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 .
Election/Restrictions
Amended claim 45 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Applicant has elected the device in the response for restriction/election dated July 2, 2025. The Examiner notes that claim 45 is directed to a method for manufacturing/producing a medical implant structure.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 45 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of the Claims
This Office Action is responsive to the amendment filed February 9, 2026. As directed by the amendment: Claims 1-24 have been cancelled. Claims 48-50 are newly added. Claims 25-35, 45, and 47 have been withdrawn. Claims 36-44 and 46 have been amended. Claims 25-50 are presently pending in this application.
Examiner’s Note
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.
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) 36-44, 46, and 48-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Preiss-Bloom et al. (US 2021/0369314), herein referred to as Preiss-Bloom, and in view of Terzian et al. (US 5,198,173), herein referred to as Terzian.
Regarding claim 36, Preiss-Bloom discloses a molded fiber-reinforced medical implant structure (Abstract and figure 7), comprising a fiber-reinforced rigid insert (706, 708) (figure 7), wherein the fiber-reinforced rigid insert (706, 708) includes continuous fibers (¶396 and figure 7) that are impregnated with at least one first thermoplastic polymer (¶94 and figure 7), and at least one second thermoplastic polymer (702) (¶94 and figure 7), such that the fiber-reinforced rigid insert (706, 708) is covered by over-molding (¶327) by the at least one second thermoplastic polymer (702) (¶94 and figure 7) in the molded fiber-reinforced medical implant structure (figure 7), wherein the at least one first thermoplastic polymer (¶94 and figure 7) and the at least one second thermoplastic polymer (¶94 and figure 7) are the same or different (¶94).
Yet, Preiss-Bloom’s figure 7 embodiment lacks a detailed description on the at least one second thermoplastic polymer further contains additive(s), wherein the additive is at least one of calcium phosphate, beta-tricalcium phosphate (beta-TCP), glass particles, and mineral additive(s).
However, Preiss-Bloom teaches in an alternative embodiment, an additional section or layer comprises an additive (¶335), wherein the additive is at least one of calcium phosphate (¶336), beta-tricalcium phosphate (beta-TCP) (¶336), glass particles, and mineral additive(s).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Preiss-Bloom’s molded fiber-reinforced medical implant structure having the at least one second thermoplastic polymer with additive(s) (e.g. calcium phosphate, beta-tricalcium phosphate) as taught by Preiss-Bloom, since such material(s) are osteoconductive (¶336).
The modified Preiss-Bloom’s molded fiber-reinforced medical implant structure further lacks a detailed description on the fiber-reinforced rigid insert being controllably expanded towards mold walls during the over-molding (the Examiner notes such features are considered a product by process).
However, Terzian teaches a rigid insert (30) being controllably expanded (col. 5, ll. 30-34) towards mold walls (12) during over-molding (col. 1, ll. 6-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Preiss-Bloom’s fiber-reinforced rigid insert with a rigid insert being controllably expanded towards mold walls during the over-molding as taught by Terzian, since such a modification is considered a product by process.
Regarding claim 37, the modified Preiss-Bloom’s molded fiber-reinforced medical implant structure has wherein the molded fiber-reinforced medical implant structure has a shape of a pate, screw, or nail (¶351 of Preiss-Bloom).
Regarding claim 38, the modified Preiss-Bloom’s molded fiber-reinforced medical implant structure has wherein the at least one second thermoplastic polymer comprises plain thermoplastic polymer (¶94 of Preiss-Bloom), or a polymer blend.
Regarding claim 39, the modified Preiss-Bloom’s molded fiber-reinforced medical implant structure has wherein the molded fiber-reinforced medical implant structure comprises one or more of polymeric fiber(s), glass fiber(s) (¶164 of Preiss-Bloom), carbon fiber(s), and aramid fiber(s) impregnated with the at least one first thermoplastic polymer (¶94 and figure 7 of Preiss-Bloom).
Regarding claim 40, the modified Preiss-Bloom’s molded fiber-reinforced medical implant structure has wherein the fiber-reinforced rigid insert (706, 708 of Preiss-Bloom) comprises multiple layers of continuous fibers (¶396 and figure 7 of Preiss-Bloom), with each layer being in a selected fiber orientation in the fiber-reinforced rigid insert (¶396 and figure 7 of Preiss-Bloom).
Regarding claim 41, the modified Preiss-Bloom’s molded fiber-reinforced medical implant structure has wherein the fiber-reinforced rigid insert comprises multiple layers of continuous fibers (¶396 and figure 7 of Preiss-Bloom), with each layer being in a selected fiber orientation in the fiber-reinforced rigid insert (¶396 and figure 7 of Preiss-Bloom) and a 3D printed construction 3D printed on top of the layered fiber-reinforced rigid insert (¶327, ¶329 of Preiss-Bloom).
Regarding claim 42, the modified Preiss-Bloom’s molded fiber-reinforced medical implant structure has wherein the fiber-reinforced rigid insert comprises multiple layers of continuous fibers (¶396 and figure 7 of Preiss-Bloom), with each layer being in a selected fiber orientation in the fiber-reinforced rigid insert (¶396 and figure 7 of Preiss-Bloom) and a 3D printed construction 3D printed on a core of the layered fiber-reinforced rigid insert (¶327, ¶329 of Preiss-Bloom).
Regarding claim 43, the modified Preiss-Bloom’s molded fiber-reinforced medical implant structure has wherein the fibers (708) are at least as long as a shortest dimension of the molded fiber-reinforced medical implant structure, a thinnest wall thickness, or any other dimension determined by a geometry of the molded fiber-reinforced medical implant structure (figure 7 of Preiss-Bloom).
Regarding claim 44, the modified Preiss-Bloom’s molded fiber-reinforced medical implant structure has wherein the fiber-reinforced rigid insert (706, 708 of Preiss-Bloom) is located in a core of the molded fiber-reinforced medical implant structure (¶396 and figure 7 of Preiss-Bloom), or inside the medical implant structure.
Regarding claim 46, Preiss-Bloom discloses a medical implant comprising a medical implant structure (Abstract and figure 7), the medical implant structure comprising a fiber-reinforced rigid insert (706, 708) (figure 7), wherein the fiber-reinforced rigid insert (706, 708) includes continuous fibers (¶396 and figure 7) that are impregnated with at least one first thermoplastic polymer (¶94 and figure 7), and at least one second thermoplastic polymer (702) (¶94 and figure 7), such that the fiber-reinforced rigid insert (706, 708) is covered by over-molding (¶327) by the at least one second thermoplastic polymer (702) (¶94 and figure 7) in the molded fiber-reinforced medical implant structure (figure 7), wherein the at least one first thermoplastic polymer (¶94 and figure 7) and the at least one second thermoplastic polymer (¶94 and figure 7) are the same or different (¶94).
Yet, Preiss-Bloom’s figure 7 embodiment lacks a detailed description on the at least one second thermoplastic polymer further contains additive(s), wherein the additive is at least one of calcium phosphate, beta-tricalcium phosphate (beta-TCP), glass particles, and mineral additive(s).
However, Preiss-Bloom teaches in an alternative embodiment, an additional section or layer comprises an additive (¶335), wherein the additive is at least one of calcium phosphate (¶336), beta-tricalcium phosphate (beta-TCP) (¶336), glass particles, and mineral additive(s).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Preiss-Bloom’s medical implant structure having the at least one second thermoplastic polymer with additive(s) (e.g. calcium phosphate, beta-tricalcium phosphate) as taught by Preiss-Bloom, since such material(s) are osteoconductive (¶336).
The modified Preiss-Bloom’s medical implant structure further lacks a detailed description on the fiber-reinforced rigid insert being controllably expanded towards mold walls during the over-molding (the Examiner notes such features are considered a product by process).
However, Terzian teaches a rigid insert (30) being controllably expanded (col. 5, ll. 30-34) towards mold walls (12) during over-molding (col. 1, ll. 6-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Preiss-Bloom’s fiber-reinforced rigid insert with a rigid insert being controllably expanded towards mold walls during the over-molding as taught by Terzian, since such a modification is considered a product by process.
Regarding claim 48, the modified Preiss-Bloom’s molded fiber-reinforced medical implant structure has wherein the at least one second thermoplastic polymer comprises one or more of homopolymer(s), copolymer(s) (¶94 of Preiss-Bloom), and terpolymer(s).
Regarding claim 49, the modified Preiss-Bloom’s molded fiber-reinforced medical implant structure has wherein the at least one second thermoplastic polymer further contains one or more of chopped carbon fibers and chopped fiber glass (¶50, ¶164 of Preiss-Bloom), as additive(s) (¶335 of Preiss-Bloom).
Regarding claim 50, the modified Preiss-Bloom’s molded fiber-reinforced medical implant structure has wherein the fibers (figure 7 of Preiss-Bloom) are at least as long as a longest main dimension, diameter, or other dimension of the molded fiber-reinforced medical implant structure (figure 7 of Preiss-Bloom).
Response to Arguments
Applicant's arguments filed February 9, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 9-11, under 35 U.S.C. 103, of the Remarks are directed to the amended claim 36 and the reference Preiss-Bloom. Applicant argues the amended feature of “the fiber-reinforced rigid insert being controllably expanded towards mold walls during the over-molding”. Thus, the Examiner has relied upon the reference Terzian to teach applicant’s amended features. Lastly, the Examiner notes such a feature is considered a product by process.
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 SI MING KU whose telephone number is (571)270-5450. The examiner can normally be reached Monday-Friday, 9:30am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SI MING KU/Primary Examiner, Art Unit 3775
Prosecution Insights