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 Interpretation
Examiner notes that the limitation “providing at least one photo-crosslinkable polymeric material coated with at least one transparent material” is interpreted below as --the transparent material is in contact with a bath of photo-crosslinkable material--.
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.
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.
Claim(s) 1-3 and 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirkin (US 2019/0160733 – of record) in view of de Montmorillon (US 7,995,889).
Regarding claim 1, Mirkin teaches a process for producing a three-dimensional structure (Abstract), the process comprising the steps of:
a) providing a light source (light engine) (see Figs. 4-6);
b) coupling said light source to a proximal end of at least one optical fibre (fiber optic cable), in such a way as to propagate a light generated by said light source through the at least one optical fibre and produce, at a distal end of the at least one optical fibre, a predetermined incident optical field .. (see Fig. 5; [0020]);
c) providing at least one photo-crosslinkable polymeric material (polymerizable ink) coated with at least one transparent material (transparent member and de-wetting phase), wherein the at least one transparent material comprises a first surface (i.e. outer surface of the de-wetting phase) placed in contact with the at least one photo-crosslinkable polymeric material and a second surface (i.e. a surface of the transparent member facing the end portion of the fiber-optic cable as depicted in Fig. 5) placed not in contact with the at least one photo-crosslinkable polymeric material and opposite to the first surface (see Fig. 5;[0020], [0038-0043] and [0093]);
d) placing the distal end of the at least one optical fibre at a distance D from the second surface of the at least one transparent material, the distance D ranging from 0 mm to 5 mm (see Fig. 5; [0020] and [0147]); and
e) irradiating the second surface of the at least one transparent material with the light propagated and exiting the distal end of the at least one optical fibre for a period of time comprised between 1 second and 5 minutes (see [0185]), so as to obtain propagation of the light through the at least one transparent material towards the at least one photo-crosslinkable polymeric material and to obtain photo-crosslinking, by irradiation, of the polymeric material thus irradiated, with consequent formation of the three-dimensional structure (see Fig. 5).
However, Mirkin does not explicitly teach wherein said optical field maintains the same phase profile, the same spatio-temporal intensity, and the same frequency during propagation of the light through the at least one optical fibre and exit of the light from the at least one optical fibre.
In analogous art, processes utilizing optical transmission fiber system, de Montmorillon teaches a process using an optical transmission fiber, comprises providing a single mode optical fiber (i.e. maintaining optical field properties such as phase profile of the optical field is preserved) designed to maintain fundamental propagation mode with controlled mode field diameter and phase velocity (see column 1, lines 28-37). de Montmorillon further teaches that the optical fiber designed to maintain a stable mode field diameter and phase velocity across the fiber (see column 6, lines 65-66; column 7, lines 1-4 and claim 3)
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have modified the process for producing a three-dimensional structure as taught by Mirkin in view de Montmorillon by utilizing a single mode optical fiber mode configured to provide an optical field maintaining the same phase profile, the same spatio-temporal intensity, and the same frequency during propagation of the light through the at least one optical fibre and exit of the light from the at least one optical fibre as such is known in the art of optical fiber systems given the discussion of de Montmorillon above; and doing so is combining prior art elements according to known methods to yield predictable results, with the added benefits of doing so would eliminate modal dispersion by supporting a single mode, ensuring a stable phase profile, spatio-temporal intensity, and frequency which lead to a uniform irradiation and improving the precision and quality of the 3D structure.
Furthermore, a person of ordinary skill in the art, upon reading Mirkin would have recognized that maintaining same optical properties (thermal phase, intensity and frequency) for a predetermined incident optical field is one of a finite number of identified, predictable solutions, known to be useful for ensuring optimal performance, as this standard practice in the field of optical engineering. Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the invention to try maintaining same optical properties of incident optical field of varying optical properties in the method by Mirkin because a person with ordinary skill has good reason to pursue the known option within his or her technical grasp. "A person of ordinary skill has good reason to pursue the known option within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but or ordinary skill and common sense. "KSR int'l Co. v. Teleflex Inc., 127 S.Ct. 1727,82 USPQ2d 1385 (2007).
