Ex Parte Egle et alDownload PDFPatent Trial and Appeal BoardJun 9, 201612580203 (P.T.A.B. Jun. 9, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/580,203 10/15/2009 46155 7590 06/09/2016 ALEXANDER R SCHLEE SCHLEE IP INTERNATIONAL P.C. 3770 HIGHLAND A VENUE, SUITE 203 MANHATTAN BEACH, CA 90266 FIRST NAMED INVENTOR Markus Egle 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. P401136 9858 EXAMINER ADAMS, MICHELLE ART UNIT PAPER NUMBER 1797 MAILDATE DELIVERY MODE 06/09/2016 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 MARKUS EGLE, ROBERT GROPP, STEFAN KL,NKEL, and KARL-HEINZ WESTERHOFF 1 Appeal2014-009530 Application 12/580,203 Technology Center 1700 Before BRADLEY R. GARRIS, ADRIENE LEPIANE HANLON, and MICHAEL P. COLAIANNI, Administrative Patent Judges. GARRIS, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. § 134 from the Examiner's decision rejecting claims 1, 4--8, and 10-13. We have jurisdiction under 35 U.S.C. § 6. We AFFIRM. 1 Leica Biosystems Nussloch GmbH, Heidelberger Strasse is identified as the real party in interest. App. Br. 3. Appeal2014-009530 Application 12/508,203 Appellants claim a method for determining reagent quality in a specimen-treatment device having multiple treatment stations comprising: treating a reference test material carrier element having a reference test material by the reagents in the treatment stations, determining characteristic properties of the reference test material resulting from the treatment, and storing these characteristic properties as reference data; providing a slide magazine of the device with a plurality of specimen slides and a test material carrier element; transferring and treating the specimen slides and test material carrier element together in the treatment stations; determining reagent quality after treatment via an evaluation device by comparing characteristic properties of the test material with characteristic properties of the reference test material stored as reference data; and controlling by the evaluation device at least one of replacing and metering of the treatment stations (sole independent claim 1 ). A copy of representative claim 1, taken from the Claims Appendix of the Appeal Brief, appears below. 1. A method for determining reagent quality of reagents in treatment stations in a device having multiple treatment stations for treatment of at least one of a plurality of cytological and histological specimens, the method compnsmg: a) treating a reference test material carrier element having a reference test material by the reagents in the treatment stations in a predefined sequence; and after treatment of the reference test material in a last treatment station in sequence, determining characteristic properties of the reference test material that are due to treatment and storing characteristic properties of the reference test material as reference data; b) providing a plurality of specimen slides and placing the plurality of specimens on respective specimen slides; c) providing a test material carrier element that comprises at least one test material that is separate from and in addition to the plurality of 2 Appeal2014-009530 Application 12/508,203 specimens and is provided on a test material slide that differs from the specimen slides; d) providing at least one specimen slide magazine for holding a plurality of specimen slides carrying the specimens to be treated in the multiple treatment stations; e) inserting the plurality of specimen slides and the test material carrier element into the specimen slide magazine; t) transferring and treating the test material carrier element having the at least one test material according to a predefined sequence in a plurality of the treatment stations together with the specimen slides held in the same specimen slide magazine as the test material carrier element; g) determining the reagent quality by evaluating the at least one test material by means of an evaluation device after treatment in the last treatment station in sequence by comparing characteristic properties of the at least one test material with characteristic properties of the reference test material stored as reference data; and h) controlling by the evaluation device at least one of replacing and metering of the treatment stations. The Examiner rejects claims 4---6 and 13 under 35 U.S.C. § 112, 2nd paragraph, as being indefinite on the grounds that the claim 4 limitation "the characteristic properties of the test material" lacks sufficient antecedent basis (Non-final Action 2)2 and that it is unclear what distinction exists between the claim 13 limitations "polymers having ionic groups" and "ion-containing polymers" (id.). We agree with Appellants' arguments that the rejection is not well taken (App. Br. 23). The claim 4 limitation finds antecedent basis in the claim 1, step (g), recitation "characteristic properties of the at least one test 2 The Examiner incorrectly states "[ c ]laim 4 recites the limitation 'the characteristic properties of the reference test material'" (Non-final Action 2 (underlining added); see also Ans. 2). In fact, the limitation in question does not contain the word "reference." 3 Appeal2014-009530 Application 12/508,203 material." Further, the claim 13 limitations are distinguishable in the sense that the "ion-containing polymers" limitation is broader than the "polymers having ionic groups" limitation. In addition, we emphasize that the Examiner does not respond to Appellants' arguments but instead merely indicates that the rejection would be overcome if the claims were amended in a particular way (Ans. 17). For these reasons, we do not sustain the§ 112, 2nd paragraph, rejection of claims 4---6 and 13. The Examiner rejects claims 1, 4--8, and 10-13 under 35 U.S.C. § 103(a) as unpatentable over Floyd (US 7,271,008 B2 issued September 18, 2007) in view ofOrihashi (US 2007/0072299 Al published March 29, 2007). We agree with the Examiner that the Floyd and Orihashi references establish a prima facie case of obviousness for the reasons expressed in the Non-final Action, the Answer, and below. 3 Concerning the claim l requirements involving multiple treatment stations, the Examiner finds that Floyd discloses a device or slide (i.e., corresponding to the claim 1 carrier element) having thereon quality control materials for testing the quality of reagents in diagnostic assays generally and concludes that it would have been obvious to use this device in prior art 3 In assessing the merits of the § 103 rejection on appeal, we have not considered the references cited by the Examiner in the "Response to Arguments" section of the Answer that are not positively included in the statement of the rejection (see, e.g., Ans. 8). See In re Hoch, 428 F.2d 1341, 1342 n. 3 (CCP A 1970) (where a reference is relied on to support a rejection, that reference should be positively included in the statement of the rejection). 4 Appeal2014-009530 Application 12/508,203 assays having multiple treatment stations specifically (Non-final Action 3- 4). Appellants argue that "Floyd teaches a diagnostic kit performing an assay ... [wherein] use of such diagnostic kits is typically not in several treatment stations" (App. Br. 6) and that "no pointers are believed to be derivable from Floyd as to automatic evaluation and if need be replacing of [] reagent in [multiple] treatment stations" (id. at 7). 4 Appellants' argument is not persuasive. A preponderance of evidence supports the Examiner's finding that Floyd's device is disclosed for use in assays generally including multistep assays (see, e.g., Floyd abst.). Moreover, Appellants admit that assays having multiple treatment stations were known in the prior art (see, e.g., App. Br. 4). These circumstances provide convincing support for the above obviousness conclusion. Regarding, for example, steps (a) and (g) of claim 1, the Examiner further concludes that it would have been obvious to effect Floyd's goal of determmmg reagent quality by comparing the properties of Floyd's treated quality control materials with those of a treated reference quality control material as evidenced by Floyd's disclosure of comparing the properties 4 The Evidence Appendix of the Appeal Brief includes an unverified Declaration by Markus Egle, one of the inventors named in the subject application, and the Declaration is referred to in various arguments in the Appeal Brief. The Examiner has refused to enter or consider this Declaration on the ground that it is untimely citing 37 C.F.R. § 41.63(c) and § 41.67(c)(2) (Ans. 8). Appellants do not challenge the Examiner's refusal in the record of this appeal. Under these circumstances, we also will not consider the Declaration. However, positions expressed in the Appeal Brief that may correspond to those of the Declarant will be considered albeit only as arguments not evidence. 5 Appeal2014-009530 Application 12/508,203 resulting from one set of reagents with those of a reference set of (e.g., fresh) reagents (Non-final Action 5 (citing, e.g., Floyd col. 29, 11. 3-23; see also id. at 11. 24--38)). To accomplish such a comparison, the Examiner concludes that it would have been obvious to store the properties of the treated reference quality control material as reference data particularly in view of Orihashi (id. at 5---6). Appellants "dispute[] that it would have been obvious in Floyd to compare a reference test material with a test material both treated through a sequence of a number of treatment stations" (App. Br. 7). Appellants acknowledge Floyd's column 29 disclosure (id. at 9-10) but contend "this teaching in Floyd is believed to distinguish fundamentally from the incident invention where a reference test material is processed through multiple treatment stations and then to compare the treatment result of the reference test material with the treatment result of the test material that has been treated together with the specimens" (id. at 10). The deficiency of Appellants' contention is that Appellants do not explain with any reasonable specificity why the disclosure of comparing in column 29 of Floyd would not have suggested comparing the properties of Floyd's quality control materials, which would have been treated along with specimens in multiple treatment stations, with the properties of a previously treated reference quality control material as required by claim 1. Based on the record before us, a preponderance of evidence supports the Examiner's finding that Floyd would have suggested such a comparison. With regard to the replacing and/or metering limitation recited in step (h) of claim 1, Appellants acknowledge Floyd's disclosure that "by having multiple dilutions of each reference compound, the user will be able to assess the quality of the detection reagents used, as well as correct for any 6 Appeal2014-009530 Application 12/508,203 variation, should results be analyzed in a qualitative manner" (Floyd col. 6, 11. 16-20) (App. Br. 16-17). Appellants argue that "[r]eading of the passage column 6, lines 16-20 in context, it is believed that the expression 'correct for any variation ' can only be reasonably interpreted as correcting measurement values depending on the reagent quality" (id. at 17). However, Appellants do not provide any support for their proposed interpretation of Floyd's column 6 disclosure. For example, Appellants fail to identify any teaching in Floyd of "correcting measurement values depending on the reagent quality" (id.). On the other hand, Floyd's disclosure of correcting for any variation in reagent quality would have suggested replacing low-quality reagent with fresh reagent because the purpose of Floyd's invention is to maintain acceptable reagent quality and assay performance (see, e.g., Floyd title, abst., col. 1, 11. 12-18). Appellants' remaining arguments concerning the other limitations of independent claim 1 as well as the limitations of dependent claims 4--8 and 10-13 (App. Br. 8-22) also fail to show error in the Examiner's determination that Floyd and Orihashi establish a prima facie case of obviousness. For example, Appellants' arguments regarding steps (d) and ( e) of claim 1 lack persuasive merit because they are based on the unconvincing premise that Floyd is limited to a diagnostic kit to the exclusion of an assay having multiple treatment stations as claimed (App. Br. 11-12). Similarly, Appellants' contention regarding dependent claim 8 relies on the unsuccessful argument regarding the test material of parent claim 1 (id. at 21 ). As a final example, Appellants' arguments concerning the test materials of dependent claims 10-13 (e.g., the biological, organic, inorganic, and/or synthetic test materials of claim 10) (id. at 21-22) do not address Floyd's explicit disclosure of corresponding quality control 7 Appeal2014-009530 Application 12/508,203 compounds (see, e.g., Floyd cols. 7 (1. 48) through 21 (1. 5) and Example 1 of col. 37). Because Appellants do not reveal harmful error on the Examiner's part, we sustain the§ 103 rejection of claims 1, 4--8, and 10-13 as unpatentable over Floyd in view of Orihashi. The decision of the Examiner is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l). AFFIRMED 8 Copy with citationCopy as parenthetical citation