Ex Parte Houriet et alDownload PDFPatent Trial and Appeal BoardNov 30, 201612692897 (P.T.A.B. Nov. 30, 2016) 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. 12/692,897 01/25/2010 John W. HOURIET JR. 10001-33U2 2989 570 7590 12/02/2016 PANITCH SCHWARZE BELISARIO & NADEL LLP ONE COMMERCE SQUARE 2005 MARKET STREET, SUITE 2200 PHILADELPHIA, PA 19103 EXAMINER LONG, FONYA M ART UNIT PAPER NUMBER 3626 NOTIFICATION DATE DELIVERY MODE 12/02/2016 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): u sptomail @ panitchlaw. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN W. HOURIET, JR. and JIANBO PENG Appeal 2014-006860 Application 12/692,897 Technology Center 3600 Before BIBHU R. MOHANTY, NINA L. MEDLOCK, and TARA L. HUTCHINGS, Administrative Patent Judges. MOHANTY, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE The Appellants seek our review under 35 U.S.C. § 134 of the final rejection of claims 1—36, which are all the claims pending in the application. We have jurisdiction under 35 U.S.C. § 6(b). SUMMARY OF THE DECISION We REVERSE. Appeal 2014-006860 Application 12/692,897 THE INVENTION The Appellants’ claimed invention is directed to managing a database lock for a clinical trial study (Spec., page 3, lines 8—9). Claim 1, reproduced below, is representative of the subject matter on appeal. 1. An automated method of generating summary data regarding task items that must occur to achieve a database lock for a clinical trial study that is performed based on a previously defined clinical trial protocol, the clinical trial study being managed using (i) a processor, and (ii) a database in communication with the processor, the database including clinical trial data and the status of the data for a plurality of patients participating in the clinical trial study, the method comprising: (a) defining, using the processor, at least one clinical database lock criterion for the study from at least a plurality of user-selected subsets of the clinical trial data, wherein the clinical database lock criterion is defined using the previously defined clinical trial protocol; (b) inputting into the processor: (i) the at least one clinical database lock criterion for the study, and (ii) the clinical trial data and the status of the data, as retrieved from the database, for the plurality of patients participating in the clinical trial study as defined by the clinical database lock criteria; and (c) automatically and programmatically generating, using the processor, summary data regarding task items that must occur to achieve the database lock as defined by the at least one clinical database lock criterion, using the clinical trial data and the status of the data, wherein different summary data will be generated for different clinical database lock criteria. THE REJECTIONS The following rejections are before us for review: 2 Appeal 2014-006860 Application 12/692,897 1. Claims 1—14, 16, 19-32, and 34 are rejected under 35 U.S.C. § 103(a) as unpatentable over Briegs et al. (US 7,054,823 Bl, issued May 30, 2006) (“Briegs”). 2. Claims 15 and 33 are rejected under 35 U.S.C. § 103(a) as unpatentable over Briegs and Shah (US 2004/0093240 Al, issued May 13, 2004). 3. Claims 17 and 35 are rejected under 35 U.S.C. § 103(a) as unpatentable over Briegs and Omni Comm’s TrialMaster (TrialMaster brochure, Omni Comm Systems, Inc. (2007). 4. Claims 18 and 36 are rejected under 35 U.S.C. § 103(a) as unpatentable over Briegs and Rosenberg (US 2008/0270181 Al, published Oct. 30, 2008. FINDINGS OF FACT We have determined that the findings of fact in the Analysis section below are supported at least by a preponderance of the evidence.1 ANALYSIS The Appellants argue that the rejection of claim 1 is improper because the cited prior art fails to disclose elements of claim limitation (a) identified above (App. Br. 9—13; Reply Br. 2—5). In contrast, the Examiner has determined that the cited claim limitation would have been obvious in view of the following portions of 1 See Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Patent Office). 3 Appeal 2014-006860 Application 12/692,897 Briegs: the Abstract, col. 2:11—14, col. 2:35—43, col. 9:39-40, col. 24:12— 19, col. 25:11-12, and col. 31:24—34 (Ans. 2, 3, 9). We agree with the Appellants. Claim limitation (a) requires: (a) defining, using the processor, at least one clinical database lock criterion for the study from at least a plurality of user- selected subsets of the clinical trial data, wherein the clinical database lock criterion is defined using the previously defined clinical trial protocol. (Claim 1, emphasis added). Initially we note the claimed distinction between a “clinical trial study” and a “previously defined clinical trial protocol” that is set forth in both the preamble and body of the claim. The cited claim limitation requires “defining . . . at least one clinical database lock criterion for the study from at least a plurality of user-selected subsets of the clinical trial data . . . defined using the previously defined clinical trial protocol.” Here, the above citations to Briegs do disclose disparate elements of the claim limitation, but not in the specific manner claimed. For example, the Abstract does disclose designing and monitoring clinical trials and that protocols of prior clinical trials are stored in a database. However, the Abstract fails to disclose a “database lock criterion for the study from at least a plurality of user-selected subsets of the clinical trial data.” Briegs at col. 15:10-22 does disclose changing the status from “‘Concept to Finalize’” (locking from further change), but this also fails to disclose a “database lock criterion for the study from at least a plurality of user-selected subsets of the clinical trial data.” Even assuming arguendo that the cited portions of Briegs describe the discrete elements of the argued claim limitation, the rejection nonetheless lacks the requirements to show obviousness. Here, there is no articulated reasoning with rational underpinnings for modifying 4 Appeal 2014-006860 Application 12/692,897 the cited portions of Briegs to meet the argued claim limitation in the specific manner claimed without impermissible hindsight. For these reasons, the rejections of claim 1 and its dependent claims are not sustained. The remaining independent claims contain limitations similar to the one discussed above, and the rejections of these claims and their dependent claims are not sustained for these same reasons. CONCLUSIONS OF LAW We conclude that Appellants have shown that the Examiner erred in rejecting the claims as listed in the Rejections section above. DECISION The Examiner’s rejections of claims 1—36 are reversed. REVERSED 5 Copy with citationCopy as parenthetical citation