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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/29/2025 has been entered.
Response to Amendment
Applicant’s amendments, filed 9/29/2025, have been fully considered and reviewed by the examiner. The examiner notes the amendments to claims and the cancellation of claims 10, 12, 29 and 31. Claims 1-9, 11, 13-28, 30 and 32-47 remain pending in the instant application.
Response to Arguments
Applicant's arguments filed 9/29/2025 have been fully considered but they are not persuasive.
Applicant’s argue that the cited prior art each discusses applying a coating or growing a film layer on top of the base material and thereafter modifying that layer, but does not discloses that there are ceramic enriched subsurface regions with an orthopedic implant consisting of a base material.
The applicant argues that the claim amendment “orthopedic implant consists of a base material” forecloses additional layers and thus overcomes the applicant’s reading of the claims. Initially, the claims as drafted merely require positioning an orthopedic implant consists of a base material into the vacuum chamber and therefore contrary to the applicant’s assertions does not actually foreclose additional layers (i.e. additional layers that are deposited in the vacuum chamber as the film grows).
Applicant’s argument with respect to the individual references are noted and addressed herein after.
With respect to Burns, Applicant argues that the prior art’s elimination and/or reducing the formation of interfacial voids is being on the surface and not the same as being embedded underneath the outermost surface as recited in the claims. Applicant proffered a graphic illustration and argued that the Burns reference only discloses intermixing to fill interfacial voids and not that the molecules are underneath an outermost surface. The Applicant’s fail to provide factual evidence to support their position and merely make assertions that are unsupported by the record. Initially, the disclosure of the interfacial voids appears to be in relation to the sputtering and redeposition of the coating material that is loosely bound to the surface to increase the film density of the growing film. Even taking the Applicant’s diagram as factual, which the examiner cannot agree, the outermost surface of the orthopedic implant encompasses the substrate material within the intermixed region.
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Finally, the applicant has fails to appreciate the Burns discloses the sputtering of the substrate atoms and redeposition via the IBAD process so that “an intermixed zone of the substrate and coating atoms” and therefore would include the sputtering of the substrate atoms (i.e. the outermost) and redeposition within the coating material to form the intermixed embedded within and underneath the substrate surface (i.e. where the sputtering atoms used to be) to create an increased adhesion.
Initially, the Ti substrate with the homo-metallic layer is an optional layer that may be deposited for adhesion, but the claims do not define the substrate to be devoid of additional layers and therefore the presence or absence of the Ti homo-metallic layer is not commensurate in scope with the claims as drafted. Specifically, the IBAD process creates an intermixed zone as set forth below between the substrate and coating material, which include the ceramic (see 0038-0044). Here the applicant’s appear to be confusing the adhesion layer Ti deposited at 0044 (an optional layer that is not required) with the IBAD ceramic layer (0041-0042).
The examiner additionally notes the Burns reference, when describing the process of IBAD and its deposition mechanism, discloses “The sputtering and re-deposition process may also create an intermixed zone of the substrate and coating atoms. Such an intermixed zone may improve film adhesion by eliminating and/or reducing the formation of interfacial voids.” (0033). Here the Burns reference discloses that the IBAD process results in an intermixed zone of the coating atoms and the substrate to improve adhesion and this intermixed zone is related to the “coating atoms” and not limited to the titanium as arguments (as the preceding paragraph discloses the IBAD process includes the vapor flux and ion beam). Burns further deposits the Ag doped Ti/TiO film by an IBAD process and forming a ceramic during the process (0041-0042). Therefore, the examiner has set forth a prima facie case of obviousness that an intermixed region exists that includes the coating material (ceramic) and the base material (Ti).
Applicant’s arguments with respect to the Sioshansi reference are noted, but unpersuasive as the reference is utilized for a showing of known and suitable substrate temperatures for IBAD onto implants.
Applicant’s arguments with respect to the Bricault reference are noted. Applicant’s argue that the atoms are deposited on the catheters and the ion source accelerates ions into the growing film as part of the IBAD process. Applicant argues that Bricault discloses the IBAD process and argues that the surface 216 is the tissue interfacing surface and is thus the the top surface or outermost surface which is the film deposited thereon and not the implant material itself. The examiner does not agree with this interpretation as Bricault discloses “the atoms 212 are embedded in the material of the catheter and the atomic penetration extends below the surface 216” and thus clearly disclose the embedding into the implant material. The explicit words of this requirement illustrates that subsurface region “below the surface”. The applicants position that this is the coating material and not the implant is clearly misplaced as the reference explicitly discloses the coating material is embedded into the material of the implant. The examiner can not agree that the applicant’s interpretation, which appears to be against the explicit words of the reference, is persuasive.
