DETAILED ACTIONNotice 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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the container comprises a mask to selectively limit contact between the polymer solution and the salt solution, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered, and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1 – 16 is /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 – 2 recites the limitation "…the polymer…" in line 4 & line 1 respectively. There is insufficient antecedent basis for this limitation in the claim. It should read “…the polymer solution…” for the purposes of claim consistency.
Claim(s) 1 & 17 – 20 recites the limitation "…the solidified polymer…" in line(s) 5 & 1 respectively. There is insufficient antecedent basis for this limitation in the claim. Currently claim 1 reads “inducing solidification of the polymer through salting-out effects; and removing the solidified polymer from the salt solution, or a mixture thereof.” it should read “inducing solidification of the polymer through salting-out effects to form a solidified polymer; and removing the solidified polymer from the salt solution, or a mixture thereof.”
Claim 12 recites the limitation "…printing head…" in line 1. While there is sufficient antecedent basis for this limitation in claim 10. It should read “…the printing head…” for the purposes of claim consistency. For the purposes of examination, it will be understood to be the printing head found in claim 10.
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.
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.
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.
A.) Claim(s) 1 – 4, 8 – 9 & 20 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yanbing et al. (CN 103224586 A, hereinafter Yanbing)Regarding claim 1,
A method for additive manufacturing, comprising:
placing a polymer solution comprising a polymer susceptible to solidification due to salting-out effects into contact with a salt solution;
inducing solidification of the polymer through salting-out effects; and
removing the solidified polymer from the salt solution, or a mixture thereof.
Yanbing teaches the following:
– c.) ([0041]) teaches that the prepared poly(N-isopropylacrylamide) (pNIPAM) nanogel dilute dispersion 1000mL, keep the temperature at 40 °C, add 50 g of sodium sulfate under stirring (300 rpm) to completely dissolve it, and let it stand at a constant temperature of 40 °C. As such, a polymer solution comprising poly(N-isopropylacrylamide) (pNIPAM) which is susceptible to solidification due to salting-out effects is found to be brought into contact with a salt solution that comprises sodium sulfate (Na2SO4 – inorganic sodium salt) to induce solidification of the polymer through salting-out effects.
([0041]) teaching After 1.0 h, the white precipitate was collected by suction filtration. As such, removing the solidified polymer from the salt solution is performed collected by suction filtration. Highlighting, the case law for substantially identical process and structure may be recited. Where, it has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or a substantially identical processes, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitations that stem from the claimed structure. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spada, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977), MPEP 2144.
Regarding claim(s) 2 – 3 as applied to claim 1 respectively,
Wherein the polymer comprises a protein, DNA, a polyacrylamide, or a mixture thereof.
Wherein the polymer comprises poly(N-isopropylacrylamide) (PNIPAM), a PNIPAM-based copolymer, or a mixture thereof.
Yanbing teaches the following:
([0041]) teaches that the prepared poly(N-isopropylacrylamide) (pNIPAM) nanogel dilute dispersion 1000mL. Where, poly(N-isopropylacrylamide) (pNIPAM) is understood to be a polyacrylamide in particular poly(N-isopropylacrylamide) (PNIPAM).
Regarding claim 4 as applied to claim 1,
Wherein the salt solution comprises a kosmotropic salt, a chaotropic salt, or a mixture thereof.
Yanbing teaches the following:
([0041]) teaches adding 50 g of sodium sulfate under stirring (300 rpm) to completely dissolve it. Where sodium sulfate (Na2SO4 – inorganic sodium salt) is understood to be a kosmotropic salt.
Regarding claim(s) 8 – 9 as applied to claim 1 respectively,
Wherein the method is performed at a temperature in a range of from about 20 °C to about 30 °С.
Wherein the method is performed at a temperature in a range of from about 23 °C to about 27 °C.
Yanbing teaches the following:
& 9a.) ([0024]) teaches that within a temperature range of 20 – 60°C (preferably 20 – 40 °C), add V ml of an aqueous solution of inorganic precipitant X (concentration 5–20 wt%, preferably 5–9 wt%) or an aqueous solution of organic precipitant X’ (concentration 30–80% (v/v), preferably 30–60% (v /v)) with stirring to an equal volume of a dilute dispersion of pNIPAM nanogel (concentration approximately 1.0–1.2 wt%), ensuring uniform dispersion in the nanogel dispersion; allow to stand for 10–60 minutes (preferably 10–30 minutes) to ensure complete precipitation of the pNIPAM nanogel, filter, and collect the precipitate. As such, the method is performed at a temperature in a range of 20 – 40 °C which is found to overlap with applicant’s range of from about 23 °C to about 27 °C. ([0020]) notes that that NIPAM is the main temperature-sensitive monomer, and the phase transition temperature of pNIPAM nanogel is about 32℃. The phase transition temperature can be controlled between 25 and 37°C by copolymerizing with other monomers. As such, NIPAM is understood to have a phase transition in which the phase transition is temperature dependent. As such, the temperature utilized for processing is understood to impact the NIPAM temperature dependent phase transition. Accordingly, while no discrepancies are perceived to exist regarding the method being performed at a temperature in a range of from about 23 °C to about 27 °C. However, the case law for the result effective may be recited for any supposed differences.
