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 . This action is in response to the Applicant
Arguments/ Remarks Made in an Amendment received on June 15, 2026. Claims 1 and 80-89 are currently pending.
Response to Arguments
Applicant's arguments filed June 15, 2026 have been fully considered but they are not persuasive, because the prior art reference, Preiss-Bloom et al. (US Publication 2021/0369314) anticipates amended claim 1 (see the rejection below).
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 80, and 84-86 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Preiss-Bloom et al. (US Publication 2021/0369314), hereinafter “Preiss-Bloom”.
Regarding claim 1, Preiss-Bloom discloses a composite comprising: a core region and at least one outer region (i.e., an implant 700 having an internal core 706 and an outer shell 702 (see Figure 7, paragraphs 396-399]; wherein the core region comprises a degradable and bioabsorbable polymeric matrix material (i.e., the biocomposite matrix is a polymer resin that is degradable and bioabsorbable [paragraphs 350-367]); one or more fiber bundles dispersed in the polymeric matrix material of the core region, the one or more fiber bundles including a plurality of degradable fibers and/or filler (i.e., the strands comprise continuous reinforcement fibers or bundles impregnated with bioabsorbable polymer [paragraph 276] and the internal core contains a plurality of wound fibers 708 [paragraph 0396]); wherein the polymeric matrix material of the core region, the degradable fibers and/or the filler of the core region, or both are configured to be degradable according to a predetermined degradation profile (i.e., the mechanical-strength degradation rate approximates the material-degradation measured by weight loss [paragraph 0358] and that the implant retains greater than 50% of its mechanical strength after three months while greater than 50% material degradation and weight loss occurs within twelve months [paragraphs 359-0361]; wherein the core region comprises a plurality of layers that comprise the degradable fibers and/or the filler (see the outer shell 702 of Figure 7 containing a plurality of straight fibers 704 [paragraphs 397-399]; wherein the at least one outer region comprises a degradable and bioabsorbable polymeric matrix material and a plurality of degradable fibers and/or filler dispersed in the polymer matrix material of the at least one outer region (i.e., the biodegradable composite layers comprise continuous reinforcement fibers embedded in a polymer matrix comprising one or more bioabsorbable polymers and that the reinforcing filler may comprise biodegradable glass or a bioabsorbable polymer fiber[paragraphs 0155-0159]).
Regarding claim 80, Preiss-Bloom discloses wherein the degradable fibers and/or the filler of the core region differ from the degradable fibers and/or the filler of the at least one outer region in one or more of the following ways: ion makeup and/or amounts; composition; concentration; density; form; average size; at least one dimension; average diameter; Ca/P ratio; solubility; porosity; average porosity; average pore size; distribution of pore sizes; pore volume; pore structure; pore orientation; surface roughness; aspect ratio; specific surface area; composition; solubility; fabrication method; surface charge; wetting angle (i.e., The limitations form, at least one dimension and fabrication method are described in the prior art. The implant comprises and internal core 706 containing would fibers 708, whereas outer shell 702 contains straight parallel fibers 704 [paragraphs 396-399]. The fibers in the core differ from those in the outer region at least in form, configuration, orientation, and fabrication arrangement.).
Regarding claim 84, Preiss-Bloom discloses wherein the at least one outer region comprises a plurality of outer regions, and one or more outer regions of the plurality of outer regions comprise a same or different material as one or more other outer regions of the plurality of outer regions (i.e., Six full length fiber containing layers extending along the implant and positioned outwardly from five helical internal layers [paragraph 394]. The outer shell 702 contains a plurality of straight parallel fibers 704 and regions having straight parallel fibers in the outer shell and wound fibers in the core [paragraphs 396-399]).
Regarding claim 85, Preiss-Bloom discloses wherein the at least one outer region comprises a plurality of layers (i.e., Six full length fiber containing layers extending along the implant and positioned outwardly from five helical internal layers [paragraph 394]. The outer shell 702 contains a plurality of straight parallel fibers 704 and regions having straight parallel fibers in the outer shell and wound fibers in the core [paragraphs 396-399]).
Regarding claim 86, Preiss-Bloom discloses wherein the plurality of layers of the at least one outer region comprises at least two layers which each comprise the degradable fibers and/or the filler of the at least one outer region, which at least two layers differ in one or more of the following ways: ion makeup and/or amounts of the degradable fibers and/or the filler; concentration of the degradable fibers and/or the filler; average diameter of the degradable fibers and/or the filler; aspect ratio of the degradable fibers and/or the filler; fabrication method of the degradable fibers and/or the filler; density of the degradable fibers and/or the filler; form of the degradable fibers and/or the filler; average size of the degradable fibers and/or the filler; at least one dimension of the degradable fibers and/or the filler; Ca/P ratio of the degradable fibers and/or the filler; specific surface area of the degradable fibers and/or the filler; surface charge of the degradable fibers and/or the filler; solubility of the degradable fibers and/or the filler; porosity of the degradable fibers and/or the filler average porosity by volume of the degradable fibers and/or the filler; average pore size of the degradable fibers and/or the filler; distribution of pore sizes of the degradable fibers and/or the filler; pore volume of the degradable fibers and/or the filler; pore structure of the degradable fibers and/or the filler; pore orientation of the degradable fibers and/or the filler; surface roughness of the degradable fibers and/or the filler; wetting angle of the degradable fibers and/or the filler; composition of the degradable fibers and/or the filler (i.e., the bolded limitations are taught by the prior art. Two layers contain 5 mm chopped fibers in the head region; one layer containing 15 mm chopped fibers in the distal threaded region, and six layers contain full implant length fibers along the implant length. The difference in fiber length satisfies the “average size” and/or “at least one dimension”).
Allowable Subject Matter
Claims 81-83 and 87-88 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.
Regarding claim 89, none of the prior art discloses core fiber bundles have a fiber volume of about 25% or more; a core later has a fiber volume of about 25-75%; and outer-region fiber volume of about 5% or more.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 DIANA S JONES whose telephone number is (571)270-5963. The examiner can normally be reached Monday to Friday (8am to 4pm EST).
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/Diana Jones/Examiner, Art Unit 3775
/KEVIN T TRUONG/Supervisory Patent Examiner, Art Unit 3775
