Ex Parte 7,217,392 et alDownload PDFPatent Trial and Appeal BoardJun 1, 201595001613 (P.T.A.B. Jun. 1, 2015) 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. 95/001,613 05/03/2011 7,217,392 1205100-00731US1 2566 21005 7590 06/01/2015 HAMILTON, BROOK, SMITH & REYNOLDS, P.C. 530 VIRGINIA ROAD P.O. BOX 9133 CONCORD, MA 01742-9133 EXAMINER DAWSON, GLENN K ART UNIT PAPER NUMBER 3993 MAIL DATE DELIVERY MODE 06/01/2015 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 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. 95/001,692 07/19/2011 7,217,392 1205100-00731US3 3732 21005 7590 06/01/2015 HAMILTON, BROOK, SMITH & REYNOLDS, P.C. 530 VIRGINIA ROAD P.O. BOX 9133 CONCORD, MA 01742-9133 EXAMINER DAWSON, GLENN K ART UNIT PAPER NUMBER 3993 MAIL DATE DELIVERY MODE 06/01/2015 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 ____________ LEICA BIOSYSTEMS MELBOURNE PARTY LTD. Requester and Respondent v. DAKO DENMARK A/S Patent Owner and Appellant ____________ Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 Technology Center 3900 ____________ Before MARK NAGUMO, RICHARD M. LEBOVITZ, and RAE LYNN P. GUEST, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This is a decision on the appeal by the Patent Owner from the Patent Examiner’s decision to reject claim 7 in the above-identified inter partes reexamination of US 7,217,392 B2. The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6(b), 134, and 315. We affirm. Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 2 I. BACKGROUND The patent in dispute in this appeal is US 7,217,392 B2 (“the ’392 patent”) which issued May 15, 2007. The named inventors are Steven A. Bogen, Herbert H. Loeffler, and John A. Purbrick. The Patent Owner is Dako Denmark A/S1 (“Patent Owner”). Appeal Brief (“Appeal Br.”) 1, dated April 17, 2014. The ’392 patent was filed June 9, 2004 and claims priority back to an application filed Feb. 27, 1998. ’392 patent, “Related U.S. Application Data.” A request for inter partes reexamination of the ’392 patent under 35 U.S.C. §§ 311–318 and 37 C.F.R. §§ 1.902–1.997 was filed May 3, 2011 by Leica Biosystems Melbourne Party Ltd. (“Leica” or “Requester”). The request was assigned control number 95/001,613. Subsequently, Leica filed a second request for inter partes reexamination of the ’392 patent on July 19, 2011. This second request was assigned control number 95/001,692 (“’692 Request”). The reexaminations were merged on Nov. 18, 2011. Decision, Sua Sponte, to Merge Reexamination Proceedings. The ’392 patent expired on May 11, 2012 because of terminal disclaimers to US Patents 5,947,167 and 6,180,061, which expired May 11, 2012. Appeal Br. 2. No amendments may be proposed for entry in an expired patent. 37 C.F.R. § 1.530(j). See Right of Appeal Notice (“RAN”) 4-5. The ’392 patent is the subject of pending litigation in the U.S. District Court for the District of Delaware, C.A. No. 11-390-GMS, Dako Denmark A/S, et al. v. Leica Microsystem, Inc., et al. Appeal Br. 1. On October 7, 2011, the district 1 The original patent owner is CytoLogix Corp. Appeal Br. 19. See also Assignment Reel/Frame 20762-402. Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 3 court granted a stay of the litigation pending the outcome of this reexamination proceeding. Id. U.S. Patent No. 7,553,672 (“the ’672 Patent”), which claims priority to the ’392 Patent, is also the subject of inter partes reexamination proceedings (Control No. 95/001,671). Patent Owner appealed from the Examiner’s determination to reject all pending claims in this proceeding as unpatentable. A decision affirming the Examiner’s determination was issued by the Board on August 25, 2014. Appeal 2014-002692. Several other related patents have been involved in reexaminations and/or litigation. Appeal Br. 1. An oral hearing took place on April 1, 2015, with both Patent Owner and Requester in attendance. A transcript has been entered into the record. Claim 7 The ’392 patent issued with 8 claims. Claims 1–8 have been rejected by the Examiner. Appeal Br. 1; RAN 7. Only the rejection of claim 7 is appealed. Appeal Br. 1. Claim 7 reads as follows: 7. A microscope slide stainer, comprising: a staining protocol program comprising instructions for applying reagents and heat to a plurality of microscope slides bearing biological samples; a plurality of slide supports, each support being comprised of a heating element that underlies only one microscope slide and having a surface on which only one microscope slide rests so as to transfer heat to the one microscope slide; at least one reagent dispenser that can dispense a liquid reagent onto a microscope slide on one of the slide supports; a movable carriage that causes the reagent dispenser to be aligned over a desired microscope slide on one of the slide supports, as specified in the slide Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 4 staining program, so that reagent dispensed out of the reagent dispenser drops onto an underlying microscope slide on one of the slide supports; and a control system that issues commands to cause relative motion between the reagent dispenser and the microscope slide on one of the slide supports so that the reagent dispenser is aligned over the microscope slide on one of the slide supports, as specified in the staining protocol program, and that issues commands to cause the heating elements to heat at the times specified in the staining protocol program, the control system controlling heating of one heating element to a different temperature than another. Rejections Claim 7 stands rejected by the Examiner as follows: 1. Under 35 U.S.C. § 102(b) (pre-AIA) as anticipated by U.S. Patent No. 5,439,649 (issued Aug. 8, 1995) to K. Tseung, W.B. Wong, G.K. Takayama, C.M. Jones, and K.L. Kalra (“Tseung”). 2. Under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view Tseung. 3. Under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view of Tseung and U.S. Patent No. 5,601,141 (issued Feb. 11, 1997) to S.J. Gordon and A.J. Christopher (“Gordon”). 4. Under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view of Tseung and U.S. Patent No. 5,273,905 (issued Dec. 28, 1993) to U.R. Muller, L.J. Mika, D.J. Lindley, and E.J. Wisner (“Muller”). 5. Under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view of Tseung and WO 96/30124 (published Oct. 3, 1996) to T. Freeman (“Freeman”). We REVERSE the anticipation rejection over Tseung and AFFIRM the obviousness rejection over Tseung and Muller. The obviousness rejections of claim 7 over Tseung, alone, and Tseung in combination with Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 5 Gordon and Freeman have not been reached since the rejection of claim 7 is affirmed on other grounds. Cf. Beloit Corp. v. Valmet Oy, 742 F.2d 1421, 1423 (Fed. Cir. 1984) (having decided a single dispositive issue, the ITC (an agency bound by the Administrative Procedures Act) was not required to review other matters decided by the presiding officer). II. CLAIM INTERPRETATION Issue Claim 7 is directed to a microscope slide stainer that comprises: (1) “a plurality of slide supports, each support being comprised of a heating element that underlies only one microscope slide” and (2) the slide support “having a surface on which only one microscope slide rests so as to transfer heat to the one microscope slide.” The Examiner interpreted limitations (1) and (2) as reproduced above as “reciting what the device is capable of,” rather than “structural limitations” of the slide stainer, itself. RAN 17. Requester agrees with this interpretation, arguing that there is no support in the ’392 patent for an embodiment with a support that holds only one slide. Requester Respondent Brief (“Req. Resp’t. Br.”) 8–9 (May 13, 2014). Patent Owner challenges this interpretation. Patent Owner contends that the recitation that the support has “a surface on which only one microscope slide rests” (emphasis added) means that “the slide support structure be able to support one and only one slide.” Patent Owner Rebuttal Brief (“Owner Rebuttal Br.”) 3–4 (Jul. 22, 2014). Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 6 Principles of Law The ’392 patent expired May 11, 2012, because of terminal disclaimers to U.S. Patent Nos. 5,947,167 and 6,180,061. Appeal Br. 2. The “Board’s review of the claims of an expired patent is similar to that of a district court’s review, Ex Parte Papst-Motoren, 1 USPQ2d 1655, 1655–56 (B.P.A.I. Dec. 23, 1986); see also MPEP § 2258 I.G (directing Examiners to construe claims pursuant to Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), during reexamination of an expired patent).” In re Rambus, Inc., 694 F.3d 42, 46 (Fed. Cir. 2012). As explained in Philips: [C]laims ‘must be read in view of the specification, of which they are a part.’” [Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996)]. [The] specification ‘is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.’ [Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).]. Philips, 415 F.3d at 1315. In addition to the patent specification, the prosecution history of the patent is also pertinent in construing the terms in a claim. Id. With these principles in hand, we turn to the claim. Discussion Claim 7 is directed to a “microscope slide stainer.” The stainer has a “plurality of slide supports,” where each slide support is comprised of “a heating element that underlies only one microscope slide,” each slide support “having a surface on which only one microscope slide rests so as to transfer heat to the one microscope slide.” The requirements that the heating element “underlies only one” slide and the support has a surface with “only one slide” are reasonably interpreted Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 7 to be structural limitations of the slide warmer because the claim is drawn to an apparatus, and the recited limitations would, therefore, most logically represent a structure of the apparatus. The Examiner’s contention that the limitations indicate what the apparatus is “capable of” is not supported by any language in the claim. RAN 17. The Examiner simply set forth this interpretation of the claim without identifying any support in the claim language or written description of the ’392 patent. Requester