FINAL REJECTION
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 .
Response to Amendment
On 6/25/2026, Applicant submitted an amendment to the application which contains an amended claim set and remarks. The amendment has been entered and considered for this Office action.
Response to Arguments
Applicant's arguments filed 6/25/2026 have been fully considered but they are not entirely persuasive.
The amendments are sufficient to overcome the §112(b) rejection raised in the previous Office action. In view of the amendments to the claims, new grounds of rejection under §102 are presented below. Therefore, this application is not in condition for allowance.
Claim Rejections - 35 USC § 102
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 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parimore et al., US 2008/0177387 A1 (hereinafter “Parimore”).
Regarding claim 1: Parimore discloses an implant system comprising:
a structural part which is implantable into a damaged tissue area (a vertebra damaged by tumor or trauma is removed and replaced by an implant, ¶ [0020]-[0021]) and which has:
at least one first region (central portion):
formed from a first material (e.g., titanium; ¶ [0028], [0030]),
is arranged to support the structural part (load-bearing central portion supports the remaining skeletal structures; ¶ [0020], [0028], [0030]) and
is substantially impenetrable for a specified radiation for diagnostics or for medical radiation therapy (the central portion is radiopaque; the metal can “prevent of severely impar” X-ray/fluoroscopic monitoring and substantially absorbs or reflects the diagnostic energy; ¶ [0025]-[0027]); and
at least one second region (end-caps/end members and the openings in the central portion that the end caps are fitted therein):
formed from a second material (e.g., PEEK, ¶ [0028], [0030]),
is arranged to supplement the first region to form the structural part (radiolucent end-caps/end members connect to the central portion and complete the implant; ¶ [0026], [0028], [0030], [0038]-[0039]) and
is provided with at least one section which is penetrable for the specified radiation for diagnostics or for medical radiation therapy (the end-cap material is radiolucent; i.e., substantially transmissive to that diagnostic energy; ¶ [0026]-[0027]).
Regarding claim 2: The second material is different from the first material (e.g., PEEK vs titanium, ¶ [0028], [0030]).
Regarding claim 3: The second of the second region is in the form of an insert in the first region (end-cap connectors 34 – sections of the radiolucent cap – snap-fit into openings in the central portion; ¶ [0042]-[0044]).
Regarding claim 4: The section of the second region is in the form of a cut-out in the first region (the openings in the central portion as discussed above regarding claims 1 and 3).
Regarding claim 5: The second of the second region has a lower material density than its surrounding area (the ordinarily skilled artisan would understand that PEEK has a lower density than titanium).
Regarding claim 6: The second region has a regular or irregular perforated grid structure (the aforementioned openings as part of the second region are arranged in a regular/irregular pattern to form a grid, ¶ [0043], [0045], [0047]).
Regarding claims 7 and 8: The first material is metallic material formed from titanium, titanium alloys, molybdenum, molybdenum alloys, magnesium, magnesium alloys, implantable stainless steels or a combination of at least two of these materials (titanium or alloys thereof, ¶ [0028], [0030]).
Regarding claims 9-12: The second material is in the form of a plastics material, ceramic material, composite or a resorbable combination of these:
wherein the plastics material is formed from PEEK (polyetheretherketone), PEKK (polyetherketoneketone), PE (polyethylene), PPSU (polyphenylsulfone), or a combination of at least two of these materials (PEEK, PEKK, UHMWPE, etc., ¶ [0028], [0030]);
wherein the ceramic material formed from aluminum oxide or zirconium oxide (aluminum oxide, zirconium oxide, ¶ [0028], [0030]);
wherein the resorbable component is composed of HA (hydroxyapatite), p-TCP (beta-tricalcium phosphate), combinations of HA/3-TCP, 3-TCP/Mg, PDLLA/Mg (poly-d,l-lactic acid), PDLLA/p-TCP, PDLLA/CaCC or similar materials (hydroxyapatite, calcium phosphate, etc., ¶ [0048]-[0049]).
Regarding claim 13: The radioactive radiation is particle radiation, in particular electron radiation, or wave radiation, in particular X-radiation (X-rays and fluoroscopy, ¶ [0025]-[0027]).
Regarding claim 14: The claim recites “wherein the structural part is designed to replace a damaged bone area in the region of the cranium or mandible”. This is being construed as a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the structural part to be used in the recited manner. In this case, since the device/system of Parimore is concerned with replacing damaged bones such as vertebrae, long bones, appendages, ribs, etc. (¶ [0021]), the ordinarily skilled artisan would have recognized that it could similarly be used to replace damaged bone in other regions such as the cranium or mandible.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Istephanous et al., US 2004/0243241 A1
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 COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M. RAYMOND can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
4 September 2026
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