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 .
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 1 – 8, 16, 17, and 19 are 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.
Claims 1 and 16 now set forth the volume fraction of void space is defined by a mixing speed of the high-shear mixing method. The instant specification does contain disclosure that the volume fraction of void space, i.e. porosity, is impacted/influenced by mixing speed. However, the instant specification also suggests a number of other variables which affect porosity, including the amount of blowing agent, silane, surfactant, etc. (see [0021] of the PG-PUB of the instant application). Therefore, the original disclosure does not appear to support the new limitation that it is mixing speed that defines the volume fraction of void space of the claimed product.
As Claims 2 – 8, 17, and 19 ultimately depend on Claim 1, they incorporate the subject matter thereof and are also consequently rejected under this statute.
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 – 8, 16, 17, and 19 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.
The term “high-shear” mixing in Claims 1 and 16 is a relative term which renders the claim indefinite. The term “high-shear” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
As Claims 2 – 8 and 17 ultimately depend on Claim 1, they incorporate the subject matter thereof and are also consequently rejected under this statute.
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.
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.
Claims 1, 2, 5 – 8, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/0183803 to Reese et al. (hereinafter Reese) in view of US 2021/0130244 to Studart et al. (hereinafter Studart).
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 intra-filament porosities in which first and second intra-filament porosities comprise different volume fractions of voids spaces, as well as a gradient of porosity. 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.
Reese does not expressly teach the selective conditions forming voids provides a porosity characteristic of a gas-bubble mixture produced by a high-shear mixing method or that the volume fraction of void space is defined by a mixing speed of the high-shear mixing method. However, Studart teaches the concept of incorporating bubbles of air into a mixture via a high-shear mixing method prior to 3-D printing ([0067], [0112], and [0115]). Studart further teaches the concept of changing mixing speed to adjust the pore size, and thereby the porosity, of the foam [0103]. Reese and Studart are analogous art as they are from the same field of endeavor, namely porous articles which may be obtained via 3-D printing. Before the effective filing date of the instantly claimed invention, it is consequently the Office’s position that it would have been obvious to a person of ordinary skill in the art to selectively form voids in the 3-D printed article in Reese by adjusting a high-shear mixing speed prior to 3-D printing as taught by Studart, thereby providing a porosity characteristic of a gas-bubble mixture produced by a high-shear mixing method and a volume fraction of void space which is defined by a mixing speed of the high-shear mixing method. The motivation would have been that altering mixing speed would provide for the selective formation of voids in the article of Reese in an efficient and inexpensive manner, as Studart’s method requires no additional processing steps or equipment to alter the porosity of the article.
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.
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.
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) in view of US 2021/0130244 to Studart et al. (hereinafter Studart), 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].
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/0183803 to Reese et al. (hereinafter Reese) in view of US 2021/0130244 to Studart et al. (hereinafter Studart).
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 intra-filament porosities in which first and second intra-filament porosities comprise different volume fractions of voids spaces, as well as a gradient of porosity. 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.
Reese does not expressly teach the selective conditions forming voids provides a porosity characteristic of a gas-bubble mixture produced by a high-shear mixing method or that the volume fraction of void space is defined by a mixing speed of the high-shear mixing method. However, Studart teaches the concept of incorporating bubbles of air into a mixture via a high-shear mixing method prior to 3-D printing ([0067], [0112], and [0115]). Studart further teaches the concept of changing mixing speed to adjust the pore size, and thereby the porosity, of the foam [0103]. Reese and Studart are analogous art as they are from the same field of endeavor, namely porous articles which may be obtained via 3-D printing. Before the effective filing date of the instantly claimed invention, it is consequently the Office’s position that it would have been obvious to a person of ordinary skill in the art to selectively form voids in the 3-D printed article in Reese by adjusting a high-shear mixing speed prior to 3-D printing as taught by Studart, thereby providing a porosity characteristic of a gas-bubble mixture produced by a high-shear mixing method and a volume fraction of void space which is defined by a mixing speed of the high-shear mixing method. The motivation would have been that altering mixing speed would provide for the selective formation of voids in the article of Reese in an efficient and inexpensive manner, as Studart’s method requires no additional processing steps or equipment to alter the porosity of the article.
Response to Arguments
Applicant’s arguments, see page, filed July 2, 2026, with respect to the rejection(s) of the instant claims have been fully considered and are persuasive. The Office agrees that Reese does not expressly teach the new limitations with respect to an intra-filament porosity obtained by the claimed high-shear mixing method, which presumably results in a structurally different product. Therefore, the rejection has been withdrawn.
However, upon further consideration, new grounds of rejection are made under 35 U.S.C. 112(a) and (b), as well as under 35 U.S.C. 103 over Reese in view of newly discovered US 2021/0130244 to Studart.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arrie Lanee Reuther can be reached at (571)270-7026. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA A RIOJA/Primary Examiner, Art Unit 1764
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