Kenny Koay et al.Download PDFPatent Trials and Appeals BoardSep 4, 201914193317 - (D) (P.T.A.B. Sep. 4, 2019) 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. 14/193,317 02/28/2014 Kenny KOAY 10139/28802 4307 76960 7590 09/04/2019 Fay Kaplun & Marcin, LLP 150 Broadway, suite 702 New York, NY 10038 EXAMINER WAGGLE, JR, LARRY E ART UNIT PAPER NUMBER 3775 MAIL DATE DELIVERY MODE 09/04/2019 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 KENNY KOAY, ROD MCMILLAN, and RENE HAAG __________ Appeal 2019-000161 Application 14/193,317 Technology Center 3700 __________ Before CHARLES N. GREENHUT, MICHAEL J. FITZPATRICK, and WILLIAM A. CAPP, Administrative Patent Judges. FITZPATRICK, Administrative Patent Judge. DECISION ON APPEAL Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s final decision rejecting claims 1–9, 20, and 22. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 DePuy Synthes Products, Inc. (“Appellant”) is the applicant, as provided for under 37 C.F.R. § 1.46, and is also identified as the sole real party in interest. Appeal Br. 2. Appellant further notes that Appellant is owned by Johnson & Johnson, Inc. Id. Appeal 2019-000161 Application 14/193,317 2 STATEMENT OF THE CASE The Specification The “Background” portion of the Specification explains: Bone fixation devices such as drills, reamers, chisels and needles are typically formed of metal to permit the devices to withstand forces applied thereto as they are applied in bone fixation procedures. Generally, such bone fixation devices are not constructed out of implant-grade metal since implant-grade metal is not strong enough to withstand the forces repeatedly applied during use. Thus, the use of drills and reamers constructed out of implant-grade metal would result in damage to the device and require frequent replacement. Typically, tools used in bone fixation such as drill and reamers are constructed of non-implant-grade metal. However, if such bone fixation devices fracture of break during surgical use, fragments may be dislodged into the body. The time required to locate and remove such non-implant-grade metal fragments is lengthy and may exceed the time required to perform a target bone fixation procedure. Spec. ¶¶1–2. Thus, the Specification discloses a bone fixation device “formed of implant-grade material and having a carburized or nitrided outer surface configured to increase a surface hardness thereof to a desired level.” Id. ¶5 (3:14–16). The Rejected Claims Claims 1–9, 20, and 22 are rejected. Final Act. 1.2 Claim 1, the sole independent claim, is representative and reproduced below. 2 Claims 10–19 are withdrawn from consideration, claim 21 is canceled, and no other claims are pending. Final Act. 1–2; Appeal Br. 13–14. Appeal 2019-000161 Application 14/193,317 3 1. A bone cutting device extending from a proximal end to a distal end and having a sharpened cutting surface adjacent the distal end, the cutting surface being dimensioned to permit cutting of bone, the bone cutting device being formed of an implant grade material and an outer surface of the bone cutting device is one of carburized and nitrided. Appeal Br. 13. The Examiner’s Rejections The following rejections, under 35 U.S.C. § 103, are before us for review: 1. claims 1, 2 and 4–9 as being unpatentable over Kumar,3 Sander,4 Karapetian,5 and Total Materia6 (Final Act. 2); and 2. claims 3, 20, and 22 as being unpatentable over Kumar, Sander, Karapetian, Total Materia, and Henthorne7 (id. at 5). DISCUSSION Rejection 1 Appellant argues the rejection of claims 1, 2, and 4–9 together. Appeal Br. 3–10. We select claim 1 as representative. See 37 C.F.R. § 41.37(c)(1)(iv). Kumar discloses a dental drill with a bit for cutting into a jawbone. Kumar 2:46–57. Kumar teaches that the bit may be fabricated of “stainless steel,” “UNS S45500 (ASTM-A564),” or “a variety of other materials, such 3 US 6,641,395 B2, issued Nov. 4, 2003 (“Kumar”). 4 US 5,522,817, issued June 4, 1996 (“Sander”). 5 US 9,198,649 B2, issued Dec. 1, 2015 (“Karapetian”). 6 https://www.totalmateria.com/page.aspx?ID=CheckArticle&LN= EN&site=kts&NM=117 (Nov. 2003) (“Total Materia”). 7 US 4,371,394, issued Feb. 1, 1983 (“Henthorne”). Appeal 2019-000161 Application 14/193,317 4 as metals, alloys, ceramics, [or] plastics.” Id. at 13:42–50 (cited at Final Act. 3). Thus, the Examiner found that Kumar discloses the subject matter of claim 1 except for “the bone cutting device being formed of an implant grade material and an outer surface of the bone cutting device is one of carburized and nitride,” as recited in claim 1. Final Act. 3. Sander discloses “the attachment of bone penetrating elements to bioabsorbable polymer implant devices, such as fasteners, thereby enabling the implant devices to be drilled or driven directly into bone or other hard tissue.” Sander 2:58–62. Sander states: Unlike prior art fasteners, the fastening body portion 101 