KYUNGPOOK NATIONAL UNIVERSITY INDUSTRY-ACADEMIC COOPERATION FOUNDATIONDownload PDFPatent Trials and Appeals BoardSep 15, 20212020004351 (P.T.A.B. Sep. 15, 2021) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/128,735 09/23/2016 Kyo Han Kim 697-0051 1084 145742 7590 09/15/2021 Paratus Law Group, PLLC 1765 Greensboro Station Place Suite 320 Tysons Corner, VA 22102 EXAMINER TRAN, BINH X ART UNIT PAPER NUMBER 1713 MAIL DATE DELIVERY MODE 09/15/2021 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KYO HAN KIM, TAE YUB KWON, and JUN SIK SON Appeal 2020-004351 Application 15/128,735 Technology Center 1700 Before JEFFREY T. SMITH, GEORGE C. BEST, and LILAN REN, Administrative Patent Judges. REN, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–3, 5–7, 30, and 31. Final Act. 2, 3, 5, 9. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as “Kyungpook National University Industry-Academic Cooperation Foundation, of Daegu, Republic of Korea.” Appeal Br. 4. Appeal 2020-004351 Application 15/128,735 2 CLAIMED SUBJECT MATTER Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method of preparing a titanium or titanium alloy implant, the surface of which has various hierarchical surface structures comprising (a) micrometer-sized sponge-like network structures of at least 1 micrometer and (b) continuous or discontinuous line-shaped open channel-shaped nanometer-sized bumps less than 100 nanometers formed on the micrometer-sized structures above, in such a way that a surface hydrophilicity and wettability of the surface of the titanium or titanium alloy implant has been increased by further imposing the hierarchical surface structures on the titanium or titanium alloy implant, said method comprising: preparing a mixed etching composition with a pH of 7 to 8, comprising hydrogen peroxide, a base, and water; and oxidatively etching an implant made of titanium or a titanium alloy by immersing the same in the etching composition in such way that the hierarchical surface structures of the titanium or titanium alloy implant is defined by the oxidatively etching, wherein the hierarchical surface structures of the titanium or titanium alloy implant lead to increasing the contact and/or binding areas with cells and increasing the titanium or titanium alloy implant’s surface adsorption of protein or growth factor present in a body fluid, as well as promoting adhesion, proliferation or differentiation of cells as compared to an implant without said hierarchical surface structures. Claims Appendix (Appeal Br. 16). Appeal 2020-004351 Application 15/128,735 3 REFERENCES The Examiner relies upon the following prior art: Name Reference Date Liao US 2009/0204213 Al Aug. 13, 2009 Mayfield US 2011/0233169 Al Sept. 29, 2011 Ok H. Ryu et al., Gingival Epithelial Cell Expression of Macrophage Inflammatory Protein-la Induced by lnterleukin-1β, and Lipopolysaccharide, 78 J Periodontal, August 2007 Bone-Wikipedia, www.wikipedia.org/wiki/bone Ti6Ai-4V ELI, www.fwmetals.com/services/resource-library/ti-6al-4v- eli/ REJECTIONS Claims Rejected 35 U.S.C. § Reference(s)/Basis 1–3, 5–7, 30, 31 112(a) or first paragraph Written description 1–3, 5–7, 30, 31 112(b) or second paragraph Indefiniteness 1, 2, 5, 7, 31 102 Mayfield 3, 6, 30 103 Mayfield, Liao OPINION Written Description The Examiner rejects claims 1–3, 5–7, 30, and 31 for failing to meet the written description requirement, finding that the claim language “micrometer-sized sponge-like network structure[s] of at least 1 micrometer” is unsupported. Final Act. 3. The Examiner reasons that the claim term may broadly encompass “any value greater [or] equal to 1 micrometer” which is not supported by the Specification. Id. “Adequate written description means that, in the specification, the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Hyatt v. Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007) (alteration Appeal 2020-004351 Application 15/128,735 4 in original) (citation and internal quotation marks omitted). “In the context of the written description requirement, an adequate prima facie case must . . . sufficiently explain to the applicant what, in the examiner’s view, is missing from the written description.” Id. In this case, the Specification provides an SLA (sandblasted, large- grit, acid etched) method having the characteristic that “various sizes of micrometer-sized pores form sponge-like network structures[.]” Spec. pg. 2.2 The Examiner also acknowledges that Application Figure 1A shows a “micrometer size sponge-like network structure having a dimension approximately 1 micrometer.” Ans. 12. Compliance with the written description requirement is not determined based on whether the Specification uses the specific term “at least 1 micrometer” or whether the Specification provides examples for every possible embodiment of the recited broad range of sizes. “[T]o satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). “[T]he PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims.” In