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 .
Status of the application
This is a final rejection in response to the Applicant's remarks and amendment filed on 08/27/2026. Claim 1 is currently amended, claims 2-10 are previously presented. Accordingly claims 1-10 are examined herein.
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 § 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.
Claims 1-10 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 recites “a three-dimensional profile designable as desired depending on a three-dimensional intensity profile of the optical field exiting the fibre” which is indefinite. The term “as desired” is a relative term that renders the claim indefinite. The term “as desired” is not defined by the claim, 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. Paragraphs [0027] and [0051] state only that the mode shape “can be complicated as desired” and that the profile maybe designed as desired” without identify any objective boundary, fiber type, mode, or design method. The disclosed examples (Figs. 2-4 and 7; [0047]-[0050]) employ only the fundamental Gaussian mode. Further, the limitation is unclear because it defines the three-dimensional profile of the optical field as depending on the three-dimensional intensity profile of the same optical field. See MPEP 2173.05(b).
Claim(s) 2-10 is/are rejected as being dependent from claim 1 and therefor including all the limitation thereof.
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 – of record) and Royer (US 2004/0264860).
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 on the first surface of the transparent material (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).
Mirkin in view de Montmorillon does not explicitly teach wherein the predetermined incident optical field exiting the distal end of the optical fibre has a three-dimensional profile designable as desired depending on a three-dimensional intensity profile of the optical field exiting the fibre; wherein the three-dimensional structure has a geometry on the shape of the incident optical field exiting the distal end of the optical fibre.
In analogous art, processes using optical transmission fiber system, Royer teaches method of making monomode or multimode lens ended optical fibers (4) comprising depositing on one end of the fibers a formulation of a transparent polymer to form micro-tips (see Figs. 2 and 6-8; [0006]). Royer teaches that, before exposure, the desired guided mode(s) are selected by applying mechanical stresses to fiber and modifying the conditions of injection of green light until the required mode(s) are obtained (see [0034]). The three-dimensional profile of the optical field exiting the fibre is thus designable as desired by selecting the mode and its corresponding to the intensity distribution of the selected mode exiting the fibre. An LP11 mode produces a double micro-tip whose transmitted intensity distribution is the same as the distribution used to create it, and an LP21 mode produces a four-tip structure (see Figs. 6a,7a-7b,8a-8b; [0035-0037]).
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 process as taught by Mirkin in view de Montmorillon by selecting the three-dimensional intensity profile of the optical field exiting the distal end of the optical fibre, as taught by Royer, so that the photo-crosslinked three-dimensional structure has a geometry corresponding to the shape of that optical field. Mirkin already delivers the polymerizable light through a fibre optic cable whose distal end irradiates the polymerizable material through a transparent member (see Fig. 5). Royer teaches that the intensity profile of the light exiting a fibre directly defines the geometry of the photopolymerized structure, and that this profile can be selected to obtain different predictable geometries without external patterning elements. One of ordinary skill in the art would have been motivated to make this modification to tailor the geometry of the fabricated structures (e.g., single-peak versus multi-peak structures) by controlling the fibre output alone, reducing reliance on pattern-generating hardware such as masks, pinholes, or DMD. This is the use of known technique to improve a similar method in the same way, yielding predictable results. See MPEP 2143(I) (C).
Regarding claim 2, Mirkin in view de Montmorillon and Royer 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 and Royer 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 and Royer 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 and Royer 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 and Royer 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 and Royer 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 - of record) and Royer (US 2004/0264860) as applied to claim 3 above, and further in view of Wang (CN 113069683 with English Machine Translation Attached - of record).
Regarding claim 4, Mirkin in view de Montmorillon and Royer 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, Royer 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 – of record) and Royer (US 2004/0264860) as applied to claim 1 above, and further in view of Hu (US 2012/0045169 – of record).
Regarding claim 10, Mirkin in view de Montmorillon and Royer 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.
Response to Arguments
With respect to the claim rejection(s) under 35 U.S.C. § 103, Applicant’s amendment(s) to the claim(s) has/have overcome the claim rejection(s). Therefore, the rejections are withdrawn. However, upon further consideration, a new ground of rejection is made in view of Royer (US 2004/0264860). Applicant’s arguments are moot in view of the new grounds of rejection.
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.
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
