Ex Parte Andersson

Patent Trials and Appeals BoardMar 28, 2019

11452102 - (D) (P.T.A.B. Mar. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 11/452,102 06/12/2006 Karl Andersson 52082 7590 04/01/2019 General Electric Company GE Global Patent Operation 901 Main Avenue 3rd Floor Norwalk, CT 06851 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. 229751-5 1581 EXAMINER SKIBINSKY, ANNA ART UNIT PAPER NUMBER 1631 NOTIFICATION DATE DELIVERY MODE 04/01/2019 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): gpo.mail@ge.com marie.gerrie@ge.com lori.E.rooney@ge.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KARL ANDERSSON Appeal2017-007753 Application 11/452, 102 1 Technology Center 1600 Before DONALD E. ADAMS, JOHN G. NEW, and DAVID COTTA, Administrative Patent Judges. COTTA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134 involving claims to a method of determining affinity for a molecular binding interaction from measured steady state binding data. The Examiner rejected the claims on appeal under 35 U.S.C. Â§ 101 as directed to patent ineligible subject matter. We affirm. 1 According to Appellant, the real party in interest is GE Healthcare Bio- Sciences AB. App. Br. 2. Appeal2017-007753 Application 11/452, 102 STATEMENT OF THE CASE The Specification discloses that there is a need for an "automated procedure for the evaluation of steady state affinity data, especially where large sets of interaction data, such as sensorgrams, are produced." Spec. 3. "A crucial problem to overcome in this context is to ensure that the binding curves obtained have at least substantially reached equilibrium before the binding level is read." Id. The Specification discloses that an object of the claimed method is to "at least partially automate[]" "a method for determining the affinity for a molecular binding interaction from steady state binding level data" and to "automatically exclude unreliable steady state binding level data." Id. at 3. According to the Specification, "[t]hese and other objects and advantages are achieved by a method based on the finding that other interaction data than steady state binding data from a data set ( usually a binding curve) may be used to estimate or determine if the steady state binding data of the data set is reliable." Id. Put another way, "data from one domain of a binding curve (e.g., the dissociation phase) may be used to determine if it is meaningful to evaluate data from another domain of the same binding curve (e.g., steady state)." Id. at 3--4. 2 Appeal2017-007753 Application 11/452, 102 Figure 2 of the Specification (reproduced below) helps illustrate Appellant's claimed method. J>RIORART Figure 2 is "[a] representative sensorgram (binding curve) for a reversible interaction at the sensor chip surface" in which the "sensing surface" of the sensor chip has an "immobilized capturing molecule, or ligand, for example an antibody," that "interact[s] with a binding partner there[ofJ, or analyte, in a sample." Spec. 9. The Specification describes the phases A-D of the sensorgram in Figure 2 as follows. Id. Initially, buffer is passed over the sensing surface giving the baseline response A in the sensorgram. During sample injection, an increase in signal is observed due to binding of the analyte. This part B of the binding curve is usually referred to as the "association phase". Eventually, a steady state [ or equilibrium] condition is reached at or near the end of the association phase where the resonance signal plateaus at C (this state may, however, not always be achieved). . . . At the end of sample injection, the sample is replaced with a continuous flow of buff er and a decrease in signal reflects the dissociation, or release, of analyte from the surface. This part D of the binding curve is usually referred to as the "dissociation phase". The Specification discloses that steady state binding data (phase C of Figure 2) is "usually read at a report point" - "a short time window, typically about five seconds, over which the detected response values are averaged" - 3 Appeal2017-007753 Application 11/452, 102 "at or near the end of the association phase." Id. at 15. The Specification teaches, however, that it is not sufficient to study the slope of this binding curve region to determine if equilibrium has been reaches because, "detection noise will usually cause even equilibrated binding curves to have sloping report points." Id. The Specification discloses that "[ a ]ccording to the invention, the reliability of the steady state data [phase C of Figure 2] of a binding curve is estimated based on binding data taken from other parts, or domains, of the binding curve." Id. at 15. More specifically, the Specification teaches to draw "'reliability indicators'" from data outside of the steady state portion of the binding curve. "A first such reliability indicator is the dissociation rate, which may be used to determine if it is likely that the interaction has approached equilibrium." Id. "Binding data to determine the dissociation rate is usually taken from the dissociation phase [D of Figure 2] but may also be taken from the association phase [B of Figure 2], or from both domains of the binding curve." Id. at 17. The Specification also discloses that "[a] second reliability indicator that basically may be determined from a domain on the binding curve that is different from the report point window is the last part of the sensorgram, such as, e.g., the last 30 seconds of the association phase [B of Figure 2]." Id. Additionally, "other reliability indicators may be used in combination with the [these] two indicators." Id. Claims 1, 3, 5-22, 24--27, and 29 are on appeal. 2 Claim 1 is illustrative and reads as follows: 2 Appellant submitted an amendment cancelling claim 32 with the Appeal Brief. App. Br. 2. The Examiner entered this amendment. Dec. 9, 2016 Advisory Action 2. Accordingly, claim 32 is no longer part of this appeal. 4 Appeal2017-007753 Application 11/452, 102 1. A method of determining affinity for a molecular binding interaction from measured steady state binding data, which method comprises the steps of: a) providing a plurality of experimental binding data sets for a binding interaction between two chemical species; wherein each experimental binding data set includes binding data measured at multiple time points during an association phase and a dissociation phase of the binding interaction using a biosensor, and wherein the plurality of experimental binding data sets comprise binding data representing a concentration series of at least one of the two chemical species, b) selecting association phase data measured at a defined report point window at or near an end of the association phase from each of the experimental binding data sets as representing steady state binding data; c) subjecting each experimental binding data set to a quality control which comprises estimating a reliability of the steady state binding data by calculating at least one reliability indicator using binding data other than binding data in the report point window of the same data set and comparing the reliability indicator with a predetermined limit using a computer connected to the biosensor; wherein at least one reliability indicator is selected from a value for dissociation rate and a value of slope of a binding curve represented by continuous association phase binding data, wherein the value of slope of the binding curve represented by continuous association phase binding data is calculated from an association region of the binding curve, wherein the value for dissociation rate indicates unreliable steady state binding data if the value for dissociation rate is below a predetermined value, and wherein the value of slope of a binding curve represented by continuous association phase binding data indicates unreliable steady state binding data if the value of slope of the binding curve represented by continuous association phase binding data is negative, 5 Appeal2017-007753 Application 11/452, 102 d) excluding each experimental binding data set which is estimated in step c) to contain unreliable steady state binding data; wherein at least one of the experimental binding data sets which is estimated to contain unreliable steady state binding data is automatically excluded by software, e) determining an affinity for a molecular binding interaction from the steady state binding data of remaining data sets; and f) providing the affinity for the molecular binding interaction to an output device. App. Br. 15-16 (Claim App.). The Examiner rejected claims 1, 3, 5-22, 24--27, and 29 under 35 U.S.C. Â§ 101 as directed to patent ineligible subject matter. ANALYSIS Appellant agues claims 1, 3, 5-22, 24--27, and 29 together. We designate claim 1 as representative. An invention is patent-eligible if it claims a "new and useful process, machine, manufacture, or composition of matter." 35 U.S.C. Â§ 101. However, the Supreme Court has long interpreted 35 U.S.C. Â§ 101 to include implicit exceptions: "'[l]aws of nature, natural phenomena, and abstract ideas"' are not patentable. E.g., Alice Corp. v. CLS Bank Int 'l, 573 U.S. 208,216 (2014). In determining whether a claim falls within an excluded category, we are guided by the Supreme Court's two-step framework, described in Mayo and Alice. Id. at 217-18 ( citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework, we first determine what concept the claim is "directed to." See Alice, 573 6 Appeal2017-007753 Application 11/452, 102 U.S. at 219 ("On their face, the claims before us are drawn to the concept of intermediated settlement, i.e., the use of a third party to mitigate settlement risk."); see also Bilski v. Kappas, 561 U.S. 593, 611 (2010) ("Claims 1 and 4 in petitioners' application explain the basic concept of hedging, or protecting against risk."). Concepts determined to be abstract ideas, and thus patent ineligible, include certain methods of organizing human activity, such as fundamental economic practices (Alice, 573 U.S. at 219-20; Bilski, 561 U.S. at 611 ); mathematical formulas (Parker v. Flook, 437 U.S. 584, 594--95 (1978)); and mental processes ( Gottschalk v. Benson, 409 U.S. 63, 69 (1972)). Concepts determined to be patent eligible include physical and chemical processes, such as "molding rubber products" (Diamond v. Diehr, 450 U.S. 175, 191 (1981 )); "tanning, dyeing, making water-proof cloth, vulcanizing India rubber, smelting ores" (id. at 183 n.7 (quoting Corning v. Burden, 56 U.S. 252, 267---68 (1854))); and manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))). In Diehr, the claim at issue recited a mathematical formula, but the Supreme Court held that "[a] claim drawn to subject matter otherwise statutory does not become nonstatutory simply because it uses a mathematical formula." Diehr, 450 U.S. at 176; see also id. at 191 ("We view respondents' claims as nothing more than a process for molding rubber products and not as an attempt to patent a mathematical formula."). Having said that, the Supreme Court also indicated that a claim "seeking patent protection for that formula in the abstract ... is not accorded the protection of our patent laws, ... and this principle cannot be circumvented by attempting to limit the use of the formula to a particular technological 7 Appeal2017-007753 Application 11/452, 102 environment." Id. ( citing Benson and Flook); see, e.g., id. at 187 ("It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection."). If the claim is "directed to" an abstract idea, we tum to the second step of the Alice and Mayo framework, where "we must examine the elements of the claim to determine whether it contains an 'inventive concept' sufficient to 'transform' the claimed abstract idea into a patent- eligible application." Alice, 573 U.S. at 221 (quotation marks omitted). "A claim that recites an abstract idea must include 'additional features' to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea]."' Id. (quoting Mayo, 566 U.S. at 77). "[M]erely requir[ing] generic computer implementation[] fail[ s] to transform that abstract idea into a patent-eligible invention." Id. The PTO recently published revised guidance on the application of Â§ 101. USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (January 7, 2019) ("Memorandum"). Under that guidance, we first look to whether the claim recites: ( 1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and (2) additional elements that integrate the judicial exception into a practical application (see MPEP Â§ 2106.05(a}-(c), (e}-(h)). Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim: (3) adds a specific limitation beyond the judicial exception that are not "well-understood, routine, conventional" in the field (see MPEP 8 Appeal2017-007753 Application 11/452, 102 Â§ 2106.05(d)); or ( 4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. See Memorandum. Following the Guidance, we begin by considering whether claim 1 is directed to a judicial exception. In rejecting claim 1 as directed to patent ineligible subject matter, the Examiner found that the "method is drawn to data and mathematical analysis that can be performed as mental steps or by use of a pen/paper." Ans. 4. The Examiner also found that "[a]s a whole the method relies on the abstract ideas of organizing information through mathematical correlations." Id. We agree with the Examiner that claim 1 is directed to a judicial exception. Consistent with Mayo, the Guidance expressly identifies mental processes - i.e. "concepts performed in the human mind (including an observation, evaluation, judgment, opinion)" - as judicial exceptions. See Memorandum 52; Mayo, 566 U.S. at 71 ("'[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work"'). The limitations of steps (b) - (f) of claim 1 recite mental processes. Step (b) requires "selecting association phase data .... " This limitation simply requires one to choose data from among the data provided in step (a). This can be done mentally. Step ( c) requires "subjecting each experimental binding data set to a quality control .... " This limitation requires that one perform a calculation to generate a "reliability indicator" and compare that reliability indicator to a "predetermined limit." While the claim specifies that the step is performed 9 Appeal2017-007753 Application 11/452, 102 "using a computer," it is capable of being performed mentally. Consistent with case law, the Guidance instructs that "if a claim ... covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind." Memorandum 52; Mortg. Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d. 1314, 1324 (Fed. Cir. 2016) (Holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer."); Versata Dev. Grp. v. SAP Am., Inc., 793 F.3d 1306, 1335 (Fed. Cir. 2015) ("Courts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person's mind."). Step ( d) requires "excluding each experimental binding data set which is estimated in step ( c) to contain unreliable steady state binding data .... " This limitation requires that one exclude data from among the data provided in step (a). This can be done mentally. Step ( e) requires "determining an affinity for a molecular binding interaction from the steady state binding data of remaining data sets." This limitation simply requires an analysis of the steady state binding data that remains after excluding the unreliable data in step ( d). See Spec. 14. Like steps (b) - ( d), this step can be done mentally. Steps (b) - ( e) are the focus of claim 1. It is these steps, rather than steps (a) and (f) that address the "crucial problem" identified in the Specification as being overcome by the claimed method. Spec. 3; see also App. Br. 12 ("The inventive concept rests on taking binding data from non- report window parts of a binding curve to generate specific reliability 10 Appeal2017-007753 Application 11/452, 102 indicators that indicate the reliability of steady state binding data in the report window, and using those reliability indicators to automatically exclude poor quality curves."). Accordingly, we conclude that claim 1 is directed to a mental process, which is one of the groups of ineligible subject matter identified in the Guidance, and thus an abstract idea. Appellant argues that the Examiner oversimplified the claim and that the Examiner's characterization of claim 1 as "directed to comparing, categorizing, and organizing information through mathematical correlations" is overbroad because it encompasses activities that are "plainly not captured by Appellant's claims." App. Br. 7. Appellant contends that "[t]he focus of the claims, when read in light of the [S]pecification, is on a specific method of determining affinity for a molecular binding interaction from measured steady state binding data." Id. at 8. We are not persuaded because, as discussed above, we agree with the Examiner that claim 1 is directed to mental processes. Ans. 6 ("The reason that the instant claims are not patent eligible is because the entirety of the claimed calculation process steps can be carried out using paper/pen or as a mental process."). Appellant argues that prior to Appellant's method, "the quality control process was not automated but rather consisted of an operator manually identifying and excluding binding curves that gave rise to a bad fit." App. Br. 8. According to Appellant, the claimed method provides a "particular solution" addressing the "need for automated procedures that facilitated curve quality control and ensured that measured binding data had at least substantially reached equilibrium before kinetic analysis." Id. Appellant argues that claim 1 is directed to an "improvement to an existing technological method" that "improves the way in which molecular binding 11 Appeal2017-007753 Application 11/452, 102 interaction affinities are determined from measured steady state binding." Id. at 9. We are not persuaded. Claim 1 simply provides a new and better method of analyzing steady state molecular binding data. While the method may be new and improved, the claim is still focused on patent ineligible subject matter. See Flook, 437 U.S. at 595 (finding a claim directed to a method that provided "a new and presumably better method for calculating alarm limit values" ineligible, explaining, "if a claim is directed essentially to a method of calculating, using a mathematical formula, even if the solution is for a specific purpose, the claimed method is nonstatutory"). Having determined that claim 1 recites a judicial exception, the Guidance directs us to next consider whether the claims integrate the judicial exception into a practical application. Summarizing the relevant case law, the Guidance notes that courts have generally not considered an "additional element [that] adds insignificant extra-solution activity," like "mere data gathering," to integrate a judicial exception into a practical application. See Memorandum 55, 55 n.31 (Citing Mayo as teaching that the "additional element of measuring metabolites of a drug administered to a patient was insignificant extra-solution activity, which was insufficient to confer patent eligibility."). Here, in addition to the recited judicial exception the claim includes method step (a), which requires providing the data to be analyzed in method steps (b) - ( e ), and method step ( f), which requires providing the results of method steps (b )- ( e ), i.e. the calculated affinity, to an "output device." These steps do not integrate the claim into a practical application because they represent insignificant extra-solution activity. Method step (a) is 12 Appeal2017-007753 Application 11/452, 102 analogous to a data gathering step, which the Guidance identifies as an example of insignificant extra-solution activity. Memorandum 55 n. 31; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015) (finding that gathering statistics generated based on customer testing for input to a pricing calculation "fail[ s] to 'transform' the claimed abstract idea into a patent-eligible application."). Method step (c) is analogous to displaying the results of an abstract process, which the Federal Circuit has found insufficient to confer patentability on an otherwise ineligible process. Elec. Power Grp., v. Alstom S.A., 830 F.3d 1350, 1354 (Fed. Cir. 2016) ("[M]erely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis."). Accordingly, we conclude that the ineligible subject matter in claim 1 is not integrated into a practical application. Having determined that the judicial exception is not "integrated into a practical application," the Guidance directs us to "evaluate the additional elements individually and in combination ... to determine whether they provide an inventive concept (i.e., whether the additional elements amount to significantly more than the exception itself)." Memorandum 56. Here, we find that remaining additional elements do not amount to significantly more than the exception itself because they simply append steps that have been recognized as insignificant extra-solution activity. Appellant argues that "the limitations of the claims, taken together as an ordered combination, recite an invention that is not merely the routine and conventional use of comparing, categorizing, and organizing information." App. Br. 11. We are not persuaded because, as discussed 13 Appeal2017-007753 Application 11/452, 102 above, method steps (b) - ( e) are directed to ineligible subject matter and method steps (a) and (f) simply add insignificant extra solution activity. Moreover, considering the claim together as an ordered combination, the clear focus of claim 1 is on the ineligible subject matter. See App. Br. 12 ("The inventive concept rests on taking binding data from non-report window parts of a binding curve to generate specific reliability indicators that indicate the reliability of steady state binding data in the report window, and using those reliability indicators to automatically exclude poor quality curves."). Appellant argues that claim 1 does not "preempt[] all uses of the alleged abstract idea" because it "articulate[ s] a physical system and specific parameters for how to control biosensor curve quality." App. Br. 9. We are not persuaded because even accepting Appellant's argument that monopolization of excepted subject matter is not a concern in this case, "the absence of complete preemption does not demonstrate patent eligibility." Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015). According, we affirm the Examiner's rejection of claim 1 as directed to patent ineligible subject matter. Because they were not argued separately, claims 3, 5-22, 24--27, and 29 fall with claim 1. SUMMARY For the reasons set forth herein, and those set forth in the Examiner's Answer and Final Office Action, we affirm the Examiner's rejection of claims 1, 3, 5-22, 24--27, and 29 under 35 U.S.C. Â§ 101 as directed to patent ineligible subject matter. 14 Appeal2017-007753 Application 11/452, 102 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l ). See 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 15