re Wertheim, 541 F.2d 257, 263 (CCPA 1976). In this case, the rejection lacks adequate analysis as to why the Specification which describes a method for producing a structure of approximately 1 micrometer (Ans. 12) does not support the 2 The Specification lacks pagination and we therefore provide our own. Appeal 2020-004351 Application 15/128,735 5 claim term “micrometer-sized sponge-like network structures of at least 1 micrometer.” We do not sustain the written description rejection. Indefiniteness The Examiner rejects claims 1–3, 5–7, 30 and 31 for failing to meet the definiteness requirement finding that the claim language “micrometer- sized sponge-like network structure of at least 1 micrometer” broadly encompasses any size larger than 1 micrometer ambiguous. Final Act. 4 (emphasis omitted). The use of terms of degree does not automatically render a patent claim indefinite. When a term of degree is employed in a claim there should be some indication in the Specification or extrinsic evidence available to demonstrate that the term provides the claim with “objective boundaries” for those skilled in the art. See, e.g., Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1371 (Fed. Cir. 2014) (citing Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2130 & n.8 (2014) (additional citation omitted). The Specification states: The implant according to the present invention is characterized in that it has micrometer-sized irregular bumps and channel-shaped nanometer-sized bumps on the surface thereof. As described above, the complex bump structures in micrometer and nanometer levels formed on the surface of the implant significantly increase the surface area and surface energy, increasing hydrophilicity and at the same time, increasing the surface adsorption of cell adhesion-mediated proteins including fibronectin and various growth factors present in the body fluid, thereby promoting adhesion, proliferation, and differentiation of osteogenic cells, and osseointegration of the implant. Spec. paragraph bridging 11–12. Appeal 2020-004351 Application 15/128,735 6 One having ordinary skill preparing dental implants would have understood this claim limitation “micrometer-sized sponge-like network structure of at least 1 micrometer” to encompass structures of about a micrometer size. Accordingly, we conclude that the Examiner’s indefiniteness rejection is not well-founded. The Examiner rejects claims 1–3, 5–7, 30 and 31 for failing to meet the definiteness requirement for the additional reason that the claim language “in such a way that a surface hydrophilicity and wettability of the surface of the titanium or titanium alloy implant has been increased by further imposing the hierarchical surface structures on the titanium or titanium alloy implant” is ambiguous. Final Act. 4. The Examiner finds that “it is unclear from the claim what is the base line or initial value that the surface hydrophilicity and wettability has been increased from.” Id. (emphasis removed). Appellant, on the other hand, argues that the claim language is clear for stating that the increase in value is based on a comparison to the structure without the recited “hierarchical surface structures.” Appeal Br. 9. “The claims, when read in light of the specification and the prosecution history, must provide objective boundaries for those of skill in the art.” Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1371 (Fed. Cir. 2014). In this case, the mere fact that the claim language does not specify a base line or initial surface hydrophilicity and wettability values does not render the scope of the claim language ambiguous. A skilled artisan reading the plain language of the claim would understand that the recited “increase” is based on a comparison before and after the recited “hierarchical surface structures” has been “further impos[ed]” onto the recited titanium or Appeal 2020-004351 Application 15/128,735 7 titanium alloy implant. Moreover, the Specification provides various descriptions of such an increase in surface hydrophilicity and wettability values. See Spec. 12 (“As described above, the complex bump structures in micrometer and nanometer levels formed on the surface of the implant significantly increase the surface area and surface energy, increasing hydrophilicity and at the same time, increasing the surface adsorption of cell adhesion-mediated proteins including fibronectin and various growth factors present in the body fluid, thereby promoting adhesion, proliferation, and differentiation of osteogenic cells, and osseointegration of the implant.”), 5– 6 (“The surface of a titanium alloy treated with the mixed etching composition including hydrogen peroxide and a carbonate compound or the etching composition containing hydrogen peroxide and a basic solution of the present invention includes micrometer-sized bumps and channel-shaped nanometer-sized bumps, and thus has an increased surface area, and can not only improve