Ex Parte Stephens et al

Patent Trial and Appeal BoardApr 25, 2016

11639586 (P.T.A.B. Apr. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 11/639,586 12/15/2006 95723 7590 04/25/2016 Muirhead and Satumelli, LLC and Ventana Medical Systems, Inc. 200 Friberg Parkway Suite 1001 Westborough, MA 01581 FIRST NAMED INVENTOR Randy Stephens 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 ATTORNEY DOCKET NO. CONFIRMATION NO. VMS-003US 5645 EXAMINER WRIGHT, PATRICIA KATHRYN ART UNIT PAPER NUMBER 1798 MAILDATE DELIVERY MODE 04/25/2016 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 RANDY STEPHENS and BRIAN H. KRAM Appeal2014-008960 Application 11/639,586 Technology Center 1700 Before CHUNG K. PAK, MICHELLE N. ANKENBRAND, and JENNIFER R. GUPTA, Administrative Patent Judges. GUPTA, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal 1 under 35 U.S.C. Â§ 134 from the Examiner's decision2 rejecting claims 2, 16, 18, 19, 22, 28, 31, 32, and 34--36. Although the action appealed from was a non-final rejection, we have jurisdiction pursuant to 35 U.S.C. Â§Â§ 6 and 134 since the claims have been twice presented and rejected. See Ex parte Lemoine, 46 USPQ2d 1420, 1423 (BPAI 1994). We affirm. 1 Appellants identify the real party in interest as Ventana Medical Systems, Inc. Appeal Brief filed May 15, 2014 ("App. Br."), 1. 2 Non-Final Office Action mailed December 13, 2013 ("Non-Final Act."). Appeal2014-008960 Application 11/639,586 The claims are directed to a method of coordinating tissue sample information in a laboratory staining process. Claim 2, reproduced below, is illustrative of the claims on appeal. 2. A method of coordinating tissue sample information in a laboratory staining process comprising: reading cassette data identifying a tissue cassette comprising a tissue sample to be tested, said reading being performed using a LIS-networked machine-vision system that reads machine- readable information including the cassette data from a data element associated with the tissue cassette and encoded with the machine-readable information; transferring, over a network using the LIS-networked machine- vision system, the machine-readable information associated with said tissue sample to an LIS; accessing, using a computer, a database of the LIS and the cassette data, test instructions for said tissue sample, wherein the cassette data is correlated with the tissue sample and tests to be performed to the tissue sample, the test instructions determining a number of tissue sections to be cut from the tissue sample and protocols to be performed on respective tissue sections; instructing, using a computer, a label printer to print a required number of slide labels encoding machine readable test protocol identifiers for the protocols to be performed on the respective tissue sections, wherein the machine readable test protocol identifiers directly identify the protocols independently of any information identifying the respective tissue sections; printing, using the label printer, said slide labels; attaching each of said slide labels to one of a plurality of slides; placing at least one of the tissue sections on each of said plurality of slides; and staining the at least one tissue section on each of the plurality of slides in accordance with at least one of the protocols uniquely identified by one of the machine readable test protocol identifiers 2 Appeal2014-008960 Application 11/639,586 encoded on one of the slide labels attached to said each slide; wherein said staining said each slide includes reading from the one slide label the one machine readable test protocol identifier uniquely corresponding to the at least one protocol from the one slide label and then using the one machine readable test protocol identifier to look up one or more steps in a protocol table, wherein said one or more steps are peiformed in said staining for the at least one protocol. App. Br. Al (Claims Appendix) (emphasis added). REJECTIONS On appeal, the Examiner maintains the following rejections: 1. Claims 2, 18, 19, and 22 under 35 U.S.C. Â§ 102(b) as anticipated by or, in the alternative, under 35 U.S.C. Â§ 103(a) as unpatentable over Torre-Bueno et al. (US 2003/0120633 Al, published June 26, 2003); and 2. Claims 16, 28, 31, 32, and 34--36 under 35 U.S.C. Â§ 103(a) as unpatentable over Torre-Bueno in view of Showalter et al. (US 2005/0159982 Al, published July 21, 2005). Examiner's Answer mailed June 4, 2014 ("Ans."), 3, 7. Claims 2, 18, 19, and 22 Appellants argue for patentability of claims 2, 18, 19, and 22, subject to the first ground of rejection, as a group. See App. Br. 2-7. We choose independent claim 2 as representative of this group, and claims 18, 19, and 22 stand or fall with claim 2. Appellants argue the rejection should be reversed because the Examiner erred in finding Torre-Bueno discloses or suggests printing slide labels encoding machine readable test protocol identifiers for protocols to be 3 Appeal2014-008960 Application 11/639,586 performed on respective tissue sections where "the machine readable test protocol identifiers directly identify the protocols independently of any information identifying the respective tissue sections," as in claim 2. Reply Brief filed August 4, 2014 ("Reply Br."), 4--5. The term "test protocol identifier" is defined in the Specification as "the unique number used to associate a protocol with its individual steps or the recipe for the protocol." Spec. 11: 10-11. The Specification explains that the test protocol identifier typically is encoded in a machine-readable identifier such as a barcode label, so that when an automated staining system reads the slide label, it uses the protocol identifier to look up in a protocol table the steps for performing the staining operation. Id. at 11:15-18. The Examiner finds Torre-Bueno teaches printing labels with unique identifiers on a slide (Torre-Bueno i-fi-f 12, 23). Ans. 10-11. The Examiner finds that Torre-Bueno teaches that the labels "may be designed to hold information used in a laboratory equipped with scanners or other devices for inputting data into the system" and the information "may be patient information and/or information concerning the tests to be run" (Torre- Bueno i127). Non-Final Act. 4--5. Torre-Bueno discloses that the unique identifier may be in the form of a barcode (Torre-Bueno i-f 22), and the scanners may be barcode readers or a similar device that can "input" data directly or indirectly into a computer or computer system (Torre- Bueno i-f 10). Thus, a preponderance of the evidence supports the Examiner's finding that Torre-Bueno teaches or would have suggested printing slide labels with machine readable test protocol identifiers (barcodes) that directly identify the protocols independently of any information identifying the respective tissue sections. 