Ex Parte Van Ommering et alDownload PDFPatent Trial and Appeal BoardFeb 27, 201713498635 (P.T.A.B. Feb. 27, 2017) 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. 13/498,635 03/28/2012 Kim Van Ommering 2009P01269WOUS 1552 24737 7590 03/01/2017 PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS EXAMINER 465 Columbus Avenue XU, XIAOYUN Suite 340 Valhalla, NY 10595 ART UNIT PAPER NUMBER 1797 NOTIFICATION DATE DELIVERY MODE 03/01/2017 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): marianne. fox @ philips, com debbie.henn @philips .com patti. demichele @ Philips, com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KIM VAN OMMERING, JOHANNES JOSEPH HUBERTINA BARBARA SCHLEIPEN, and JEROEN HANS NIEUWENHUIS Appeal 2016-000391 Application 13/498,63 51 Technology Center 1700 Before CATHERINE Q. TIMM, N. WHITNEY WILSON, and CHRISTOPHER L. OGDEN, Administrative Patent Judges. OGDEN, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s decision2 finally rejecting claims 1—10 and 12—21 in the above-identified application. We have jurisdiction pursuant to 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify Koninklijke Philips, N.V. as the real party in interest. Appeal Br. 3, Feb. 10, 2015. 2 Office Action, Aug. 27, 2014 [hereinafter Action]; Examiner’s Answer, Aug. 3, 2015 [hereinafter Answer], Appeal 2016-000391 Application 13/498,635 BACKGROUND Appellants’ invention relates to “intensity measurements of a light scattering label bound to a surface of a support using an optical evanescent field.” Spec. 1. Independent claim 1 is representative: 1. A method comprising: a) Providing an assay comprising at least one light scattering label bound to a surface of a support by at least one bond; b) Measuring the fluctuations in the intensity of scattered light of the label in an optical evanescent field over time while the label is bound to the surface. Appeal Br. 18 (emphasis added). Claim 15 is also independent, and according to Appellants, “includes features substantively the same as the emphasized features of claim 1.” Id. at 6. The Examiner maintains the following grounds of rejection: 1. Claims 1, 2, 4, 6, 8—10, 14—16, 19, 20, and 21 are rejected under 35 U.S.C. § 102(b) as being anticipated by Stimpson.3 See Action 2-4. 2. Claims 3, 5, 7, 12, 13, 17, and 18 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Stimpson. See Action 5. In the Appeal Brief, Appellants argue claims 1, 2, 4, 6, 8—10, 14—16, 19, 20, and 21 as a group, see Appeal Br. 5—13, and argue that the remaining claims are patentable for the same reasons, see id. at 13—14. Appellants also present further arguments regarding claim 3. See id. at 14—15. Therefore, consistent with 37 C.F.R. § 41.37(c)(l)(iv) (2016), we limit our discussion to claims 1 and 3. Claims 2, 4—10 and 12—21 stand or fall with claim 1. 3 Stimpson et al., U.S. Patent No. 5,599,668 (issued Feb. 4, 1997). 2 Appeal 2016-000391 Application 13/498,635 DISCUSSION Figure 3 of Stimpson is reproduced below: fig. 3 Figure 3 depicts an oligonucleotide 72 that is immobilized on the surface of a waveguide 62, which captures a light scattering particle 68 (called an “LSL”) within an evanescent wave penetration depth 76. See Stimpson 7:53—58, 16:27—31, 18:62—19:3, 19:29-36. According to Stimpson, the waveguide 62 is “illuminated in a manner to effect total reflection,” and “the scattering of the evanescent wave is illustrated at 78.” Id. at 19:49-49. Stimpson states that this scattered light may be observed from the underside, possibly using a mirror. See id. at 12:60-62. According to Stimpson, At the sites where light-scattering specific binding complexes have formed, the scattering of light is observed as lighter areas against a darker background of the non-situs portions. The brighter the situs appears, the more LSL is bound and the more 3 Appeal 2016-000391 Application 13/498,635 analyte is present at that situs. The method can be used to quan titate or semi-quantitate by reading the gray tones into a com puter and, using calibrators, estimating the amount of analyte present at each situs. Id. at 51—59 (citation omitted). Stimpson discloses that the extent of binding “can be monitored in real time as various conditions are changed.” Id. at 20:45—46. As is clear from the fact that it is used in an anticipation rejection, the Examiner finds that Stimpson discloses all the limitations of claim 1. Action 2—3; Answer 2-4 (citing Stimpson abstract, 3:46—55, 5:53—59, 21:19-24, 22:50-56, Figs. 1, 3); Answer 2—5. In particular, for the limitation that fluctuations of intensity of the scattered light of the label are measured “over time,” the Examiner