takes the position that the Examiner is correct in his interpretation because the ’392 patent does not describe a slide support with a single surface holding only one slide. Requester Rebuttal Br. 9. The weight of the evidence does not support this interpretation. Figure 17, reproduced below, is consistent with Patent Owner’s interpretation of the claim: Figure 17 (reproduced above) shows a second embodiment of the patent. ’392 patent, col. 3, ll. 40–55; col. 8, ll. 39–40, 45–55. The slide warmer has forty- Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 8 nine slide positions (only 8 positions are depicted in drawing). Id. at col. 10, ll. 36–37. Each slide in this configuration is held in place by slide chamber clips 76 (not shown) with lateral walls which are said to form a “cavity.” Id. at col. 8, ll. 20–26; Figs. 14A and 14B. The slides are mounted on a slide rotor 77. Id. at col. 8, l. 38; Fig. 14A. A single heating element 78 is said to provide “a location 88 for a single slide to be heated.” Id. at col. 10, l. 29; col. 8, ll. 45–55. Figures 14A and 14B, which demonstrate a cavity having lateral walls formed by a slide chamber clip 76, are referenced as demonstrating “[t]he physical layout of this location 88.” Id. at col. 10, ll. 29-31; col. 8, ll. 20-23. Location 88, therefore, serves as “a surface on which only one microscope slide rests,” consistent with Patent Owner’s interpretation of the phrase being a structural limitation of the claim. The surface 88 has a heating element 78 which “underlies only one microscope slide,” providing a written description of this aspect of the claim, as well. In sum, based on the language of the claim, and its written description in the ’392 patent, we construe the limitations (1) “a plurality of slide supports, each support being comprised of a heating element that underlies only one microscope slide” and (2) the slide support “having a surface on which only one microscope slide rests so as to transfer heat to the one microscope slide” to be a structural limitation of the slide stainer and to require that a support structurally can hold only one microscope slide and have its own heating element. III. ANTICIPATION BY TSEUNG The Examiner rejected claim 7 as anticipated by Tseung. With respect to the claim interpretation that the slide support can structurally hold only one slide, the Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 9 Examiner relied on claim 21 of Tseung which the Examiner found to describe a surface holding a single slide. RAN 17. Claim 21 of Tseung is reproduced below, with claims 18–20 from which claim 21 depends. 18. The apparatus of claim 1, wherein said apparatus further comprises a removable microscope tray adapted to retain multiple microscope slides in a fixed array at said fourth location. 19. The apparatus of claim 18, wherein said tray comprises individual wells for microscope slides and said wells are partially open on their bottom surfaces. 20. The apparatus of claim 19, further comprising a microscope slide heating surface, wherein when said tray with any microscope slides contained in said tray is inserted into said microscope slide holder, said microscope slides contact said heating surface through the partially open bottom surface of said wells. 21. The apparatus of claim 20, wherein individual segments of said heating surface are controlled by said control means, thereby providing different temperatures for said segments. The Examiner appears to have interpreted “segments of said heating surface” to cover a segment which holds only one microscope slide as required by claim 7. However, while claim 21 covers heating segments which can be heated to different temperatures, the claim does not specify how many slides are held on each segment. The segments recited in Tseung’s claim 21 are part of the heating surface. The term “segment” only appears in claim 21, but not elsewhere in the written description of Tseung. Requester contends that a “segment” must correspond to a raised portion 202 of a heater block 200 described in Tseung. Requester Resp’t Br. 10–11. Fig. 9B of Tseung showing this configuration is reproduced below: Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 10 Fig. 9B shows heating block 200 with ten raised positions 202, each raised position 202 accommodates a single slide. Tseung also teaches a configuration with four heating blocks, each with ten raised positions 202. Tseung, Fig. 10. Tseung describes that when heating blocks 200 are configured in an array “[i]t is then possible to individually heat each of the heater blocks to different temperatures.” Id. at col. 12, ll. 59-66. Even if Requester is correct that raised position 202 corresponds to a “segment,” raised position 202 is not “comprised of a heating element that underlies only one microscope slide,” but rather the heating element is a heating block 200 which underlies ten raised areas 202. Tseung, Fig. 9B & 10; col. 12, ll. 46–51. Requester’s interpretation requires one of ordinary skill in the art to read “segment” as the raised area 202 holding only one slide, and then to ignore the disclosure in Figs. 9 and 10 that a heating block underlies multiple segments. As there is no description of a “segment” in the description of Tseung, the term could alternatively be read by a skilled artisan to include more than just one raised area 202 or be read on one heating block 200 of four that are formed in an array, as shown in Fig. 10 of Tseung. There is insufficient evidence to support Requester’s contention that one of ordinary skill in the art would have read “segment” as recited in claim 21 to necessarily mean a structure which holds only one slide as required by claim 7. Accordingly, we reverse the Examiner’s determination that claim 7 is anticipated by Tseung. Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 11 IV. OBVIOUSNESS IN VIEW OF TSEUNG AND MULLER Claim 7 stands rejected as obvious in view of Tseung and Muller. The Examiner relies on the statement of the rejection on pages 175–179 of the ’692 Request. See also ’692 Request, Claim chart B-10. For the claimed requirement of a slide support having only one heating element and holding only one slide, Requester relied on Muller’s description of “block member 37.” Claim chart B-10, p. 23–24. Muller describes an “apparatus and methods for the sequential, multi- step, controlled processing of slide surface mounted material, or the like,” particularly slide mounted biological materials. Muller, col. 2, ll. 4–50. Muller describes its apparatus useful for immunohistochemical staining (IHC), in situ hybridization, and other staining techniques. Id. at col. 1, l. 14 to col. 2:45. Muller describes a block member 37 which “generally has a rectangular configuration and includes a flat surface 38 for accommodating adjacently thereto one surface 39 of a conventional glass slide 41, or the like.” Muller, col. 15, ll. 21– 24; Fig. 5. The block member 37 is heated and individually controlled. Id. at col. 3, ll. 46–51; col. 4, ll. 4–7; col. 17, ll. 36–43; Fig. 5. The Examiner held in the Action Closing Prosecution (“ACP”) that it would have been obvious to have incorporated Muller’s single slide supports into Tseung because it “would be arbitrary how many slides are included in a particular slide support, including using individual slide supports. Increasing the cost of the device is offset by the ability to concurrently heat different slides to different temperatures for different reagents increasing the flexibility of the use of the device.” ACP 24; see also ACP 36. Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 12 Patent Owner contends that one of ordinary skill in the art would not have been motivated to modify Tseung with Muller’s teachings. Specifically, Patent Owner argues: Muller is an in situ hybridization (ISH) stainer for which individual heating was typically used. A further aspect of ISH is that very small amounts (around 10 microliters, (Muller, col. 22, line 22)) of expensive ISH reagents must be conserved. Accordingly, Muller teaches heating of slides within a “tightly-sealed” chamber to prevent evaporation during high temperature incubations. Appeal Br. 22. Patent Owner states that Tseung, on the other hand, describes a stainer designed for IHC (immunohistochemical) staining in which evaporation “is not such a problem at room or body temperature. Consequently, IHC slide stainers are amenable to the open architecture that permits automated reagent dispensing.” Id. at 22–23. Patent Owner further states that the “individual heating provided by Muller allows for the rapid heating and cooling and the high temperature heating necessary to perform the ISH protocols for which Muller was designed.” Id. at 23. Patent Owner contends that this “heating system would not have been appropriate or necessary for the open staining protocols for which Tseung was designed. . . . Thus, looking to Muller for individual slide heating is based on hindsight in view of the claimed invention.” Id. at 23–24. Patent Owner supports this argument with testimony by Dr. Alton D. Floyd. Dr. Floyd stated that he has over forty years of experience in the field of cell and tissue research, diagnostic laboratory operation, and product and business development. Subst. Floyd Decl. ¶ 1 (dated July 24, 2012) (referred to as “Substitute Declaration” in Patent Owner Response filed Jul. 25, 2012). He also stated that he has held faculty appointments at The University of Michigan School Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 13 of Medicine and Indiana University School of Medicine. Id. Dr. Floyd testified that he entered into a consulting agreement with Patent Owner (“Dako”) to provide expert opinions regarding matters related to the Reexamination. Id. at ¶ 7. Dr. Floyd testified that based on Tseung’s description of the prior art and the description of Tseung’s device, “one of skill in the art would recognize that the Tseung device was designed for use with IHC staining. In fact, the commercialized embodiment of Tseung was designed and used for IHC staining.” Id. at ¶ 34. Dr. Floyd also stated that a commercial IHC stainer, which was “developed by Glenn Takayma, Ken Tseung and others, did not include heating of slides during staining incubation despite their showing the possibility of heating in the Tseung, et al. patent.” Id. at ¶ 20. The evidence does not support Patent Owner’s argument that Tseung’s device is limited to IHC staining. While it is true that Tseung describes IHC staining in its “Background” section, broader disclosure also appears in it, with reference to IHC (i.e., “immune staining”) as a preferred (“particularly”) embodiment. All of these apparatuses have attempted to solve certain conflicting goals in automated apparatuses of this type. For example, it is desirable to use a minimum of expensive or toxic reagents, particularly reagents used in immuno staining (e.g., antibodies and other reagents of biological origin), while insuring that complete coverage of the microscope slide by the reagent will occur. Tseung, col. 2, ll. 3–10. In the “Summary of the Invention” of Tseung, it is stated that an “object of the invention” is “to provide an automated staining apparatus that is readily programmable to allow automated staining of individual microscope slides with different techniques without operator intervention in a single operation.” Id. at col. Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 14 2, ll. 27–31. The subsequent disclosure refers to staining reagents, but does not limit them to antibodies used for IHC. Id. at col. 2, l. 33; col. 3, l. 18; col. 6, l. 23– 24; col. 11, ll. 63–64; col. 16, l. 18. While Tseung may have initially focused on IHC staining in its background section, we have not been directed to a disclosure in the Tseung that would limit the described device to this type of staining. Moreover, even if Tseung were limited to the use of the described device for IHC applications, contrary to Patent Owner’s arguments (Owner Appeal Br. 22– 23), Muller is not limited to ISH applications. Muller expressly describes IHC staining, the same staining procedure as in Tseung. Muller, col. 1, ll. 30–32; col. 11, ll. 25–63. Consequently, Muller’s teachings are directly pertinent to Tseung. Since Muller describes its device as useful for IHC staining, it would have been obvious to have used its features in the device of Tseung, which is taught for the same purpose. Patent Owner attempts to distinguish Muller from Tseung because Muller describes a closed chamber system with specific heating and cooling characteristics. Owner Appeal Br. 22. One of skill in the art would only consider modifying the Tseung system with the heating of Muller in order to support ISH protocols. The heating of Muller is designed for the particular requirements of ISH, including individual heating and cooling and closed chambers to avoid evaporation. These closed chambers are critical to the operation of the Muller device; without them, ISH could not be performed due to the evaporation of reagents and denaturation of the samples. Subst. Floyd Decl. ¶ 59. Dr. Floyd also argued that Muller is incompatible with a moving platform. Id. at ¶ 60. However, Dr. Floyd’s testimony is not supported by the evidence since Muller’s device is not limited to ISH. See above. While it may be true that the Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 15 closed chambers are “critical” to Muller’s device, the rejection is based on the application to Tseung of Muller’s teaching of providing individualized heating for each slide on its own block member. Muller, col. 15, ll. 17–24; col. 17, ll. 36–43. Patent Owner has not disputed that Muller teaches individualized heating but takes the position that individualized heating would not be applied to Tseung since Tseung is directed to an open system for processing IHC slides. This reasoning is factually flawed since Tseung’s device is not limited to IHC. Tseung is described as generally useful for staining reagents. Tseung, col. 2, ll. 32-35; col. 3, l. 18; col. 5, ll. 3–5. Muller teaches the desirability of heating individual slides at different temperatures for staining procedures. Muller, col. 3, ll. 46–51; col. 4, ll. 4–7; col. 17, ll. 36–43. Consequently, it would have been obvious to one of ordinary skill in the art to implement individual slide heating in Tseung for those staining procedures which are accomplished in an open system and for which heating to different temperatures is desired. Complexity Argument Dr. Floyd testified in his written declaration about the complexity of modifying Tseung with individual heating elements: [M]odifying a stainer with four heating blocks each holding ten slides [Tseung] to forty individual slide heaters is far more than an arbitrary design choice and would result in substantial increases in cost and complexity. For example, such a modification could require a ten- fold increase in the number of heating elements, supply wires, temperature sensing wires, power switching circuits, etc. Increasing the number of these elements by an order of magnitude also has an effect on reliability since there would be more parts subject to failure. Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 16 Subst. Floyd Decl. ¶ 36. Dr. Floyd made similar statements in paragraphs 39 and 40 of his declaration. Dr. Floyd’s testimony is not persuasive when weighed against the teachings in Muller and Tseung that show providing a plurality of slide heaters would have been within the skill of the ordinary artisan. Muller teaches that its apparatus can be used to process a plurality of slides, where each slide is processed differently. In another aspect, this invention provides such apparatus and methods that can be utilized, if desired, with one or more slides being simultaneously processed in a sequential manner, each slide being associated with a different processing station. The individual slide at each station when a slide plurality is being processed can be, if desired, identically or variously processed relative to other slides. For example, . . . the slides of such plurality can each be undergoing a processing sequence which is different from the processing sequences which others of such slide plurality are undergoing. Muller, col. 3, ll. 24–36. Each station has its own heater. Id. at col. 4, ll. 4–7. Muller describes how to heat a plurality of heat block members. Id. at col. 17, ll. 37–43; Claim chart B-10, pp. 13–14. Tseung also teaches multiple heating blocks. Tseung, Fig. 9. Dr. Floyd’s testimony about the complexity and costs of having a multiplicity of heating blocks is not persuasive because both Muller and Tseung describe a multiplicity of heating blocks. While Tseung exemplifies four heating blocks with ten slides in each block (see Tseung, Fig. 1), claim 1 of Tseung, for example, is not limited to such a number. Id. at col. 17, ll. 20–23. Heating Dr. Floyd also stated that in “1998, the staining part of IHC was typically performed at room temperature because heating was not required to achieve staining, and in fact was considered to be harmful if used during staining, at least Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 17 for some primary antibodies. Most automated IHC stainers did not include heating for incubation.” Subst. Floyd Decl. ¶ 19. Furthermore, Dr. Floyd testified: One of ordinary skill in the art would not have seen the need to include the kind of heating enabled by the claims of the ’392 Patent in the apparatus disclosed by Tseung. At the time of the Tseung patent application, IHC staining techniques, to which Tseung is directed, simply did not require or benefit from individual heating of microscope slides. Subst. Floyd Decl. ¶ 38. This testimony is not supported by preponderance of the evidence. Tseung expressly teaches the desirability of heating in staining operations within the scope of Tseung’s disclosure and claims: Although many staining operations can be carried out without heating the slides, some staining techniques can be enhanced by providing heat so that either incubation or drying times are shortened, thereby increasing the speed of the overall operation. Numerous techniques exist for heating microscope slides and can be adapted to the present apparatus. Tseung, col. 12, ll. 5–11. This disclosure by Tseung not only provide a reasons to have utilized heating in it apparatus, but also to have “adapted” Muller’s approach of individualized heaters for each slide. Moreover, as discussed above, Tseung is not limited to IHC staining. In fact, Dr. Floyd’s testimony that IHC did not require the heating described by Tseung further supports our finding that Tseung’s staining apparatus is not limited to IHC applications. Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 18 Special stains Patent Owner contends that at the time of the invention one of ordinary skill in the art “did not believe special staining protocols could be automated at all.” Owner Appeal Br. 8. Patent Owner argues that “it was not obvious to provide such a system because it was not even believed that special stains could be automated, and it certainly was not known how to do so effectively and economically.” Id. at 9. Patent Owner acknowledges that the claims are not limited to special stains, but argues: However, automation of specials stains was the impetus for the invention. Nothing in the prior art provides the motivation to combine individual temperature control of microscope slides with dispensing of reagent onto individual microscope slides by dropping the reagent onto the slides in view of the substantial added cost, complexity and loss of reliability. Id. This argument is not persuasive, since neither Tseung nor Muller is restricted to a special staining protocol. Each utilizes heating in their automated staining devices, providing a reason to apply the individualized heating of Muller to Tseung. Patent Owner has not identified a limitation in the claim that would structurally distinguish the claimed automated slide stainer from the automated slide stainers described in Tseung and Muller. Copying As further evidence of nonobviousness, Patent Owner contends that the claimed invention was copied. Appeal Br. 18. A declaration by Steven A. Bogen, a co-inventor of the ’392 patent, was provided by Patent Owner as evidence of Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 19 copying. Substitute Declaration of Steven A. Bogen, M.D., Ph.D., dated July 25, 2012 (“Subst. Bogen Decl.”). According to Patent Owner, a competitor, Ventana, gained access to a confidential business plan (Ex. D of Subst. Bogen Decl.) from CytoLogix, the original owner of the ’392 patent, and used that plan to develop their own device. Id. The proffered evidence of copying is found in a talk given by Jack Schuler, Chairman of Ventana. Ex. C of Subst. Bogen Decl. In this speech, Mr. Schuler stated: So, a healthy company is one that is paranoid about competition. Let me give you an example of how this worked for us at Ventana. Two years ago, Ventana’s only business was in the field of immuno histo chemistry. We have looked at a related field of special stains but determined that the pricing was too low. A small startup company in Boston called Cytologix had developed an instrument for special stains. They need additional funding to complete development and circulated financing memorandum that happened to cross my desk – this is when we first heard of this start-up. The document outlined why Ventana had underestimated this market, that customers were ready to pay a higher price for automation. One they got a foothold in this special stains market the document boasted that they would “back door” Ventana in its base business, Immuno Histo Chemistry, because their instrument could do both. Essentially they crowed that they were going to eat Ventana’s lunch. Id. at 6. Well, what a wonderful opportunity they gave us to motivate our organization. Sometimes help comes from the most unusual source. Talk about a random event! We received the information in November 97. Cytologix claimed they would be on the market in six months. We gathered our engineers and asked them what was their reaction to Cytologix’ boasting. Did they want to take the challenge? We confirmed their market research and finalized our design 2 months later. Fortunately, it only required a modification to one of our existing instruments. Six months later we launched the instrument and the rest is history. Id. Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 20 Patent Owner alleges that the business plan “described the invention disclosed and claimed in the ’392 Patent,” but Patent Owner only generally pointed to pages 26–28 and 30–31 of the business plan (Ex. D) and did not identify where the limitations of the claim could be found (Appeal Br. 20) in the business plan or in the device said to be copied by Ventana, a necessary showing to establish that the claimed subject matter had in fact been copied by Ventana. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1325 (Fed. Cir. 2004). Despite Patent Owner’s failure to show where the copied claim limitations are found in the business plan, we note that page 26 of the plan states: The company has identified an approach in which the slide holders could be made into single units and the heating elements made part of the instrument (instead of the current design which holds five slides and consists of a bottom piece which incorporates the heating element). This new design would create significant advantages, including: . . . 3) the heating can now be controlled for each slide, instead of groups of five slides. Dr. Bogen further stated “Ventana copied important aspects of our technology and developed a new automated slide stainer that included independent and individual heating.” Bogen Decl. ¶ 15. Patent Owner contends further evidence of copying comprises 1) licensing by Ventana of two related patents upon which Ventana had been sued for infringement and of the ’672 patent as part of a settlement after the infringement suit was remanded and 2) filing a patent application directed to a device said to incorporate individual heating to samples. Subst. Bogen Decl. ¶ 18; Appeal Br. 18–19. Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 21 “Copying requires duplication of features of the patentee's work based on access to that work . . . .” Institut Pasteur & Universite Pierre et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013). Neither the Examiner nor the Requester provided sufficient evidence to dislodge Patent Owner’s contention that Ventana had access to CytoLogix’s business plan. Mr. Schuler expressly describes getting access to CytoLogix’s business plan and using it to design a new instrument. However, statements by Dr. Bogen that Ventana developed a stainer with independent and individual heating is not sufficiently supported by evidence. Patent Owner did not provide evidence that the device developed by Ventana contained individual heaters for each slide support. Mr. Schuler in his talk did not say so. Patent Owner did not introduce evidence that the Ventana device referred to by Mr. Schuler in his talk contained such structures. No evidence of Ventana’s device has been identified in the Appeal Brief before us. In order for evidence of secondary considerations to be persuasive, the Patent Owner has the burden to show a “nexus” or link between what is claimed, and in this case, the alleged copy. See In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995). Logically, for a secondary consideration to be persuasive evidence of nonobviousness, it must be connected to the features of the claimed invention. Although it is evident that Ventana had access to CytoLogix’s business plan, Patent Owner did not show that CytoLogix’s concept of individually controlling heat to a microscope slide was copied by Ventana and incorporated into their device. The evidence of a nexus between copying and the subject matter of claim 7 has been not established by a preponderance of the evidence. Patent Owner alleges that Ventana filed a patent application directed to a device incorporating individual heating to the sample and identified US Patent Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 22 6,296,809 (“the ’809 patent,” filed Feb. 26, 1999) as having been issued from this application. Appeal Br. 19. The ’809 patent discloses that “[a]nother disadvantage of the heating units typically employed with automated tissue stainers is that they do not permit the temperature of individual slides to be separately controlled.” ’809 patent, col. 2, ll. 47–50. The ’809 specifically discloses: Individualized slide temperature control is accomplished by the heating system according to the present invention that has thermal platforms radially mounted to the carousel for heating the slides and sensing the temperature of each. ’809 patent, col. 3, ll. 57–60. Nonetheless, even if Ventana had copied Patent Owner’s concept of heating individual slides by incorporating into their own patent application, this is not dispositive because “copying” is only one factor in an obviousness determination. Tseung, which is prior art to the ʼ809 patent, expressly teaches heating blocks at different temperatures and, thus, addressed the need for heating slides at different temperatures — the same need identified by the ’392 patent. ’392 patent, col. 2, ll. 8–19. The ’392 patent describes individual heaters for each slide support, but describes the advancement in the art more narrowly, namely disclosing a specific structure for reducing the wiring complexity (id. at col. 2, ll. 20–38; col. 11, ll. 21–22), a feature which is not recited in claim 7. Claim 7 only requires two slides — not the 49 described in the preferred embodiment of the ’392 patent, which is said to increase the wiring difficulty and cost of manufacture and servicing. Modifying Tseung by decreasing the size of the heating block to contain a single microscope slide doesn’t involve reengineering Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 23 Tseung’s wiring, but simply reduces the number of slides that can be processed by the automated stainer. In sum, we do not find the evidence of evidence of secondary considerations persuasive because the concept of heating slides at two different temperatures in an automated slide stainer had already been disclosed by Tseung and Muller, and it would have been routine to reduce the support to comprise only a single slide, when a cheaper device was desired. A preponderance of the evidence supports the Examiner’s determination that claim 7 would have been obvious to one of ordinary skill in the art in view of Tseung and Muller. TIME PERIOD FOR RESPONSE In accordance with 37 C.F.R. § 41.79(a)(1), the “[p]arties to the appeal may file a request for rehearing of the decision within one month of the date of: . . . [t]he original decision of the Board under § 41.77(a).” A request for rehearing must be in compliance with 37 C.F.R. § 41.79(b). Comments in opposition to the request and additional requests for rehearing must be in accordance with 37 C.F.R. § 41.79(c), (d), respectively. Under 37 C.F.R. § 41.79(e), the times for requesting rehearing under paragraph (a) of this section, for requesting further rehearing under paragraph (d) of this section, and for submitting comments under paragraph (c) of this section may not be extended. An appeal to the United States Court of Appeals for the Federal Circuit under 35 U.S.C. §§ 141–144 and 315 and 37 C.F.R. § 1.983 for an inter partes reexamination proceeding “commenced” on or after November 2, 2002 may not be taken “until all parties’ rights to request rehearing have been exhausted, at which Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 24 time the decision of the Board is final and appealable by any party to the appeal to the Board.” 37 C.F.R. § 41.81. See also MPEP § 2682 (8th ed., Rev. 7, July 2008). In the event neither party files a request for rehearing within the time provided in 37 C.F.R. § 41.79, and this decision becomes final and appealable under 37 C.F.R. § 41.81, a party seeking judicial review must timely serve notice on the Director of the United States Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and 1.983. AFFIRMED peb Appeal 2015-000224 Reexamination Control 95/001,613 & 95/001,692 Patent 7,217,392 B2 25 CC: Patent Owner: HAMILTON, BROOK, SMITH & REYNOLDS, P.C. 530 Virginia Road PO Box 9133 Concord, MA 01742-9133 Third Party Requester: Andreas Danckers LEICA BIOSYSTEMS RICHMOND, INC. PO Box 528 Richard, IL 60071 K. Shannon Mrksich DANAHER LEGAL 1500 Mittel Blvd. Wood Dale, IL 60191 Copy with citationCopy as parenthetical citation