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 .
Response to Amendment
Applicant’s amendments, filed 5/19/2025, have been fully considered and reviewed by the examiner. The examiner notes the cancelation of claims and the addition of new claims 46-67.
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 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 46-67 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20130302512 by McEntire et al. (hereinafter USPP 512) taken with US 5474797 by Sioshansi et al, hereinafter US 797 and US Patent 5055318 by Deutchman et al. (hereinafter US 318) as evidenced by or further in view of US 5520664 by Bricault et al. or US Patent Application Publication 20080221683, hereinafter USPP 683.
Claim 46: USPP 512 discloses a process for producing an orthopedic implant having an integrated ceramic surface layer (0099), comprising the steps of: positioning the orthopedic implant inside a vacuum chamber; vaporizing metalloid atoms inside the vacuum chamber (0099, 107-110). US 512 discloses the integrated layer substantially comprises the ceramic (see e.g. SiN at 0107). US 512 discloses the deposition of Si using nitrogen ion assistance.
USPP 512 discloses codeposition of SiN onto the implant surface (0050 related to various implant materials) and discloses performing such by known techniques include IBAD (0110); however, fails to disclose the particulars of the IBAD process.
However, US 797, also in the art of deposition an antibacterial coating onto the surface of a medical implant using an IBAD process (column 2, lines 30-50). US 797 discloses the IBAD process includes emitting a ion beam into the at least evaporants (see “one or more”) inside the vacuum chamber to cause a collision. US 797 discloses the implant simultaneously while maintaining the outer surface of the orthopedic implant at a temperature below 200C (column 3, lines 60-65). As for the claimed ranges, the examiner notes the prior art discloses a temperature within the claimed range and thus makes obvious the claim as drafted.
USPP 512 with US 797 discloses IBAD of an implant for coating and discloses antibacterial coatings including IBAD depositing SiN; however, fails to explicitly disclose the evaporation of a metalloid (i.e. Si) atoms to form the IBED embedded ceramic. However, US 318, also discloses an IBED imbedded layer discloses using the Si target and N ions to form the SiN layer (Example 4) and therefore taking the references collectively it would have been obvious to have modified USPP 512 with US 797 which discloses evaporating the precursor and using IBED for alloying to use the Si target that is known to be used for the SiN IBED layer.
As for the requirement of driving the ceramic molecule into the outer surface of the implant to form underneath the outer surface and modifying the preexisting body, the prior art discloses IBAD for the formation of the antibacterial coating that is well adhered; however, fails to disclose the intermixed layer. However, Bricault discloses that the IBAD process including an ion source to accelerate the PVD film and discloses that the collisions mix the film atoms with the substrate atoms to cause the film atoms to become embedded within the interfacing surface (column 3, lines 30-50, column 5, lines 30-45, column 7, lines 35-50) and therefore the use of IBAD will include the formation the integrated ceramic surface layer and the base material cooperate to sandwich the intermix layer in between as instantly claimed.
Additionally, Bricault disclose the benefits of IBAD to form the intermixed zone (i.e. surface layer, intermixed layer, and base, with intermixed layer formed on a subsurface level film atoms mixed with the base material of the implant) provides the benefits of nonleaching surface, ensures proper adhesion, and ensures that the layer benefits (i.e. antibacterial or antimicrobial) properties persist into the subsurface stratum thereby providing long lasting effects (column 10, lines 14-20) and therefore taking the references collectively, at the very least, it would have been obvious to one of ordinary skill in the art to have modified USPP512, US 797 and US 318 to provide the intermixed layer as suggested by Bricault to reap the benefits as specifically articulated therein, i.e. adhesion of layer and properties persist int a subsurface stratum thereby providing long lasting effect.
Alternatively, USPP 683 discloses orthopedic implants coated by IBED, including various ceramic materials and various orthopedic implants (0024-0025) at a temperature of less than 600 F, which overlaps the claimed range. USPP 683 discloses implants consisting of a bulk material with original surfaces, see Figure 3 and accompanying text. USPP 683 discloses using ion beam enhanced deposition (IBED) process, “a ceramic material is first alloyed into and below the original surfaces” and “the presence of ceramic material in the sub-surface alloyed case layers” provide certain benefits including “producing bonding zones” and no distinct interface and thus less likely to delaminate from the surfaces (0031). Annotated Figure 3 included herein.
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The disclosure of USPP 683 supports and illustrates the function of the IBED process and the obviousness of embedding and creating a subsurface ceramic region using IBED to reap the benefits as specifically disclosed by USPP 683. Both USPP 683 and Bricault would result in intermixed with the implant body under neath the outer surface as claimed, where in the ceramic layer and the base material will sandwich the intermixed region see e.g. annotated figure above).