wettability, but also effectively promote cell proliferation and osteocyte differentiation.”). We accordingly do not sustain the indefiniteness rejection for this additional reason. Anticipation We review the appealed rejection for error based upon the issues identified by Appellant and in light of the arguments and evidence produced thereon. Cf. Ex parte Frye, 2010 WL 889747, *4 (BPAI 2010) (precedential) (cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections.”)). After having considered the evidence presented in this Appeal and each of Appellant’s contentions, we are not persuaded that reversible error has been identified, and we affirm Appeal 2020-004351 Application 15/128,735 8 the Examiner’s § 102 and § 103 rejection for the reasons expressed in the Final Office Action and the Answer. We add the following primarily for emphasis. In rejecting claim 13 over Mayfield, the Examiner finds that Mayfield discloses both recited steps, namely the “preparing” and “oxidatively etching” steps. Final Act. 5–6. Because Mayfield discloses an identical process, the Examiner finds that the product of Mayfield’s process would have identical properties as that recited. Id. at 7. Appellant argues that the Examiner reversibly erred because Mayfield “does not teach forming the micrometer-sized structures using an etching composition having a pH of 7 to 8 (i.e., neutral to basic).” Appeal Br. 10. We are not persuaded by the argument because it is unsupported by the record. As Appellant acknowledges, Mayfield discloses “a mixed etching composition having a pH of 7 to about 14.” Appeal Br. 10 (citing Mayfield ¶¶ 36–39, 46); see Final Act. 6. Appellant’s argument that the etching composition in Mayfield “refers only to the nanopitting portion of the process (i.e., the second step)” (Appeal Br. 9 (emphasis omitted)) is unpersuasive because it does not adequately explain why the recited “preparing” and “oxidatively etching” steps are distinguished from the prior art. As the Examiner points out, claim 1, reciting a method “comprising” the “preparing” and “oxidatively etching” steps, is open-ended and may include additional steps. Ans. 17. 3 Appellant does not separately argue any other claims. See Appeal Br. 9–15. All claims stand or fall together with claim 1. See id.; see also 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2020-004351 Application 15/128,735 9 Appellant next argues that Mayfield does not disclose the structure of “line-shaped open channel-shaped nanometer-sized bumps [less than 100 nanometers formed on the micrometer-sized structures].” Appeal Br. 10. From the outset, Appellant’s argument is unpersuasive because it does not dispute the Examiner’s finding that both recited steps are disclosed in Mayfield and the argument is therefore incommensurate in scope with the method claim.4 Moreover, Appellant’s argument that the process of Mayfield may include acid etching whereas “the one-step oxidative etching process . . . simultaneously forms the micro-sized and nano-sized structures” (Appeal Br. 12) is unpersuasive. The argument is incommensurate in scope with the open-ended language of claim 1 which does not recite the simultaneously formation of the structures as Appellant argues, nor does it exclude an additional acid etching step as the process in Mayfield. Appellant’s argument that Mayfield’s product would not have the increased hydrophilicity and wettability is unpersuasive. The Examiner has established a reasonable belief that such properties would have been inherent to the prior art product produced by an identical prior art process, the burden of proof therefore shifts to Appellant to show that this characteristic or property is not possessed by the prior art. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Appellant does not distinguish the recited process steps, nor does Appellant provide evidence showing that the prior art product 4 Appellant’s argument is unpersuasive also because it does not address the Examiner’s finding that Figures 9A and 9B of Mayfield disclose such structures. Compare Appeal Br. 10 (arguing that Figure 9C of Mayfield does not disclose the structure), with Final Act. 6 (citing various portions of Mayfield including Figures 9A–9C). Appeal 2020-004351 Application 15/128,735 10 would not exhibit such properties. Appeal Br. 13 (citing Wikipedia for an explanation of the Lotus effect which is described neither in Mayfield nor the pending application). “Attorneys’ argument is no substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). CONCLUSION The Examiner’s anticipation and obviousness rejections are affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3, 5–7, 30, 31 112(a) or first paragraph Written description 1–3, 5–7, 30, 31 1–3, 5–7, 30, 31 112(b) or second paragraph Indefiniteness 1–3, 5–7, 30, 31 1, 2, 5, 7, 31 102 Mayfield 1, 2, 5, 7, 31 3, 6, 30 103 Mayfield, Liao 3, 6, 30 Overall Outcome 1–3, 5–7, 30, 31 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation