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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 19, 2026 has been entered.
Claim Rejections - 35 USC § 112
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 are 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 1 recites the limitation "the inner wall." There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the outer wall." There is insufficient antecedent basis for this limitation in the claim.
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), and having pores being continuous from an inner wall to an outer wall of the prosthesis (fig. 1). 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 “Mariscio remains silent about the foam having continuous pores throughout the structure.” This argument has been considered but is not persuasive. Mariscio teaches wall-to-wall micro and macro porosity continuous pores throughout the structure in at least figure 1.
Applicant further argues “Therefore, clearly, Marascio remains completely silent about the foam being reticulated, and indeed, does not explicitly disclose or even remotely suggest that the pores should be continuous and run from one side of the structure to the other, allowing free flow of air throughout the structure.” (Emphases in Applicant’s response.) This argument has been considered but is not persuasive for two reasons. First, Marascio discloses reticulated foam with continuous pores running from one wall to another in figure 1. Second, the argument is not commensurate in scope with the claims. The instant claims do not require a free flow of air throughout the structure.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Susan Leong can be reached at 571-270-1487. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LARRY W THROWER/ Primary Examiner, Art Unit 1754
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