95000428 (P.T.A.B. Dec. 11, 2014)

Ex Parte 6818020 et al

Patent Trial and Appeal BoardDec 11, 2014

95000428 (P.T.A.B. Dec. 11, 2014)

MOD PTOL-90A (Rev.06/08) APPLICATION NO./ CONTROL NO. FILING DATE FIRST NAMED INVENTOR / PATENT IN REEXAMINATION ATTORNEY DOCKET NO. 95/000,428 01/22/2009 6,818,020 EXAMINER LERNER, DAVID, LITTENBERG, KRUMHOLZ & MENTLIK 600 SOUTH AVENUE WEST WESTFIELD, NJ 07090 Jastrzab, Krisanne ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 12/12/2014 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. UNITED STATES DEPARTMENT OF COMMERCE U.S. Patent and Trademark Office Address : COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov UNITED STATES PATENT AND TRADEMARK OFFICE _____________________________________________________________________________________ 1 UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE PATENT TRIAL AND APPEAL BOARD ____________ SMITH & NEPHEW, INC. AND ZIMMER, INC. Requester v. HOWMEDICA OSTEONICS CORP. Patent Owner and Appellant ____________ Appeal 2013-007710 Reexamination Control 95/000,428 Patent 6,818,020 B2 Technology Center 3900 ____________ Before MARK NAGUMO, RICHARD M. LEBOVITZ, and RAE LYNN P. GUEST, Administrative Patent Judges. GUEST, Administrative Patent Judge. DECISION ON REHEARING Appeal 2013-007710 Reexamination Control 95/000,428 Patent 6,818,020 B2 2 In the Decision on Appeal dated April 30, 2014 (“Decision”), the panel affirmed the Examiner’s rejection of claims 1-6 of U.S. Patent 6,818,020 B2 (hereinafter, “the ’020 Patent”) under 35 U.S.C. § 102(b) as anticipated by Lue,1 as evidenced by the Clough Declaration.2 Patent Owner requests rehearing of this decision under 37 C.F.R. § 41.79. Request for Rehearing (“Req. R’hg.”) dated May 30, 2014. Requester submitted comments on Patent Owner’s Request for Rehearing on June 30, 2014 (hereinafter “Comments”). Initially, Patent Owner contends the Board misapprehended or overlooked that: I. The preamble phrase “medical implant” limits the claims to a grade of Ultra high molecular weight polyethylene (hereinafter “UHMWPE”) suitable for a medical implant. Req. R’hg. 5. II. Dr. Clough’s use of industrial grade UHMWPE cannot be used to show anticipation by inherency because Requester has not provided sufficient evidence that the industrial grade 1 Ching-Tai Lue, “Effects of Gamma Irradiation and Post Heat-Treatments on the Structure and Mechanical Properties of Ultra High Molecular Weight Polyethylene (UHMW-PE),” Masters Thesis, University of Lowell, 1979 (hereinafter referred to as “Lue”). 2 First Declaration of Roger L. Clough, dated January 16, 2009, and made of record as Appendix B to the Request on January 22, 2009 (hereinafter “Clough Declaration” or “Clough Decl.”). The Clough Declaration is further supported by additional testimony of Dr. Clough in the Second Clough Declaration, dated July 9, 2009, and made of record on the same date with Requester’s Comments (hereinafter “2nd Clough Declaration” or “2nd Clough Decl.”), and in the Third Clough Declaration, dated January 1, 2011, and made of record on January 5, 2011 with Requester’s Comments (hereinafter “3rd Clough Declaration” or “3rd Clough Decl.”). Appeal 2013-007710 Reexamination Control 95/000,428 Patent 6,818,020 B2 3 UHMWPE tested by Dr. Clough is either medical grade or the same UHMWPE used by Lue. Req. R’hg. 8-12. III. The evidence and explanations that definitively show that Dr. Clough’s testing was faulty. Req. R’hg. 12-15. I. Interpretation of preamble phrase “medical implant” Claim 1, as a representative claim, reads as follows: 1. A medical implant comprising an irradiated ultra-high molecular weight polyethylene having a weight average molecular weight greater than 400,000 and a solubility of less than 80.9% in trichlorobenzene. Patent Owner contends that the preamble phrase “medical implant” is not a statement of purpose or intended use. Req. R’hg. 4-5. Rather, Patent Owner argues that the phrase provides a structural limitation requiring a grade of UHMWPE suitable for use as a medical implant. Id. at 5. After carefully consideration of Patent Owner’s contentions, we are not persuaded