4 Appeal2014-008960 Application 11/639,586 Appellants argue that the Examiner erred in finding Torre-Bueno discloses or suggests "reading and using the machine readable protocol identifiers encoded on the slide labels in staining the tissue sections of the slides." Reply Br. 7-8. Torre-Bueno teaches samples are cut for placement on slides, labeled with barcodes (machine readable identifiers), and then loaded on an autostainer that "reads" the barcodes and "checks" a central database to see what stains need to be applied to the slide (i.e., steps to be performed in staining the slide). Torre-Bueno i-fi-137-38. Torre-Bueno teaches that the sample can include tissue and the label can hold information concerning the tests to be run on the slide (protocols). Torre-Bueno i-fi-127, 33. Based on this disclosure, we are not convinced the Examiner reversibly erred in finding Torre-Bueno teaches or would have suggested reading and using the one machine readable test protocol identifier to stain the tissue section on the slide. Appellants contend that Torre-Bueno teaches using a machine readable sample identifier, not a machine readable test protocol identifier, to access the central database which contains information regarding how the stainer should process the slides. See Reply Br. 8. As discussed above, Torre-Bueno teaches slide labels with unique identifiers (machine readable identifiers in the form of a barcode) that may hold information concerning the tests to be run on the slide. Torre-Bueno i-fi-122, 27. Torre-Bueno further teaches that the autostainer reads the labeled slides and checks the central database to see what stains need to be applied to each slide. Id. i138. Thus, the Examiner's finding that Torre-Bueno teaches or would have suggested using a machine readable test protocol identifier to access a central database 5 Appeal2014-008960 Application 11/639,586 that contains information regarding how the stainer should process the slides (see Non-Final Act. 5---6) is supported by Torre-Bueno's disclosure. Appellants argue that the Examiner erred in rejecting claims 2, 18, 19, and 22 under 35 U.S.C. Â§ 102(b) because paragraph 12 of Torre-Bueno "teaches away" from a slide label including a machine readable protocol identifier, as recited in claim 2. Reply Br. 10. This argument is not persuasive. Although teaching away is relevant to an obviousness analysis, "whether a reference 'teaches away' from [an] invention is inapplicable to an anticipation analysis." Clearvalue, Inc. v. Pearl River Polymers, Inc., 668 F.3d 1340, 1344 (Fed. Cir. 2012) (quoting Celeritas Techs., Ltd. v. Rockwell Int'! Corp., 150 F. 3d 1354, 1361 (Fed. Cir. 1998)). Moreover, as discussed above, the preponderance of the evidence supports the Examiner's finding that Torre-Bueno teaches or would have suggested printing slide labels with machine readable test protocol identifiers (barcodes) that directly identify the protocols independently of any information identifying the respective tissue sections. See Torre-Bueno i-fi-f 12, 23, 27. In sum, Appellants have not presented any arguments which persuade us of error in the Examiner's finding that Torre-Bueno teaches or suggests all the limitations of independent claim 2. Accordingly, we sustain the Examiner's anticipation and obviousness rejection of claims 2, 18, 19, and 22 over Torre-Bueno. Claims 16, 28, 31, 32, 34, and 35 Claims 16, 28, 31, 32, 34, and 35 depend directly (claims 16, 28, and 3 5) or indirectly (claims 31, 3 2, and 34) from independent claim 2. Appellants argue that Showalter does not overcome the deficiencies of Torre-Bueno in the rejection of claim 2. See App. Br. 7-8; see also Reply 6 Appeal2014-008960 Application 11/639,586 Br. 10. This argument is not persuasive of error in the Examiner's rejection because, for the reasons discussed above, we are not persuaded of any deficiencies in Torre-Bueno's disclosure. Accordingly, we sustain the obviousness rejection of claims 16, 28, 31, 32, 34, and 35. Regarding claim 36, 3 Appellants argue that Torre-Bueno does not disclose or suggest having a slide label with two different identifiers and associated different uses-(1) a machine readable test protocol identifier for protocols to be performed on the tissue sample, and (2) a case number for tracking the tissue sample in the laboratory. Reply Br. 11; see also Spec. 15: 16-17 (explaining that the case number is identifying information associated with the tissue sample). We are not persuaded by this argument. As the Examiner properly finds, Torre-Bueno teaches using machine readable slide labels designed to hold patient information and/or information concerning tests to be run (Torre-Bueno i-fi-f 12, 27) (emphasis added). See Non-Final Act. 4--5. Accordingly, we sustain the rejection of claim 36. DECISION The rejections are affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). AFFIRMED 3 Claim 36 depends from claim 35, which depends from independent claim 2. The Examiner relies solely on Torre-Bueno for teaching the limitations of claim 36. Thus, the Examiner's rejection of claims 2, 18, 19, and 22 under 35 U.S.C. Â§ 102(b) as anticipated by or, in the alternative under 35 U.S.C. Â§ 103(a) as unpatentable over Torre-Bueno (Rejection 1) should have included claim 36 as well. 7