Claim 47: USPP 318 discloses ions are selected from the group consisting of nitrogen ions which can reasonably be considered to include N+ ions or N2+ ions (see Example 4), i.e. prior art discloses nitrogen ion beam, as does the instant application and thus the prior art must have the same results unless the applicant is performing different process steps that are not disclosed or claimed as being required to achieve the results.
Claim 48-49: USPP 318 fails to disclose the amount of nitrogen to the amount of vaporized metal/metalloid; however, the amount of nitrogen ions is a result effective variable, directly affecting the deposited layer composition (i.e. not enough Nitrogen and insufficient reaction) and therefore determining the amount would have been obvious through routine experimentation.
Claim 50: USPP 318 discloses the step of cleaning the outer surface of the substrate with the ion beam at an energy level at 1000 electron volts and therefore makes obvious the claimed range and precleaning as claimed (see Example 4).
Claim 51: US 797 discloses positioning step includes the step of mounting the orthopedic implant to a selectively movable platen for repositioning an orientation of the orthopedic implant relative to the ion beam (Column 5, lines 40-45). See also US 318.
Claim 52: US 797 discloses IBAD discloses vaporizing using an evaporator (column 5, lines 26-45) and therefore it would have been obvious to one of ordinary skill in the art to evaporate using ingots.
Claim 53: US 797 discloses a step of propagating the ion beam (figure 2 and accompanying text), see beam propagating from ion source at Figure 2.
Claim 54: US 318 which discloses controlling the energy and deposition rates (column 6,lines 8-15) and therefore it would have been obvious as predictable to adjust the energy and deposition rate to control the film formation process.
Claim 55: US 318 would encompass what can reasonably be considered “backfilling” the chamber (see US 318 at Figure and accompanying text).
Claim 56: US 318, also discloses an IBED imbedded layer discloses using the Si target and N ions to form the SiN layer (Example 4) and therefore taking the references collectively it would have been obvious to have modified USPP 512 with US 797 which discloses evaporating the precursor and using IBED for alloying to use the Si target that is known to be used for the SiN IBED layer and SiN would “substantially comprise” the SiN as claimed.
Claim 57: USPP 512 discloses the driving comprises the integrated surface layer to less than the entire outer surface (i.e. see Figure 4A and accompanying text, i.e. portion of implant coated).
Claim 58: USPP 512 discloses what can reasonably be within the scope of “substantially uniform thickness”, see Figure 4A and 4B and accompanying text. At the very least the thickness is taught by USPP 512 (0071) and the uniformity of the thickness would have been recognized as a result effective variable (too little uniformity will detrimental to the implant and its intended insertion) and it would have been obvious to have determined the optimum thickness through routine experimentation, including a substantially uniform thickness, through routine experimentation as such would have provided predictable results to the implant to provide a coating.
Claim 59: US 318, also discloses an IBED imbedded layer discloses using the Si target and N ions to form the SiN layer (Example 4) and therefore taking the references collectively it would have been obvious to have modified USPP 512 with US 797 which discloses evaporating the precursor and using IBED for alloying to use the Si target that is known to be used for the SiN IBED layer and SiN IBED layer would meet the claims requirements.
Claim 60-67: Each of the limitations of these claims are specifically addressed above and therefore these claims are taught/made obvious by the collection of prior art cited above and for the reasons set forth above.
Claim 48-49 and 61-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over USPP512, US 797 and US 318 as evidenced or further with Bricault or USPP 683 and further with US Patent Application Publication 20040115343 by Carcia et al.
Claims 48 and 61: While the examiner maintains the position above, the examiner cites here Carcia, which also discloses ion beam deposition of SiN and disclose adjusting the ratio of Si and N ions to reap the benefits to control the amount of Si and N in the film (0029) and thus it would have been obvious to control the ratio through routine experimentation to achieve the desired film stoichiometry.
Claims 49 and 62: The claims is merely a result of controlling the nitrogen content and is not a active process step and thus the prior art meets this requirement (i.e. “when . . . ” is mere recognition and not an actual process step) and Carcia discloses the ratio of Si to N (SiNx) is adjusted by independently controlling and adjusting the Si and N fluxes arriving at the substrate (0029). In other words, the claims do not require one nitrogen for each silicon atom nor does it require five nitrogen for each silicon atom, but merely “when” such occurs the claims recognize the natural result that flows from such a ratio of fluxes. Here, such a modification would be directly recognized and understood as evidenced by Carcia and thus this is a mere recognition of a latent property/inherent property.
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 46-67 rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12416077. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 12416077 fully encompass and therefore make obvious and/or anticipate the instant claim requirements.
Claim 46-67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 17/713791 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims of US Patent Application 17/713791 fully encompass and therefore make obvious and/or anticipate the instant claim requirements.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID P TUROCY whose telephone number is (571)272-2940. The examiner can normally be reached Mon, Tues, Thurs, and Friday, 7:00 a.m. to 5:30 p.m.
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/DAVID P TUROCY/ Primary Examiner, Art Unit 1718
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