DexCom, Inc.

Patent Trials and Appeals Board

Jan 27, 2022

2021002581 (P.T.A.B. Jan. 27, 2022)

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. 16/504,175 07/05/2019 Naresh C. Bhavaraju 0569-US7CON 1076 180232 7590 01/27/2022 FIG. 1 Patents/DexCom, Inc. 116 West Pacific Suite 200 Spokane, WA 99201 EXAMINER CATINA, MICHAEL ANTHONY ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 01/27/2022 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): Dexcom.pair@anaqua.com Fig1Docket@fig1patents.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte NARESH C. BHAVARAJU, MICHAEL A. BLOOM, LEIF N. BOWMAN, ALEXANDRA LYNN CARLTON, KATHERINE YERRE KOEHLER, HARI HAMPAPURAM, JONATHAN HUGHES, LAUREN HRUBY JEPSON, APURV ULLAS KAMATH, ANNA LEIGH RACK-GOMER, PETER C. SIMPSON, and STEPHEN J. VANSLYKE ____________ Appeal 2021-002581 Application 16/504,175 Technology Center 3700 ____________ Before STEFAN STAICOVICI, WILLIAM A. CAPP, and JILL D. HILL, Administrative Patent Judges. STAICOVICI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision in the Final Office Action (dated June 18, 2020, hereinafter “Final Act.”) to reject claims 23-32. We have jurisdiction over this appeal under 35 U.S.C. § 6(b). 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. DEXCOM, INC. is identified as the real party in interest in Appellant’s Appeal Brief (filed Sept. 16, 2020, hereinafter “Appeal Br.”). Appeal Br. 3. Appeal 2021-002581 Application 16/504,175 2 SUMMARY OF DECISION We AFFIRM. INVENTION Appellant’s invention relates “to control of operation of an analyte monitor upon changes in available data in a continuous analyte monitoring system.” Spec. para. 2. Claims 23-30 are independent. Claim 23 is illustrative of the claimed invention and is reproduced below: 23. A method of monitoring glucose using a processor in a monitoring device including sensor electronics coupled to a glucose sensor, the method comprising: a. receiving measurement data from sensor electronics indicative of a subject glucose concentration measured by a glucose sensor and transmitting an indication of the glucose concentration to a monitoring device for display on a user interface, the monitoring device operating in a first mode of decision support, the first mode of decision support being non- adjunctive use; b. using the processor, evaluating usability data indicative of a clinical usability of the glucose concentration data, wherein the usability data indicative of a clinical usability of the glucose concentration data is a glucose level; and c. using the processor, transitioning to a second decision support mode based on a comparison of the usability data against one or more decision support mode transition criteria, the one or more decision support mode transition criteria being a glucose level threshold, the second decision support mode being adjunctive use; and d. displaying an indication of the adjunctive use decision support mode on the user interface of the monitoring device. Appeal 2021-002581 Application 16/504,175 3 REJECTIONS I. The Examiner rejects claims 23-32 under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter. II. The Examiner rejects claims 23-30 under 35 U.S.C. § 103 as being unpatentable over Mastrototaro2 and Palerm.3 III. The Examiner rejects claim 31 under 35 U.S.C. § 103 as being unpatentable over Mastrototaro, Palerm, and Shaya.4 IV. The Examiner rejects claim 32 under 35 U.S.C. § 103 as being unpatentable over Mastrototaro, Palerm, Shaya, and Bohm.5 ANALYSIS Rejection I Section 101 states, “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C. § 101. However, the Supreme Court has “long held that this provision contains an important implicit exception: [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. See Alice, 573 U.S. at 217-18 (citing Mayo Collaborative Servs. 2 Mastrototaro et al., US 2008/0161664 A1, published July 3, 2008. 3 Palerm et al., US 2015/0165117 A1, published June 18, 2015. 4 Shaya, US 2010/0262434 A1, published Oct. 14, 2010. 5 Bohm et al., US 2012/0265037 A1, published Oct. 18, 2012. Appeal 2021-002581 Application 16/504,175 4 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.” Id. 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. Kappos, 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, 67 (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 182 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))). If the claim is “directed to” an abstract idea, we turn 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. (alteration in the original) (quoting Mayo, 566 U.S. at 77). “[M]erely requir[ing] generic computer Appeal 2021-002581 Application 16/504,175 5 implementation[] fail[s] to transform that abstract idea into a patent-eligible invention.” Id. The PTO has published revised guidance on the application of § 101. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (hereinafter “2019 Guidance”).6 Under Step 2A of 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 § 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, in Step 2B, to whether the claim: (3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 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. Appellant does not present arguments for the patentability of claims 24-32 apart from claim 23. See Appeal Br. 14-17. Therefore, in 6 The Manual of Patent Examining Procedure (“MPEP”) now incorporates this revised guidance and subsequent updates at § 2106 (9th ed. Rev. 10.2019, rev. June 2020). Appeal 2021-002581 Application 16/504,175 6 accordance with 37 C.F.R. § 41.37(c)(1)(iv), we select claim 23 as the representative claim to decide the appeal of the rejection of these claims, with claims 24-32 standing or falling with claim 23. Step 1 - Statutory Category We first determine whether claim 23 recites one or more of the enumerated statutory classes of subject matter, i.e., process, machine, manufacture, or composition of matter, eligible for patenting under 35 U.S.C. § 101. Independent claim 23 recites “[a] method of monitoring glucose,” which includes a series of steps, and, therefore, is a process. See Appeal Br. 20 (Claims App.). Step 2A, Prong 1 - Recitation of Judicial Exception We next look to whether claim 23 recites any judicial exceptions, including certain groupings of abstract ideas, i.e., mathematical concepts, certain methods of organizing human activity, or mental processes. In determining that claim 23 “recites an abstract idea,” the Examiner determines that the claim “falls within the ‘Mental Processes’ grouping of abstract ideas.” Final Act. 3. According to the Examiner, “other than reciting ‘using the processor’ nothing in the claim element precludes the step from practically being performed in the mind.” Id. at 2. The Examiner explains that “[t]he mode transition itself can . . . be performed mentally by a user monitoring a data output and switching the mode based on changes they see in the data stream output.” Examiner’s Answer (dated Jan. 11, 2021, hereinafter “Ans.”) 3. Appellant does not argue the Examiner’s determination that claim 23 “recites an abstract idea.” See Appeal Br. 14 (“Even assuming arguendo Appeal 2021-002581 Application 16/504,175 7 that this is correct, Appellant respectfully submits that the claim is eligible under prong 2 of Step 2A.”). Accordingly, Appellant has waived any argument of error, and, thus, we proceed to Prong 2 of Step 2A. Step 2A, Prong 2 - Integrated Into a Practical Application If a claim recites a judicial exception, then, in Prong 2, we determine whether the recited judicial exception is integrated into a practical application of that exception by: (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (b) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application. See 2019 Guidance 54-55. This evaluation requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. See id. at 54. The Examiner finds that “[t]he judicial exception is not integrated into a practical application.” Final Act. 3. According to the Examiner, “[t]he claimed components of the glucose sensor and the monitoring device are recited at a high level of generality and are merely invoked as tools to perform the abstract idea.” Id. Appellant argues that “claim 23 sets forth additional elements that implement the allegedly abstract idea with a particular machine or manufacture that is integral to the claim.” Appeal Br. 15. According to Appellant, “claim 23 does not involve a transformation of any generic machine, but rather a very particularized machine, namely, a transformation in a ‘monitoring device including sensor electronics coupled to a glucose Appeal 2021-002581 Application 16/504,175 8 sensor.’” Id. As such, Appellant contends that “the claimed method is performed by a highly specialized machine (i.e., a monitoring device including sensor electronics coupled to a glucose sensor) for the express purpose of transforming the operating mode of that specialized machine between different modes, which themselves are very particularized to that specialized machine.” Id. In other words, Appellant asserts that “the different decision support modes between which the specialized machine transitions are operating modes that only arise in a specialized machine that provide decision support such as the claimed monitoring device that incorporates a glucose sensor.” Id. at 16. We are not persuaded by Appellant’s arguments because the question here is whether the claims as a whole “focus on a specific means or method that improves the relevant technology” or are “directed to a result or effect that itself is the abstract idea and merely invoke generic processes and machinery.” McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314 (Fed. Cir. 2016). In this case, Appellant’s claim 23 is distinguished from those claims that our reviewing court has found to be patent eligible by virtue of reciting technological improvements to a computer system because claim 23 employs generic elements, such as, “glucose sensor,” “sensor electronics,” and “processor” to implement the abstract idea without any improvement to the computer system itself. Stated differently, the judicial exception is not integrated into a practical application because the “glucose sensor,” “sensor electronics,” and “processor” represent generic elements, and “displaying” represents insignificant extra solution activity. The Examiner is correct that “the monitoring device is a generic machine” because “[i]t is essentially a computer processor that is connected Appeal 2021-002581 Application 16/504,175 9 to a glucose sensor,” which “is a generic and routine element.” Ans. 3. We appreciate Appellant’s position that “the claimed method is performed by a highly specialized machine (i.e., a monitoring device including sensor electronics coupled to a glucose sensor).” Reply Brief (filed Mar. 5, 2021, hereinafter “Reply Br.”) 3. However, the recited “glucose sensor,” “sensor electronics,” and “processor” are not the central focus, but in themselves rather constitute generic computing elements to perform the claimed method steps, the results of which are functionally recited without implementation details. In other words, the focus of claim 23, as a whole, does not purport to improve the elements themselves, but merely uses the generic computing elements as a tool to perform the abstract idea of “transitioning to a second decision support mode based on a comparison of the usability data against one or more decision support mode transition criteria.” See Final Act. 2; see also 2019 Guidance 55. We also find no indication in Appellant’s Specification that the claimed invention effects a transformation or reduction of a particular article to a different state or thing. Nor do we find anything of record that attributes an improvement in technology and/or a technical field to the claimed invention or that otherwise indicates that the claimed invention integrates the abstract idea into a “practical application,” as that phrase is employed in the 2019 Guidance. In particular, the Specification states that the improvement is “requiring less user interaction . . . enhancing usability and user friendliness of a monitoring device.” Spec. para. 45. Thus, the improvement is not grounded in improvements to the “glucose sensor,” “sensor electronics,” and “processor”; rather, the improvement is in the abstract idea of transitioning between modes of operation. Appeal 2021-002581 Application 16/504,175 10 Accordingly, for the foregoing reasons, we determine that claim 23 of Appellant’s invention: (1) does not improve the functioning of a computer or other technology; (2) is not applied with any particular machine; (3) does not affect a transformation of a particular article to a different state; and (4) is not applied in any meaningful way beyond generally linking the use of the judicial exception to a particular technological environment. See MPEP § 2106.05(a)-(c), (g), (h). In conclusion, for the foregoing reasons, we are not persuaded of error in the Examiner’s determination that claim 23 is directed to an abstract idea, and we find that the claimed additional elements do not integrate the abstract idea into a practical application. Step 2B - Well-Understood, Routine, Conventional Activity Having determined that claim 23 recites a judicial exception, and does not integrate that exception into a practical application, under Step 2B we consider whether the claim adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field. See 2019 Guidance 56. Here, the Specification indisputably shows that the recited “glucose sensor,” “sensor electronics,” and “processor” were conventional at the time of filing. See Spec. paras. 315 (“The glucose sensor can be any device capable of measuring the concentration of glucose.”), 316 (“enzymatic, chemical, physical, electrochemical, optical, optochemical, fluorescence- based, spectrophotometric, spectroscopic (e.g., optical absorption spectroscopy, Raman spectroscopy, etc.), polarimetric, calorimetric, iontophoretic, radiometric, and the like.”), 346 (“a general purpose processor, a digital signal processor (DSP), an application specific integrated Appeal 2021-002581 Application 16/504,175 11 circuit (ASIC), a field programmable gate array signal (FPGA) or other programmable logic device (PLD), discrete gate or transistor logic, discrete hardware components or any combination thereof”) (“the processor may be any commercially available processor, controller, microcontroller or state machine”), 326 (“any appropriately sized and powered battery can be used (e.g., AAA, Nickel-cadmium, Zinc-carbon, Alkaline, Lithium, Nickel-metal hydride, Lithium-ion, Zinc-air, Zinc-mercury oxide, Silver-zinc, or hermetically-sealed)”), 327 (RF module, optical, infrared radiation, ultrasonic). Hence, no genuine issue of material fact exists as to the well- understood, routine, or conventional nature of the claimed elements. Considered as an ordered combination, the components of Appellant’s claim 23 add nothing that is not already present when the steps are considered separately. Receiving measurement data, generating/analyzing data (“evaluating usability data” and “transitioning” from a first to a second decision support mode), and displaying results is equally generic and conventional or otherwise held to be abstract. See Electric Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1354-56 (Fed. Cir. 2016) (holding that the sequence of gathering, analyzing, and displaying in real-time was abstract). As such, we are not persuaded that the Examiner erred in determining that the elements of claim 23, considering all elements both individually and as an ordered combination, do not amount to significantly more than the abstract ideas of mental processes in terms of “concepts performed in the human mind.” In other words, the elements of claim 23, both individually and as an ordered combination, are not sufficient to amount to significantly more that the abstract idea itself. Hence, claim 23 fails to add a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field. Appeal 2021-002581 Application 16/504,175 12 Claim 23 is directed to merely ordinary functionality of the above- recited additional elements to apply an abstract idea. Thus, there is no inventive concept. We conclude that none of the limitations of claim 23, viewed “both individually and as an ordered combination,” amount to significantly more than the judicial exception in order to sufficiently transform the nature of the claims into patent-eligible subject matter. See Alice, 573 U.S. at 217 (internal quotations omitted) (quoting Mayo, 566 U.S. at 77-78). In conclusion, for the foregoing reasons, we sustain the rejection of claim 23 under the judicial exception to 35 U.S.C. § 101 as being directed to patent-ineligible subject matter. Claims 24-32 fall with claim 23. Rejection II Appellant does not present arguments for the patentability of claims 24-30 apart from claim 23. See Appeal Br. 17-19. Therefore, we select claim 23 as the representative claim to decide the appeal of the rejection of these claims, with claims 24-30 standing or falling with claim 23. The Examiner finds that Mastrototaro discloses a method for monitoring glucose using a monitoring device having sensor electronics coupled to a glucose sensor including most of the limitations of independent claim 23, but “does not specifically disclose displaying an indication of the decision support mode.” Final Act. 3-4 (citing Mastrototaro, paras. 4, 35, 48, 49, 65). Nonetheless, the Examiner finds Palerm discloses a closed loop system for monitoring glucose “that notifies the user of changes in the operation conditions and teaches the reliability data is a glucose value compared to a threshold or range and that the transition is based on the Appeal 2021-002581 Application 16/504,175 13 glucose level.” Id. at 4 (citing Palerm, paras. 33, 87, 88, 101). Thus, the Examiner concludes that it would have been obvious to a person of ordinary skill in the art “to combine the device of Mastrototaro with the teachings of Palerm in order to notify the user.” Id (citing Palerm para. 33). Appellant argues that “the Examiner has failed to explain how combining Mastrototaro with the alleged teaching of Palerm concerning the use of a glucose or other sample measurement level threshold as a decision support transition criterion allows such a notification to be provided.” Appeal Br. 18. Relying on Palerm’s paragraphs 87 and 88, Appellant contends that although Palerm discloses “the sample level threshold being employed as a measure of usability of the data sample,” Palerm “does not show this measure of usability being employed as a decision support transition criterion, as required by the claimed invention.” Id. In a similar manner, Appellant points to Palerm’s paragraph 101 and contends that “[n]owhere does this cited passage show or suggest that the sample level threshold, which may be used to determine when a measurement sequence is invalid or unacceptable, may be employed as a decision support transition criterion, as required by the claimed invention.” Id. We are not persuaded by Appellant’s arguments because “[n]on-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. [Each reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (citation omitted). In this case, we agree with the Examiner that the rejection relies on Mastrototaro’s disclosure of “using a determination usability . . . to transition to a different mode” and on Palerm to disclose glucose level as Appeal 2021-002581 Application 16/504,175 14 “usability data” and comparing a glucose “reading to a threshold as part of its usability determination.” Ans. 4 (citing Mastrototaro, paras. 48, 49, 65; Palerm, paras. 87-89). In particular, Mastrototaro discloses operational switching between redundant sensors to determine which sensor readings are faulty based upon comparing glucose readings to a threshold value of a meter value using the traditional finger prick method and reporting which sensor is faulty. Mastrototaro, Abstract, paras. 48, 49, 64, 65, Fig. 20. The Examiner’s rejection also employs Palerm’s control method to flag, indicate, or mark (display) an unusable sensor measurement based on a threshold value and indicate that the sensor measurement is unacceptable, and, thus, the infusion device is in a non-operating mode. Palerm, paras. 33, 87-89. Hence, the combined teachings of Mastrototaro and Palerm disclose a method of operational switching between redundant sensors to determine which sensor readings are faulty based upon comparing glucose readings to a threshold value and to flag, indicate, or mark (i.e., display) an unusable sensor measurement indicating a non-operational sensor or a non-operational infusion device when all sensor readings are faulty. Accordingly, we do not agree with Appellant’s position that “the [E]xaminer has failed to specify exactly of what the user is to be notified” (see Appeal Br. 18) because the combination “notif[ies] the user of the operation mode of the device.” Ans. 4. Therefore, we do not agree with Appellant that “the purported advantage that would arise from the combination-notification to the user- does not arise from the alleged teaching of Palermo that is being combined with the alleged teachings Mastrototaro.” Reply Br. 4. Appeal 2021-002581 Application 16/504,175 15 In conclusion, for the foregoing reasons, we sustain the rejection of independent claim 23 over the combined teachings of Mastrototaro and Palerm. Claims 24-30 fall with claim 23. Rejections III and IV Appellant does not separately argue the rejections of claims 31 and 32. See Appeal Br. 17-19. Therefore, for the same reasons discussed supra in Rejection II, we likewise sustain the rejections under 35 U.S.C. § 103 of claim 31 as unpatentable over Mastrototaro, Palerm, and Shaya and of claim 32 as unpatentable over Mastrototaro, Palerm, Shaya, and Bohm. CONCLUSION Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 23-32 101 Eligibility 23-32 23-30 103 Mastrototaro, Palerm 23-30 31 103 Mastrototaro, Palerm, Shaya 31 32 103 Mastrototaro, Palerm, Shaya, Bohm 32 Overall outcome 23-32 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED