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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09 Oct 2025 has been entered.
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 09 Oct 2025 has been entered.
Claims 1, 2, 4-6, 8-19, 28, 39, 43 and 44 remain pending.
Claims 1 and 18 are amended.
Claims 3, 7, 20-27, 29-38, 40-42, 45 and 46 are cancelled.
Claims 11, 13, 14, 19 and 28 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1, 2, 4-6, 8-10, 12, 15-18, 39, 43, and 44 are under consideration to the extent of the elected species, i.e., that the metal alloy is a titanium alloy and that the medical device is an orthopedic implant.
Objections Withdrawn
Objections to the Specification
The specification objections set forth in the Final Office Action mailed 09 Apr 2025 are hereby withdrawn in light of applicant’s amendments of the specification.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejection of claim 45 pursuant to 35 U.S.C. 112(a) set forth in the Final Office Action mailed 09 Apr 2025 is hereby withdrawn in light of applicant’s cancelation of the claim.
The rejection of claim 3 pursuant to 35 U.S.C. 112(b) set forth in the Final Office Action mailed 09 Apr 2025 is hereby withdrawn in light of applicant’s cancelation of the claim.
Rejections Pursuant to 35 USC § 103
The rejection of claim 3 under 35 U.S.C. 103 as being unpatentable over Desai et al. (US 2007/0282247, published 06 Dec 2007) in view of Webster et al. (US 2006/0204538, published 14 Sep 2006) as applied to claims 1, 7, 12, 15-18, 39, and 46 and further in view of Aarik et al. (Applied Surface Science 172, 148-158, published 2001) is withdrawn in light of applicant’s cancelation of the claim.
The rejection of claim 45 under 35 U.S.C. 103 as being unpatentable over Desai et al. (US 2007/0282247, published 06 Dec 2007) in view of Webster et al. (US 2006/0204538, published 14 Sep 2006) as applied to claims 1, 7, 12, 15-18, 39, and 46 above and further in view of Neilan et al. (US 2016/0361472, published 15 Dec 2016) as evidenced by the instant specification is withdrawn in light of applicant’s cancelation of the claim.
Rejections Maintained
Claim Rejections - 35 USC § 103
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.
The rejection below reapplies the art used previously and is updated to address the new claim amendments.
Claims 1, 12, 15-18 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Desai et al. (US 2007/0282247, published 06 Dec 2007) in view of Webster et al. (US 2006/0204538, published 14 Sep 2006).
Desai teaches medical devices such as orthopedic implantable devices which comprise nanostructure enhanced surfaces that may be coated ([0006]). Desai teaches the nanostructures may comprise nanofibers such as nanowires ([0006]). Desai teaches that the coatings may be hemocompatible materials such as TiO2 (titanium dioxide) ([0178], [0406]). Desai teaches a preferred technology for depositing thin conformal layers of material is atomic layer deposition which allows for a layer by layer deposition process “at low temperature” ([0178]). Thus, Desai renders obvious an orthopedic implant with a layer by layer coating of titanium dioxide. Regarding claim 17, Desai teaches that substrates covered with high densities of nanofibers resist bacterial colonization ([0362]), rendering obvious the “inhibits growth of bacteria on the titanium dioxide surface. Regarding claims 15 and 16, Desai teaches that the nanofiber surface may be specifically tailored to allow one or more specific types of cells to grow on some portions of the surface where cellular integration and proliferation is needed ([0379], [0393]). Desai teaches substrates that induce the attachment of mammalian cells to the nanofiber surface and encourages cell growth ([0363], [0381]), rendering obvious the “promotes adhesion” and “proliferation of mammalian cells to the titanium dioxide coating.” Regarding claim 18, Desai teaches atomic layer deposition which is a layer by layer deposition process where the cycle can be continued numerous times to attain a Ti-O2 film of desired thickness ([0178]), rendering obvious the “deposited using two or more cycles of atomic layer deposition.” Regarding claim 39, Desai teaches kits and the inclusion of instructional materials ([0385]-[0389]).
