Ex Parte Linder et alDownload PDFPatent Trial and Appeal BoardFeb 17, 201612408179 (P.T.A.B. Feb. 17, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. 12/408,179 7590 Theodore Allen, Esq, Hologic Inc. FILING DATE 0312012009 02/17/2016 250 Campus Drive Marlborough, MA 01752 FIRST NAMED INVENTOR James Linder 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. 11.023011 CON 8768 EXAMINER MUMMERT, STEPHANIE KANE ART UNIT PAPER NUMBER 1637 MAILDATE DELIVERY MODE 02/17/2016 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 JAMES LINDER, MENASHI COHENFORD, ERIN COFFMAN, BRIAN B. LENTRICHIA, HENRIK STENDER, and KENNETH OLIVEIRA Appeal2013-007468 Application 12/408, 179 Technology Center 1600 Before DONALD E. ADAMS, MELANIE L. McCOLLUM, and JACQUELINE T. HARLOW, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL 1 This appeal under 35 U.S.C. § 134(a) involves claims 1-24 (Br. 2).2 Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. 1 Appellants identify the Real Party in Interest as "Cytyc Corporation" (Br. 2). 2 The Appeal Brief is not paginated. Therefore, all reference to page numbers in the Appeal Brief refer to page numbers as if the Appeal Brief was number consecutively beginning with the first page. Appeal2013-007468 Application 12/408, 179 STATEMENT OF THE CASE Claim 1, the only independent claim on Appeal, is directed to a method for the detection of a target in a sample (Appellants' claim 1 ). Claim 1 is representative and reproduced in the Claims Appendix of Appellants' Brief. Claims 1---6, 8-14, and 16-24 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Lorincz3 and Hyldig-Nielsen.4 Claim 7 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Lorincz, Hyldig-Nielsen, and Einsele. 5 Claim 15 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Lorincz, Hyldig-Nielsen, and Challberg. 6 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Lorincz discloses a universal collection medium (UCM) formulation that comprises alcohol in the range of "about 1 % to about 75% of the UCM formulation" (Lorincz 5: 12-15; see Ans. 5 and 14). FF 2. Lorincz exemplifies an "assay for nucleic acids," wherein a sample is collected, stored, and lysed according to the methods disclosed by Challberg and thereafter a[] [150 µl] aliquot of the lysed sample is mixed with 50 µl of a probe mix (Lorincz 10:55-59; see Ans. 5 and 15 ("a 150 µl 3 Lorincz et al., US 6,969,585 B2, issued Nov. 29, 2005. 4 Hyldig-Nielsen et al., US 6,280,946 B2, issued Aug. 28, 2001. 5 Hermann Einsele et al., Detection and Identification of Fungal Pathogens in Blood by Using Molecular Probes, 35 J. Clin. Micro.1353-1360 (1997). 6 Challberg et al., WO 93/10263, published May 27, 1993. 2 Appeal2013-007468 Application 12/408, 179 aliquot of the lysed sample is [] added to 50 µl of a probe mixture [] result[ing] in a 200 µl final volume"); see generally Br. 8-9; Challberg 26:29-31). FF 3. Challberg exemplifies the collection and storage of a sample in 1 ml of a storage solution followed by lysis of the sample by the addition of 0.5 ml of a hydrolysis reagent (Challberg 26:21-26; see Ans. 13-14; see generally Br. 8). FF 4. Examiner finds that "Lorincz does not teach PNA probes" and relies on Hyldig-Nielsen to make up for this deficiency in Lorinca (Ans. 7). FF 5. Examiner finds that the combination of Lorincz and Hyldig-Nielsen fails to suggest the "detection of C. Albicans nucleic acid" and relies on Einsele to make up for this deficiency in the combination of Lorincz and Hyldig-Nielsen (Ans. 10). FF 6. Examiner relies on Challberg to disclose the use of a negative control (Ans. 11 ). ANALYSIS The combination of Lorincz and Hyldig-Nielsen: Based on the combination of Lorincz and Hyldig-Nielsen, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious "to substitute the PNA probe and the plurality of probes taught by Hyldig-Nielsen into the method of hybridization and detection of nucleic acids" (Ans. 9). Claim 1: The method of Appellants' claim 1 requires an aqueous alcohol solution of at least approximately 20% by volume. Lorincz discloses a 3 Appeal2013-007468 Application 12/408, 179 universal collection medium formulation that comprises alcohol in the range of "about 1 % to about 75% of the UCM formulation (FF 1). As Appellants' recognize, Lorincz incorporates the storage and lysis method suggested by Challberg (FF 2-3; see Ans. 14--15). Therefore, the alcohol concentration in Lorincz' s composition at the end of the lysis stage will be 50% (cf Ans. 15).7 Lorincz further suggests, by its reference to Challberg, that the mixture of a 150 µl aliquot of the composition comprising 50% alcohol with 50 µl of probe (FF 2; see Ans. 15). Therefore, the alcohol concentration in Lorincz's composition after addition of probe will be 37.5% (cf Ans. 15).8 For the foregoing reasons, we are not persuaded by Appellants' contentions that Lorincz's method would not result a method, wherein a "sample [is contacted] with one or more PNA probe(s) in an aqueous alcohol solution of at least approximately 20% by volume under conditions in which the PNA probe(s) can bind to the target" (Br. 7). Lorincz discloses a UCM formulation that comprises a range of alcohol concentrations that, when diluted as disclosed by Lorincz, would result in the alcohol range required by Appellants' claimed range. "[W]here there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness." Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004). Therefore, we are not persuaded by Appellants' contentions regarding Lorincz's disclosure of a UCM formulation that comprises an alcohol in the range of "about 1 % to about 75% of the UCM formulation" (FF 1; cf Br. 10). 7 V1C1=V2C2 = 1.0 ml*75%=1.5 ml*C2 = C2=50%. 8 V1C1=V2C2 = 150 µ1*50%=200 µl*C2 = C2=37.5%. 4 Appeal2013-007468 Application 12/408, 179 Claims 22-24: Claims 22-24 depend from and further limit claim 1 to require that the aqueous alcohol solution is at least approximately 40%, 50%, and 60% by volume, respectively (see Appellants' Claims 22-24). Examiner directs attention to Lorincz's disclosure of the alcohol concentration of the undiluted UCM formulation to address the specific alcohol percentages required by Appellants' claims 22-24 (see Ans. 7; see also FF 1 ). Examiner failed to establish that the combination of Lorincz and Challberg suggests a method wherein a probe is contacted with a sample in the presence of an alcohol concentration of at least approximately 40%, 50%, and 60% by volume (see Br. 12). The combination of Lorincz, Hyldig-Nielsen, and Einsele: Based on the combination of Lorincz and Hyldig-Nielsen, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious "to include the additional target species and strains, including C. albicans, as taught and suggested by Einsele to arrive at the claimed invention with a reasonable expectation for success" (Ans. 11 ). Having found no error in the combination of Lorincz and Hyldig- Nielsen as it relates to Appellants' claim 1, we are not persuaded by Appellants' contention that Einsele fails to make up for Appellants' alleged deficiency in the combination of Lorincz and Hyldig-Nielsen (Br. 13). 5 Appeal2013-007468 Application 12/408, 179 The combination ofLorincz, Hy/dig-Nielsen, and Challberg: Based on the combination of Lorincz and Hyldig-Nielsen, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious "to incorporate the sample controls taught by Challberg to arrive at the claimed invention with a reasonable expectation for success" (Ans. 12). Having found no error in the combination of Lorincz and Hyldig- Nielsen as it relates to Appellants' claim 1, we are not persuaded by Appellants' contention that Challberg fails to make up for Appellants' alleged deficiency in the combination of Lorincz and Hyldig-Nielsen (Br. 14). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness with respect to claims 1, 7, and 15. The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over the combination of Lorincz and Hyldig-Nielsen is affirmed. Claims 2- 6, 8-14, and 16-21 are not separately argued and fall with claim 1. The rejection of claim 7 under 35 U.S.C. § 103(a) as unpatentable over the combination of Lorincz, Hyldig-Nielsen, and Einsele is affirmed. The rejection of claim 15 under 35 U.S.C. § 103(a) as unpatentable over the combination of Lorincz, Hyldig-Nielsen, and Challberg is affirmed. The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness with respect to claims 22-24. The rejection of claims 22-24 under 35 U.S.C. § 103(a) as unpatentable over the combination of Lorincz and Hyldig-Nielsen is reversed. 6 Appeal2013-007468 Application 12/408, 179 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED-IN-PART sl 7 Copy with citationCopy as parenthetical citation