Regarding claim 20 as applied to claim 1,
Further comprising contacting, the solidified polymer with water to dissolve the solidified polymer.
Yanbing teaches the following:
([0041]) teaches that after filter and collect the white precipitate. Next is to add it to 120 mL of ultrapure water under constant temperature of 40 °C water bath and stirring (300 rpm) to ensure complete dispersion and obtain a concentrated dispersion of pNIPAM nanogel with a mass percentage concentration of approximately 10.0 wt%. Followed by 120 mL of boiling ultrapure water was added at a constant temperature of 70 °C and allowed to stand for 3 minutes to obtain a white clump-like precipitate Highlighting, while dissolving of the solidified polymer is not directly mentioned. The case law for substantially identical process and structure may be recited. Where, it has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or a substantially identical processes, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitations that stem from the claimed structure. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spada, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977), MPEP 2144.
B.) Claim(s) 5 & 7, is/are rejected under 35 U.S.C. 103 as being anticipated by / unpatentable over Yanbing in view of Deng et al. (Poly(N-Isopropylacrylamide) Based Electrically Conductive Hydrogels and Their Applications, 2022, hereinafter Deng)
Regarding claim(s) 5 & 7 as applied to claim 1 & claim 5 respectively,
Wherein the polymer solution further comprises a functional material comprising a dye, a non-conductive particle, a conductive particle, a different polymer, or a mixture thereof.
Wherein the conductive particle comprises an active carbon, carbon nanotube (CNT), boron nitride, graphite, graphite oxide, graphene, graphene oxide, MXene, or a combination thereof.
Regarding claim(s) 5 & 7, Yanbing is silent on the polymer solution further comprises a functional material. In analogous art for Poly(N-Isopropylacrylamide) Based Hydrogels, (Abstract) and using salt solution with the hydrogels, (2.5. PNIPAM-ECHs with Ion Served as Conductive Components), Deng suggest details regarding the polymer solution further comprises a functional material, and in this regard, Deng teaches the following:
& 7a.) (Pg. 4, Preparation and Performance of PNIPAM-ECHs, ¶1) teaches that this section is focused on the preparation and performance of PNIPAMECHs. Based on the conductive components of PNIPAM-ECHs shown in Table 1, they can be divided into a conductive polymer, carbon material, MXene material, metal nanoparticles, ions, and multiple conductive components based PNIPAM-E. (
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 production method and apparatus for manufacturing poly(N-Isopropylacrylamide) based hydrogels that are treated with a salt solution of Yanbing. By modifying the poly(N-Isopropylacrylamide) based hydrogels to comprise an additive including conductive polymer, carbon material, MXene material amongst others, as taught by Deng. Highlighting, one would be motivated to implement an additive in the poly(N-Isopropylacrylamide) based hydrogels including a conductive polymer, carbon material, MXene material amongst others as it provides for fabricating an electrically conductive hydrogels that possess both flexibility (originating from hydrogel) and electrical conductivity (originating from conductive component, (Pg. 2, Introduction, ¶2). Additionally, the use of a known material, i.e, MXene, graphite, etc. for its intended use, explicitly used to improve conductive, in a known environment, specifically hydrogels, provides for the recitation of known material in the art case law. Where, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), MPEP 2144.07.Regarding claim(s) 5 – 7 as applied to claim 1 & claim 5 respectively,
Wherein the polymer solution further comprises a functional material comprising a dye, a non-conductive particle, a conductive particle, a different polymer, or a mixture thereof.
Wherein the non-conductive particle comprises aluminum oxide (Al2O3), boron nitride (BN), mica, illite, magnesium hydroxide (Mg(OH)2), aluminum nitride (AIN), boron carbide (B4C), Mg-Al-based layered double hydroxide, Ca-Al-based layered double hydroxide, Li-Al-based layered double hydroxide, or a combination thereof.
Wherein the conductive particle comprises an active carbon, carbon nanotube (CNT), boron nitride, graphite, graphite oxide, graphene, graphene oxide, MXene, or a combination thereof.