Desai further teaches that the orthopedic implantable devices with nanostructures can enhance bone growth reaction at the implant site by encouraging and enhancing proliferation of osteoblasts ([0216]).
Desai does not teach the titanium dioxide coating RMS surface roughness (claim 1: “about 35 nm to about 50 nm”). This deficiency is made up for in the teachings of Webster.
Webster teaches a composition for use as a biomaterial for orthopedic implants ([0002]). Webster teaches that in order to achieve cytocompatibility, it is desirable that the biomaterial surface characteristics at the interface be optimally compatible with pertinent bone cell types and that the surface texture of the biomaterial is important to control for orthopedic implant efficacy to closely harmonize the mass and kinetics of the osseous biomolecular events ([0003]). Webster teaches that it is desirable to increase the adhesion between the implant and tissue surfaces (referred to as osteoblast adhesion) ([0006]). Webster teaches metal nanoparticles with a surface roughness of between about 11 and 360 nm RMS ([0008]) and that materials within this surface roughness showed increased osteoblast adhesion ([0015]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed an orthopedic implant device comprising a nanostructure enhanced surface with titanium dioxide deposited on the device, as rendered obvious by Desai, with a surface roughness between 11 and 360 nm rms. 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). Desai does not teach the surface roughness of the implants but it is known that the surface texture is an important variable in controlling orthopedic implant efficacy and that surface roughness of 11-360 nm rms for metal implants is suitable for orthopedic implants, as taught by Webster, rendering it obvious to control the roughness of the coating within this range. One would further have a reasonable expectation of success as surfaces within this range have shown increased osteoblast adhesion, as taught by Webster.
Regarding the limitation of claim 1 that the ALD process occurs from 120 °C to 190 °C, the examiner notes that this is a limitation on the process of forming the device and not on the final device itself and thus it is a product-by-process limitation. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). In the instant case, the implant device with an RMS roughness between 11-360 nm appears to be the same product claimed.
Additionally, it is known from Desai that high density coverage of substrates with nanofibers are able to resist bacterial colonization ([0362]), and thus there is a general expectation of inhibition of bacterial growth with the coated substrates. Desai further teaches the preferred use of atomic layer deposition even at low temperatures. Coupled with the optimization of surface roughness encompassing the instant claimed range as taught by Webster, Desai’s suggested use of atomic layer deposition would result in optimizing these result effective variables (e.g. temperature and surface thickness) to obtain an optimal temperature range for achieving the expected inhibition of bacterial growth predicted by Desai. See MPEP 2144; 2144.05 and In re Aller.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Desai and Webster.
Response to Arguments
Applicant's arguments filed 09 Oct 2025 have been fully considered but they are not persuasive. The applicant presents data in a declaration under C.F.R. 1.132 filed 09 Oct 2025 and argues that the results weigh in favor on non-obviousness as the results indicate an optimum range of forming the device between 120 °C and 190 °C and a final RMS roughness between about 35 and 50 nm. Figures 1A-1C presented in the declaration indicate inhibition of bacterial growth for titanium dioxide coated titanium materials when the coating if formed from 120 °C and 190 °C. Figure 2 in the declaration is presented to correlate the RMS roughness with the process temperature and to suggest that RMS values between 35-49 nm provide optimal inhibition of bacterial growth.
