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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 5, 2026 has been entered.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5 – 8, 17, and 19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2018/0183803 to Reese et al. (hereinafter Reese).
Regarding Claims 1, 7, and 8. Reese teaches a three-dimensional silicone article/product comprising first and second layers prepared by printing with a three-dimensional printer [0005], corresponding to a three-dimensional printed polymer structure having a plurality of layers.
The first and second layer may be formed from at least one filament [0043].
The plurality of layers may be arranged in a parallel pattern or cross-hatching pattern presenting perpendicular angles [0043], i.e. the plurality of layers may be arranged in a geometric pattern.
Reese teaches the first composition, from which the filament is prepared, comprises a silicone composition. The silicone may contain an organopolysiloxane which is cured/polymerized [0076] – [0080], thereby forming a polysiloxane material. Reese further teaches the silicone material may have internal voids and correspond to a closed-cell foam [0052] – [0053].
The first and second layer may be formed together from a continuous filament [0043].
Reese further teaches the layers may be selectively exposed to conditions forming voids [0065]. This selective application across layers would be readily envisioned to result in first and second layers having different filament porosities and thereby a gradient of porosities. Further, porosity would be readily recognized as a property which is interconnected with stiffness; thus, a product having a gradient of porosities would be expected to also have a varying degree of stiffness in the x-y and/or z-directions.
Regarding Claim 5. Reese teaches the product of Claim 1. That the at least one filament is configured to have a predefined intra-filament before extrusion from a nozzle during formation of the layers is a product-by-process limitation that is not further limiting in as so far as the structure of the product is concerned. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695,698, 227 USPQ 964, 966 (Fed. Cir. 1985) (MPEP 2113) Once a product appearing substantially identical is found, the burden shifts to the applicant to show an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1993) (MPEP 2113)
Regarding Claim 6. Reese teaches the product of Claim 1 wherein the layers are formed from a first and second layers are formed from one continuous filament [0043].
Regarding Claim 17. Reese teaches the product of Claim 1 wherein the 3D printer used to make the process may be a direct ink deposition printer [0050], i.e. the three-dimensional structure may be formed using a direct ink writing additive manufacturing technique.
Regarding Claim 19. Reese teaches the product of Claim 1 wherein the voids/closed cells may be formed from chemical blowing agents such as silicone hydrides with water [0067], wherein said compounds react to form hydrogen gas.
Claim 16 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2018/0183803 to Reese et al. (hereinafter Reese).
Regarding Claim 16. Reese teaches a three-dimensional silicone article/product comprising first and second layers prepared by printing with a three-dimensional printer [0005], corresponding to a three-dimensional printed polymer structure having a plurality of layers.
The plurality of layers may be arranged in a parallel pattern or cross-hatching pattern presenting perpendicular angles [0043], i.e. the plurality of layers may be arranged in a geometric pattern. The first and second layer may be formed together from a continuous filament [0043].
Reese teaches the first composition, from which the filament is prepared, comprises a silicone composition. The silicone may contain an organopolysiloxane which is cured/polymerized [0076] – [0080], thereby forming a polysiloxane material. Reese further teaches the silicone material may have internal voids and correspond to a closed-cell foam [0052] – [0053].
Reese further teaches the layers may be selectively exposed to conditions forming voids [0065]. This selective application across layers would be readily envisioned to result in first and second layers having different filament porosities and thereby a gradient of porosities. Further, porosity would be readily recognized as a property which is interconnected with stiffness; thus, a product having a gradient of porosities would be expected to also have a varying degree of stiffness in the x-y and/or z-directions.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/0183803 to Reese et al. (hereinafter Reese), as applied to Claim 1 above.
Regarding Claim 2. Reese teaches the product of Claim 1 but does not expressly teach the three-dimensional silicone polymer structure is a foam having an open cell structure comprising the polysiloxane material having the plurality of closed cell pores therein. However, Reese does teach the article defines a plurality of voids/pores which may be external, i.e. defined by an exterior surface of the porous 3D silicone article, and/or internal, i.e. defined by an interior volume of the porous 3D silicone article. Reese further indicates the voids are typically both external and internal [0052] – [0053]. Reese also teaches including a gaseous blowing agent in the compositions prior to printing [0055]. [0110] of the PG-PUB of the instant application teaches that the addition of gas blowing agents to polysiloxane composition results in a closed cell pore structure. Reese additionally teaches embodiments in which an open-cell structure is provided [0053]; that the voids may be defined by the printed filaments themselves or at the interface of adjacent layers [0056]; and patterned or cross-hatching arrangement of the first and second filaments [0043], which would be readily envisioned to produce an open-cell external pore structure. Before the effective filing date of the instantly claimed invention, it is then the Office’s position that it would have been obvious to provide an open-cell external pore/foam structure in an embodiment of Reese in which the polysiloxane material having an internal, closed-cell pore structure is provided. The motivation would have been that it has been held that it is obvious to select a known material based on its suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960); and MPEP 2144.07. Per above, Reese teaches open-cell external pore structures are suitably selected as the external pore structure for the disclosed three-dimensional printed products.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/0183803 to Reese et al. (hereinafter Reese), as applied to Claim 2 above, and further in view of EP 3 403 806 to Marascio et al. (hereinafter Marascio).
Regarding Claims 3 and 4. Reese teaches the product of Claim 1 but is silent with respect to the porosity of the foam. However, Marascio also teaches a product having a porosity as high as 80.26% [0018]. Reese and Marascio are analogous are as they are from the same field of endeavor, namely porous, three-dimensional printed articles. Before the effective filing date of the instantly claimed invention, it would have been obvious to a person of ordinary skill in the art to prepare the foam of Reese with a porosity as high as 80.26%, as taught by Marascio. The motivation would have been that Marascio shows this to a be suitable porosity for porous, three-dimensional printed articles utilized in drug delivery systems ([0018] and [0023]), which is one of the applications envisioned by Reese for its articles [0075].
Response to Arguments
Applicant's arguments filed February 5, 2026 have been fully considered but they are not persuasive because:
35 U.S.C. 112
The Office agrees that cancelation of Claim 18 overcomes the outstanding rejection under 35 U.S.C. 112(a). Accordingly, this rejection has been withdrawn.
35 U.S.C. 102
With respect to Claims 1 and 16, applicant argues that Reese is silent regarding a structure having two layers formed from a continuous filament. However, Reese does teach the disclosed first and second layers may be formed together from a continuous filament in [0043].
35 U.S.C. 103
Applicant argues that the rejection of Claims 2 – 4 under 35 U.S.C. 103 suffer the same deficiencies as set forth with respect to amended Claim 1. This is not persuasive, as the alleged deficiencies of Claim 1 have been addressed in the 35 U.S.C. 102 Response to argument section above.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA RIOJA whose telephone number is (571)270-3305. The examiner can normally be reached Monday - Friday 10:00 am - 6:30 pm EST.
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/MELISSA A RIOJA/Primary Examiner, Art Unit 1764