Huan-Ping Wu et al.

Patent Trials and Appeals BoardAug 5, 2019

14231874 - (D) (P.T.A.B. Aug. 5, 2019)

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. 14/231,874 04/01/2014 Huan-Ping Wu 08DC051 PCT- USD/438USD1 3104 71331 7590 08/05/2019 NIXON PEABODY LLP 70 West Madison, Suite 3500 CHICAGO, IL 60602 EXAMINER WHALEY, PABLO S ART UNIT PAPER NUMBER 1631 NOTIFICATION DATE DELIVERY MODE 08/05/2019 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): docketingchicago@nixonpeabody.com ipairlink@nixonpeabody.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE _________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD _________________ Ex parte HUAN-PING WU and SUNG-KWON JUNG _________________ Appeal 2018-004941 Application 14/231,874 Technology Center 1600 _________________ Before ERIC B. GRIMES, DEBORAH KATZ, and RYAN H. FLAX, Administrative Patent Judges. KATZ, Administrative Patent Judge. DECISION ON APPEAL Appeal 2018-004941 Application 14/231,874 2 Appellants1 seek our review, under 35 U.S.C. § 134(a), of the Examiner’s decision to reject claims 1–25. (Appeal Brief dated September 29, 2017 (“App. Br.”) 1.) We have jurisdiction under 35 U.S.C. § 6(b). An oral argument was held on July 12, 2019.2 We REVERSE. The Examiner rejected claims 1–25 as being drawn to ineligible subject matter under 35 U.S.C. § 101. (See Final Office Action issued May 1, 2017 (“Final Act.”) 2–5.) The Examiner also3 provisionally rejected claims 1–25 under the doctrine of obviousness-type double patenting over claims 1–28 of co- pending application 12/329,698. (See Final Act. 11–12.) Appellants do not argue for the separate patentability of the claims. (See App. Br. 4.) We focus on claim 1 in our review. See 37 C.F.R. § 41.37(c)(1)(iv). Appellants explain that their invention is a biosensor system for determining analyte concentrations in a biological sample. (See Spec. ¶ 23.) The system uses a “complex index function,” to determine error by calculating slope deviations, ΔS values, modified with weighing coefficients that represent bias. (See id.) 1 Appellants report that the real party in interest is Ascensia Diabetes Care Holdings AG. (App. Br. 1.) 2 The oral argument was held for both this appeal and appeal 2018-001958 of the rejection in application 13/053,722, which has the same real party-in- interest and claims drawn to similar subject matter. 3 The Examiner withdrew a rejection of claims 1–25 as being indefinite under 35 U.S.C. § 112, second paragraph. (See Examiner’s Answer 3.) Appeal 2018-004941 Application 14/231,874 3 Appellants’ claim 1 recites: A biosensor system, for determining an analyte concentration in a fluid sample, comprising: a test sensor having a sample interface adjacent to a fluid reservoir, wherein the test sensor generates at least one output signal from the sample; and a measurement device having a processor, a sensor interface, and a storage medium, wherein the processor is connected to the sensor interface, wherein the sensor interface has electrical communication with the sample interface, and the processor has electrical communication with a storage medium, wherein the processor determines at least one output signal value from the output signal received from the sensor interface, wherein the at least one output signal value represents an unknown concentration of the analyte in the sample, wherein the processor determines at least one ΔS value from at least a complex index function stored in the storage medium, wherein the at least one ΔS value represents a slope deviation of a slope of a correlation between analyte concentration and the at least one output signal from a hypothetical slope of a perfect correlation between analyte concentration and output signals, the correlation between analyte concentration and the at least one output signal determined from at least one previously determined reference correlation between previously determined reference output signal values and reference sample analyte concentration values, the reference sample analyte concentration values obtained from a reference instrument, wherein the complex index function includes at least two terms, wherein each of the at least two terms is modified by a weighing coefficient, wherein at least one of the at least two terms modified by the weighing coefficients is responsive to a bias between the reference correlation of analyte concentrations and the at least one output signal, wherein the complex index function is responsive to at least one error parameter, wherein the weighing coefficients are numerical values other than one or zero, and wherein the processor determines the analyte concentration in the sample from the output signal value and a slope compensation equation stored in the storage medium, wherein the slope Appeal 2018-004941 Application 14/231,874 4 compensation equation adjusts a slope of the at least one reference correlation with the at least one determined ΔS value. (Response to October 26, 2017 Communication of Non-Compliant Appeal Brief (“Suppl. Appeal Brief.”), 2–3.) 