Regarding claim 2, Mirkin in view de Montmorillon further teaches the process, wherein the first surface of the at least one transparent material is a curved surface (curved surface; see [0037] of Mirkin), and wherein the at least one transparent material is selected from: transparent natural polymer, transparent synthetic polymer, transparent pre-polymerized photo-crosslinked polymer, transparent polyethylene terephthalate, transparent polypropylene, transparent glass, transparent hydrogel, and transparent silicone hydrogel (transparent material composition; see [0089] and [0091] of Mirkin).
Regarding claim 3, Mirkin in view de Montmorillon further teaches the process, wherein the at least one photo-crosslinkable polymeric material comprises: at least one photo-crosslinkable biocompatible hydrogel or mixtures thereof, at least one photoinitiator and optionally at least one non-photo-crosslinkable element (see [0049], [0051] and [0067] of Mirkin).
Regarding claim 6, Mirkin in view de Montmorillon further teaches the process, wherein the at least one photoinitiator is selected from: 2-hydroxy-2- methylpropiophenone, 2-hydroxy-4'-(2-hydroxyethoxy)-2-methylpropiophenone, and lithium phenyl-2,4,6-trimethylbenzoylphosphinate (LAP) (see [0190] of Mirkin discloses 2-hydroxy-2-methylpropiophenone as photo-radical initiator).
Regarding claim 7, Mirkin in view de Montmorillon further teaches the process, wherein the at least one non-photo-crosslinkable element is selected from: silk fibroin, silica nanoparticle, titania nanoparticle, zirconia nanoparticle, gold nanoparticle, silver nanoparticle, zinc nanoparticle (see [0062] and [0151] of Mirkin), substance having the biological activity to act as a pharmaceutical active ingredient, functionalized nanoparticle, free protein, protein covalently linked to hyaluronic acid methacrylate, and substance having the biological activity to act as a pharmaceutical active ingredient included in a poly(lactic-co-glycolic acid) microsphere.
Regarding claim 8, Mirkin in view de Montmorillon further teaches the process, wherein in step e) the period of time is comprised between 10 seconds and 60 seconds (see [0185] of Mirkin).
Regarding claim 9, Mirkin in view de Montmorillon further teaches the process, wherein in step d) the distance D is comprised between 0 mm and 1 mm (see Fig. 5 of Mirkin).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirkin (US 2019/0160733 - of record) in view of de Montmorillon (US 7,995,889) as applied to claim 3 above, and further in view of Wang (CN 113069683 with English Machine Translation Attached).
Regarding claim 4, Mirkin in view de Montmorillon teaches the process as discussed in claim 3 above.
Mirkin further teaches the at least one photo-crosslinkable biocompatible hydrogel comprises dimethacrylate oligomer and diacrylate (HDDA) (see [0042-0043] and [0181-0182]). However, Mirkin in view de Montmorillon does not explicitly teach the at least one photo-crosslinkable biocompatible hydrogel comprises at least one of: hyaluronic acid acrylate derivatives, hyaluronic acid acrylate, hyaluronic acid methacrylate, acrylate or methacrylate gelatin derivatives, gelatin-methacryloyl (GelMA), or mixtures thereof.
In analogous art, Wang teaches a method for preparing soluble micro-needle patch (Abstract), comprises preparing a composition includes one photo-crosslinkable biocompatible hydrogel comprises at least one of: hyaluronic acid acrylate derivatives and a methyl propylene gelatin (GelMA) (Abstract; [0009] of English Machine Translation Attached). Wang further teaches the composition is useful for making soluble microneedle patch for wound repair (Abstract).
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have the at least one photo-crosslinkable biocompatible hydrogel comprises at least one of: hyaluronic acid acrylate derivatives, hyaluronic acid acrylate, hyaluronic acid methacrylate, acrylate or methacrylate gelatin derivatives, gelatin-methacryloyl (GelMA), since it has been held to be within the ordinary skill of worker in the art to select a known material on the basis of its suitability for the intended use. One would have been motivated to the at least one photo-crosslinkable biocompatible hydrogel comprises at least one of: hyaluronic acid acrylate derivatives, hyaluronic acid acrylate, hyaluronic acid methacrylate, acrylate or methacrylate gelatin derivatives, gelatin-methacryloyl (GelMA) in order to obtain a composition is useful for making soluble microneedle patch for wound repair.
