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
Claim 39 depends from withdrawn claim 38 and therefore is withdrawn from consideration. It appears the claim was marked as original instead of withdrawn in error in the claim set submitted 3/2/2026. It is noted that the Nonfinal office action dated 10/28/2025 already withdrew claim 39 from consideration.
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) 17 and 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wei (2018/0296343A1).
In regard to claim 17, Wes teaches a 3D-printed scaffold 70 formed from a composite filament 40 comprising:
a matrix formed from a blend comprising a bioresorbable polymer [0081: bioresorbable biopolymer] and an inorganic component [0186: examples of porogens include sodium chloride; salts are inorganic components; the claim does not require the inorganic substance to remain as part of the implant]
wherein the inorganic component is formed of particles having sizes within a range of about 1 to about 25 microns. [0185: porogen diameter ranging from approximately 5 microns to approximately 1 nanometer] It is noted that the specification has defined “about” as within 20% and accordingly the claimed range is actually 0.8 microns to 30 microns.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05I
In regard to claim 33, West meets the claim limitations as discussed in the rejection of claim 17, and further teaches wherein the 3D-printed scaffold 70 is porous. (fig 4, 5B)
In regard to claim 34, Wes meets the claim limitations as discussed in the rejection of claim 17, and further teaches the bioresorbable polymer to the inorganic component in the composite filament has a weight ratio in a range between about 20:1 and about 1:1, between about 10:1 and about 1:1, between about 5:1 and about 1:1, between about 2:1 and about 1:1, or about 1:1. [0185: The amount of porogen may vary in the porous implant from 1-80% by weight]. Accordingly, 1:1 weight ratio is within 1-80% (50%) by weight.
It is noted that “about” in the instant disclosure refers to within 20% of.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wei (2018/0296343A1) in view of Lin (2020/0253727A1).
In regard to claim 31, Wes meets the claim limitations as discussed in the rejection of claim 17, but does not teach a compressive modulus between 32-240MPa.
Lin teaches a support comprising a compressive modulus between about 40 and about 200 MPa. “About” is defined in the instant disclosure as within 20%. Accordingly, the claimed range is actually 32-240MPa. [0084: 150MPa]
It would have been obvious to one of ordinary skill in the art of implantable devices and scaffolds at the time the invention was filed to modify the scaffold of Wei to have the modulus as taught by Lin because this matches the compressive modulus of bone [0084: bone has a compressive modulus of about 150MPa].
Response to Arguments
In regard to the 112b rejection of claims 17 and 34, the amendments overcome the rejections.
In regard to the 102(a)(1) rejection of claims 17 and 33 as anticipated by Wei (2018/0296343A1), the applicant’s arguments have been fully considered but are all directed towards new claim limitations which have been addressed above.
In regard to the 103(a) rejection of claim 31 as unpatentable over Wei (2018/0296343A1) in view of Lin (2020/0253727A1), the applicant’s arguments have been fully considered. The applicant has submitted post filing sheep study data. “The arguments of counsel cannot take the place of evidence in the record. Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant.” MPEP 716(C) While the submitted experiment appears to show the scaffold with TCP performed better than the straight polymer scaffold, the relevance of this experiment as related to the prior art or current rejection are not clear.
In regard to the 103(a) rejection of claim 34 as unpatentable over Wei (2018/0296343A1), no further arguments have been submitted.
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 CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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