35 U.S.C. § 101 The Examiner rejected Appellants’ claims under 35 U.S.C. § 101, concluding that they are directed to the judicial exception of an abstract idea, without adding significantly more. (See Final Act. 2–5.) In Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), the Supreme Court put forth a framework for determining subject matter eligibility, wherein [f]irst, we determine whether the claims at issue are directed to one of those patent-ineligible concepts . . . . If so, we then ask, “[w]hat else is there in the claims before us?” . . . To answer that question, we consider the elements of each claim both individually and “as an ordered combination” to determine whether the additional elements “transform the nature of the claim” into a patent-eligible application. Alice Corp. Pty. v. CLS Bank Int’l, 573 U.S. 208, 217 (2014) (quoting Mayo, 566 U.S. at 78). After determining that a claim is directed to one of the categories expressly provided in 35 U.S.C. § 101 (process, machine, manufacture, or composition of matter), under the framework of Mayo we are instructed to perform two steps. First, we are to determine whether the claims are directed to a judicial exception (laws of nature, natural phenomena, or abstract ideas). See Diamond v. Diehr, 450 U.S. 175, 185 (1981) (holding that “laws of nature, natural phenomena, and abstract ideas” are not eligible subject matter). If so, we must undertake the second step Appeal 2018-004941 Application 14/231,874 5 and ask whether there is anything additional that, when the claim is viewed as a whole, adds significant elements beyond the sum of their parts taken separately. (See Mayo, 566 U.S. at 79–80.) After acknowledging that Appellants’ claims are directed to processes, the Examiner determined that the claims recite the patent- ineligible concept of abstract ideas. (See Final Act. 3.) Specifically, the Examiner highlighted the following elements: “determines at least one output signal value from the output signal . . .,” “determines at least one ΔS value from at least a complex index function . . .,” and “determines the analyte concentration in the sample from the output signal value . . . .” (See id., quoting elements of claim 1; see also Examiner’s Answer issued February 8, 2018 (“Ans.”) 4.) The Examiner found that these recited steps are mathematical manipulations of data. (See id.) The Examiner determined, further, the additional elements recited in claim 1 (a “test sensor” and a “measurement device”) fail to rise to the level of significantly more than the judicial exception because they are recited with a high level of generality and perform nothing more than well- understood, routine, and conventional activities previously known in the industry. (See Final Act. 3–4, citing Spec. 1–4.) For example, the Specification refers to portable measurement systems available from Bayer HealthCare and bench-top systems available from CH Instruments. (See Spec. ¶ 3.) Appeal 2018-004941 Application 14/231,874 6 The Examiner determined that the inventive concept necessary to transform a patent ineligible abstract idea into patentable subject matter cannot be furnished by the abstract idea itself. (See Final Act. 6; see also Ans. 4–5, citing Mayo, 556 U.S. at 72–73 and Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015).) In conclusion, the Examiner rejected Appellants’ claims after determining that the limitations of the claims, individually, and in ordered combination as a whole, do not rise to the level of significantly more than the judicial exception of an abstract idea. (See Ans. 8.) When evaluating rejections under 35 U.S.C. § 101, we refer to the revised guidance of the U.S. Patent and Trademark Office. See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50–57 (2019) (“2019 Guidelines”). This guidance requires that after determining that claimed subject matter falls within one of the four categories of patentable subject matter identified in 35 U.S.C. § 101, a “revised step 2A” is performed, which corresponds to the first step of the Alice/Mayo test articulated above. Specifically, in a first prong of step 2A we determine whether a claim recites at least one of the judicial exceptions of laws of nature, natural phenomena, and abstract ideas. (See 2019 Guidelines, 84 Fed. Reg. 50, 53–54.) If a judicial exception is identified, a second prong of step 2A requires a determination of whether the judicial exception is integrated into a practical application. (See id.) If so, the claim is determined to be directed to eligible subject matter under the 2019 Guidelines and the inquiry ends. (See id. at 54 (“When the exception is so integrated [into a practical application], then the claim is not directed to a judicial exception (Step 2A: NO) and is eligible. This concludes the Appeal 2018-004941 Application 14/231,874 7 eligibility analysis.”).) If not, the analysis continues to “step 2B” to determine if the claim provides an inventive concept. (See id. at 56.) We agree with the Examiner that Appellants’ claim 1 is drawn to a process and that it recites the judicial exception of an abstract idea. Specifically, we