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 .
Priority
The instant application is a CON of application 17/053,480 (now US 12,115,277) filed 6 November 2020 which is the national stage entry of PCT/EP2019/061011 filed 30 April 2019. Acknowledgement is made of the Applicant’s claim of foreign priority to application EP18171026.0 filed 7 May 2018. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-8 and 13-19) in the reply filed on 9 July 2026 is acknowledged. Claims 9-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of the Claims
Claims 1-19 are pending.
Claims 9-12 are withdrawn.
Claims 1-8 and 13-19 are rejected.
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 1-8 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Machado et al. (Journal of Nano Research Vol. 25 (2013) pp 67-76) in view of Sapieszko et al. (US 6,383,519).
Machado teaches a thin film composed of titanium nitride (TiN) doped with silver wherein the Ag ranges from 0-50 at% (abstract). The film can be used in the biomedical research area and, due to the low antibacterial activity of TiN alone, has the added benefit of antibacterial activity imparted by the Ag (pg 67, ¶2). The concentration of titanium is 99.96 at%, which is higher than the at% of silver (pg 68, ¶4). When the film is prepared and annealed at 500 ºC, Ag clusters form on the film’s surface at about 1 mm thick (pg 71, ¶2; Fig 6). Machado teaches that the overall coating thickness is also about 1 mm (id). Machado teaches their film as have a “self-lubricating” effect due to the silver on the surface, which is essential for tribological-based applications (pg 68, ¶1).
Machado does not teach the thickness of the thin film of 2.5-6 mm. Machado does not teach the thin film coated on an implant in a spinal implant or cage.
Sapieszko teaches that spinal implants such as cages can be coated with coatings such as titanium nitride (col 43, lns 20-28).
It would have been prima facie obvious to prepare the thin film of Machado for use in biomedical applications wherein the film comprises TiN and silver deposits wherein the titanium is present in 99.96 at% and the silver ranges from 0-50 at%. When annealed at 500 ºC, the silver agglomerates at the surface of the film in clusters of approximately 1 mm. Regarding claim 5, the Applicant does not define the meaning of “stoichiometric TiN layer” and thus the prior art teaching of a titanium nitride coating is presumed to read on a 1:1 ratio of Ti to N and thus a stoichiometric amount. Regarding claim 8, the titanium is blended with nitride, therefore it is an alloy.
Moreover, it would have been prima facie obvious to prepare the spinal implant of Sapieszko and modify the TiN coating to be the TiN doped with silver coating of Machado, which is taught as being useful in biomedical applications. The added silver agglomerates of Machado provide additional anti-microbial and anti-infective properties to the coating as well as additional lubrication which can be necessary for an implant. Neither Machado nor Sapieszko recite oxide layers being present in their invention.
Regarding the thickness of the thin film, the art teaches the thickness to be about 1 mm, due to the many uses of the film including in biomedical applications, it would have been obvious to modify the thickness of the film. That being said and in lieu of objective evidence of unexpected results, the thickness can be viewed as a variable which achieves the recognized result of providing a desired film coating property to a surface. The optimum or workable range of film thickness can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized film thickness nonobvious. As such, the art renders obvious instant claims 1-8 and 13-19.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 and 13-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,115,277. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘277 claims are towards a coating composition comprising ceramic titanium nitride comprising 5-30 at% Ag, wherein the Ag is agglomerates in the range of 5-30 mm, and wherein a portion of the Ag agglomerates are exposed on the surface of the coating, and wherein there is no oxide layer between the implant and the coating. The instant claims recite the same limitations with broader ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05 (I).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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