The examiner is not persuaded that the results presented are sufficient to overcome the prima facie case of obviousness from the teachings of Desai and Webster. The Examiner has the initial burden of establishing a prima facie case obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Prima facie obviousness can be rebutted by presenting evidence of secondary considerations and when such evidence is submitted, all of the evidence must be considered anew. In re Piasecki, 745 F.2d 1468, 1472— 1473 (Fed. Cir. 1984). Secondary considerations include: long-felt but unsolved needs, failure of others, unexpected results, commercial success, copying, licensing, and praise. In re Rouffet, 149 F.3d 1350, 1355 (Fed. Cir. 1998). Forming implant devices with ALD is known from Desai and forming the devices with a roughness between about 11 and 360 nm RMS for enhanced osteoblast adhesion is obvious in light of the teaching of Webster, as noted in the rejection above. Thus, the device as a whole is the same as the claimed device and one would expect it to necessarily have the same functional properties such as inhibiting bacterial adhesion. It is noted that the ALD temperature between 120 °C and 190 °C is a process limitation that has not been established as resulting a product different from what is obvious from the prior art. Further, it is known from Desai that high density coverage of substrates with nanofibers are able to resist bacterial colonization ([0362]), and thus there is a general expectation of inhibition of bacterial growth with the coated substrates.
Further, the results should demonstrate a difference in kind, rather than degree. See In re Huang, 100 F.3d 135, 139 (Fed.Cir.1996) (holding that claimed ranges must “produce a new and unexpected result which is different in kind and not merely in degree from results of the prior art”). The Court explained that a “32—43% increase in stress-rupture life, however, does not represent a ‘difference in kind’ that is required to show unexpected results.” Harris, 409 F.3d at 1344. Here, the evidence in Figure 2 indicates that the titanium dioxide coating led to bacterial inhibition resulting in significantly different growth from the control for each of the tested temperatures and RMS values. Figure 2 has lines drawn around the results from 35-49 nm RMS, however, an explanation has not been given was to why the small difference in bacterial growth in this region (~8 CFU/Cm2) in comparison to the growth with RMS values outside this region (~17-22 CFU/Cm2) is unexpected. Similarly, the applicant has not demonstrated that the results at the RMS 64 and 26 nm devices are significantly different from the 35-49 nm RMS results. It is noted that the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). The improved inhibition to bacterial growth observed at each of the RMS values suggests that determining the RMS should be between 35-49 nm is as a matter of optimization rather than a result that is truly unexpected and thus, the asserted unexpected result data receives less persuasive weight.
The examiner further notes that the results provided have not been presented in such a way as to make a full comparison and assessment of the data as the applicant has not provided the methods used to generate the data. There are a number of parameters to consider with an ALD method and it is not clear how each of the conditions were tested. For example, the purge time can affect the layer growth but it is now known if this was consistent between the scenarios. Similarly, it is not known if the same precursor was used in each experiment. The lack of information regarding the precursor used and a lack of comparison between precursors also suggests that the is insufficient to establish that the results are commensurate in scope with the claims. The type of precursor used to form the titanium dioxide may will result in layers with differing properties, but the claims are open to any precursor and it has not been established that the precursor used is not a factor in the RMS to bacteria inhibition results.
Finally, the unexpected results are insufficient, when weighed with the strong prima facie case of obviousness. The limited evidence is insufficient to overcome the strong showing of obviousness in this case to have a roughness between 11-360 nm RMS as taught by Webster for the undisclosed roughness of the coated devices of Desai. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2007) (“[W]e hold that even if Pfizer showed that amlodipine besylate exhibits unexpectedly superior results, this secondary consideration does not overcome the strong showing of obviousness in this case. Although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion.”).
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Desai et al. (US 2007/0282247, published 06 Dec 2007) in view of Webster et al. (US 2006/0204538, published 14 Sep 2006) as applied to claims 1, 12, 15-18, and 39 above and further in view of Carlisle et al. (US 2006/0251875, published 09 Nov 2006).
The teachings of Desai and Webster are described supra.
Desai further teaches that the titanium dioxide coating may be formed through atomic layer deposition using precursors such as TiCl4 and H2O ([0178]).
Desai and Webster do not teach that the titanium dioxide is amorphous (claim 2) or that the titanium dioxide coating is from about 70-130 nm (claim 5). These deficiencies are made up for in the teachings of Carlisle.
Carlisle teaches a layered coating for implantable devices ([0003]). Carlisle teaches that the coating may be TiO2 and is composed of one or more layers deposited by atomic layer deposition ([0008]) and teaches the use of precursors such as TiCl4 and H2O ([0017]).Carlisle teaches that the coating is bio-compatible and amorphous ([0006], [0010]). Carlisle teaches an example coating of TiO2 with a thickness of 92 nm ([0017]) and teaches that a pin-hole free coating should be about 100 angstroms in thickness and should be less than about 10 microns in thickness to be useful as an implantable device ([0018], claims 7 and 12).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used amorphous titanium dioxide at about 100 angstroms in thickness as the coating for the orthopedic implants rendered obvious by Desai and Webster. Desai does not teach whether the titanium dioxide is amorphous or not, however, it is known that amorphous titanium dioxide is used as a coating material for implantable bio-compatible devices, as taught by Carlisle. Similarly, while Desai teaches a layer by layer deposition process where the cycle can be continued numerous times to attain a Ti-O2 film of desired thickness, a specific thickness for the titanium dioxide is not specified. It is known, however, that thicknesses of about 100 angstroms (10 nm) for coatings of biocompatible implants helps ensure a pinhole free surface and coatings should be less than about 10 microns (10,000 nm) for use in an implant, as taught by Carlisle. Thus, it would have been desirable to have a titanium dioxide layer at least about 100 angstroms (10 nm) to 10 microns (10,000 nm) thick to ensure the surface is pinhole free and suitable for implant devices. It is noted that the implantable devices of Carlisle are biocompatible and the coatings are formed from atomic layer deposition using the same TiCl4 and H2O precursors as taught by Desai, and Carlisle has demonstrated layers of titanium dioxide 92 nm thick, thus further providing a reasonable expectation of success to one of ordinary skill in the art.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Desai, Webster and Carlisle.
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Desai et al. (US 2007/0282247, published 06 Dec 2007) in view of Webster et al. (US 2006/0204538, published 14 Sep 2006) and Carlisle et al. (US 2006/0251875, published 09 Nov 2006) as applied to claims 1, 2, 5, 12, 15-18, and 39 above and further in view of Aarik et al. (Applied Surface Science 172, 148-158, published 2001).
The teachings of Desai, Webster and Carlisle are described supra.
Desai, Webster and Carlisle do not teach the thickness of a single layer of titanium dioxide (claim 3) or the number of atomic layers of titanium dioxide (claims 4 and 6). These deficiencies are made up for in the teachings of Aarik.
Aarik teaches atomic layer deposition of titanium dioxide from TiCl4 and H2O (abstract). Aarik teaches that a typical growth rate of titanium dioxide where TiCl4 and H2O are used as precursors have ranged from 0.04 to 0.07 nm (i.e. 0.4-0.7 Å) per cycle (page 148 right column).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention for the single layer thickness of the titanium dioxide coating of Desai to be from 0.04 to 0.07 nm (0.4-0.7 Å). This is a typical growth rate for titanium dioxide from atomic layer deposition and is achievable using the same precursors taught by Desai, thus providing one of ordinary skill a reasonable expectation of success in achieving a single layer thickness of 0.04 to 0.07 nm (0.4-0.7 Å). Regarding the number of total layers of about 600 to about 3250 (claim 4) and about 2500 (claim 6), these layer totals are obvious based on the obviousness of having an overall thickness of the coating of from about 10 nm to 10,000 nm. Assuming a per layer thickness of titanium dioxide of 0.4 angstroms, as described above, an overall thickness of 10 nm to 10,000 nm would lead to total layers ranging from about 250 – 250,000 layers. 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).
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Desai, Webster, Carlisle and Aarik.
Claims 8, 9, 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Desai et al. (US 2007/0282247, published 06 Dec 2007) in view of Webster et al. (US 2006/0204538, published 14 Sep 2006) as applied to claims 1, 12, 15-18, and 39 above and further in view of Aiguo et al. (CN 104962779, published 07 Oct 2015) as evidenced by the instant specification.