agree with the Examiner that claim 1 recites mathematical calculations at least in the limitations of determining values of the output signal and the ΔS and using them to determine an analyte concentration. (See Final Act. 3.) Under the 2019 Guidelines our next inquiry must be whether the abstract ideas in claim 1 are integrated into a practical application. (See 2019 Guidelines 54–55.) The 2019 Guidelines provide examples of the integration of judicial exceptions into practical applications, including when the claim recites an additional element that integrates the judicial exception in conjunction with a particular machine that is integral to the claim. (See 2019 Guidelines 55.) Appellants’ claim 1 recites a biosensor system with a “test sensor” and a “sensor interface.” (Suppl. App. Br. 2.) Although, as the Examiner finds, the system recited in claim 1 is a generic biosensor system, without physical features that are unique from systems known in the art, the mathematical calculations recited in claim 1 are used in conjunction with the particular elements of the test sensor and the sensor interface to achieve the determination of analyte concentration. Appellants’ claims are drawn to a system for determining analyte concentration, specifically by being responsive to errors that could bias the determined concentration, in an apparently non-conventional way after receiving input from the recited biosensor. Appellants’ claims are limited to Appeal 2018-004941 Application 14/231,874 8 reducing errors in concentration determinations with a biosensor and do not encompass reducing errors in any measurement with any machine. Thus, under the particular facts before us, the abstract mathematical calculations recited in Appellants’ claims are integrated into a practical application. Under the 2019 Guidelines, we determine that Appellants’ claims are not directed to an abstract idea and, thus, are not directed to a judicial exception to an eligible process under 35 U.S.C. § 101. See Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348–49 (Fed. Cir. 2018) (holding that claims to system of tracking motion with a mathematical calculation are drawn to eligible subject matter because the system included a unique configuration of inertial sensors, which was found to be “a non-conventional manner to reduce errors in measuring the relative position and orientation of a moving object on a moving reference frame.”); see also SiRF Tech., Inc. v. Int'l Trade Comm'n, 601 F.3d 1319, 1332–33 (Fed. Cir. 2010) (holding that claims to methods of calculating the position of a GPS are drawn to eligible subject matter because a GPS receiver is a machine that is integral to each of the claims at issue, even though the GPS machine was not recited to have novel features). Accordingly, we reverse the Examiner’s rejection under 35 U.S.C. § 101 in light of the 2019 Guidelines. Obviousness-Type Double-Patenting The Examiner provisionally rejected Appellants’ claims 1–25 on the grounds of nonstatutory obviousness-type double-patenting over claims 1– 28 of co-pending application 12/329,698 (“the ’698 application”). (See Final Act. 11–12.) Appeal 2018-004941 Application 14/231,874 9 The final rejections under 35 U.S.C. § 101 and § 112, second paragraph of the claims of the ’698 application were reversed by the Board, but the rejection for obvious-type double patenting over patent 9,164,076 was affirmed. (See Decision on Appeal in the ’698 application, entered March 28, 2019, 25–30.) A Notice of Abandonment was entered in the ’698 on June 26, 2019, but Appellants have since filed a terminal disclaimer over patent 9,164,076 and a petition to revive the application as having been unintentionally abandoned, both on June 28, 2019. Under the circumstances, where the petition may be granted and the claims of the ’698 application will then be allowed and issue, we review the provisional rejection of Appellants’ current claims over the claims of the ’698 application as currently presented. Claim 1 of the ’698 application does not include determining a ΔS value from a complex index function, but claim 7, which depends from claim 1, includes using at least one predetermined index function determined by a regression equation. (See Final Act. 11; see Appendix for claims 1 and 7 of the ’698 application.) In rejecting Appellants’ current claims over these claims of the ’698 application, the Examiner found that the predetermined index function of claim 7 broadly reads on the index function in Appellants’ current claimed because “regression equations inherently include at least two terms and a weighting coefficient (e.g. y = mx + b).” (Id.) The Examiner supports this finding by noting that the current Specification does not provide a definition of “weighing coefficient” that limits the claims to exclude this interpretation. (See Ans. 12–13.) Appellants argue that the “complex index function” of the current claims is different from the “predetermined index function” recited in claim Appeal 2018-004941 Application 14/231,874 10 7 of the ’698 application. (See App. Br. 30–31.) According