C2 DIAGNOSTICS

Patent Trials and Appeals BoardSep 28, 2020

2019005220 (P.T.A.B. Sep. 28, 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. 15/294,274 10/14/2016 Olivier MAGNIN 0501-1208-1 5955 466 7590 09/28/2020 NIXON & VANDERHYE, PC 901 NORTH GLEBE ROAD 11TH FLOOR ARLINGTON, VA 22203 EXAMINER HURST, JONATHAN M ART UNIT PAPER NUMBER 1799 NOTIFICATION DATE DELIVERY MODE 09/28/2020 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): pair_nixon@firsttofile.com ptomail@nixonvan.com yandtpair@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte OLIVIER MAGNIN, LAURENT DAMONNEVILLE, and SERGE CHAMPSEIX Appeal 2019-005220 Application 15/294,274 Technology Center 1700 ____________ Before JEFFREY T. SMITH, JAMES C. HOUSEL, and BRIAN D. RANGE, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–16, which constitute all the claims pending in this application. 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 C2 Diagnostics. Appeal Br. 2. Appeal 2019-005220 Application 15/294,274 2 STATEMENT OF THE CASE Appellant’s invention is generally directed an optical measurement method for counting and/or differentiating leucocytes in an automatic blood analysis apparatus. (Spec. 3.) Independent claim 1 is representative of the appealed subject matter and is reproduced below: 1. An optical measurement method for counting and/or differentiating leucocytes in an automatic blood analysis apparatus, comprising steps of: - using a blood sample, the dilution rate of which is between 1/100 and 1/500; - injecting a non-hydrofocused blood sample using a tank, the section of which having at least one transverse dimension comprised between 1 and 5 millimetres, - injecting the blood sample flow with a diameter greater than 50 μm using an injector, of the tank, having an outlet orifice with a diameter of 50-150 μm; - illuminating the blood sample flow circulating in the optical tank along an injection axis by using a light source having an electroluminescent diode, which emits a light beam along an optical axis substantially transversely to said injection axis, - focusing said light beam on the blood sample flow; and - measuring light originating from the optical tank after interception by a blood cell of the blood sample, - detecting light issued from the electroluminescent diode and diffracted by said blood cell according to narrow angles, smaller than 10 degrees, relative to the optical axis. Claims Appendix (emphasis added). The following rejections are presented for our review: 2 2 The complete statement of the rejections on appeal appear in the June 25, 2018 Non-Final Action. (Non-Final Act. 2–12.) Appeal 2019-005220 Application 15/294,274 3 I. Claims 1–3, 6, and 9–15 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Singh (US 2004/0022685 A1; Feb. 5, 2004), Valet (US 4,751,188; June 14, 1988), Hoffman (US 6,813,017 B1; Nov. 2, 2004), Fritz ( US 2003/0002027 A1; Jan. 2, 2003), and Johnson (US 6,256,096 B1; July 3, 2001). II. Claims 4, and 5 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Singh, Valet, Hoffman, Fritz, Johnson, and further in view of Lefevre (US 5,730,941; Mar. 24, 1998). III. Claims 7 and 8 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Singh, Valet, Hoffman, Fritz, Johnson, Lefevre, and further view of Unterleitner (US 4,498,766; Feb. 12, 1985). IV. Claim 16 is rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Singh, Valet, Hoffman, Fritz, Johnson, and further view of Tycko (US 4,735,504; Apr. 5, 1988). OPINION We consider the record to determine whether Appellant has identified reversible error in the Examiner’s rejections. See In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections,” citing Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential)). Appellant argues independent claim 1 clearly states that the blood sample to be analyzed is non-hydro-focused. Appellant argues the Examiner’s rejection is based on an erroneous interpretation. (Reply Br. 1– Appeal 2019-005220 Application 15/294,274 4 2.) Appellant further argues none of the cited references disclose a non- hydro-focused sample at the analysis zone. The dispositive issue for this appeal is the following: Did the Examiner err in determining that the method of independent claim 1 is not limited to analysis of non-hydrofocused blood sample?3 We answer this question in the affirmative. We agree with Appellant that the Examiner erred reversibly in the determination of obviousness for independent claim 1. The Examiner bears the initial burden of presenting a prima facie case of obviousness. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). “[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (quoted with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)). The Examiner’s rejection is premised on the analysis of hydrofocused blood samples. The Examiner states: The examiner notes that the claims only require a step of “injecting a non-hydrofocused blood sample using a tank”. Importantly, the claims do not prohibit hydrofocusing throughout the sample flow but merely prior to injection from a tank. (Ans. 4.) Utilizing this interpretation, the Examiner finds Singh discloses an optical tank in which a blood sample is injected through sample inlets. The Examiner acknowledges that the blood sample is subsequently hydrofocused 3 We limit our discussion to independent claim 1, the only independent claim on appeal. Appeal 2019-005220 Application 15/294,274 5 by the addition of a buffer after introduction. The Examiner specifically states: Regarding claim 1 Singh et al. discloses an optical measurement method for counting cells in an automatic sample analysis apparatus comprising the steps of: - using a cell sample, - injecting a non-hydrofocused sample using a tank, the section of which having at least one transverse dimension comprised between 1 and 5 millimetres. (See Singh Fig.1 and [0055]-[0057] wherein an optical tank 1 has an inlet 2 with a transverse dimension, i.e.[,] diameter, of 2 mm. Also non-hydrofocused sample fluid is injected into the tank utilizing sample inlets 4. It is noted that while the sample may be hydro-focused focused by buffer fluids after it has been injected into the tank the sample is a not hydro-focused prior to injection and as such a non-hydrofocused sample is injected using the inlet of the tank as is required by the claim and only after injection would/could the sample be hydrofocused.) (Non-Final Act. 3 (emphasis added).) Contrary to the Examiner’s position, the claimed invention specifies an optical measurement method for counting and/or differentiating leucocytes in an automatic blood analysis apparatus wherein the steps describes analysis of a non-hydrofocused blood sample. The claimed invention does not describe method steps wherein the character of the blood sample is changed. In particular, claim 1 refers to “injecting a non- hydrofocused blood sample” and then later refers to “the blood sample.” The recitation of “the blood sample” refers back to the “a non-hydrofocused blood sample.” None of the steps indicate that “the blood sample” becomes non-hydrofocused, or is otherwise altered, at any point. Therefore, “the blood sample” remains non-hydrofocused in each step. Appeal 2019-005220 Application 15/294,274 6 Accordingly, we REVERSE the Examiner’s prior art rejections of claims 1–8 under 35 U.S.C. § 103(a) for the reasons the Appellant presents and we give above. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3, 6, 9–15 103(a) Singh, Valet, Hoffman, Fritz, Johnson 1–3, 6, 9– 15 4, 5 103(a) Singh, Valet, Hoffman, Fritz, Johnson, Lefevre 4, 5 7, 8 103(a) Singh, Valet, Hoffman, Fritz, Johnson, Lefevre, Unterleitner 7, 8 16 103(a) Singh, Valet, Hoffman, Fritz, Johnson, Tycko 16 Overall Outcome 1–16 REVERSED