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 .
The amendment filed November 23, 2025 has been entered.
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 1-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Yan (CN105997313; page references to attached English language translation) in view of Marascio (EP 3403806).
Claim 1: Yan discloses a method of manufacturing an external breast prosthesis (abstract; page 1). The method includes providing a 3D image of the breast prosthesis (abstract; pages 1-5), and forming the breast prosthesis using an additive manufacturing process by forming a structure of a polymer (pages 2-6), the structure corresponding to the 3D image of the breast prosthesis (pages 2-6).
Yan is silent as to using a thermoplastic elastomer or being a reticulated solid foam. However, Marascio discloses a method of manufacturing a breast prosthesis (¶ 21), including forming the breast prosthesis using an additive manufacturing process by forming a structure of a polymer (¶ 21), wherein the structure is formed as a reticulated solid foam and the polymer used is a thermoplastic elastomer (¶¶ 4-18, 21; figs. 1-6; claim 6). As taught by Marascio, soft breast prostheses made by custom-shaped additive manufacturing of microcellular thermoplastic elastomers with controllable porosity improve local and global deformation, and damping performance, while preserving individualized fit (¶ 21). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have included the thermoplastic elastomer of Marascio in the method of Yan to control porosity and improve local and global deformation, and damping performance, while preserving individualized fit.
Claims 2-3: Marasio discloses porosity levels of 53.23% and 68% (¶¶ 15-17).
Claim 7: Yan discloses using 3D printing technology (p. 5-6).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Yan (CN105997313; page references to attached English language translation) in view of Marascio (EP 3403806), as applied to claim 1 above, further in view of Ketchum (US 2017/0281367).
Modified Yan is silent as to the thermoplastic elastomer being non-biodegradable. However, in the same field of endeavor of additive manufacturing of breast prosthetics, Ketchum discloses using thermoplastic polyurethane in 3D printing of prosthetics (¶¶ 2, 53). As taught by Ketchum, using thermoplastic polyurethane in 3D printed prosthetics provides dynamic support and a desired aesthetic appearance (¶ 6). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have included the thermoplastic polyurethane of Ketchum in the method modified Yan in order to provide dynamic support and a desired aesthetic appearance.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Yan (CN105997313; page references to attached English language translation) in view of Marascio (EP 3403806), as applied to claim 1 above, further in view of Laghi (US 2009/0183822).
Modified Yan is silent as to the elastomer being SEBS. However, in the same field of endeavor of forming breast prosthetics, Laghi discloses a method of manufacturing external breast prostheses including using SEBS (¶ 13). As taught by Laghi, utilizing SEBS in the manufacture of breast prostheses provides the texture, appearance and elasticity of a normal human breast (¶ 10).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yan (CN105997313; page references to attached English language translation) in view of Marascio (EP 3403806), as applied to claim 1 above, further in view of Sun (US 2009/0148813).
Modified Yan is silent as to using inkjet technology. However, in the same field of endeavor of manufacturing prosthetics using additive manufacturing, Sun discloses depositing polymer droplets that fuse together after being deposited as part of the inkjet deposition technology (¶ 125). As taught by Sun, utilizing inkjet deposition achieves good dimensional stability and advantageous mechanical integrity. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have included the inkjet deposition technology of Sun in the method of modified Yan in order to achieve good dimensional stability and better mechanical integrity of the prosthetic.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yan (CN105997313; page references to attached English language translation) in view of Marascio (EP 3403806), as applied to claim 1 above, further in view of Kelley (US 2014/0309750).
Modified Yan is silent as to thermal conductors. However, in the same field of endeavor of manufacturing prosthetics, Kelley discloses a method of manufacturing prosthetics that includes elongated thermal conductors (¶¶ 70-72). As taught by Kelley, including enhanced thermal conductivity in a prosthetic enhances heat absorption capabilities (¶ 70). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have included the thermal conductors of Kelley in the method of modified Yan in order to enhance heat absorption capabilities of the prosthetic.
Response to Arguments
Applicant's arguments filed November 23, 2025 have been fully considered but they are not persuasive.
Applicant argues that Marascio does not disclose a thermoplastic elastomer. This argument has been considered but is not persuasive. Marascio discloses thermoplastic elastomers for breast prostheses in paragraph 21.
Applicant further argues that Marascio does not disclose a reticulated foam where “the pores are continuous, from inner wall to outer wall, as opposed to local pores.” (Emphasis in Applicant’s response.) This argument has been considered but is not persuasive because it is not commensurate in scope with the claims. The claims do not require the pores to be continuous from inner wall to outer wall. Instant claim 1 requires a “reticulated solid foam.” As described in the instant specification, “reticulated means resembling a net or network, typically having veins, fibers, or lines that cross” (page 6). As described in paragraph 17, and shown in figure 6, of Marascio, “The possibility to layer different filaments/strands with internal specific microstructures (Figure 6) to create complex 3D shapes of foamed materials is thus demonstrated . . .” Thus, Marascio discloses a network of crossed filaments and strands that form a reticulated solid foam, which is no less than is required by the claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 LARRY THROWER whose telephone number is (571)270-5517. The examiner can normally be reached 9am-5pm MT M-F.
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/LARRY W THROWER/Primary Examiner, Art Unit 1754