to Appellants, the index function in claim 7 of the ’698 application does not have the elements of a regression equation and that the Examiner has failed to explain why one of ordinary skill in the art would have this understanding. (See id. at 31.) Appellants argue that if the ordinarily skilled artisan did consider the index function to include the regression equation y = mx + b, wherein “m” is the weighing coefficient, it would be unclear why “m” must be restricted to between 0 and 1, as required in Appellants’ current claims. (See id.) Similarly, Appellants argue that it would be unclear why “m” would be “responsive to a bias between the reference correlation of analyte concentrations and the at least one output signal” as recited in claim 1. (See id.) We are persuaded by Appellants’ arguments. The Examiner’s rejection does not take into account the restrictions on the weighing coefficient recited in Appellants’ currently appealed claim 1, for example that it be between 0 and 1 and that it be responsive to a bias between the reference of the analyte concentration and the output signal. The rejection also fails to explain why these features would have been obvious over claims 1 and 7 of the ’698 application. Accordingly, we reverse the Examiner’s rejection of Appellants’ appealed claims for obviousness-type double patenting over the claims of the ’698 application. Appeal 2018-004941 Application 14/231,874 11 Conclusion Upon consideration of the record and for the reasons given, the rejections of claims 1–25 under 35 U.S.C. § 101 and obviousness-type double patenting rejection are not sustained. Therefore, we reverse the decision of the Examiner. REVERSED Appeal 2018-004941 Application 14/231,874 12 Appendix Application 12/329,698, claims 1and 7, as presented on June 28, 2019: 1. A method for determining an analyte concentration in a fluid sample via a biosensor system comprising: providing an analyte measurement device and a sensor strip, the analyte measurement device including a storage device, a sensor interface, and a processor, the processor coupled to storage device and the sensor interface, the sensor interface for receiving the sensor strip, the sensor strip including an electrode that contacts the sensor interface of the measurement device when the sensor strip is placed in the sensor interface; applying an electrical input signal to the sample via the electrode of the sensor strip when the sensor strip is placed in the sensor interface of the analyte measurement device and a fluid sample is applied to the sensor strip; generating at least one output signal value from an analysis of the fluid sample via the sensor interface of the analyte measurement device, the at least one output signal value responsive to the analyte concentration in the sample; determining at least one ΔS value from at least one error parameter via the processor of the analyte measurement device, where the at least one ΔS value is a value of slope deviation or a value of normalized slope deviation in relation to at least one previously determined reference correlation relating previously determined reference output signal values to reference sample analyte concentration values, the previously determined reference sample analyte concentration values obtained from a reference instrument, the previously determined reference correlation stored in the storage device of the analyte measurement device, and where the at least one error parameter causes one or more errors in the at least one output signal value; and determining the analyte concentration in the sample from the at least one output signal value, the at least one L1S value, and the at least one previously determined reference correlation relating the at least one output signal value to one of the reference sample analyte Appeal 2018-004941 Application 14/231,874 13 concentration values via the processor of the analyte measurement device, where the determining the analyte concentration in the sample comprises adjusting the at least one previously determined reference correlation with the at least one ΔS value, and where the determining the at least one ΔS value from at least one error parameter and the determining the analyte concentration in the sample from the at least one output signal value are performed by the processor of the analyte measurement device using computer readable software code. 7. The method of claim 1, where the determining of the at least one L1S value from the at least one error parameter includes determining the at least one L1S value from at least one predetermined index function, the predetermined index function being determined by a regression equation of a plot between the deviation in a slope of the reference correlation in response to the at least one error parameter and, where the at least one predetermined index function is responsive to the at least one error parameter and provides the at least one L1S value as a value of slope deviation or a value of normalized slope deviation in relation to the at least one previously determined reference correlation.