The teachings of Desai and Webster are described supra.
While Desai teaches that the nanofibers or nanowires of the medical device may comprise a material such as a metal alloy ([0009], [0136]), Desai does not teach that the device comprises a titanium alloy such as Ti-V-Al (claims 8 and 9) or a higher water contact angle (claim 43) or a lower surface energy (claim 44). These deficiencies are made up for in the teachings of Aiguo.
Aiguo teaches a Ti6Al4V alloy for orthopedic implants and that the Ti6Al4V alloy can effectively lower infection in the human body (abstract, page 1 lines 50-52). Aiguo teaches that the Ti6Al4V alloy has excellent mechanical properties, corrosion resistance and biocompatibility and that it is a widely used titanium alloy for surgical implants (page 1 lines 19-20).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used a Ti6Al4V alloy as the metal alloy in the orthopedic devices rendered obvious by Desai and Webster. The Ti6Al4V alloy is widely used, has excellent mechanical properties, corrosion resistance and biocompatibility and may be used as an orthopedic implant with reduced infection rate, as taught by Aiguo. Thus, it would be desirable to use the Ti6Al4V alloy for these benefits and one would have a reasonable expectation of success as Desai teaches that the structures comprise metal alloys and the Ti6Al4V alloy is known for use in orthopedic implants.
Regarding claims 43 and 44, the features of a higher water contact angle and a lower surface energy of the titanium dioxide coated devices compared to the uncoated devices are features that are necessarily present in the devices rendered obvious from the prior art. As evidenced by the instant specification, Ti-V-Al devices with a titanium dioxide coating had a lower surface tension (as surface energy, mN/m) and a higher glycerol (polar solvent as water) contact angle as compared to a non-coated Ti-V-Al device (see tables 5 and 8). It is obvious to form devices from Ti6Al4V alloy and to deposit titanium dioxide layers on the nanostructured surface of the device, as described in the rejection above, and the higher water contact angle and lower surface energy properties as compared to the non-coated device would necessarily be present. "[T]he discovery of a previously unappreciated property 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). Devices of Ti-V-Al coated with titanium dioxide are known to have a higher contact angle and lower surface energy compared to non-coated devices, as evidenced by the instant specification and the structure is obvious form the prior art and thus the same property would necessarily be present.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Desai, Webster and Aiguo.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Desai et al. (US 2007/0282247, published 06 Dec 2007) in view of Webster et al. (US 2006/0204538, published 14 Sep 2006) as applied to claims 1, 12, 15-18 and 39 above and further in view of Ciccone et al. (J Am Acad Orthop Surg 2001;9:280-288).
The teachings of Desai and Webster are described supra.
Desai further teaches that the orthopedic implants may comprise materials such as polymers and other orthopedic implant structures known to those of ordinary skill in the art ([0215]).
Desai and Webster do not teach that the device comprises a bioresorbable material as in claim 10. This deficiency is made up for in the teachings of Ciccone.
Ciccone teaches that bioabsorbable implants are used frequently in orthopaedic procedures and that these implants offer the advantages of gradual load transfer to the healing tissue, reduced need for hardware removal and radiolucency which facilitates postoperative radiographic evaluation (abstract). Ciccone teaches the use of various polymer materials known for use in forming implant materials (page 280).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed the orthopedic implant device rendered obvious over Desai and Webster as a bioabsorbable (bioresorbable) material. Bioabsorbable orthopedic implants offer various advantages such as gradual load transfer to the healing tissue, reduced need for hardware removal and radiolucency, as taught by Ciccone. Thus, it would have been obvious to form the orthopedic implant with bioabsorbable material such as a polymer material for the known benefits cited above. One would have had a reasonable expectation of success as bioabsorbable implants are formed from polymers, as taught by Ciccone, and the orthopedic devices of Desai may include polymer materials, as taught by Desai.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Desai, Webster and Ciccone.
New Grounds of Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4-6, 8-10, 15-18, 39, 43, and 44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention (NEW MATTER REJECTION).
The amendment filed 09 Oct 20205 has introduced new matter into the claims. Amended claim 1 recites a “temperature in the range of 120°C to 190°C”. The response filed 10/09/2025 indicates that support for amended claim 1 can be found in Figure 22. This has been fully considered but is not found persuasive. The originally filed disclosure at Figure 22 discloses titanium dioxide formed at three separate temperatures, 120°C, 160°C and 190°C. These are individual temperatures and not a range of temperatures and do not support the instantly claimed range. The examiner notes that page 6 line 3 discloses a range of about 130 °C to about 165 °C, but this does not provide sufficient support for the wider range now recited. Instant claim 1 now recites limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in newly amended claim 1, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in present claim 1 in the specification or claims, as-filed, or remove these limitations from the claims in response to this Office Action.
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, 2, 4-6, 8, 9, 12, and 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (International Journal of Nanomedicine 2017:12 8711–8723).
Liu teaches TiO2 deposited onto Ti implant substrates (page 8712 left column, page 8713 top left). Liu teaches the TiO2 films were grown using atomic layer deposition at a temperature of 120°C, 160°C and 190°C and a total of 2,500 cycles corresponding to ~100 nm of the TiO2 were carried out (page 8713 top left). These teachings meet the limitations of a titanium dioxide coating with two or more single atomic layers of titanium dioxide deposited on an implantable device by ALD performed in the range of 120-190°C, as in claim 1, and the layer and thickness limitations of claims 4-6 and the two or more cycles of ALD limitation of claim 18. The Ti implant substrate meets the limitation of a Ti metal device of claims 8 and 9. Liu teaches that the titanium surfaces coated with titanium dioxide formed at 120°C, 160°C and 190°C had RMS roughness values of approximately 40 nm (see Figure 2), meeting the limitation of claim 1 of RMS roughness from about 35-50 nm.
Regarding claim 2, Liu teaches that amorphous films form at relatively low temperatures and anatase surfaces at high temperatures (page 8712 right column) and the XRD patterns of the TiO2 coatings at 120°C and 160°C did not show the crystalline anatase structure (Figure 3). Thus, the titanium dioxide coatings taught by Liu comprise amorphous titanium dioxide.
Liu teaches that the coating is specifically for orthopedic implants (page 8722 Conclusion, Title) meeting the limitation of claim 12.
Regarding claims 15 and 16, Liu teaches enhanced osteoblast cell adhesion and proliferation where osteoblast cell numbers on Ti-TiO2
Regarding claim 17, Liu teaches that the Ti-TiO2 samples, specifically Ti-TiO2 (160°C), inhibited the adhesion and growth of three types of bacteria (page 8717 Antimicrobial assays).
Claim Rejections - 35 USC § 103
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.
Claims 1, 2, 4-6, 8, 9, 12, 15-18 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (International Journal of Nanomedicine 2017:12 8711–8723) in view of Desai et al. (US 2007/0282247, published 06 Dec 2007).
The teachings of Liu are described supra.
Liu does not teach a kit for the implantable device as in instant claim 39. This deficiency is made up for in the teachings of Desai.
Desai teaches medical devices such as orthopedic implantable devices which comprise nanostructure enhanced surfaces that may be coated ([0006]). Desai teaches the nanostructures may comprise nanofibers such as nanowires ([0006]). Desai teaches that the coatings may be hemocompatible materials such as TiO2 (titanium dioxide) ([0178], [0406]). Desai teaches a preferred technology for depositing thin conformal layers of material is atomic layer deposition which allows for a layer by layer deposition process ([0178]). Regarding claim 39, Desai teaches kits for the nanofiber enhanced substrates and the inclusion of instructional materials ([0385]-[0389]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have incorporated the titanium dioxide implantable devices of Liu into a kit. Implantable devices are known to be compatible with kits, as taught by Desai. It thus would have been obvious to have the device as part of a kit as this is a suitable system for containing the device and the convenient packaging of a kit would be beneficial for the end user.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 1, 2, 4-6, 8-10, 12, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (International Journal of Nanomedicine 2017:12 8711–8723) in view of Ciccone et al. (J Am Acad Orthop Surg 2001;9:280-288).