of the present surgical fastener 100 has one or more bone penetrating elements such as tips 104 attached to the distal ends of legs 102, for penetrating bone or hard tissue. The tips 104 must have a hardness sufficient for such penetration. Thus, tips 104 are preferably made of a metal, such as stainless steel, titanium and its alloys, cobalt-chromium-molybdenum alloys, or other implant grade metal alloys. Id. at 3:49–56 (emphasis added) (cited at Final Act. 4); see also id. at 6:26– 32 (“The tips 301 and 401 are fabricated from material which has hardness and strength suitable for its purpose of drilling bone. Such materials have been mentioned above and include ceramics and implant grade metal elements and alloys.” (emphasis added) (also cited at Final Act. 4)). The Examiner determined: It would have been obvious to one of ordinary skill in the art at the time the invention was made to construct the invention of Kumar et al. with the bone cutting device being formed of an implant grade material in view of Sander et al. in order to provide a known, alternative and effective material having the hardness and strength suitable for cutting bone. Final Act. 4. Appeal 2019-000161 Application 14/193,317 5 The Examiner found (as relevant to claim 2, in particular8) that Karapetian teaches the use of an anchor, for anchoring soft tissue to bone, which has a cutting tip “fabricated of 316L stainless steel (i.e., an implant grade/quality austenitic material).” Final Act. 4; see also id. at 7 (repeating same finding and citing Karapetian 8:55–57). The Examiner found that Total Materia teaches “gas nitriding austenitic stainless steels of the 300 series (see actual pages 2–3).” Final Act. 4. The Examiner concluded: It would have been obvious to one of ordinary skill in the art at the time the invention was made to construct the invention of Kumar et al. in view of Sander et al. with an outer surface of the bone cutting device being nitrided, wherein the bone cutting device is formed of implant quality austenitic stainless steel in view of Karapetian et al. and Total Materia in order to provide a bone cutting device fabricated from a material capable of being nitrided in order to obtain a high surface hardness, to increase wear resistance, and to improve fatigue life of the cutting device. Final Act. 4. Appellant’s arguments against this rejection are not persuasive. First, some of Appellant’s arguments are simply inapposite. For example, Section I.B. of the Appeal Brief is titled: “Kumar and Sanders Do Not Teach or Suggest a Bone Cutting Device Formed of Implant Grade Material Having a Carburized or Nitrided Outer Surface Carburized as 8 Claim 2 recites: “The device of claim 1, wherein the bone cutting device is formed of one of implant quality austenitic stainless steel, cobalt alloys, CCM (Co-28Cr-6Mo Alloy), MP35N, L605, ASTM-F-1058, elgiloy, titanium, titanium alloys, Ti-6Al-4V, Ti-6Al-7Nb and Ti-15Mo.” (Emphasis added). Appeal 2019-000161 Application 14/193,317 6 Claimed.” Appeal Br. 3. However, the rejection is based, not on these two references alone, but on four references. Final Act. 4; Ans. 7; cf. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.”). In fact, Appellant concludes Section I.B. of the Appeal Brief by conceding that the Examiner’s rejection is not based on merely Kumar and Sander, stating: Indeed, the Examiner acknowledges in the Final Office Action that Kumar in combination with Sanders does not teach or suggest an outer surface of a bone cutting device “is one of carburized and nitrided,” as recited in claim 1, nor do they teach or suggest a bone cutting device formed of implant quality austenitic stainless steel. See Final Office Action, 4. Appeal Br. 4. Appellant’s Section I.B. arguments (and others like them9) are unpersuasive. As much of Appellant’s arguments are inapposite, the Examiner has repeatedly reminded Appellant for what the references are relied on, stating: 9 In a different section of the Appeal Brief, Appellant argues that “Karapetian does not teach or suggest any bone cutting device formed of ‘an implant grade material’ where ‘an outer surface of the bone cutting device is one of carburized and nitride,’ as recited in claim 1.” Appeal Br. 5. However, the Examiner did not rely exclusively on Karapetian for teaching the latter recitation of claim 1. See Final Act. 4 (“Karapetian et al. teach the use of an anchor (10) capable of being formed with a tissue cutting tip (32), wherein the tissue cutting tip is fabricated from 316L stainless steel (i.e. an implant grade/quality austenitic material). . . . Total Materia teach gas nitriding austenitic stainless steels of the 300 series.”). Appeal 2019-000161 Application 14/193,317 7 Kumar et al. was relied upon for disclosing the majority of the claimed limitations regarding the “bone cutting device.” Sander et al. was relied upon for teaching the implant grade