Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 11-13 and 19-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jardan-Smith et al. (WO2010/007424) in view of Wang et al. (“An investigation of friction and wear properties of nanometer Si3N4 filled PEEK” Wear, Vol. 196, 1996, pp. 82-86) and Voisard et al. (USPGPub 2012/0310368).
Regarding claims 11-13 and 19-21, Jardan-Smith teaches that it is known to incorporate “fugitive material” or fillers into PEEK implants such as TCP or sodium chloride for the purpose of providing bioactive components or porosity to a craniomaxillofacial implant or a spinal implant (see pg-24-25). Jardan-Smith fails to teach wherein the implant material filler is a silicon nitride material. However, Wang teaches that it is known to fill PEEK with Si3N4 in order to increase the thermal stability, resistance to dissolution and wear resistance of a part formed from PEEK (see Introduction). Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to fill the PEEK material implant of Jardan-Smith with the silicon nitride material of Wang in order to provide the improvement in qualities to PEEK described by Wang. Further, the discovery of a previously unappreciated property (such as improved antibacterial properties and bone-forming characteristics such as osteoblast proliferation) of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112. A reference which is silent about a claimed invention’s features is inherently anticipatory if the missing feature is necessarily present in that which is described in the reference. Inherency is not established by probabilities or possibilities. In re Robertson, 49 USPQ2d 1949 (1999). Furthermore, each claim must include all elements which applicant has described as essential. See, e.g., Johnson Worldwide Assoc. Inc. v. Zebco Corp., 175 F.3d at 993, 50 USPQ2d at 1613; MPEP 2163, Section II, Subsection A, Subsection 3, Subsection (b). As such, if it is not the mere presence of silicon nitride in the PEEK material that provides the essential bone forming or antibacterial characteristics of the current claims, then whatever provides those qualities must be present in the claim. The teachings of Jardan-Smith in view of Wang are as shown above. Jardan-Smith in view of Wang fails to teach wherein the Si3N4 employed is specifically alpha or beta Si3N4. However, given a limited number of possible phases of Si3N4 (i.e., beta, alpha and etc) it would have been considered “obvious to try” for one of ordinary skill in the art before the effective filing date of the claimed invention to use any phase of Si3N4 wherein all solutions would presumably function in a predictable manner and have a reasonable expectation of success. The teachings of Jardan-Smith in view of Wang are as shown above. Jardan-Smith in view of Wang fails to teach wherein the material employed is PEKK. However, Voisard teaches that for the purposes of forming medical implants PEKK is a known substitute for PEEK and that both materials are of a known limited class of materials referred to as PAEKs (claim 17). Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to replace the PEEK of Jardan-Smith in view of Wang with the PEKK of Voisard as a simple substitution of one known surgical implantable PAEK for another.
Claims 13-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kuyler et al. (USPGPub 2020/0337860) in view of Wang et al. (“An investigation of friction and wear properties of nanometer Si3N4 filled PEEK” Wear, Vol. 196, 1996, pp. 82-86).
Regarding claims 13-15 and 18-21, Kuyler teaches that it is known to form implant comprising a diamond lattice core, 3D printed [0101] from PEEK and its composites including ceramic composites [0114] wherein the implant may comprise an outer shell and several parts that may read upon and inner shell as well as several parts that may read upon a “support hole”. Kuyler fails to teach wherein the implant material filler is a silicon nitride material. However, Wang teaches that it is known to fill PEEK with Si3N4 in order to increase the thermal stability, resistance to dissolution and wear resistance of a part formed from PEEK (see Introduction). Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to fill the PEEK material implant of Kuyler with the silicon nitride material of Wang in order to provide the improvement in qualities to PEEK described by Wang. Further, the discovery of a previously unappreciated property (such as improved antibacterial properties and bone-forming characteristics) of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112. A reference which is silent about a claimed invention’s features is inherently anticipatory if the missing feature is necessarily present in that which is described in the reference. Inherency is not established by probabilities or possibilities. In re Robertson, 49 USPQ2d 1949 (1999). Furthermore, each claim must include all elements which applicant has described as essential. See, e.g., Johnson Worldwide Assoc. Inc. v. Zebco Corp., 175 F.3d at 993, 50 USPQ2d at 1613; MPEP 2163, Section II, Subsection A, Subsection 3, Subsection (b). As such, if it is not the mere presence of silicon nitride in the PEEK material that provides the essential bone forming or antibacterial characteristics of the current claims, then whatever provides those qualities must be present in the claim. The teachings of Kuyler in view of Wang as shown above. Kuyler in view of Wang fails to teach wherein the Si3N4 employed is specifically alpha or beta Si3N4. However, given a limited number of possible phases of Si3N4 (i.e., beta, alpha and etc) it would have been considered “obvious to try” for one of ordinary skill in the art before the effective filing date of the claimed invention to use any phase of Si3N4 wherein all solutions would presumably function in a predictable manner and have a reasonable expectation of success. Further Kuyler teaches that for the purposes of forming medical implants PEKK is a known substitute for PEEK [0114]. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to replace the PEEK of Kuyler in view of Wang with the PEKK of Kuyler as a simple substitution of one known surgical implantable PAEK for another.
Regarding claim 16, the structures on the right side of the implant of Kuyler (Fig. 82) may be considered upper and lower surface “teeth” on the implant surface among other structures.
Regarding claim 17, the teachings of Kuyler in view of Wang are as shown above. Kuyler in view of Wang fails to teach the concentration of silicon nitride in terms of vol.%. However, Wang’s data indicates that the amount of silicon nitride filler clearly controls the physical properties of the filled PEEK (see Fig. 3). Therefore, in the absence of criticality of the specific silicon nitride volume percentage of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of silicon nitride by weight percentage (and therefore by volume percentage well) within a range in order to control the physical properties of the material of Kuyler in view of Wang in the same way. Discovery of optimum value of result effective variable in known process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J BOWMAN whose telephone number is (571)270-5342. The examiner can normally be reached Mon-Sat 5:00AM-11:00AM.
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/ANDREW J BOWMAN/Examiner, Art Unit 1717
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