To further rebut the applicant’s argument, the examiner notes Bricault discloses IBAD deposition is employed, it is preferable for the atoms to extend about 0.01 micrometers to about 0.05 micrometers and such a penetration will provide a firmly anchored film that is non-leaching (see column 6, lines 5-27).
US Patent 5055318, hereinafter US 318 discloses coating material by using ion beam including nitrogen ions and evaporated silicon (example 4) and discloses ballistically alloying the coating using ion beam concurrently with the PVD layer (high energy beam strikes the substrate concurrently with the initial deposition of sputtered” and bombards the substrate surface until a ballistically alloyed layer formed. US 318 discloses the ballistically alloying is physically mixed within the substrate surface . . . extends into the substrate surface a short distance.
For the sake of compact prosecution, the examiner cites here US Patent Application Publication 20080221683. 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.
The argument against a single reference appears misplace as the rejection is based on a combination of reference. USPP 512 coats an implant with IBAD and US 797 discloses the IBAD process and the particulars of such for formation of a layer onto the implant. While the references do not disclose the presence or absence of an intermixed zone, the examiner notes that 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. In other words, the examiner has offered that the using IBAD (as specifically disclosed by both USPP 512 and US 797), as evidenced by Bricault, would have resulted in an intermixed zone because Bricault discloses that the 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). The applicant argues that the reference is completely silent with respect the to driving ceramic molecules into the outer surface of the implant; however, the reference suggests that this would flow from using IBAD. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The claimed IBAD parameters are well known (as taught by US 797) and thus the applicants have not provided any rebuttal evidence that the results as claimed are unexpected or unpredictable.
Here, the applicant’s own specification appears to support the examiner’s position that the intermix zone will naturally flow from the process steps taken and the prior art discloses and/or makes obvious the claimed process steps. Specifically, 0005 discloses “Ion beam enhanced deposition (IBED), also known as ion beam assisted deposition (IBAD), is a process by which accelerated ions drive a vapor phase coating material into the subsurface of a substrate.”
All other arguments not specifically addressed herein are deemed mere attorney speculation not supported by factual evidence or are deemed not commensurate in scope with the broadly drafted claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 43 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 43 includes “the steps of backfilling”; however the plural steps appears to be improper and lacks antecedent basis.
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.
Claims 1-2, 4-12, 14, 17-19, 22-31, 34-35, 39, 46 and 47 is/are rejected under 35 U.S.C. 103(a) as being obvious over US Patent Application Publication 20170157289 by Burns with US 5474797 by Sioshansi et al, hereinafter US 797 taken further with US Patent Application Publication 20080221683, hereinafter USPP 683.
Examiner incorporates herein by reference the above Response to Arguments Section as it relates to these cited references.
Claim 1: Burns discloses a process for producing an orthopedic implant having an integrated ceramic surface layer (abstract, Figure 5C), comprising the steps of: positioning the orthopedic implant inside a vacuum chamber; vaporizing at least two different metalloid or transition metal atoms inside the vacuum chamber (Figure 3 and accompanying text, 0035); emitting a relatively high energy beam comprising an energy level between 0.1-100 kiloelectron volts (KeV), discloses a range the is within this range and thus makes obvious such, into the at least two different metalloid or transition metal atoms inside the vacuum chamber to cause a collision to form ceramic molecules (Figure 3 and accompanying text, Figure 5 and accompanying text, see 0034-0035); driving the ceramic molecules with the same beam into an outer surface of the orthopedic implant at a relatively high energy such that the ceramic molecules implant therein and form at least a part of the molecular structure of the outer surface of the orthopedic implant simultaneously, thereby forming the integrated ceramic surface layer; and forming an intermix layer underneath the integrated ceramic surface layer, the intermix layer including a mixture of subsurface level ceramic molecules and a base material of the orthopedic implant, wherein the intermix layer is molecularly integrated with the base material, wherein the integrated ceramic surface layer and the base material cooperate to sandwich the intermix layer in between (Figure 5A-5C and accompanying text, 0032-0033 related to intermixed zone).
Burns discloses all that is taught above; however, fails to disclose the temperature of the implant. However, US 797 also in the art of IBAD of an antibacterial coating onto an implant discloses maintaining the substrate surface below 200C (column 3, lines 60-65) and therefore such would have been obvious to one of ordinary skill in the art.
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.
Claim 2: Burns discloses beam comprises an ion beam comprising nitrogen ions selected from the group consisting of N+ ions and N.sub.2+ ions. (see 0037).
Claim 4: Burns discloses step of cleaning the outer surface of the orthopedic implant with the beam at an energy level between about 1-1000 electron volts (0033).
Claim 5: Burns discloses the position steps includes moving the platen into the chamber (0036).
Claim 6: Burns discloses Ti and Ag ingots (0035).
Claim 7: Burns discloses propagating the beam (figure 3)
Claim 8: Burns discloses adjusting the energy or density (0037).
Claim 9: Burns would encompass what can reasonably be considered “backfilling” the chamber (Figure 3 and accompanying text).
Claim 10: Surface comprises the ceramic molecules (see Burns at Figure 5C).
Claims 11-12: Burns discloses less than the entire surface and a uniform thickness (Figure 9 and accompanying text).
Claim 14: Burns discloses Ti and Ag as claimed (0035).
Claim 17: Burns discloses titanium (0026).
Claims 18-19, 22-31, 34-35 and 39: These claims are rejected for the same reasons as set forth above.
Claim 46: Burns discloses the base material comprises a non-polymeric material (see 0026).
Claim 47: US 797 also in the art of IBAD of an antibacterial coating onto an implant discloses maintaining the substrate surface below 200C (column 3, lines 60-65) and therefore such would have been obvious to one of ordinary skill in the art.
Claim 1-47 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 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 USPP 683.
Examiner incorporates herein by reference the above Response to Arguments Section as it relates to these cited references.
Claim 1: 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 at least two different metalloid or transition metal atoms inside the vacuum chamber (0099, 107-110). USPP discloses codeposition of SiN and Ag as the antibacterial coating 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 relatively high energy beam comprising an energy level, e.g. 5 or 10 keV (examples) or 0.2 to 20kev (column 3,line 60-65), which makes obvious the claimed range of 0.1-100 kiloelectron volts (keV), 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 and energy 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 codeposition of Silver and 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 the intermix layer, 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.
Claim 2: 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 3: 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 4: 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 5: 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 6: US 512 discloses depositing silver and silicon nitride simultaneously via PVD techniques, including IBAD and 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 multiple ingots to achieve the vapor deposition of multiple materials.
Claim 7: 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 8: 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 9: US 318 would encompass what can reasonably be considered “backfilling” the chamber (see US 318 at Figure and accompanying text).
Claim 10: US 512 discloses the integrated layer substantially comprises the ceramic (see e.g. SiN at 0107).
Claim 11: 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 12: USPP 512 discloses a layer with substantially uniform thickness (see e.g. Figure 4A and accompanying text).
Claim 13-16: US 512 discloses codepositing vapors for the formation of Ag and SiN using IBAD and therefore would reasonably read on these claims as broadly drafted. At the very least, the references suggest the codeposition of Ag and Si using nitrogen ion assistance and a full review of the specification illustrates that such will result in the applicant’s claimed SiNAg and therefore the prior art must necessarily have the same results because the collection of prior art makes obvious each and every process step that the applicant’s disclose as being required to achieve the claimed results.
Claim 17: US 512 discloses the base can be any number of materials, including medical grade titanium.
Claim 18-34: 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 35-45: 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 46: US 512 discloses the base can be any number of materials, including medical grade titanium.
Claim 47: US 797 also in the art of IBAD of an antibacterial coating onto an implant discloses maintaining the substrate surface below 200C (column 3, lines 60-65) and therefore such would have been obvious to one of ordinary skill in the art.
Claim 3, 20 and 36 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.
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.
Claim 6, 25, and 35-45 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 Burns
While the examiner maintains the position above, the examiner cites here Burns, also in the art of the formation of the antibacterial film via ion assisted PVD (IBAD, see 0032, 0033) by codepositing multiple coating materials on the substrate surface (abstract, figure 4), including a first and second material. Burns discloses using a similar IBAD arrangement of ion beam, evaporator, medical device (see Figure 3). Burns discloses placing the multiple separate ingots into the evaporator so as to evaporate individual ingots (0035) to deposit the materials concurrently. As USPP 512 desires for codeposition of materials via PVD or IBAD, it would have been obvious to one of ordinary sill in the art at the art at the time of the invention to have modified USPP512, US 797 and US 318 as evidenced or further with Bricault or USPP 683 to use multiple ingots of materials for IBAD codeposition as such is taught by Burns as a method for codeposition in antibacterial film formation.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gordon Baldwin can be reached on 571-272-5166. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID P TUROCY/ Primary Examiner, Art Unit 1718