Regarding claim(s) 6, Yanbing is silent on the polymer solution further comprises a functional material. In analogous art as applied above, Deng suggest details regarding the polymer solution further comprises a functional material, and in this regard, Deng teaches the following:
, 6a.) & 7a.) (Pg. 12, 2.6. PNIPAM-ECHs with Multiple Components as Conductive Components, ¶1) teaches that apart from introducing a new function, the mechanical property of PNIPAM-ECHs could also be enhanced, for instance, as proof shown in Figure 9d, in which samples prepared show strong physical crosslinked PNIPAM-ECHs with self-healing, adhesive, and photothermal responsive properties by using NIPAM, PEDOT:PSS, functionalized boron nitride nanosheets (f-BNNS), and nanoclay. The constructed hydrogel displayed a maximum strain of ~2600% and it can even withstand 90% compressive strain without mechanical failure, demonstrating superior mechanical performances. These results were 2 times higher than their previously reported PNIPAM/f-BNNS/nanoclay hydrogel. Because PSS could form strong hydrogen bond interactions with PNIPAM and f-BNNS, and other physical interactions such as electrostatic interactions, π-π static interactions. As such, the use of boron nitride (BN) i.e., functionalized boron nitride nanosheets (f-BNNS) is understood to be disclosed.
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 production method and apparatus for manufacturing poly(N-Isopropylacrylamide) based hydrogels that are treated with a salt solution of Yanbing. By modifying the poly(N-Isopropylacrylamide) based hydrogels to comprise an additive including boron nitride (BN) i.e., functionalized boron nitride nanosheets (f-BNNS), as taught by Deng. Highlighting, one would be motivated to implement an additive in the poly(N-Isopropylacrylamide) based hydrogels including boron nitride (BN) i.e., functionalized boron nitride nanosheets (f-BNNS) as it provides for superior mechanical performances including tailoring mechanical properties such as the compressive strain without the sample undergoing mechanical failure, (Pg. 12, 2.6. PNIPAM-ECHs with Multiple Components as Conductive Components, ¶1). Additionally, the use of a known material, i.e, boron nitride (BN) i.e., functionalized boron nitride nanosheets (f-BNNS), for its intended use, explicitly used to improve mechanical properties, in a known environment, specifically hydrogels, provides for the recitation of known material in the art case law. Where, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), MPEP 2144.07.C.) Claim(s) 5 – 7, is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanbing in view of Xue et al. (Boron Nitride Nanosheets/PNIPAM Hydrogels with Improved Thermo-Responsive Performance, 2018, hereinafter Xue)
Regarding claim(s) 5 – 7 as applied to claim 1 & claim 5 respectively,
Wherein the polymer solution further comprises a functional material comprising a dye, a non-conductive particle, a conductive particle, a different polymer, or a mixture thereof.
Wherein the non-conductive particle comprises aluminum oxide (Al2O3), boron nitride (BN), mica, illite, magnesium hydroxide (Mg(OH)2), aluminum nitride (AIN), boron carbide (B4C), Mg-Al-based layered double hydroxide, Ca-Al-based layered double hydroxide, Li-Al-based layered double hydroxide, or a combination thereof.
Wherein the conductive particle comprises an active carbon, carbon nanotube (CNT), boron nitride, graphite, graphite oxide, graphene, graphene oxide, MXene, or a combination thereof.
Regarding claim(s) 5 – 6, Yanbing is silent on the polymer solution further comprises a functional material. In analogous art for Poly(N-Isopropylacrylamide) Based Hydrogels, (Abstract), Xue suggest details regarding the polymer solution further comprises a functional material including a non-conductive particle and conductive particle, and in this regard, Xue teaches the following:
, 6a.) & 7a.) (Pg. 2, Materials, ¶1) teaches that the N-isopropylacrylamide (NIPAM), amino functionalized boron nitride nanosheet (BNNS-NH2) are used as reactants, the N,N′-methylenebisacrylamide (BIS) and the azobisisobutyronitrile (AIBN) are used as crosslinking agent and initiator respectively. (Pg. 7, Conclusion, ¶1) teaches that the PNIPAM/BNNS-NH2 hydrogels which transfer heat much faster than pure PNIPAM hydrogels can move faster under heating. The thermal sensitive hydrogels can absorb and release Rhodamine B and oil under the control of heating and cooling. These features mean the composite hydrogels are promising actuators and can find potential applications in wide areas including drug delivery and water purification. As such, the implementation of boron nitride, i.e., amino functionalized boron nitride nanosheet (BNNS-NH2) provides for tailoring the thermal sensitive hydrogels fabricated.
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 production method/apparatus for manufacturing poly(N-Isopropylacrylamide) based hydrogels that are treated with a salt solution of Yanbing. By modifying poly(N-Isopropylacrylamide) based hydrogels to comprise an additive including boron nitride, i.e., amino functionalized boron nitride nanosheet (BNNS-NH2), as taught by Xue. Highlighting, one would be motivated to implement an additive to poly(N-Isopropylacrylamide) based hydrogels in particular boron nitride, i.e., amino functionalized boron nitride nanosheet (BNNS-NH2) as it provides for tailoring the thermal sensitive hydrogels fabricated, (Pg. 7, Conclusion, ¶1). Additionally, the use of a known material, i.e, boron nitride (BN) i.e., boron nitride, i.e., amino functionalized boron nitride nanosheet (BNNS-NH2), for its intended use, explicitly used to improve thermal response, in a known environment, specifically hydrogels, provides for the recitation of known material in the art case law. Where, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), MPEP 2144.07.D.) Claim(s) 10 – 14, is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanbing in view of Feinberg et al. (US 20160167312 A1, hereinafter Feinberg)
Regarding claim 10, as applied to claim 1,
Wherein the placing the polymer solution into contact with the salt solution comprises dispensing the polymer solution into a container comprising the salt solution.
Regarding claim(s) 10, Yanbing also teaches that the precipitant in step A can be an inorganic precipitant, such as one or two inorganic salts including sodium sulfate, sodium chloride, calcium chloride, amongst others. Yanbing is silent on the placing the polymer solution into contact with the salt solution comprises dispensing the polymer solution into a container comprising the salt solution. In analogous art for a method includes providing support material within which the structure is fabricated, depositing, into the support material, structure material to form the fabricated structure, and removing the support material to release the fabricated structure from the support material, Feinberg suggest details regarding the placing the polymer solution into contact with the salt solution comprises dispensing the polymer solution into a container comprising the salt solution, and in this regard, Feinberg teaches the following:
(Abstract) teaches a method includes providing support material within which the structure is fabricated, depositing, into the support material, structure material to form the fabricated structure, and removing the support material to release the fabricated structure from the support material. ([0010]) teaches that the printing operation may include providing a gelatin slurry support bath within which the tissue scaffold is fabricated, extruding, from a nozzle, a hydrogel into the gelatin slurry support bath to form the tissue scaffold. The gelatin slurry support bath includes calcium chloride to provide divalent cations to crosslink the hydrogel as the hydrogel is extruded out of the nozzle. (Claim 8) teaches that EFM can also be used to print biologically derived structure material that comprises at least one of an alginate material, a collagen material, a fibrin material, a hyaluronic acid material, a protein material, a polysaccharide hydrogel material, synthetic gel material, an elastomer polymer material, a rigid polymer material, or a polydimethylsiloxane (PDMS) elastomer.
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 production method and apparatus for manufacturing poly(N-Isopropylacrylamide) based hydrogels that are treated with a salt solution of Yanbing. By modifying the process to include placing the polymer solution into contact with the salt solution comprises dispensing the polymer solution into a container comprising the salt solution, as taught by Feinberg. Highlighting, one would be motivated to implement dispensing the polymer solution into a container comprising the salt solution as it provides for enabling true freeform printing of complex geometries and enables the geometrically uninhibited fabrication of biopolymers and cell suspensions by embedding them in thermo-reversible support material. FRESH printing may be a significant improvement over alternative 3D bioprinting approaches in terms of capability, cost, safety, speed, and ease of use. FRESH is cross-platform and can therefore be easily adopted for use on an open-source or proprietary FDM 3D Printer, ([0048]).
Regarding claim 11 as applied to claim 10,
Wherein the polymer solution is extruded using a syringe or/and printing head, or through a printer,
Regarding claim(s) 11, Yanbing is silent on the polymer solution being extruded using a syringe or/and printing head, or through a printer. In analogous art as applied above, Feinberg suggest details regarding the polymer solution being extruded using a syringe or/and printing head, and in this regard, Feinberg teaches the following:
([0009]) teaches the structure material may be deposited using a syringe-based extruder that is inserted into the support material and extrudes the structure material into the support material.