that the panel misapprehended or overlooked the concerns raised by Patent Owner in interpreting the preamble phrase “medical implant.” The Decision follows Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997), which states that “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.” The claims of the ’020 patent define in their body “an irradiated ultra-high molecular weight polyethylene” having particular properties. Thus, the body of the claims recite a structurally complete invention. The body of the claims are silent as to any particular grade of UHMWPE. Further, Patent Owner did not persuasively identify disclosure in the ’020 Patent that would Appeal 2013-007710 Reexamination Control 95/000,428 Patent 6,818,020 B2 4 have led one of ordinary skill in the art to construe “medical implant” narrowly to require a specific grade of UHMWPE. Consistently, the panel determined in the Decision that “We disagree that the recitation in the preamble of a ‘medical implant’ structurally defines the UHMWPE otherwise recited in the claims.” Decision 18. Accordingly, the panel did not misapprehend or overlook the phrase “medical implant” in the preamble of claim 1. Further, even if the phrase “medical implant” required that the prior art teach UHMWPE suitable for use as a medical implant, Lue states that UHMWPE was extensively used “for prosthetic body implants,” particularly for “use in artificial hips, fingers, knees, etc.” as “the best material available for these applications.” Lue, p. 23, third full ¶. Thus, Lue expressly teaches treated UHMWPE that is suitable for use as medical implant. II. Dr. Clough’s use of industrial grade UHMWPE Patent Owner contends that Dr. Clough’s use of industrial grade UHMWPE cannot be used as evidence to show anticipation by inherency because “[w]ithout a showing that Lue used GUR 4030 or 4130 [the industrial grade UHMWPE used by Dr. Clough] or a showing that one or both are in fact the same or sufficiently similar to the UHMWPE used by Lue, a finding of inherency is precluded.” Req. R’hg. 11. The panel did not overlook either the difference in grade of Dr. Clough’s UHMWPE samples or the silence in Lue as to the grade used. The Decision states Lue was silent as to the type or grade of UHMWPE treated according to the process that he discloses. We find that Dr. Clough took reasonable steps to find similar UHMWPE to that Appeal 2013-007710 Reexamination Control 95/000,428 Patent 6,818,020 B2 5 available at the time of Lue. Clough Decl. ¶¶ 23-26. Accordingly, we find that the materials used by Dr. Clough to be sufficiently similar to those used at the time of Lue to shift the burden to Patent Owner to show that such differences are significant. Patent Owner has directed us to no persuasive evidence to show that particular resins or grade used by Dr. Clough would have created a significant difference in Dr. Clough’s results. Decision 19. In other words, the evidence of record is persuasive that GUR 4030 or 4130 are “sufficiently similar to the UHMWPE used by Lue” for a finding of inherency. Accordingly, it has not been shown that it would have been necessary for Dr. Clough to reproduce all the testing described in Lue to show the identical nature of the UHMWPE tested by Lue. On the present record, Dr. Clough’s testing is probative of surgical grades of substantially identical industrial grade UHMWPE. Moreover, the ’020 patent suggests that differences in the types or grades of UHMWPE are unlikely to substantially change the effects of an identical process. For example, while the ’020 patent uses “surgical grade UHMWPE” in its examples (see ’020 patent, col. 7, ll. 21-22), the ’020 patent is otherwise silent as to any particular grade. Further, the ’020 patent states that The present invention relates to a method for providing a polymeric material, such as UHMWPE, with superior oxidation resistance upon irradiation. For the purpose of illustration, UHMWPE will be used as an example to describe the invention. However, all the theories and processes described hereafter should also apply to other polymeric materials such as polypropylene, high density polyethylene, polyester, nylon, polyurethane and poly(methylmethacrylate) unless otherwise stated. ’020 patent, col. 3, ll. 35-43 (emphasis added). Appeal 2013-007710 Reexamination Control 95/000,428 Patent 6,818,020 B2 6 Accordingly, the panel did not misapprehend or overlook Dr. Clough’s use of industrial grade UHMWPE. III. Evidence that Dr. Clough’s testing was faulty Patent Owner directs us to Ms. Mary Kaplar’s3 testimony, presented as an Exhibit A to Dr. Li’s declaration, that there were 15 minutes between samples as contradicting Dr. Clough’s testimony that the samples were not cooled, but still at 170°C. Req. R’hg. 12. Ms. Kaplar’s testimony is not contradictory, as argued by Patent Owner. As stated in the Decision, Dr. Clough testified that the samples were kept in insulating heating mantles, were not left at room temperature, were still at 170°C, and were not cooled. Decision 21 (citing Third Clough Declaration ¶ 8 and ¶ 9). Thus, despite the fact that the samples were sitting for up to 15 minutes before being tested, it does not mean that the samples cooled to a significant extent, as they were retained in heating mantles and not at room temperature. Ms. Kaplar further testifies that the solvent was hot when tested. See Second Li Declaration, dated December 6, 2010, Exhibit A (Deposition of Mary Kaplar of December 15, 2008) 91:18-19 (“A. So the fluid was hot. The TCB was hot going in.”). Accordingly, the Decision did not overlook or misapprehend the details of Dr. Clough’s solubility testing, and we decline to address Patent Owner’s further arguments directed towards the temperature of the solubility testing. See Req. R’hg. 13-15. 3 Ms. Kaplar is said to be Dr. Clough’s technician who performed the actual testing reported in Dr. Clough’s Declaration. Second Li Declaration, dated December 6, 2010, ¶ 25. Appeal 2013-007710 Reexamination Control 95/000,428 Patent 6,818,020 B2 7 Patent Owner contends that the Board overlooked Dr. Li’s testimony that “[Dr. Clough’s] description of the samples during testing—no swelling, no gelling, not translucent—means that Clough's testing failed to provide an accurate, let alone any, solubility result.” Req. R’hg. 13 (citing Li Declaration, dated June 9, 2009, ¶ 56). As pointed out by Requester, Dr. Clough testifies that due to the high degree of crosslinking, swelling and gelling would be very minimal and not visually apparent. See Comments 10 (citing 2nd Clough Declaration ¶ 9; 3rd Clough Declaration ¶ 10). Dr. Li and Dr. Clough both opine as to the visual appearance and swellability/gellability of treated UHMWPE in TCB at 170°C. However, neither expert provides any underlying evidentiary support for their opinion as to the visual appearance of UHMWPE as evidence of successful solubility testing. Moreover, the ’020 patent is silent as to the appearance of the treated UHMWPE during the solubility testing described in Example 3. See ’020 patent, col. 9, l. 28 to col. 10, l. 35. We decline to credit Dr. Li’s description of visual appearance over Dr. Clough’s explanation to the contrary, where both lack supporting evidence that the visual appearance is indicative of the experiment’s success. Accordingly, as Dr. Clough has declared personal knowledge that the steps for the solubility testing specifically recited in the ’020 patent were followed, we accord the reported visual appearance of the materials during the solubility testing little, if any, probative value. Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997) (“Nothing in the rules or in our jurisprudence requires the fact finder to credit the unsupported assertions of an expert witness.”). Appeal 2013-007710 Reexamination Control 95/000,428 Patent 6,818,020 B2 8 Therefore, we decline to make any changes in the Decision mailed April 30, 2014. Accordingly, the Request for Rehearing is denied. DENIED alw PATENT OWNER: LERNER, DAVID, LITTENBERG, KRUMHOLZ & MENTLIK 600 SOUTH AVENUE WEST WESTFIELD, NJ 07090 THIRD-PARTY REQUESTER: JEFF B. VOCKRODT, ESQ. HUNTON & WILLIAMS LLP 1900 K. STREET NW, SUITE 1200 WASHINGTON, DC 20006-1109 BRYAN RUTSCH, ESQ. KIRKLAND & ELLIS LLP 300 NORTH LaSALLE CHICAGO, IL 60654