior portion (fig. 2A) and a posterior portion (fig. 2A),
wherein the posterior portion comprises a fluid collection component (135, reinforcement material, fig. 1B) configured to absorb extracellular fluid adjacent the tissue expander upon implantation. The phrase “a 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 reinforcement material is a Dacron mesh and is considered to be capable of absorbing extracellular fluid adjacent the tissue expander upon implantation. Dacron has absorption properties as evidenced by Payne (col 9 lines 29-49).
wherein at least a portion of the posterior portion of the tissue expander comprises a laminate structure including the fluid collection component (fig. 2B, ¶ [0053]),
the laminate structure extending from a perimeter of the posterior portion of the tissue expander (fig. 2A) and configured to wick the extracellular fluid from tissue adjacent the tissue expander. The phrase “the laminate structure . . . configured to wick the extracellular fluid from tissue adjacent the tissue expander” 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 reinforcement material is a part of the laminate structure and is considered to be capable of wicking extracellular fluid from tissue adjacent the tissue expander. Dacron has wicking properties as evidenced by Payne (col 9 lines 29-49).
Regarding claim 18, Mosharrafa further discloses positioning the tissue expander within the subdermal cavity such that the posterior portion 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 reinforcement material of the laminate structure on the posterior portion of the tissue expander is considered to be capable of absorbing extracellular fluid from the inferior portion of the subdermal cavity.
Regarding claim 19, Mosharrafa further discloses 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 discloses 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 discloses expanding the expandable shell by filling the expandable shell with a fluid (¶ [0033]).
Regarding claim 22, Mosharrafa discloses 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) comprising a fluid collection component (135, reinforcement material, fig. 1B) configured to absorb extracellular fluid within a subdermal cavity. The phrase “a 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 reinforcement material is a Dacron mesh and is considered to be capable of absorbing extracellular fluid within a 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),
wherein at least a portion of the posterior portion of the tissue expander comprises a laminate structure including the fluid collection component (fig. 2B, ¶ [0053]),
the laminate structure extending from a perimeter of the posterior portion of the tissue expander (fig. 2A) and configured to wick the extracellular fluid from tissue adjacent the tissue expander. The phrase “the laminate structure . . . configured to wick the extracellular fluid from tissue adjacent the tissue expander” 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 reinforcement material is a part of the laminate structure and is considered to be capable of wicking extracellular fluid from tissue adjacent he tissue expander.
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mosharrafa in view of Davila (US 2016/0262835 A1).
Regarding claim 6, Mosharrafa 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 to include suture 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 Rocco (US 2021/0161645 A1).
Regarding claim 10, Mosharrafa 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 reinforcement material of Mosharrafa to include hydrogel particles as taught by Rocco in order to allow adequate extracellular matrix deposition (¶ [0250, Rocco).
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 TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799