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 .
This Office Action is responsive to the Amendment filed 09 July 2026. Claims 1-7 and 9-20 are currently under consideration. The Office acknowledges the amendments to claims 1, 14, and 16, as well as the cancellation of claim 8.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claims 1, 2, 6, 7, 11, 12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mische et al. (U.S. Pub. No. 2005/0014993 A1; hereinafter known as “Mische”), in view of Forsell (U.S. Pub. No. 2012/0022323 A1) and Kuyava (U.S. Pub. No. 2009/0124851 A1).
Regarding claim 1, Mische discloses an implant (Abstract; Figs. 1, 14), comprising: an inflatable member 12 and a pump assembly configured to facilitate a transfer of a fluid to the inflatable member to place the inflatable member in an inflated configuration ([0027]), the inflatable member having a sidewall that defines a lumen 14 and a core member 20 disposed within the lumen, the core member having a surface, the fluid being configured to be disposed adjacent the surface of the core member when the inflatable member is in the inflated configuration ([0030]), the inflatable member includes a non-expanding material ([0029]; e.g., no change to the outer dimensions of the device when inflated). Mische also teaches an embodiment where core member 186 may comprise a cell foam material with a significant number of voids ([0058]). Mische fails to expressly disclose that this cell foam material defines a plurality of closed cells and that the non-expanding material is a fabric material. Forsell discloses a similar implant (Abstract) comprising a cell foam material that defines a plurality of closed cells in order to reduce weight ([0022]-[0023]; [0289]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mische with a closed cell foam material, as taught by Forsell, in order to reduce weight of the implant.
The combination of Mische and Forsell fails to disclose that the non-expanding material is a fabric material. Kuyava discloses a similar implant (Abstract) comprising an inflatable member that includes a non-expanding fabric material in order to constrain expansion of the inflatable member ([0005]-[0006]; [0021]-[0023]; [0027]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Mische and Forsell so the non-expanding material is a fabric material, as taught by Kuyava, in order to constrain expansion of the inflatable member.
Regarding claim 2, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, and Mische further discloses that the core member has a cylindrical shape ([0030]; [0055]).
Regarding claim 6, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, and Mische further discloses that the fluid is configured to be disposed between the core member and the surface of the sidewall when the inflatable member is in the inflated configuration (Fig. 14; [0058]).
Regarding claim 7, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, and Mische further discloses that the fluid is configured to be disposed directly adjacent the sidewall and directly adjacent the surface of the sidewall when the inflatable member is in the inflated configuration (Fig. 14; [0058]).
Regarding claim 11, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, and Mische further discloses a reservoir operatively coupled to the pump assembly and configured to retain the fluid ([0027]-[0028]).
Regarding claim 12, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, and Mische further discloses that the core member is formed of a closed cell silicone foam material ([0058]).
Regarding claim 14, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, and Mische further discloses the inflatable member has a tubular shape when in the inflated configuration (Figs. 1, 14).
Regarding claim 15, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, and Mische further discloses that the inflatable member is configured to be placed in the inflated configuration and a deflated configuration, the inflatable member having a tubular shape when in the deflated configuration and having a tubular shape when in the inflated configuration (Figs. 1, 5, 14; [0029]; [0043]).
Regarding claim 16, Mische discloses an implant (Abstract; Figs. 1, 14), comprising: an inflatable member 12, a reservoir, and a pump assembly operatively coupled to the reservoir and to the inflatable member and being configured to facilitate a transfer of a fluid from the reservoir and to the inflatable member to place the inflatable member in an inflated configuration ([0027]-[0028]), the inflatable member having a sidewall that defines a lumen 14 and a core member 20 disposed within the lumen, the core member having a surface, the fluid being configured to be disposed adjacent the surface and outside of the core member when the inflatable member is in the inflated configuration ([0030]), the inflatable member includes a non-expanding material ([0029]; e.g., no change to the outer dimensions of the device when inflated). Mische also teaches an embodiment where core member 186 may comprise a cell foam material with a significant number of voids ([0058]). Mische fails to expressly disclose that this cell foam material defines a plurality of closed cells and that the non-expanding material is a fabric material. Forsell discloses a similar implant (Abstract) comprising a cell foam material that defines a plurality of closed cells in order to reduce weight ([0022]-[0023]; [0289]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mische with a closed cell foam material, as taught by Forsell, in order to reduce weight of the implant.
The combination of Mische and Forsell fails to disclose that the non-expanding material is a fabric material. Kuyava discloses a similar implant (Abstract) comprising an inflatable member that includes a non-expanding fabric material in order to constrain expansion of the inflatable member ([0005]-[0006]; [0021]-[0023]; [0027]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Mische and Forsell so the non-expanding material is a fabric material, as taught by Kuyava, in order to constrain expansion of the inflatable member.
Regarding claim 17, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, and Mische further discloses that the fluid is configured to be disposed directly adjacent the core member when the inflatable member is in the inflated configuration (Fig. 14; [0058]).
Regarding claim 18, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, and Mische further discloses that the core member has a cylindrical shape ([0030]; [0055]).
Claims 3-5, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mische, Forsell, and Kuyava as applied to claims 1 and 16 above, and further in view of Fredrick et al. (U.S. Pub. No. 2020/0352721 A1; hereinafter known as “Fredrick”).
Regarding claims 3 and 19, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, but fails to disclose that the core member defines a lumen. Fredrick discloses a similar implant (Abstract; Fig. 9) comprising an inflatable member 750 and a core member 752, wherein the core member defines a lumen, in order to facilitate inflation of the inflatable member ([0063]-[0068]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Mische, Forsell, and Kuyava so that the core member defines a lumen, as taught by Fredrick, in order to facilitate inflation of the inflatable member.
Regarding claim 4, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, and Mische further discloses that the core member has a cylindrical shape ([0030]; [0055]). The combination of Mische, Forsell, and Kuyava fails to disclose that the core member defines a lumen. Fredrick discloses a similar implant (Abstract; Fig. 9) comprising an inflatable member 750 and a core member 752, wherein the core member defines a lumen, in order to facilitate inflation of the inflatable member ([0063]-[0068]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Mische, Forsell, and Kuyava so that the core member defines a lumen, as taught by Fredrick, in order to facilitate inflation of the inflatable member.
Regarding claims 5 and 20, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, but fails to disclose that the core member defines a lumen, the lumen being configured to receive the fluid when the inflatable member is in the inflated configuration. Fredrick discloses a similar implant (Abstract; Fig. 9) comprising an inflatable member 750 and a core member 752, wherein the core member defines a lumen configured to receive fluid when the inflatable member is in the inflated configuration, in order to facilitate inflation of the inflatable member ([0063]-[0068]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Mische, Forsell, and Kuyava so that the core member defines such a lumen, as taught by Fredrick, in order to facilitate inflation of the inflatable member.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mische, Forsell, and Kuyava as applied to claim 1 above, and further in view of Felton et al. (U.S. Pub. No. 2018/0318086 A1; hereinafter known as “Felton”).
Regarding claim 9, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the sidewall is formed of a single layer of material; Mische teaches that the sidewall may be formed to provide desired strength, flexibility, and expandability ([0027]). Felton discloses a similar implant (Abstract) comprising a sidewall 204 formed of a single layer of material ([0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Mische and Forsell so that the sidewall is formed of a single layer of material, as taught by Felton, in order to provide desired characteristics.
Regarding claim 10, the combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, and further discloses that the sidewall is formed of a non-expandable material (Mische: [0029]; Kuyava: [0021]-[0023]). The combination of Mische, Forsell, and Kuyava fails to expressly disclose that the sidewall is formed of a single layer of material; Mische teaches that the sidewall may be formed to provide desired strength, flexibility, and expandability ([0027]). Felton discloses a similar implant (Abstract) comprising a sidewall 204 formed of a single layer of material ([0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Mische, Forsell, and Kuyava so that the sidewall is formed of a single layer of material, as taught by Felton, in order to provide desired characteristics.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Mische, Forsell, and Kuyava as applied to claim 1 above, and further in view of Cornell et al. (U.S. No. 10,413,413 B1; hereinafter known as “Cornell”). The combination of Mische, Forsell, and Kuyava discloses the invention as claimed, see rejection supra, and further discloses that the core member is formed of a closed cell foam material (see rejection of claim 1). The combination of Mische, Forsell, and Kuyava fails to expressly disclose that the foam material is a urethane foam material. Cornell discloses a similar implant (Abstract) comprising a closed cell foam materials that may be silicone or urethane (col. 5, lines 25-28). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Mische, Forsell, and Kuyava so that the foam material is a urethane foam material, as taught by Cornell, as this is a known, preferred, effective material and would have been a simple substitution of one known prior art material for another with predictable results.
Response to Arguments
Applicant’s arguments with respect to the objection to claim 14 have been fully considered and are persuasive in light of the amendments. The objection has been withdrawn.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 have been fully considered and are persuasive in light of the amendments. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made, as detailed supra.
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 THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791
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