The teachings of Liu are described supra.
Liu does not teach that the device comprises a bioresorbable material as in instant claim 10. This deficiency is made up for in the teachings of Ciccone.
Ciccone teaches that bioabsorbable implants are used frequently in orthopaedic procedures and that these implants offer the advantages of gradual load transfer to the healing tissue, reduced need for hardware removal and radiolucency which facilitates postoperative radiographic evaluation (abstract). Ciccone teaches the use of various polymer materials known for use in forming implant materials (page 280).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed the orthopedic implant device taught by Liu as a bioabsorbable (bioresorbable) material. Bioabsorbable orthopedic implants offer various advantages such as gradual load transfer to the healing tissue, reduced need for hardware removal and radiolucency, as taught by Ciccone. Thus, it would have been obvious to form the orthopedic implant with bioabsorbable material such as a polymer material for the known benefits cited above.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Liu and Ciccone.
Claims 1, 2, 4-6, 8, 9, 12, 15-18, 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (International Journal of Nanomedicine 2017:12 8711–8723) in view of Aiguo et al. (CN 104962779, published 07 Oct 2015) as evidenced by the instant specification.
The teachings of Liu are described supra.
Liu does not teach that the device with the coating has a higher water contact angle and a lower surface energy of the device lacking the titanium dioxide coating as in instant claims 43 and 44. These deficiencies are made up for in the teachings of Aiguo.
Aiguo teaches a Ti6Al4V alloy for orthopedic implants and that the Ti6Al4V alloy can effectively lower infection in the human body (abstract, page 1 lines 50-52). Aiguo teaches that the Ti6Al4V alloy has excellent mechanical properties, corrosion resistance and biocompatibility and that it is a widely used titanium alloy for surgical implants (page 1 lines 19-20).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used a Ti6Al4V alloy instead of titanium in the orthopedic devices taught by Liu. The Ti6Al4V alloy is widely used, has excellent mechanical properties, corrosion resistance and biocompatibility and may be used as an orthopedic implant with reduced infection rate, as taught by Aiguo. Thus, it would be desirable to use the Ti6Al4V alloy for these benefits and one would have a reasonable expectation of success as it merely represents the use of a known prior element for its intended purpose as an implant material.
Regarding claims 43 and 44, the features of a higher water contact angle and a lower surface energy of the titanium dioxide coated devices compared to the uncoated devices are features that are necessarily present in the devices rendered obvious from the prior art. As evidenced by the instant specification, Ti-V-Al devices with a titanium dioxide coating had a lower surface tension (as surface energy, mN/m) and a higher glycerol (polar solvent as water) contact angle as compared to a non-coated Ti-V-Al device (see tables 5 and 8). It is obvious to form devices from Ti6Al4V alloy and to deposit titanium dioxide layers on the surface of the device, as described in the rejection above, and the higher water contact angle and lower surface energy properties as compared to the non-coated device would necessarily be present. "[T]he discovery of a previously unappreciated property 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). Devices of Ti-V-Al coated with titanium dioxide are known to have a higher contact angle and lower surface energy compared to non-coated devices, as evidenced by the instant specification and the structure is obvious form the prior art and thus the same property would necessarily be present.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Liu and Aiguo.
Conclusion
No claim is allowed.
Correspondence
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/E.C.M./Examiner, Art Unit 1619
/BENNETT M CELSA/Quality Assurance Specialist , Art Unit 1600