Regarding claim 5, Mirkin in view de Montmorillon and Wang further teaches, wherein the at least one photo-crosslinkable biocompatible hydrogel further comprises at least one of: di- or tetra- acrylate cross-linker, 2- or 4-arm acrylate (polyethylene glycol diacrylate (PEGDA), 4-arm PEG-Acrylate, glycerol 1,3-diglycerolate diacrylate, tetra(ethylene glycol) diacrylate (TTEGDA), di(ethylene glycol) diacrylate, bisphenol A glycerolate (1-glycerol/phenol) diacrylate, 1,6-hexanediol ethoxylate diacrylate, tricyclo [5. 2.1.02,6] decanedimethanol diacrylate) (see [0009] of English Machine Translation Attached of Wang).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirkin (US 2019/0160733 – of record) in view of de Montmorillon (US 7,995,889) as applied to claim 1 above, and further in view of Hu (US 2012/0045169).
Regarding claim 10, Mirkin in view de Montmorillon teaches the process as discussed in claim 1 above
Mirkin further teaches wherein in step b) the light source is coupled to a proximal end of a single of optical fibre (fiber -optic cable) and wherein in said the optical fibre is arranged at a mutual distance comprised between 0 mm and 10 mm, so as to control interference of relative optical fields of the optical fibre (see Fig. 5; [0020] and [0037]). However, Mirkin does not explicitly teach that the light source is coupled to a proximal end of a bundle of optical fibres, wherein said bundle comprises a number of optical fibres comprised between 2 and 1000, and wherein in said bundle the optical fibres are arranged at a mutual distance comprised between 0 mm and 10 mm, so as to control interference of relative optical fields of each optical fibre.
In analogous art, optical fiber process and systems, Hu teaches a method and apparatus for forming an optical-fiber-array assembly, which include providing a plurality of optical fibers including a first optical fiber and a second optical fiber, providing a fiber-array plate that includes a first surface and a second surface, connecting the plurality of optical fibers to the first surface of the fiber-array plate (Abstract),and the plurality of optical fibers arranged in a controlled spacing (0-10 mm) to control interface of their optical filed (see [0079]).
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have modified the process for producing a three-dimensional structure as taught by Mirkin in view Hu with a configuration of the light source is coupled to a proximal end of a bundle of optical fibres, wherein said bundle comprises a number of optical fibres comprised between 2 and 1000, and wherein in said bundle the optical fibres are arranged at a mutual distance comprised between 0 mm and 10 mm, so as to control interference of relative optical fields of each optical fibre as such is known in the art of optical fiber systems given the discussion of Hu above; and doing so is combining prior art elements according to known methods to yield predictable results, with the added benefits of doing so would enhance the uniformity and control of the irradiation pattern, improving the precision and efficiency of the photo-crosslinking process and the controlled spacing and interface of the fibers in the bundle would allow for tailored optical field distributions, which is advantageous for creating complex 3D structure.
Conclusion
The following prior arts made of record and not relied upon is considered pertinent to applicant's disclosure.
Namati (US 7,603,013) teaches a bundle of coherently arranged optical fibers with a controlled spacing to control interface of the optical field (Abstract; Fig. 1A).
Chiappetta (US 7,018,111) teaches a light amplifier includes a source of multiple light beams, each modulated with the same information, and a plurality of light amplifying optical fibers (Abstract; Fig. 2 and Figs. 4-5).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED K AHMED ALI whose telephone number is (571)272-0347. The examiner can normally be reached 10:00 AM-7:30 PM.
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/MOHAMED K AHMED ALI/ Examiner, Art Unit 1743
/GALEN H HAUTH/ Supervisory Patent Examiner, Art Unit 1743
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