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 production method and apparatus for manufacturing poly(N-Isopropylacrylamide) based hydrogels that are treated with a salt solution of Yanbing. By modifying the process to include the polymer solution being extruded using a syringe or/and printing, as taught by Feinberg. Highlighting, one would be motivated to implement dispensing the polymer solution into a container comprising the salt solution as it provides for enabling true freeform printing of complex geometries and enables the geometrically uninhibited fabrication of biopolymers and cell suspensions by embedding them in thermo-reversible support material. FRESH printing may be a significant improvement over alternative 3D bioprinting approaches in terms of capability, cost, safety, speed, and ease of use. FRESH is cross-platform and can therefore be easily adopted for use on an open-source or proprietary FDM 3D Printer, ([0048]).
Regarding claim(s) 12 – 14 as applied to claim(s) 10, 12 & 13 respectively,
Wherein the syringe and printing head are moved along a predetermined pattern.
Wherein the predetermined pattern is supplied by a computer aided design file.
Wherein the computer-aided design file is a two-dimensional pattern, a three-dimensional pattern, or a combination thereof.
Regarding claim(s) 12 – 14, Yanbing is silent on the syringe and printing head are moved along a predetermined pattern, the predetermined pattern is supplied by a computer aided design file and that the computer-aided design file is a two-dimensional pattern, a three-dimensional pattern, or a combination thereof. In analogous art as applied above, Feinberg suggest details regarding the syringe and printing head are moved along a predetermined pattern, the predetermined pattern is supplied by a computer aided design file and that the computer-aided design file is a two-dimensional pattern, a three-dimensional pattern, or a combination thereof, and in this regard, Feinberg teaches the following:
([0042]) teaches that the 3D bioprinter can lower a syringe-based extruder into the support material and move around and deposit material in arbitrary 3D geometries. As such, the syringe and printing head are moved along a predetermined pattern. With ([0065]) teaching that 3D models of the article printed in this case a right coronary arterial tree from a human heart can be scaled-down and printed using FRESH with high fidelity. (Fig. 4A) shows a 3D CAD model 400 of the coronary artery vasculature from a human heart. Coronary artery 3D models based on whole-body MRI imaging can be downloaded from a database that has 3D data for major arteries and veins in the body. The right coronary arterial tree was downloaded and the hollow model 400 was created in MeshLab by resampling the solid model to create a smaller child model with inverted normal to serve as negative space. When the models are flattened as layers into the same mesh file, a hollow model 400 with internal and external surfaces results. ([0066])adding that FIG. 4B shows a scaled-down FRESH printed vasculature 404 embedded within a support bath 406 with a US penny 408 for size reference. ([0067]) teaches that (Fig. 6) shows a parametric tubular structure 602 with a 2 mm inner diameter and bifurcation that was designed in CAD and printed, revealing a gel manifold capable of dividing fluid flow. As such, a the syringe and printing head are moved along a predetermined a three-dimensional pattern that is supplied by a computer aided design (CAD) file.
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 production method and apparatus for manufacturing poly(N-Isopropylacrylamide) based hydrogels that are treated with a salt solution of Yanbing. By modifying the process to include a syringe and printing head are moved along a predetermined a three-dimensional pattern that is supplied by a computer aided design (CAD) file, as taught by Feinberg. Highlighting, one would be motivated to implement a syringe and printing head are moved along a predetermined a three-dimensional pattern that is supplied by a computer aided design (CAD) file as it provides for enabling true freeform printing of complex geometries and enables the geometrically uninhibited fabrication of biopolymers and cell suspensions by embedding them in thermo-reversible support material. FRESH printing may be a significant improvement over alternative 3D bioprinting approaches in terms of capability, cost, safety, speed, and ease of use. FRESH is cross-platform and can therefore be easily adopted for use on an open-source or proprietary FDM 3D Printer, ([0048]).
E.) Claim(s) 15, is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanbing in view of Feinberg and in further view of D’Lima et al. (US 20220331086 A1, hereinafter D’Lima)Regarding claim 15 as applied to claim 10,
Wherein the container comprises a mask to selectively limit contact between the polymer solution and the salt solution.
Regarding claim(s) 15, Yanbing as modified by Feinberg is silent on the container comprises a mask to selectively limit contact between the polymer solution and the salt solution. In analogous art for methods of printing a bio-ink on a substrate, (Abstract), D’Lima suggest details regarding the container comprises a mask to selectively limit contact between the polymer solution and the salt solution, and in this regard, D’Lima teaches the following:
([0021]) teaches that FIG. 4B exemplifies print nozzles distributed with one or more masks (an empty space devoid of print nozzles). Highlighting, that providing a mask allows for tailoring the deposited pattern formed, namely by providing an empty space devoid of print nozzles and thus also devoid of material deposition. ([0027]) notes that Disclosed herein are methods of using inkjet printing to fabricate tissues and organs, employing an inkjet printhead with a two-dimensional array of print nozzles that ejects a bio-ink onto a substrateHighlighting, while D’Lima is silent on the mask regarding the position of the mask being on the container / substrate. The case law for the rearrgnament of parts may be recited. Where, the courts held that when shifting the location of an element would not have modified the operation of device, see In re Kuhle, 526 F.2d 553, 188 USPQ7 (CCPA 1975), MPEP 2144. Additionally, the particular placement of an element was held to be obvious, see In re Japikse, 86 USPQ 70; In re Gazda, 104 USPQ 400 & In re Kuhle, 526 F.2d 553, 188 USPQ7 (CCPA 1975), MPEP 2144.
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 production method and apparatus for manufacturing poly(N-Isopropylacrylamide) based hydrogels that are treated with a salt solution of Yanbing as modified by Feinberg. By further modifying the bioprinting apparatus to comprise a mask, as taught by D’Lima. Highlighting, one would be motivated to include a mask in the bioprinting apparatus as it provides for tailoring the pattern formed, namely by providing an empty space devoid of print nozzles and thus also devoid of material deposition, ([0021], (Fig. 4B)). Furthermore, applicant’s claims are drawn to a method, while the current limitation is directed toward structural limitation regarding the apparatus utilized to perform the method. Accordingly, the case law for structural limitation in method claims may also be recited. Where, it has been held that to be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure. Ex parte Pfeifer, 1962 C.D. 408 (1961).F.) Claim(s) 15, is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanbing in view of Feinberg and in further view of Ott et al. (US 20230193178 A1, hereinafter Ott)Regarding claim 15 as applied to claim 10,
Wherein the container comprises a mask to selectively limit contact between the polymer solution and the salt solution.
Regarding claim(s) 15, Yanbing as modified by Feinberg is silent on the container comprises a mask to selectively limit contact between the polymer solution and the salt solution. In analogous art for methods of printing a bio-ink on a substrate, (Abstract), Ott suggest details regarding the container comprises a mask to selectively limit contact between the polymer solution and the salt solution, and in this regard, Ott teaches the following:
([0044]) teaches the bioprinter 102 printing method is generally an extrusion bioprinting method wherein a bioink driver mechanism, such as pneumatic gas, mechanical piston, or screw, forces the bioink through an extrusion nozzle 106 at an end of the reservoir 104, for example, the Allevi 2 Bioprinter from Allevi. (Figs. 3A – 3B) show example steps of a printing process as seen from a bioreactor 110 window 118. The bioprinter 102 aligns the nozzle 106 above an opening 112 in the bioreactor 110 top surface. The opening 112 provides access to the bioreactor 110 inner volume containing the support medium. As illustrated in (Fig. 1 & 3A – 3B), the bioprinter nozzle with revisor is shown to be sized to fit atop the opening 112. As such, the opening 112 may act as applicant’s mask to selectively limit contact between the polymer solution and the supporting solution. Additionally, ([0053]) teaches that (Fig. 5) shows a schematic representation of the cover 406 including a view of the liquid vent 408. The cover 406 seals the opening 112 against liquid and gas ingress/egress from the opening 112 circumference and can prevent potential introduction of foreign microbes to maintain a sterile environment within the chamber housing 114. As such, the cover 406 that seals the opening 112 may also act as applicant’s mask to selectively limit contact between the polymer solution and the supporting solution.
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 production method and apparatus for manufacturing poly(N-Isopropylacrylamide) based hydrogels that are treated with a salt solution of Yanbing as modified by Feinberg. By further modifying the bioprinting apparatus to comprise a mask on the container, as taught by Ott. Highlighting, one would be motivated to include a mask on the container in the bioprinting apparatus as it provides for access to the bioreactor 110 inner volume containing the support medium and/or the cover 406 that seals the opening 112 provides for preventing potential introduction of foreign microbes to maintain a sterile environment within the chamber housing 114, ([0044]). Furthermore, applicant’s claims are drawn to a method, while the current limitation is directed toward structural limitation regarding the apparatus utilized to perform the method. Accordingly, the case law for structural limitation in method claims may also be recited. Where, it has been held that to be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure. Ex parte Pfeifer, 1962 C.D. 408 (1961).
G.) Claim(s) 16, is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanbing in view of Feinberg and in further view of Orwar et al. (US 20220389373 A1, hereinafter Orwar)Regarding claim 16 as applied to claim 10,
Wherein the container comprises a bed movable in a vertical direction, horizontal direction, or both.
Regarding claim(s) 16, Yanbing as modified by Feinberg is silent on the container comprises a bed movable in a vertical direction, horizontal direction, or both. In analogous art for methods of generating three-dimensional biological structures including depositing a first layer of a suspension over a substrate, (Abstract), Orwar suggest details regarding the container comprises a bed movable in a vertical direction, horizontal direction, or both, and in this regard, Orwar teaches the following:
([0016]) teaches (Figs. 1A – 1C) illustrate printing cells using a recirculating fluid flow. Specifically, (Fig. 1A) provides a schematic overview of the bioprinting setup consisting of; a micro-positioner-controlled printhead, an automated substrate positioner, a computer-controlled pneumatic interface, and a microscopy imaging system. ([0016]) adds that translating the surface relative to the printhead allows the deposited cells to be patterned on said surface, e.g., to modulate fluid flow over the resulting substrate. With (Fig. 1G) depicts the first stripe of the pattern being printed by translating the substrate. ([0037]) notes that the the electronically controlled position of both the printhead and the substrate can be achieved through on-demand control, e.g., through the use of a joystick, gamepad controller, scroll wheel, a touch screen and combinations thereof, and/or through the use of a computationally determined path. These paths can for example, be derived from a simple coordinate system, a design file, such as .stl (Stereolithography) CAD files, and/or through a relative feedback response, e.g., adapting to the changing position of cell propagation. As such, the container is found to comprises a bed movable in the horizontal direction.
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 production method and apparatus for manufacturing poly(N-Isopropylacrylamide) based hydrogels that are treated with a salt solution of Yanbing as modified by Feinberg. By further modifying the bioprinting apparatus to comprise a substrate that is provided with a bed movable in horizontal direction, as taught by Orwar. Highlighting, one would be motivated to provide the substrate with a bed movable in horizontal direction as it allows for the ability to translate the deposition surface relative to the printhead to be patterned on said translatable deposition surface, e.g., to modulate fluid flow and placement over the resulting substrate, ([0016]). Furthermore, applicant’s claims are drawn to a method, while the current limitation is directed toward structural limitation regarding the apparatus utilized to perform the method. Accordingly, the case law for structural limitation in method claims may also be recited. Where, it has been held that to be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure. Ex parte Pfeifer, 1962 C.D. 408 (1961).
H.) Claim(s) 17 – 19, is/are rejected under 35 U.S.C. 103 as being unpatentable over Yanbing in view of Wang et al. (US 20180354860 A1, hereinafter Wang)
Regarding claim 17 – 19 as applied to claim(s) 1, 17 & 18 respectively,
Further comprising treating the solidified polymer.
Wherein treating the solidified polymer comprises coating the solidified polymer, functionalizing the solidified polymer, or a combination thereof.
Wherein coating the solidified polymer comprises coating the solidified polymer with a silicone compound.
Regarding claim(s) 17 – 19, Yanbing is silent on treating the solidified polymer by coating the solidified polymer with a silicone compound. In analogous art for a method includes providing support material within which the structure is fabricated, depositing, into the support material, structure material to form the fabricated structure, and removing the support material to release the fabricated structure from the support material, Wang suggest details regarding treating the solidified polymer by coating the solidified polymer with a silicone compound, and in this regard, Wang teaches the following:
, 18a.) & 19a.) ([0038]) teaches that The shrinkage rate of oil containing- (silicon oil, hydrocarbon mineral oil, liquid paraffin, paraffin, synthetic hydrocarbons, etc.) or oil free-bioceramics manufactured by 3D printing before and after sintering were compared, wherein the oil-covering group had a higher shrinkage rate, a shrinkage rate up to 27.9%. When different bioceramic powders were compared, the shrinkage rate of the oil containing- or oil free-bioceramics (zirconia, ZrO2)/negative thermo-responsive hydrogel (p(NiPAAm-MMA)) manufactured by 3D printing before and after sintering were compared, similarly, the oil-covering group had a higher shrinkage rate, a shrinkage rate up to 36%. ([0052]) teaches another example in which a photo-curing printing example, in which 1 to 5% of photo-curing initiator 12959 (UV absorption wavelength was 365 mm) was added to 15% of negative thermo-responsive hydrogel and agitated for 1 to 2 days, and then agitated with hydroxylapatite (HAp) ceramic powder, 2.0 g of hydroxylapatite ceramic powder was added to 1 mL of 15% negative thermo-responsive hydrogel solution, agitated and mixed under vacuum for 8 minutes to obtain a printable slurry. ([0053]) adding that while printing, the photo-curing path and related irradiation time were provided by setting an UV module in order to cure and mold (see FIG. 7). A ceramic of 15 mm in diameter and 5 mm in height was printed, dripped and attached with silicon oil to cover, sent to a high temperature furnace to sintered at a gradient temperature of ±1250° C. for 6 to 8 hours providing for a shrinkage rate that was 25%. As such, treating the solidified polymer by coating the solidified polymer with a silicone compound is understood to be disclosed.
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 production method and apparatus for manufacturing poly(N-Isopropylacrylamide) based hydrogels that are treated with a salt solution of Yanbing. By modifying the solidified polymer by treating the solidified polymer by coating with a silicone compound, as taught by Wang. Highlighting, one would be motivated to implement a treatment of solidified polymer that comprises coating solidified polymer with a silicone compound as it provides for improve the shrinkage effect of the ceramic sintering, and as shown in the above experimental results, the shrinkage rate can be up to 20 to 40%, having a greater shrinkage rate than the one with no oil dripped and attached, ([0059]). Additionally, the use of a known material, i.e, silicone oil, etc. for its intended use, explicitly used to improve shrinkage rate, in a known environment, specifically hydrogels of p(NiPAAm), provides for the recitation of known material in the art case law. Where, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), MPEP 2144.07.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bayley et al. (US 20230193181 A1) – teaches in the (Abstract) The invention relates to an apparatus for producing a droplet assembly, which apparatus comprises: at least one droplet generator suitable for generating droplets of a viscous droplet medium; a droplet receiving region which is moveable relative to the at least one droplet generator; a temperature controller; and a control unit, which control unit is adapted to control the dispensing of droplets from the at least one droplet generator and the movement of the droplet receiving region relative to the at least one droplet generator.
Paz et al. (The Interaction between Poly(N-isopropylacrylamide) andSalts in Aqueous Media, 2003) – teaches (Pg. 35, Experimental, ¶2) teaches Solutions of 0.5 wt % PNIPA were prepared by dissolving the polymer in pure water or in water containing (0.09 or 0.15 M) Na2SO4. As such, the placing a polymer solution comprising a polymer susceptible to solidification due to salting-out effects into contact with a salt solution is understood to be disclosed. (Pg. 34, Introduction, ¶4) teaches that the main objective of this study was to further investigate the interactions be-tween salts and PNIPA in aqueous solutions at a molecular level with the ATR/FTIR technique. This study focused on the effect of the divalent anion SO4-2 ranked as a very strong salting-out anion. (Pg. 33, Experimental, ¶1) teaches that measurements with the ternary system water-PNIPA-salt were carried out with Na2SO4 and K2SO4 at concentrations of 0.09 and 0.18 M. (Pg. 42, Microcalorimetry Measurements, ¶1) teaches that the phase-separation points, indicated by the location of the endothermic peaks, are in line with the ATR/FTIR results, demonstrating the effect of the salting-out Na2 SO4 in lowering the phase-separation temperature. As such, inducing solidification of the polymer through salting-out effects is understood to be disclosed. Highlighting, while solidification is not directly mentioned, the case law for substantially identical process and structure may be recited. Where, it has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or a substantially identical processes, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitations that stem from the claimed structure. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spada, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977), MPEP 2144.
Kamei et al. (US 20190187140 A1) – teaches in the (Abstract) It was discovered that hydrogel scaffolds can be used to induce phase separation as aqueous two-phase systems (ATPSs) pass through and/or rehydrate the scaffolds, allowing for concentration of target analyte(s) (e.g., biomolecule(s)) into a particular phase of the ATPS or into a leading front.
Barrile et al. (US 20250250522 A1) – teaches in the (Abstract) A device for modelling physiological and pathophysiological states of the brain is provided. The device comprises a hydrogel with micropattern channels having a length, width and depth. The micropattern channels comprise cells selected from the group consisting of neurons, astrocytes, microglia, oligodendrocytes, neuronal organoids, cancer cells, cancer spheroids, brain tumoral cells and combinations thereof.
Bae et al. (Sustainable 3D printing by reversible salting-out effects with aqueous salt solutions) it should be noted this is applicant’s own work but published after the filing date of the instant application. However, Bae teaches in the (Abstract) that a simple yet sustainable printing technique with minimal instruments and energy remains challenging. Here, a facile and sustainable 3D printing technique is developed by utilizing a reversible salting-out effect. The salting-out effect induced by aqueous salt solutions lowers the phase transition temperature of poly(N-isopropylacrylamide) (PNIPAM) solutions to below 10 °C. It enables the spontaneous and instant formation of physical crosslinks within PNIPAM chains at room temperature, thus allowing the PNIPAM solution to solidify upon contact with a salt solution.
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/Andrés E. Behrens Jr./Examiner, Art Unit 1741
/JaMel M Nelson/Primary Examiner, Art Unit 1743