DETAILED ACTION
The following is a non-final office action is response to communications received on 03/17/2023. Claims 1-20 are currently pending and addressed below.
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 § 112
Claim 20 is 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 20 recites the limitation "the micropore" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it is assumed that Claim 20 was intended to depend from claim 19.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 7, 8, 10-13 & 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (US 11,179,416).
Regarding Claim 1, Sharma discloses the invention substantially as claimed. Sharma teaches an orthopedic repair scaffold (Col 12: lines 1-5), wherein the orthopedic repair scaffold is a three-dimensional porous (Col 13: lines 1-4) scaffold (Col 12: lines 1-5), a material of the orthopedic repair scaffold comprises a biodegradable polymer (Col 13: lines 4-7 & 19-32) and a biodegradable nanoparticle (Col 12: lines 36-41), and the biodegradable nanoparticle is a nanoparticle of manganese compound (Col 12: lines 36-41).
However, Sharma does not specifically disclose wherein a material of the orthopedic repair scaffold comprises the following components in mass percentage: 80%-95% of a biodegradable polymer and 5%-20% of a biodegradable nanoparticle.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Sharma device to comprise the following components in mass percentage: 80%-95% of a biodegradable polymer and 5%-20% of a biodegradable nanoparticle, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Sharma teaches that manganese nanoparticles can be utilized in the repair of tissue (Col 2: lines 35-54), reducing oxidative stress (Col 3: lines 13-19) by catalyzing hydrogen peroxide at the site (Col 7: lines 36-46 & Col 9: lines 52-56) and therefore providing a therapeutic effect to the tissue. Sharma teaches wherein the optimal dosage of manganese dioxide nanoparticles is easily ascertainable by a person of ordinary skill and will depend upon the joint size, condition severity, and the physical parameters of the patient (Col 5: lines 44-50). Sharma teaches that therapeutic doses can be determined by standard pharmaceutical procedures (Col 17: line 44 – Col 18: line 13) to produce an effective dosage for any particular subject. As the dosage (i.e., weight percentage) is easily determined by testing, modifying the Sharma device to comprise a 5%-20% mass percentage of a biodegradable manganese nanoparticle, would require only routine skill in the art. Further, as the biodegradable polymer provides the matrix material for the scaffold device, it would be obvious that the biodegradable polymer would comprise the remaining 80%-95% mass percentage (after the therapeutic amount was discovered).
Regarding Claim 2, the combination teaches wherein the manganese compound is selected from one or more than two of manganese dioxide (Col 5: lines 44-46), trimanganese tetraoxide, manganese gluconate, manganese chloride, manganese acetate, manganese dihydrogen phosphate, manganese carbonate, manganese sulfate, and manganese carbonyl.
Regarding Claim 3, the combination teaches wherein the nanoparticle of manganese compound has a particle size of 1 nm to 1,000 nm (Col 6: lines 23-27).
Regarding Claim 4, the combination teaches wherein the biodegradable polymer is selected from one or more than two of a polylactic acid-glycolic acid copolymer, polylactic acid, polylactic acid-glycolic acid, and polycaprolactone (Col 13: lines 33-54).
Regarding Claim 7, as set forth supra, Sharma (the combination) teaches the device as set forth in the rejection of claim 1. Further, Sharma teaches wherein the device is prepared by preparing the homogeneous solution through a curing molding process (e.g., bioplotter) into a molded three-dimensional porous scaffold (Col 14: lines 40-47); and freeze-drying the molded three-dimensional porous scaffold to obtain the orthopedic repair scaffold (Col 14: lines 40-47).
Regarding Claim 8, the combination teaches wherein in the step of preparing the homogeneous solution, the biodegradable polymer and the biodegradable nanoparticle are combined in a manner of stirring mixing or chemical reaction (Col 14: lines 12-23); and the curing molding process is a 3D printing molding process (the bioplotter taught in Col 14: lines 40-47), a fused deposition molding process, a template molding process or a pore-forming agent adding molding process (Col 14: lines 40-47).
Regarding Claims 10, 11 & 13, the combination teaches the method of using the device as set forth in the rejection of claims 2-4 supra.
Regarding Claim 12, the combination teaches wherein the nanoparticle of manganese compound has a particle size of 100 microns to 300 microns (Col 6: lines 23-27).
Regarding Claims 15-18, the combination teaches the method of using the device as set forth in the rejection of claims 1-4 supra.
Claim(s) 5-6, 14 & 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (US 11,179,416) in view of Liu et al. (US 2019/0009004).
Regarding Claim 5, as set forth supra, the combination discloses the invention substantially as claimed. Further, Sharma teaches wherein a micropore in the three-dimensional porous scaffold has a pore diameter of 300 to 500 microns (Col 14: lines 24-39).
However, the combination does not disclose wherein the three-dimensional porous scaffold has a porosity of 60%-80%.
Liu teaches an orthopedic scaffold in the same field of endeavor. Said scaffold comprising a porosity of between about 50% and 70% to allow for the infiltration of cells following implantation [0014].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the device of the combination to comprise a porosity of 60%-80% in order to allow for cellular ingrowth and infiltration following implantation.
Regarding Claim 6, the combination teaches wherein the micropore at least penetrates through two opposite surfaces of the three-dimensional porous scaffold (result of any of the methods discussed in Sharma Col 14: lines 40-47, and a required orientation to allow for cellular infiltration/ingrowth).
Regarding Claims 19-20, the combination teaches the method of using the device as set forth in the rejection of claims 5-6 supra.
Regarding Claim 14, the combination teaches the method of preparing the device as set forth in the rejection of claim 5 supra.
Allowable Subject Matter
Claim 9 is 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774