material. Karapetian et al. and Total Materia were relied upon [collectively] for teaching nitriding an implant grade, not an industrial grade, 316L stainless steel. Ans. 7; Advisory Action 2 (mailed April 9, 2018). One of Appellant’s further arguments is that “Karapetian includes no suggestion of implant grade material beyond the fact that the device is to be implanted.” Appeal Br. 5–6. The Examiner points out, however, that Sander was relied on for teaching the general concept of using implant grade material. Ans. 7; see also Final Act. 3–4 (“Sander et al. teach the use of a device (301 /401) capable of being used as a cutting device (i.e. drill) for cutting bone formed of an implant grade material (e.g. metal element or alloy).” (citing Sander, Figs. 6–7, 3:49–64, 6:12–32)). Karapetian was relied on for teaching the specific implant grade material 316L stainless steel. Final Act. 4. More specifically, Karapetian teaches a bone anchor for implantation, which is implanted by virtue of a tip of the anchor cutting into bone. Karapetian 8:53–57. That Karapetian does not focus on the cutting tip being implantable (as opposed to the entire anchor of which it is a part) does not undermine the Examiner’s rejection. Appellant next argues that “nothing in Karapetian suggests applying such material [i.e., implant grade 316L stainless steel] to a non-implantable item, such as the dental drill described by Kumar, or the bone cutting device of the present application.” Appeal Br. 6. We disagree. Karapetian explicitly discloses that implant grade 316L stainless steel is sufficient for cutting into bone. Karapetian 8:53–57. Additionally, the rejection is not Appeal 2019-000161 Application 14/193,317 8 limited to what Karapetian alone suggests or teaches. As found by the Examiner, Sander teaches the skilled artisan that “implant grade metal alloys” generally may be used for “bone penetrating elements.” Sander 3:49–56 (cited at Final Act. 3–4). Appellant asserts that the Examiner does not “point to anything in the cited references that would have lead one of skill in the art to make the proposed combination.” Appeal Br. 9. This is a blanket statement that is belied readily by the record, including Examiner’s findings and determinations quoted and cited above. The only specific argument presented in support of Appellant’s assertion is the following: In particular, the cited references do not provide any basis for modifying the material of the drill of Kumar (that is not implanted), with any material used in devices designed to remain within the body of a patient - such as, metal from a tip of a self- inserting absorbable orthopedic fixation device as described in Sander or 316L stainless steel from a suture anchor as described in Karapetian. Id. This argument is not persuasive, at least in view of Sander’s teaching that “bone penetrating elements such as tips 104 . . . are preferably made of a metal, such as stainless steel, titanium and its alloys, cobalt-chromium- molybdenum alloys, or other implant grade metal alloys.” Sander 3:49–56; see also Karapetian 8:53–57 (disclosing that implant grade 316L stainless steel is a sufficient material for cutting bone); see also Final Act. 4 (employing implant grade material in Kumar is obvious because such material is “a known, alternative and effective material having the hardness and strength suitable for cutting bone”). Appeal 2019-000161 Application 14/193,317 9 We have considered all of Appellant’s arguments but none apprises us of error in the Examiner’s rejection of claim 1 over Kumar, Sander, Karapetian, and Total Materia. Accordingly, we affirm the rejection of claim 1, as well as that of claims 2 and 4–9, which fall therewith. See 37 C.F.R. § 41.37(c)(1)(iv). Rejection 2 Claims 3, 20 and 22 depend from claim 1. Appellant argues that “Henthorne does not teach or suggest a bone cutting device ‘formed of an implant grade material,’ as recited in claim 1” and, therefore, “Henthorne does not remedy the deficiencies of Kumar, Sander, Karapetian, and Total Materia.” Appeal Br. 11. Because Appellant does not apprise of error in the Examiner’s rejection of claim 1 over Kumar, Sander, Karapetian, and Total Materia, Appellant also does not apprise us of error in the Examiner’s rejection of claims 3, 20, and 22 over the same art further in view of Henthorne. Accordingly, for similar reasons as discussed above, we affirm the rejection of claims 3, 20, and 22 as being unpatentable over Kumar, Sander, Karapetian, Total Materia, and Henthorne. SUMMARY The Examiner’s rejection of claims 1, 2, and 4–9 as unpatentable over Kumar, Sander, Karapetian, and Total Materia is affirmed. The Examiner’s rejection of claims 3, 20, and 22 as being unpatentable over Kumar, Sander, Karapetian, Total Materia, and Henthorne is affirmed. Appeal 2019-000161 Application 14/193,317 10 TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation