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 .
Election/Restrictions
Applicant’s election without traverse of Claims 1, 3-5, 13-15, 21, 22, 27, 28, 33, 34, 40, 41, and 45-47 in the reply filed on 02/26/2026 is acknowledged.
Status of Claims
Claims 1, 3-5, 13-15, 21, 22, 27, 28, 33, 34, 40, 41, 45-48, and 77 are pending, of which claims 48 and 77 are withdrawn. Claims 1, 3-5, 13-15, 21, 22, 27, 28, 33, 34, 40, 41, and 45-47 are examined below.
Claim Objections
Regarding claim 46, the claim recites a range of 100 nm to 500 microns. Please amend the claim to have consistent units (i.e., 0.1 microns to 500 microns, 100nm to 500000nm).
Regarding claim 47, the claim recites “a electric potential”. Please correct this to read “an electric potential”
Claim Rejections - 35 USC § 102
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(s) 1, 13-15, 27, 28, 33, 46, and 47 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by non-patent literature titled “Direct Writing Electrospinning of Scaffolds with Multidimensional Fiber Architecture for Hierarchical Tissue Engineering” (Chen)
Regarding claim 1, Chen discloses a method of making a solution electrowritten fibrous product (Abstract, wherein "direct writing (OW) with solution ESP to produce complex three-dimensional multiscale and ultrathin fibrous scaffolds” corresponds to a method of making a solution electrowritten fibrous product”), the method comprising: providing a solution electrowriting system (see abstract figure) comprising:
one or more nozzle(s) (Page 38189, ¶5, wherein “spinneret” corresponds to one or more nozzles);
a material supply system (see annotated abstract figure below) comprising one or more reservoir(s) fluidically coupled to the nozzle(s) and configured to supply one or more fluid stock(s) to the nozzle(s) thereby ejecting one or more jet stream(s) of the fluid stock(s) from the nozzle(s) (see abstract figure provided below, which is fluidically coupled to the nozzle and configured to eject one or more jet streams of the fluid from the nozzle)
a collector system (see annotated abstract figure below) configured to collect one or more fiber(s) formed by the jet stream(s) ejected from the nozzle(s) (Page 38189, ¶2, wherein “until it reaches the collector” corresponds to configured to collect the fibers) and
one or more power source(s) (see annotated abstract figure below) configured to provide one or more electric potential(s) to each of the nozzle(s) and, optionally, to the collector system, thereby providing one or more electric potential difference(s) between the collector system and each of the nozzle(s) (Page 38189, ¶6, “the applied voltage needs to reach a certain threshold to initiate the ESP process, see also abstract figure which shows high voltage power source);
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wherein each fluid stock comprises a solution comprising at least one first solvent and, optionally, at least one second solvent (Page 38196, ¶4, wherein the solution comprises “CHCl3, i.e. chloroform” and “, “1,1,1,3,3,3-hexafluoro-2-propanol”, i.e. HFIP), and one or more material(s) (Page 38196, ¶4, wherein a “polyethylene terephthalate/polybutylene terephthalate (PEOT/PBT) block copolymer” corresponds to one more materials”) configured to form at least a portion of a fiber upon ejection of the jet stream(s) of the fluid stock(s) from the nozzle(s) (Page 38197, ¶1, wherein ‘Initial electro spinning experiments to assess the drawing region were carried out with polymer solutions of 26−30% PEOT/PBT” corresponds to configured to form at least a portion of a fiber…)
wherein the material(s) is/are dissolvable in at least one of the at least one first solvent and/or the at least one second solvent to form a solution (Page 38196, ¶4, wherein “solutions of 26-30% of polymer in 70:30 to 80:20 CHCL3/HFIP” corresponds to dissolving the material in at least one of the solvents);
ejecting the fluid stream(s) of the fluid stock(s) from the nozzle(s) to form the fiber(s) (see abstract figure, which shows fluid stream ejected from nozzle);
collecting the fiber(s) with the collector system to form a fibrous product comprising one or more fiber(s) arranged in a predetermined pattern (Page 38191, ¶3, “DW ESP permits the tailored patterning of 3D ultrathin scaffolds with multiscale and controllable porosity”); and
releasing the fibrous product from collector system (see abstract figure, wherein the product is understood to be removed from the collector system for use”),
wherein a desired fiber fusion and/or a desired fiber stacking is observed in the fibrous product (Page 38191, ¶3, “"By tuning the distance between struts and the number of deposited layers, the pore size and scaffold thickness could be controlled”.
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Regarding claim 13, Chen further discloses wherein the fluid stock(s) comprise(s) at least one first solvent (Page 38196, ¶4, “1,1,1,3,3,3-hexafluoro-2-propanol” or HFIP) and at least one second solvent (Page 38196, ¶4, “chloroform” or CHCl3), and wherein the at least one first solvent has a dipole moment of from about 1.5 D to about 4.2 D (see table 1 below, wherien HFIP has a dipole moment of 2.05 D) wherein the at least one second solvent has a dipole moment of from about 0 D to less than about 1.5 D (en.wikipedia.org/wiki/Chloroform, wherein chloroform has a dipole moment of 1.15D)
Regarding claim 14, Chen further discloses wherein the fluid stock(s) comprise(s) at least one first solvent (Page 38196, ¶4, “1,1,1,3,3,3-hexafluoro-2-propanol” or HFIP) and at least one second solvent (Page 38196, ¶4, “chloroform” or CHCl3), and wherein a dipole moment of the at least one first solvent is about 20 % or more greater than the dipole moment of the at least one second solvent (see rejection of claim 13 above, wherein HFIP has a has a dipole moment of 2.05D and chloroform has a moment of 1.15D, 2.05D is about 78% greater than 1.15D and therefore within the claimed range)
Regarding claim 15, Chen further discloses wherein: the at least one first solvent is chosen from dichloromethane, tetrahydrofuran (THF), pyridine, trifluoroethanol, acetone, ethanol, methanol, N,N-Dimethylformamide, dimethyl sulfoxide (DMSO), isopropanol, water, ethyl acetate, trifluoroacetic acid, 1,1,1,3,3,3-hexafluoroisopropanol (Page 38196, ¶4, “1,1,1,3,3,3-hexafluoro-2-propanol” or HFIP), 1-butanol, 1,2-dichloroethane, acetic acid, diglyme, acetonitrile, and any combination thereof; and/or the at least one second solvent is chosen from cyclohexane, hexane, benzene, toluene, dioxane, diethyl ether, chloroform (Page 38196, ¶4, “chloroform” or CHCl3), anisole, triethylamine, heptane, xylene, and any combination thereof
Regarding claim 27, Chen further discloses wherein the fibrous product comprises one or more layer(s) each comprising one or more group(s) of fibers (Page 38191, ¶3, "By tuning the distance between struts and the number of deposited layers, the pore size and scaffold thickness could be controlled,"; it is understood each has a group of fibers being deposited as shown in Fig 3(A)) optionally aligned in one or more axial directions of the fibrous product within and/or between the layer(s).
Regarding claim 28, Chen further discloses wherein the group(s) of fibers is/are uniaxially, biaxially, or multi-axially oriented within and/or between the layer(s) (see Fig. 3D-3F, wherein the layers are uniaxially oriented between the layers) and/or each group of fibers has a substantially constant winding angle, relative to a longitudinal axis of the fibrous product.
Regarding claim 33, Chen further discloses wherein the one or more material(s) comprise at least one polymer (Page 38196, ¶4, wherein “a polyethylene terephthalate/polybutylene terephthalate block copolymer or PEOT/PBT” corresponds to at least one polymer) and wherein the fluid stock(s) comprising the at least one polymer is/are ejected from the nozzle(s) to form one or more fiber(s) comprising the at least one polymer (Page 38197, ¶5, “direct writing experiments and scaffold fabrication were carried with a polymer solution of 28% PEOT/PBT in 75:25 CHCl3/HFIP”)
Regarding claim 34, Chen further discloses wherein the at least one polymer (Page 38196, ¶4, “PEOT/PBT”) comprises at least one biocompatible polymer (Page 38189, ¶3, "because it has been demonstrated as a biocompatible and degradable polymer") and/or at least one biodegradable polymer or the at least one polymer is thermo-reactive at a temperature of at least about 60 °C
Regarding claim 46, Chen further discloses wherein an average diameter of the fibers is from about 100 nm to about 500 microns (Page 38192, ¶1, wherein “ultrathin fibers with a diameter of 1.42 ± 0.09 μm” falls within the claimed range)
Regarding claim 47, Chen further a step further comprising one or more times during formation of the fiber(s) one or more or all of:
altering a volume ratio of the at least one first solvent to the at least one second solvent in the fluid stock(s);
adding at least a third solvent to the fluid stock(s);
altering a concentration of a conducting agent in the fluid stock(s); and
altering a electric potential(s) applied to the nozzle(s) (Page 38190, wherein “we tested applied voltages between 2 and 16 kV” corresponds to altering a electric potential)
wherein fiber fusion, fiber stacking, or a combination thereof is altered (Page 38190, ¶1, wherein “when we deceased the voltage to 5 kV, a stable jet was achieved during its flight time” corresponds to altering fiber stacking)
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(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over non-patent literature titled “Direct Writing Electrospinning of Scaffolds with Multidimensional Fiber Architecture for Hierarchical Tissue Engineering” (Chen)
Regarding claim 3, Chen further discloses wherien the fluid stock(s) comprise(s) at least one first solvent (Page 38196, ¶4, “chloroform” or CHCl3) and at least one second solvent (Page 38196, ¶4, wherein “1,1,1,3,3,3-hexafluoro-2-propanol” or HFIP corresponds to a second solvent), and wherein the at least one first solvent has a boiling point of less than about 80 C (see annotated table below from organicchemistrydata.com/solvents/ wherein the boiling point of chloroform, 61.2 C, is below 80 C) and wherein the fibrous product comprises a plurality of fusion points between respective portion of at least two adjacent intersected fibers, such that for each fusion point, a bottom surface of a first fiber is bonded to a top surface of a second fiber (Page 38197, ¶5, wherein “stacked layers were then bound together by joining the vertexes of each scaffold and melting them” corresponds to a plurality of fusion points between respective portion of at least two adjacent intersected fibers, such that for each fusion point, a bottom surface of a first fiber is bonded to a top surface of a second fiber)
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Chen doesn't explicitly teach or disclose a second solvent with a boiling point of at least 80 C.
However, it would have been obvious to one skilled in the art to use a different solvent that has a boiling point of higher than 80 C (such as 1-butanol shown in the table above) because the solvent’s boiling point is a known result-effect variable to modify the morphology of an electrospun fibrous product. A person of ordinary skill in the art would have a reasonable expectation of success in optimizing the desired properties of the fibrous product through routine experimentation (see MPEP 2144.05)
Regarding claim 4, Chen further discloses wherein the fluid stock comprise(s) at least one first solvent (Page 38196, ¶4, “chloroform” or CHCl3) and at least one second solvent (Page 38196, ¶4, wherein “1,1,1,3,3,3-hexafluoro-2-propanol” or HFIP), wherein the at least one first solvent has a boiling point of less than about 80 °C (see rejection of claim 3, wherein chloroform has a boiling point of 61.2 C).
Chen doesn't explicitly teach or disclose wherein the boiling point of the at least one second solvent is from about 10 °C to about 200 °C higher than the boiling point of the at least one first solvent.
However. it would have been obvious to one skilled in the art to use a solvent system wherein the boiling point of the at least one second solvent is from about 10 °C to about 200 °C higher than the boiling point of the at least one first solvent. (such as 1-butanol shown in the table under rejection 3) because the solvent boiling point is a known result-effect variable to modify the morphology of an electrospun fibrous product. A person of ordinary skill in the art would have a reasonable expectation of success in optimizing the desired properties of the fibrous product through routine experimentation.(see MPEP 2144.05)
Regarding claim 5, Chen further discloses wherein the at least one first solvent is chosen from diethyl ether, dichloromethane (DCM), acetone, 1,1,1,3,3,3-hexafluoroisopropanol (HFIP) (Page 38196, ¶4, “HFIP”), chloroform, methanol, tetrahydrofuran (THF), trifluoroethanol (TFE), ethanol, acetonitrile, cyclohexane, benzene, ethyl acetate, hexane, trifluoroacetic acid, isopropanol, and any combination thereof; and/or wherein the at least one second solvent is chosen from water, dioxane, toluene, pyridine, N,N-dimethylformamide (DMF), anisole, dimethyl sulfoxide (DMSO), 1,2-dichloroethane, triethylamine, heptane, butanol, acetic acid, xylene, diglyme (diethylene glycol diethyl ether), and any combination thereof
Claim(s) 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over non-patent literature titled “Direct Writing Electrospinning of Scaffolds with Multidimensional Fiber Architecture for Hierarchical Tissue Engineering” (Chen) in view of US 2017/0217125 A1 (Li)
Regarding claim 21, Chen discloses a fluid stock (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the fluid stock(s) further comprise(s) a conductive agent and/or at least one additive.
Li, a process for electrospinning, discloses wherein the fluid stock(s) further comprise(s) a conductive agent and/or at least one additive (¶0014, wherein “dispersing the conductive metal precursor into a spinning composition” corresponds to a conductive agent”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the fluid stock of Chen with a conductive agent, as taught by Li, in order to increase the conductivity of the fiber.
Regarding claim 22, Chen discloses a fluid stock (see rejection of claim 1) but doesn't explicitly teach or disclose a conductive agent.
Li discloses wherein the conductive agent is chosen from a salt, a conductive polymer, and any combination thereof (¶0047, wherein “metal salts” corresponds to a salt) and/or the at least one additive is chosen from a therapeutic agent, a dye, an indicator agent, a drug, and any combination thereof.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the fluid stock of Chen with a conductive agent comprising a salt, as taught by Li, to in order to increase the conductivity of the fiber.
Claim(s) 40 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over non-patent literature titled “Direct Writing Electrospinning of Scaffolds with Multidimensional Fiber Architecture for Hierarchical Tissue Engineering” (Chen) in view of US 2013/0078527 (Lee)
Regarding claim 40, Chen doesn't explicitly teach or disclose wherein at least one fluid stock comprises at least one first polymer and at least one second polymer and/or wherein at least a first fluid stock comprises at least one first polymer and at least one second fluid stock comprises at least a second polymer.
Lee discloses a method for manufacturing a porous nanoweb wherein at least a first fluid stock comprises at least one first polymer (¶0040, “first polymer”) and at least one second fluid stock comprises at least a second polymer (¶0040, “second polymer”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Chen with a second fluid stock comprising a second polymer, as taught by Lee, in order to form a product with different material properties suitable to the tissue engineering application.
Regarding claim 41, Chen doesn't explicitly teach or disclose wherein the fluid stock(s) comprising the at least one first polymer and the at least one second polymer are ejected from a same or different nozzle(s) to form one or more fiber(s) comprising the at least one first polymer and/or the at least one second polymer
Lee discloses at least one first polymer and the at least one second polymer are ejected from a same or different nozzle(s) to form one or more fiber(s) comprising the at least one first polymer and/or the at least one second polymer(¶0047, “the first sub-nanoweb is formed by electrospinning the first spinning solution, and the second sub-nanoweb is formed by electrospinning the second spinning solution”, it is understood that this can be carried out with either the same nozzle or two different nozzles)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Chen with at least one first polymer and at least one second polymer ejected from a same or different nozzle, as taught by Lee, in order to form a product with different material properties suitable to the tissue engineering application.
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over non-patent literature titled “Direct Writing Electrospinning of Scaffolds with Multidimensional Fiber Architecture for Hierarchical Tissue Engineering” (Chen) in view of US 2013/0317285 (Soletti)
Regarding claim 45, Chen discloses a fibrous product (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the fibrous product has an inner diameter of from about 0.5 mm to about 300 mm and/or an outer diameter of from about 0.51 mm to about 300 mm.
Soletti discloses an electrospinning apparatus (Fig. 4) configured to produce a fibrous product has an inner diameter of from about 0.5 mm to about 300 mm (¶0013, wherien the outside diameter of the mandrel between 2mm and 6mm determines the inner diameter of the fibrous product) and/or an outer diameter of from about 0.51 mm to about 300 mm
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the fibrous product of Chen to have an inner diameter of from about 0.5 mm to about 300 mm, as taught by Soletti, in order to create a product that is suitable for tissue engineering applications such as vascular grafts (¶0004).
Conclusion
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/ Primary Patent Examiner, Art Unit 3774