DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claim(s) 1, 3, 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Limem et al. 2019/0151081.
Regarding claims 1, 3 and noting figures 12-13, Limem et al. discloses the invention as claimed comprising: A method comprising: a) applying a gas pressure around a polymer fiber solution comprising a polymer fiber to eject the polymer fiber solution; and b) collecting the polymer fiber by a collector to form a scaffold, wherein the scaffold is suitable for use as a meniscal repair device, and wherein the collector comprises a shape of a meniscus (see [0067] which states:
“[0067] Dry spun microfiber outer layers suitable for making the implants may be produced from a polymer solution by pumping the solution through a spinneret with numerous holes. A suitable equipment set up comprises a source of compressed gas, preferably air, a regulator to control the gas pressure, an inline heater to control compressed air temperature, a pump drive to control the injection rate of the polymer solution, a spinneret with multiple holes through which the polymer solution is pumped, and a collector, preferably a collector that can rotate. The microfiber layers are produced by dissolving the polymer in a volatile solvent and pumping the polymer solution through a spinneret, allowing the solvent time to evaporate so that fibers solidify from the solution and can be collected as a micro-fibrous nonwoven. Properties of the dry spun nonwoven may be optimized by controlling the concentration of the polymer in the solution, the solvent type, the weight average molecular weight of the polymer, type of polymer, gas pressure, the distance between the spinneret and the collector, and the movement of the collector, if any.”
Regarding claim 3, Limem et al. discloses that the scaffold comprising the shape of the meniscus (see [Example 5.]).
Regarding claim 6, MPEP 2173.05(b) III Approximations
III. APPROXIMATIONS
A. "About"
In determining the range encompassed by the term "about," one must consider the context of the term as it is used in the specification and claims of the application. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007). In W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), the court held that a limitation defining the stretch rate of a plastic as "exceeding about 10% per second" is definite because infringement could clearly be assessed through the use of a stopwatch. However, in another case, the court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
Limem et al. discloses that the collector rotates at least about 10 rpm noting that 12 rpm is about 10 rpm. See ([0103]).
Regarding claims 8 and 10, Limem et al. meets the limitation of the claim see [0100] which states “…The speed of the belt collector was varied..”.
Regarding claim 11 see [0101]. Regarding claim 14, see gas air pressure as disclosed supra in [0067].
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) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Limem et al. 2019/0151081. Limem et al. has been disclosed supra and discloses that the fibers may comprise collagen (see claim 9). It would have been obvious to one having ordinary skill in the art to modify the invention of Limem et al. and utilize a type I collagen, a type II collagen, a methacrylated collagen because the term collagen is broad and may encompass a variety of collagens.
Claim(s) 15 and 23, 28 are rejected under 35 U.S.C. 103 as being unpatentable over Limem et al. in 2019/0151081 view of Behrens et al. 2015/0290356.
Limem et al. has been disclosed, however does not disclose applying the gas pressure around the polymer fiber solution using an air brush. Noting figure 1, Behrens et al. teaches that an airbrush with a nozzle to eject a polymer solution may be utilized with biocompatible polymers to produce blown spun scaffold [0043].
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It would have been obvious to one having ordinary skill in the art to modify the invention of Limem et al. and use an airbrush for the production of the implant in order to give more control and detail to the production of the meniscus scaffold.
Regarding claim 28 see supra with regards to the term “about” which is broad. It is obvious that the limitation of “b” as recited in claim 1 may be performed within the broad range of time.
Claim(s) 100 is rejected under 35 U.S.C. 103 as being unpatentable over Limem et al. in view of Williams et al. 2020/0390 et al.
Limem et al. has been disclosed supra however does not disclose crosslinking at least a subset of the plurality of polymer fibers. Williams et al. teaches manufacturing scaffold implants such as meniscus repair devices [0084] by using polymer fibers (see abstract and [0006; 0009; 0076; 0079; 0134-0135; 0511; 0513] etc.) and electrospinning [0314] in conjunction with a collector [0314] and crosslinking [0091; 0112; 0140-0141]. It would have been obvious to one having ordinary skill in the art to modify the invention of Limem et al. and utilize cross-linking on the fibers as it is well known in the art for stabilizing and enhancing the structural integrity and wear upon implantation.
Allowable Subject Matter
Claims 2, 16-22, 26, 31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 49 is allowed.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claims 16-22, 26, 28, 31 the prior art does not disclose or teach in combination with independent claims 1 or 15 that: “the collector comprises a first curvature and a second curvature on a surface of the collector, wherein a degree of curvature of the first curvature and a degree of curvature of the second curvature are different”;
“the polymer fiber solution moves into the air brush via an electromagnetic pressure, an electromechanical pressure, gravity, a hydraulic pressure, a mechanical extrusion pressure, a pneumatic pressure, or a combination thereof”;
“that the air brush comprises an inner feed line or an outer feed line”.
Conclusion
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 September 29, 2026