quotes Stimpson as disclosing that “the difference over time in scattering of light provides kinetic information indicative of the amount of analyte present at said situs.” Answer 4 (quoting Stimpson 5:53— 59 (emphasis added by Examiner)). Appellants focus much of their argument on Stimpson’s disclosure in column 5, lines 46—55, arguing that there is no mention of the evanescent field in this portion of Stimpson, et al., and no mention that the light scattered at a situs is evanescent light. There is also no mention that a light is scat tered from a label, or any mention of the measure of fluctuations in the intensity of scattered light of the label in an optical ev anescent field over time. Finally, there is no mention whatso ever that the label is bound to the surface. Rather, the light is scattered from a situs. It is unclear what a “situs” is, and in view of the rather large volume of information presented in Stimpson, et al. (50 columns and 13 sheets of drawings), its determination is not readily at hand. Plainly, the Office Action has not directed Applicants to explicit features of the claim. 4 Appeal 2016-000391 Application 13/498,635 Appeal Br. 7; see also id. at 12; Reply Br. 5. Appellants also argue that the Examiner failed to comply with 37 C.F.R. § 1.104(c)(2) by failing to designate, as nearly as practical, the particular part relied on from each reference, and failing to provide a clear explanation of the pertinence of each reference. Appeal Br. 6—7. Appellants’ arguments do not persuade us that the Examiner reversibly erred in rejecting claim 1. This rejection is based on Stimpson for all that it discloses, and not merely on the passage of column 5, lines 46—55. See Answer 2—5. In addition to that passage, the Examiner cites multiple portions of Stimpson, including specific references to light scattering in an evanescent field, measurement of the intensity of the scattered light, measurement of this intensity over time, and providing a light scattering label bound to a surface. See, e.g., id. at 2—5, 8. The Examiner’s rejection meets the requirements of 37 C.F.R. § 1.104(c)(2), and clearly explains the Examiner’s findings as to why Stimpson discloses a method comprising each and every limitation of claim 1. Next, Appellants argue that Stimpson does not disclose or suggest, either in column 5 or elsewhere, measuring the fluctuations in the intensity of the scattered light of the label in an optical evanescent field, as required by claim 1. Appeal Br. 8. In particular, Appellants argue that, while Stimpson refers to photoelectric systems that “us[e] an electrical signal, which is modulated by the light intensity at the situs,” id. (citing Stimpson col. 21), “there is no disclosure of measuring fluctuations in the intensity of scattered light of the label in an optical evanescent field.” Appellants also argue that Stimpson does not disclose measuring fluctuations in intensity, and that the reference to “comparing the degree of light scattering at said 5 Appeal 2016-000391 Application 13/498,635 situs,” Stimpson 5:5:53, does not disclose “that this comparing relies on measuring fluctuations in the intensity of scattered light of the label in an optical evanescent field.” Appeal Br. 8; see also Reply Br. 5—7. We do not find these arguments persuasive of reversible error. As Appellants acknowledge, Stimpson describes a photoelectric system in which “an electrical signal is modulated by the light intensity at the situs.” Stimpson 21:60-61. These detectors, such as CCD cameras, convert fluctuations in light intensity into an electrical signal that is digitized for computer-based image processing. See id. at 21:60-22:65. The camera detection system automates the process of visual detection, by which “[scattering is observed when the situs appears brighter than the surrounding background.” Id. at 21:53—54; see also id. at 24:11—14 (“Scattered light derived from the interaction of the evanescent light wave with the light-scattering label can be detected visually, or by means of a standard video analysis system.”). Using imaging processing software, the user may analyze the digital information and determine the boundaries or contours of each situs, and the average or representative value of intensity at each situs. The intensity correlates positively with the amount of LSL present at the situs, and the amount of LSL present correlates (negatively or positively, depending on the as say format) to the amount of analyte binding member at such si tus. Id. at 22:34-41 (emphasis added). Thus, the preponderance of the evidence supports the Examiner’s finding that Stimpson discloses measuring the intensity of scattered light of the label in an optical evanescent field. Moreover, Stimpson clearly discloses the measurement offluctuations in those intensities over time. Stimpson states that “[mjultiple images of the 6 Appeal 2016-000391 Application 13/498,635 same situs may be accumulated and analyzed over time,” in order to obtain kinetic information, because “the time-dependency (i.e. rate) of the increase or decrease in the amount of light scattering may be more accurately indicative of the levels of the binding pair members present in the fluid sample than the total amount of scatter by the reaction at any given reaction point in time.” Id. at 22:51—56. Next, Appellants argue that the Examiner’s finding that Stimpson anticipates claim 1 is based on inherency, and the Examiner has not established that the measurement of fluctuations in intensity of scattered light is necessarily present in Stimpson. See Appeal Br. 8—9. Specifically, Appellants argue that the measurement discussed by Stimpson could be, “rather than an intensity measurement, a wavelength measurement, or [a] spectral analysis.” Id. at 8. We do not find this argument persuasive, because the Examiner’s rejection does not rely on or require a finding of inherency. As discussed above, a preponderance of the evidence supports the Examiner’s finding that Stimpson explicitly refers to measurement (via a CCD camera, for example) of intensity levels of scattered light of a label in an optical evanescent field over time. Appellants also argue that the Stimpson reference “does not enable the measurement of fluctuations in the intensity of scattered light of the label in an optical evanescent field,” because it “does not even nam[e] or describe the subject matter of the emphasized features of claim 1.” Appeal Br. 9—10. We do not find this argument persuasive of reversible error. Prior art references are presumed enabling, and Appellants bear the burden to come forward with evidence that Stimpson is nonenabling. See In re Sasse, 629 7 Appeal 2016-000391 Application 13/498,635 F.2d 675, 681 (CCPA 1980). However, Appellants have not directed our attention to any persuasive evidence that a person of ordinary skill in the art would have been unable able to make or use Stimpson’s disclosure. Based on the preponderance of the evidence before us on this appeal record, we find nothing to suggest that Stimpson would not have enabled a person of ordinary skill in the art to practice all of the features of claim 1. Claim 3 depends on claim 1, and requires that “the exposure time for each intensity measurement is < 40 ms, preferably < 1 ms.” Appeal Br. 3. The Examiner finds that Stimpson does not explicitly disclose this range of exposure times, but notes that Stimpson teaches that “[tjimed readings can be made continuously or discretely,” and also “teaches realtime measurement of binding of a light scattering label to the surface of the support.” Action 5 (citing Stimpson 3:46-49, 5:62—63). Further, in the Answer, the Examiner finds that exposure time directly affects the measurement of light scattering, and that a person of ordinary skill in the art would have had reason to optimize the exposure time by routine experimentation. See Answer 8. Thus, the Examiner concludes that claim 3 would have been obvious over Stimpson. See id. Appellant argues that the Examiner has not articulated reasoning with some rational underpinning to support the legal conclusion of obviousness. See Appeal Br. 15. Appellants also argue that obviousness requires that some “teaching, suggestion, or motivation must exist in the prior art,” and that that no teaching suggestion, or motivation exists in Stimpson. See Reply Br. 7—8. Appellants do not point to evidence rebutting the Examiner’s findings that exposure time was known in the art to effect the measurement of light 8 Appeal 2016-000391 Application 13/498,635 scattering, or that optimizing exposure time would have been within the ordinary skill in the art at the time of filing. “[Wjhere the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456 (Fed. Cir. 1955). Therefore, we do not find Appellants’ arguments persuasive of reversible error. For the above reasons, we are not persuaded that the Examiner reversibly erred in rejecting claims 1 and 3. Likewise, we are not persuaded of reversible error in the Examiner’s rejection of claims 2, 4—10 and 12—21. DECISION The Examiner’s decision is affirmed. No time period for taking any subsequent action in connection with this appeal maybe extended. See 37 C.F.R. § 1.136(a)(l)(iv) (2016). AFFIRMED 9 Copy with citationCopy as parenthetical citation