ABBOTT POINT OF CARE, INC.

Patent Trials and Appeals BoardJul 16, 2020

14768680 - (D) (P.T.A.B. Jul. 16, 2020)

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. 14/768,680 08/18/2015 Manav Mehta 7564-0100WOUS 6368 50811 7590 07/16/2020 O''''Shea Getz P.C. 10 Waterside Drive, Suite 205 Farmington, CT 06032 EXAMINER TURK, NEIL N ART UNIT PAPER NUMBER 1798 NOTIFICATION DATE DELIVERY MODE 07/16/2020 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): shenry@osheagetz.com uspto@osheagetz.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MANAV MEHTA and ROBERT HOLT Appeal 2019-003615 Application 14/768,680 Technology Center 1700 Before CATHERINE Q. TIMM, JEFFREY R. SNAY, and LILAN REN, Administrative Patent Judges. TIMM, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 15, 16, 22, 24, and 26–35. See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Abbot Point of Care, Inc. Appeal Br. 3. Appeal 2019-003615 Application 14/768,680 2 CLAIMED SUBJECT MATTER The claims are directed to a method of analyzing a biologic fluid sample (see, e.g., claims 15 and 29). The method involves disposing a biologic fluid sample in an analysis chamber defined by two panels (shown as panels 12 and 14 in Figure 1). See, e.g., claims 15 and 29; Spec. ¶ 23. Within the chamber, the biological fluid sample is mixed with fluorescent dye. See, e.g., claims 15 and 29; Spec. ¶ 41. Beads (shown as beads 16 in Figure 1) are disposed between the two panels. See, e.g., claims 15 and 29; Spec. ¶ 23. The beads “are configured to not reflect light incident to the beads in an amount that appreciably interferes with a photometric analysis of the fluid sample.” See, e.g., claims 15 and 29; Spec. ¶ 27. In this context, “‘appreciably’ means that to the extent that there is reflection of incident light off a bead 16, if any, the amount of that reflected light is such that the bead 16 is readily distinguishable from constituents within the sample (e.g., platelets, etc).” Spec. ¶ 27. Claim 29, reproduced below with emphasis on the limitation most at issue, is illustrative of the claimed subject matter: 29. A method of analyzing a biological fluid sample, comprising: providing an analysis chamber defined by a transparent first chamber panel having a first interior surface, and a transparent second chamber panel having a second interior surface; disposing the biologic fluid sample in the analysis chamber, and quiescently holding the fluid sample in the analysis chamber; disposing a plurality of beads, each having an exterior surface, between the interior surface of the first chamber panel and the interior surface of the second chamber panel, which Appeal 2019-003615 Application 14/768,680 3 beads are configured to not reflect light incident to the beads in an amount that appreciably interferes with a photometric analysis of the fluid sample; creating one or more images of the fluid sample by transmitting light at one or more wavelengths of light through the fluid sample while the fluid sample is quiescently residing with the beads within the analysis chamber, and the beads are disposed within the chamber such that the exterior surface of each bead is in direct contact with the fluid sample during the creation of the images, wherein the one or more images are created using a captured portion of the light transmitted through the sample ; and analyzing the quiescently residing fluid sample using at least a portion of the one or more images of the sample. Appeal Br. 17 (Claims Appendix) (emphasis added). Claim 15, the other independent claim, adds a further requirement on the beads. Claim 15 requires each bead be “configured to inhibit the at least one fluorescent dye from attaching to the exterior surface of that bead.” REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Van Ness US 5,232,830 Aug. 3, 1993 Mariella US 6,154,276 Nov. 28, 2000 Harmon US 2008/0166328 A1 July 10, 2008 Wardlaw US 2011/0294198 A1 Dec. 1, 2011 REJECTIONS The Examiner maintains the following rejections. Appeal 2019-003615 Application 14/768,680 4 Claims 15, 16, 22, 24, and 27–34 are rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Wardlaw in view of Van Ness and further evidenced by Harmon. Final Act. 4. Claims 26 and 35 are rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Wardlaw in view of Van Ness and evidenced by Harmon, and further in view of Mariella. Final Act. 7. OPINION As pointed out by Appellant, Appellant’s claimed method is directed to performing an analysis on a fluid sample quiescently residing within an analysis chamber. Appeal Br. 8. It was known in the art to include beads in the chamber, but a problem occurs during imaging, light reflecting off the beads interferes with the imaging of the sample. Spec. ¶¶ 6–9. Appellant solves the reflectance problem by using non-reflecting beads. Id. All of the claims require the limitation concerning the non-reflectivity of the beads. Wardlaw teaches analyzing a quiescent biological fluid sample using an analysis chamber having beads that separate two panels as required by the claims. Wardlaw ¶ 36; Fig. 3. There is no dispute that Wardlaw fails to specify using non-reflective beads. Final Act. 5. The Examiner turns to Van Ness to support a finding of a reason to use beads in Wardlaw’s analyzer “that will not provide optical responses in response to the incident light radiation and provide to yield more accurate photometric and fluorescence assays of the biologic sample wherein noise from the beads is avoided in the imaging and analysis of the sample.” Final Act. 6. Appeal 2019-003615 Application 14/768,680 5 We agree with Appellant that the Examiner has reversibly erred in the finding of a reason to make the combination. The Examiner’s finding is not grounded in the teachings of the prior art. Nor does the Examiner provide a basis grounded on knowledge within the skill in the art. A clue that the finding is unmoored from the teachings of the prior art is the fact that Van Ness is directed to a method with different problems than the method of Wardlaw. Wardlaw is concerned with the flexibility of the beads and panels, not their reflectivity. Wardlaw points out that it was conventional to use rigid particles, such as glass beads, to separate the panels. Wardlaw ¶ 7. Wardlaw replaces these beads with plastic beads that can be compressed. Wardlaw ¶ 36. Wardlaw’s beads are said to be formed from polymers such as polystyrene, polycarbonate, and silicone. Wardlaw ¶ 36. Wardlaw compresses the beads between planar members 12, 14 to form a chamber that holds the biologic fluid sample. Id. Wardlaw’s chamber is used in a process of counting particles such as blood cells in a liquid medium such as whole blood. Wardlaw ¶ 5. The chamber is used in an image analyzer, such as the optical analysis system of Figure 8. This system images the chamber using a light source 48 and a CCD camera 50. Wardlaw ¶ 42. Figure 11 shows the analysis field 66 from the sample film 64 of Figure 10. Wardlaw ¶ 45. What are shown are red blood cells 56, white blood cells 58, platelets 60, all surrounded by the blood plasma 62. Id. According to Wardlaw, beads 16 “are also seen but are readily distinguished from all other elements because of their size and refractive index.” Id. Wardlaw presumes that the beads have a reflective index, which would have suggested to the ordinary artisan that the beads are transparent enough to allow light to travel through them. Appeal 2019-003615 Application 14/768,680 6 Van Ness is not directed to a process of counting particles in a liquid medium such as blood. Instead, Van Ness is directed to a process of detecting sequences of nucleic acids by quantifying the extent of ligand pair binding on solid supports, where the solid supports may be beads. Van Ness col. 1, ll. 13–27; col. 2, ll. 8–36. The beads themselves are the solid support. Van Ness col. 2, ll. 23–26. The beads may intrinsically fluoresce and the ligand pair detected by fluorescent quenching. Van Ness col. 2, ll. 20–35. Or, if the product being detected is fluorescent, the beads may have their intrinsic or natural fluorescence quenched or masked, by, for instance, applying a dye and the fluorescence of the bound product detected. Van Ness col. 2, ll. 53–61. For instance, white nylon beads may be dyed black or another color that does not fluoresce at the same wavelength as the fluorescent product being detected. Van Ness col. 7, ll. 45–52. Wardlaw’s beads are separators. Van Ness’s beads are supports for ligand pairs. Wardlaw seeks to image and count particles not attached to the beads. Van Ness seeks to detect fluorescence of either the beads or the ligand pair on the beads. The suggestion of using Van Ness’s quenched or masked beads as Wardlaw’s separator beads does not flow from the teachings of the prior art, but from hindsight. Mariella does not cure the deficiency. We do not sustain the Examiner’s rejections. CONCLUSION The Examiner’s decision to reject claims 15, 16, 22, 24, and 26–35 is REVERSED. Appeal 2019-003615 Application 14/768,680 7 DECISION SUMMARY In summary: Claim(s) 35 U.S.C. § Basis/Reference(s) Affirmed Reversed 15, 16, 22, 24, 27–34 103(a) Wardlaw, Van Ness, Harmon 15, 16, 22, 24, 27–34 26, 35 103(a) Wardlaw, Van Ness, Harmon Mariella 26, 35 Overall Outcome 15, 16, 22, 24, 26–35 REVERSED