DETAILED ACTION
Notice of Pre-AIA or AIA
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 § 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.
Claims 1 and 3-18 are rejected under 35 U.S.C. 103 as being unpatentable over Carbofix (WO 2016/035010) in view of Newman (US 20170042593). All references have been cited in a prior Office action.
Regarding claims 1, 3, 4-5, 7-12, and 14-18, Carbofix teaches a composite of polyetheretherketone (PEEK) containing at least 50 volume % carbon fiber reinforcement, leaving room for up to 50 volume % PEEK matrix (p. 29, lines 3-5). The composition may be used in a bone plate implant (p. 3, lines 13-15). The terms “trauma” and “fracture” in claim 16 pertain solely to the intended use or field of use; Carbofix teaches bone plates formed from identical materials, which will necessarily be capable of performing the intended uses. Carbofix teaches use of the composite as a tape (p. 40, lines 12-13), and a method of manufacturing implant components using compression molding (p. 46, line 9).
Further, that Carbofix teaches the use of radiopaque markers to enable visualization under imaging (p. 11, lines 19-21). Carbofix does not teach barium sulfate.
Newman teaches a medical implant comprising PEEK and carbon fiber (Abstract). A radiopaque material such as barium sulfate may also be included in amounts ranging from 4-30 wt% (p. 2, [0040]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select 4-30 wt% of BaSO4 as the radiopaque additive (contrast agent) in Carbofix’s composite, as Newman demonstrates its suitability in this amount for use in this capacity in similar composite materials with similar end uses. It is prima facie obvious to select a known material based on its art-recognized suitability for its intended use. See MPEP 2144.07. This prior art range overlaps or encompasses all claimed ranges. A prima facie case of obviousness exists where the prior art range overlaps or encompasses the claimed range. See MPEP 2144.05.
Regarding claims 6 and 13, Carbofix remains as applied to claim 1 above. As previously discussed, Carbofix's carbon fiber content may range from 50-100 vol%, and PEEK content may range from 0-50 vol%, allowing volume ratios of fiber to PEEK ranging from 50:0 to 100:50, which encompasses the claimed range of 1.1-1.5:1. A prima facie case of obviousness exists where the prior art range encompasses the claimed range. See MPEP 2144.05.
Response to Arguments
Applicant’s arguments, see page 6, filed 29 December 2025, with respect to the rejections of claims 1 and 3-18 under 35 U.S.C. 103 have been fully considered and are not persuasive.
The Applicant argues that the previous rejection says nothing about the claimed amount of barium sulfate.
Newman teaches 4-30 wt% of barium sulfate as a radiopaque agent as discussed in the rejection above.
The Applicant argues that Carbofix uses a relatively low amount of radiopaque agent.
Newman demonstrates a suitable amount of a radiopaque agent to include in similar compositions with similar end uses. The claimed range would be met even if one of ordinary skill in the art were to limit experimentation to the lowest portion of Newman’s range when modifying Carbofix.
The Applicant argues that the claimed invention demonstrates unexpected results that are evidence of nonobviousness.
Whether unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support. In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. See MPEP 716.02(d). Claim 1 requires a polyaryletherketone (PAEK), whereas the examples presented in the specification do not indicate whether PAEK is present (see, e.g., p. 16, Table 1). Claim 1 is open to any type of reinforcement fiber, whereas the examples employ only carbon fiber. The claims allow for 52-58 vol% of reinforcement fiber and 3-15 wt% of barium sulfate, whereas the examples include either 55 or 58 vol% of carbon fiber and 4, 5, or 6 wt% barium sulfate. Neither the amounts or materials representative of the reinforcement fiber and contrast agent are commensurate in scope with the claims, and because the matrix resin is not specified, it is unclear whether the examples in the specification fall within the scope of the claims. The experimental data is not reasonably commensurate in scope with the claims and therefore cannot be relied upon to establish non-obviousness.
All of Applicant’s arguments are believed to have been addressed in full above.
Conclusion
THIS ACTION IS MADE FINAL. 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 ELIZABETH K AMATO whose telephone number is (571)270-0341. The examiner can normally be reached 8:30 am - 4:30 pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rob Jones can be reached at (571) 270-7733. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ELIZABETH K. AMATO
Examiner
Art Unit 1762
/ROBERT S JONES JR/Supervisory Patent Examiner, Art Unit 1762