Ex Parte Breton et alDownload PDFPatent Trials and Appeals BoardJun 24, 201913634040 - (D) (P.T.A.B. Jun. 24, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/634,040 11/21/2012 158251 7590 06/26/2019 University of Virginia (DexCom) c/o Buchanan Ingersoll & Rooney PC Post Office Box 1404 Alexandria, VA 22314 FIRST NAMED INVENTOR Marc D. Breton 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. 0087407-000057 6455 EXAMINER RIGGS II, LARRY D ART UNIT PAPER NUMBER 1631 NOTIFICATION DATE DELIVERY MODE 06/26/2019 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): ADIPDOCl@bipc.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARC D. BRETON, STEPHEN D. PATEK, BORIS P. KOVATCHEV, and COLLEENS. HUGHES 1 Appeal2017-008254 Application 13/634,040 Technology Center 1600 Before CHRISTOPHER G. PAULRAJ, TA WEN CHANG, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal2 under 35 U.S.C. § 134(a) from the Examiner's rejection of claims to a method for delivering insulin which have been 1 Appellants identify the Real Parties in Interest as the National Institutes of Health, United States Department of Health and Human Services, and the University of Virginia Patent Foundation. Appeal Br. 2. 2 We have considered and herein refer to the Specification of Sept. 11, 2012 ("Spec."); Final Office Action of Apr. 4, 2016 ("Final Act."); Appeal Brief of Oct. 4, 2016 ("Appeal Br."); Examiner's Answer of Mar. 13, 2017 ("Ans."); and Reply Brief May 15, 2017 ("Reply Br."). Appeal2017-008254 Application 13/634,040 rejected directed to non-statutory subject matter. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM, but designate our affirmance a new ground of rejection. STATEMENT OF THE CASE "Hypoglycemia is common in type 1 diabetes (TlDM) and becomes more prevalent in type 2 diabetes (T2DM) with treatment intensification." Spec. 1. "[Severe hypoglycemia] may cause cognitive dysfunction, coma, or sudden death. Consequently, hypoglycemia has been identified as the primary barrier to diabetes management." Id. "Insulin Pump and Pen therapy is becoming increasingly prevalent in TlDM and is recommended as means for improvement of glycemic control in T2DM as well." Delivery of insulin by an insulin pump or pen is determined primarily through glucose monitoring. Id. The Specification describes a system that uses requests for insulin as the primary signal for hypoglycemia monitoring. Id. Claims 1-7 and 24--37 are on are on appeal. Claim 1 representative of the rejected claims and reads as follows: 1. A processor-implemented method for delivering insulin to a diabetic patient, the method comprising: detecting, by a processor, a signal requesting delivery to said patient of an amount of insulin from an insulin delivery device, prior to said signal being sent to said insulin delivery device; in response to detection of an insulin delivery request signal, determining, by a processor, whether delivery of said amount of insulin will result in hypoglycemia in said patient, based on an assessment of blood glucose level of said patient; 2 Appeal2017-008254 Application 13/634,040 in response to a determination that delivery of said amount of insulin will result in hypoglycemia, outputting, by a processor, a signal requesting further action by said patient; in response to a signal indicating further action by said patient, sending to said insulin delivery device said signal requesting delivery of an amount of insulin to said patient, whereby said amount of insulin is delivered to said patient; and in the absence of a signal indicating further action by said patient, preventing said signal requesting delivery of an amount of insulin to said patient from being sent to said insulin delivery device, whereby said amount of insulin is not delivered to said patient. The claims have been rejected under 35 U.S.C. § 101 are directed to patent-ineligible subject matter. DISCUSSION Issue The issue with respect to this rejection is whether the Examiner properly determined that the claims are directed to patent-ineligible subject matter. The Examiner finds that while the claims are directed to a process or system, the claims are directed to determining the glucose level of a patient and then determining the amount of insulin to be administered. Final Act. 4--5. The Examiner finds that determining blood glucose level and the amount of insulin are mathematical relationships and determination of that relationship is nothing more than an abstract idea. Id. at 5. The Examiner goes on to find that the additional limitations relating to the delivery of insulin are well known and do not amount to anything significantly more 3 Appeal2017-008254 Application 13/634,040 that the abstract idea. Id. The Examiner concludes that the claims are directed to patent-ineligible subject matter. Appellants have not argued the claims separately. We, therefore, choose claim 1 as representative for our analysis. Analysis Claim Construction Before we tum our analysis under section 101, we construe the claims to aid our determination of whether the claims are directed to patent- ineligible subject matter. See Bancorp Services, L.L. C. v. Sun Like Assur. Co. of Canada (U.S.), 687 F.3d 1266, 1273-74 (Fed. Cir. 2012) (court construed claim terms to aid in analysis under 35 U.S.C. § 101). During examination, claims are given their broadest reasonable interpretation consistent with the specification. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). "Construing claims broadly during prosecution is not unfair to the applicant . . . because the applicant has the opportunity to amend the claims to obtain more precise claim coverage." Id. Here claim 1 is directed to a method for delivering insulin where the delivery of insulin is performed only if a certain condition is met. Claim 1 reads in part: in response to a determination that delivery of said amount of insulin will result in hypoglycemia, outputting, by a processor, a signal requesting further action by said patient; in response to a signal indicating further action by said patient, sending to said insulin delivery device said signal 4 Appeal2017-008254 Application 13/634,040 requesting delivery of an amount of insulin to said patient, whereby said amount of insulin is delivered to said patient; and in the absence of a signal indicating further action by said patient, preventing said signal requesting delivery of an amount of insulin to said patient from being sent to said insulin delivery device, whereby said amount of insulin is not delivered to said patient. Appeal Br. Claims App 'x. Claim 1 makes it clear that insulin is not administered unless a signal indicating further action by the patient is received. In the absence of the signal, no insulin is administered. In other words, the administration of insulin is conditioned on the receipt of the signal. The claims in the present case are similar to those in Ex parte Schulhauser, Appeal No. 2013-007847 (PTAB Apr. 28, 2016) (precedential). In Schulhauser, the claims at issue were directed to a method for monitoring cardiac conditions using an implantable medical device. Id. at 2. The claimed method included three steps that were only performed if a certain conditions were met. Id. at 2-3. The claims were rejected under 35 U.S.C. § 103(a) over a combination of references that the Examiner asserted taught the recited method. Id. at 4. On appeal to the Board, the appellant in Schulhauser contended that the combined teachings of the references did not disclose "the particular order and conditions imposed on the various comparing, determining and triggering steps by the limitations of independent claim 1." Id. at 5. The Board found this is argument unpersuasive. Id. 5 Appeal2017-008254 Application 13/634,040 In Schulhauser, the Board found that several steps of the claimed process only needed to be performed if certain conditions precedent were met. Id. at 6. If the conditions were not met, the additional steps were not performed. Id. Applying the broadest reasonable interpretation standard, the Board interpreted the claim as covering two different methods, one where the additional steps are performed and another where they are not performed. Id. at 8. The Board concluded that the broadest reasonable interpretation covered the method where the additional steps need not be performed. Id. Like the claim at issue in Schulhauser, claim 1 on appeal covers two methods with different outcomes, one where insulin is delivered to a patient and one where insulin is not delivered. Thus, under the guidance set forth in Schulhauser, we determine under the broadest reasonable interpretation of the claims that the claim method does not require administering insulin. Patent-Eligible Subject Matter An invention is patent eligible if it claims a "new and useful process, machine, manufacture, or composition of matter." 35 U.S.C. § 101. Here, there is no dispute that representative claiml falls within the statutory category of a "process." However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit exceptions to those statutory categories: i.e., "[l]aws of nature, natural phenomena, and abstract ideas" are not patentable. E.g., Alice Corp. v. CLS Bank Int'!, 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 6 Appeal2017-008254 Application 13/634,040 and Alice. Alice, 573 U.S. 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 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 (Gottschalkv. 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 182 n.7 (quoting Corning v. Burden, 56 U.S. 252, 267---68 (1853))); 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 7 Appeal2017-008254 Application 13/634,040 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 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 ( quotations 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 § 101. USPTO's January 7, 2019 Memorandum, 2019 Revised Patent 8 Appeal2017-008254 Application 13/634,040 Subject Matter Eligibility Guidance ("Memorandum"). 3 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 § 2106.0S(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 specific limitations beyond the judicial exception that are not "well-understood, routine, conventional" in the field (see MPEP § 2106.0S(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. We begin our analysis by asking whether the claimed method is directed to one or more of the judicial exceptions. The guidance identifies three judicially-excepted groupings: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. Ex parte Smith, Appeal No. 2018- 3 While the rejection was issued before the Memorandum was released, the methodology set forth in the Memorandum applies to this Appeal. 9 Appeal2017-008254 Application 13/634,040 000064 (PTAB Feb. 1, 2019) (informative). Claims directed to natural phenomena are also ineligible for patent protection. Flook, 437 U.S. at 593. Under Step 2A, Prong 1 of the Memorandum, we must first determine whether the claim "recites" a judicial exception. Here, we find that the claims recite several functions that can be performed by a human either mentally or using pen and paper. In particular, claim 1 recites: (1) "detecting ... a signal requesting delivery to said patient of an amount of insulin from an insulin delivery device," (2) "determining ... whether delivery of said amount of insulin will result in hypoglycemia in said patient, based on an assessment of blood glucose level of said patient," (3) "outputting . .. a signal requesting further action by said patient," and (4) "in the absence of a signal indicating further action by said patient, preventing said signal requesting delivery of an amount of insulin to said patient from being sent to said insulin delivery device, whereby said amount of insulin is not delivered to said patient." Although claim 1 recites that "a processor" performs the foregoing italicized functions, we find that the same functions can be otherwise performed either in the human mind or using pen and paper, and, therefore, are considered mental processes. See CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372-73 (Fed. Cir. 2011) ("All of claim 3's method steps can be performed in the human mind, or by a human using a pen and paper .... Such a method that can be performed by human thought alone is merely an abstract idea and is not patent-eligible under§ 101."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1146 (Fed. Cir. 2016) ("[W]e continue to 'treat[] analyzing information by steps people go 10 Appeal2017-008254 Application 13/634,040 through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category.'") ( citation omitted). For example, leaving aside the processor limitations, the claimed method can be performed by a medical professional such as a nurse, who receives a request from a patient to administer insulin. The nurse then determines if the requested amount of insulin might result in hypoglycemia based on an assessment of the patient's blood glucose levels. If the nurse determines there is a risk of hypoglycemia, the nurse then asks the patient for confirmation of the request. If no confirmation is received, the nurse takes no further action, thereby preventing the administration of insulin. Only if confirmation is received, does the nurse administer insulin to the patient. But as discussed above, under the broadest reasonable interpretation of claim 1, the administration step is not required by the claim, and thus not considered in our analysis. Each of the remaining steps can be performed mentally or with a pen and paper. The steps fall within the mental process category of abstract ideas. Additionally, we find that the claim's recitation of "determining ... whether delivery of said amount of insulin will result in hypoglycemia in said patient, based on an assessment of blood glucose level of said patient" can also be categorized as a law of nature, another judicial exception. In Mayo, the Supreme Court held that a claim reciting the step of "determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder" was patent-ineligible, noting that "the 'determining' step tells the doctor to determine the level of the relevant 11 Appeal2017-008254 Application 13/634,040 metabolites in the blood, through whatever process the doctor or the laboratory wishes to use." 566 U.S. at 79. As with the "determining" step in that case, the "determining" step in claim 1 allows for an assessment of the levels of blood glucose, another metabolite within the body, using any method known in the art. See Spec. 1 :23-25 (noting that "blood glucose readings ... are traditionally obtained by self-monitoring (SMBG) or, more recently, by continuous glucose monitoring (CGM)"); id. at 3:10-12 (stating that the "Insulin Delivery Supervisor (IDS)" described as aspect of the invention "can be implemented in any system based on insulin pump or pen and will work with either SMBG or CGM modes of blood glucose monitoring"). As such, we find that this step merely assesses the natural correlation of blood glucose levels to a patient's risk of hypoglycemia. Appellants contend that the present claims are directed to improved insulin delivery technology which helps prevent hypoglycemia. Appeal Br. 6. Appellants contend that, like the claims in McRO, 4 the present claims require that certain steps be performed in a specific order. Id. at 6-7. Appellants contend that the claimed method when viewed as a whole, is not directed to mathematical relationships. Id. at 7. We have considered Appellants' arguments and are not persuaded. As discussed above, other than the conditional step of administering insulin, and the recitation of a generic processor, the recited steps can be performed in the mind of a human or by pen and paper. Furthermore, the claimed determining step requires an assessment of the naturally occurring 4 McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299 (Fed. Cir. 2016). 12 Appeal2017-008254 Application 13/634,040 correlation of blood glucose levels to hypoglycemia in the patient. As such, we determine under Step 2A, Prong 1 of the Memorandum that claim 1 recites an abstract idea (mental process) and a law of nature. Following the Office's guidelines, we next determine under Step 2A, Prong 2 of the Memorandum if the claim integrates the judicial exception into a practical application. As part of this analysis, and most relevant to the issue presented here, we take into consideration whether the claim recites "an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition." Memorandum, 55. To this point, Appellants contend that the claimed method is an improved method for administering insulin. Appeal Br. 6. We would agree with Appellants if the claims required a step of administering insulin, since such a method would similar to the claims at issue in Vanda Pharms. Inc. v. West-Ward Pharms. Int'! Ltd., 887 F.3d 1117 (Fed. Cir. 2018). In Vanda, the claimed method included alternative limitations calling for administration of specific doses of a drug, with the dose depending on the patient's genotype. Id. at 1134. Our reviewing court found that the limitations requiring the administration of the drug distinguished that claimed method from the method at issue in Mayo, and therefore found the claims to be patent eligible. Id. at 1135-36. Unlike the claims in Vanda, however, claim 1 at issue here does not require the administration of insulin under the broadest reasonable interpretation. As discussed above, the method may conclude without administration of the drug to the patient in the absence of a signal indicating 13 Appeal2017-008254 Application 13/634,040 further action by said patient. Thus, we determine that the claim does not require the treatment of any disorder. In accordance with the Office's guidelines, other exemplary considerations that may be indicative that an additional element ( or combination of elements) may have integrated the exception into a practical application include whether: "[a]n additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field," "an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim an additional element effects a transformation or reduction of a particular article to a different state or thing," or "an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception." Memorandum, 55. To the extent applicable, we do not find that any of these additional considerations indicate that claim 1 integrates the judicial exception into a practical application. For instance, the claim does not reflect any improvement to the functioning of a computer such as in McRO, in which the claimed invention focused on a specific improvement to computer animation. 837 F.3d at 1314. Nor does claim 1 involve any particular machine or thing, or the transformation of a particular article into a different state or thing. In accordance with the second part of the Alice/Mayo test, we consider whether the claim contains an "inventive concept" sufficient to "transform 14 Appeal2017-008254 Application 13/634,040 the nature of the claim into a patent-eligible application." Alice, 134 S.Ct. at 2355 (quotation omitted). As part of this inquiry under Step 2B of the Memorandum, we determine whether the claim recites limitations beyond the judicial exception that are not well-understood, routine, and conventional in the field. Memorandum, 56. As to this question, the Examiner finds that the delivery of insulin to a subject is well-known, routine and conventional in the field of diabetes management. Final Act. 5. Specifically, the Examiner finds that the recited devices in the claim, such as processors, input devices, connection devices and insulin delivery devices are well- known and conventional. Ans. 7. The Examiner concludes that these additional devices do not confer patentability on the claimed method. Appellants contend that the recited method employs unconventional steps to a particularly useful application of a principle, the unconventional steps render the method patentable. Appeal Br. 7. In support of this contention, Appellants point to the limitation calling for the transmission of signal requesting further action and the requirement that a response be received before insulin is administered. Id. at 8-10. Appellants also point to the fact that the Examiner has not raised any rejection based on novelty or obviousness, suggesting that the claimed method is not well-known, routine or conventional. Id. at 8. Appellants' arguments do not persuade us that the Examiner's conclusion that the claims are directed to ineligible subject matter is in error. Under the broadest reasonable interpretation, the claimed involve steps that can be performed mentally. Even if these steps were novel and unobvious, they would not render the method patentable, because the allegedly novel 15 Appeal2017-008254 Application 13/634,040 and unobvious aspects of the claim are nonetheless directed to an abstract idea and law of nature. See Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1376 (Fed. Cir. 2016) ("[U]nder the Mayo/Alice framework, a claim directed to a newly discovered law of nature ( or natural phenomenon or abstract idea) cannot rely on the novelty of that discovery for the inventive concept necessary for patent eligibility; instead, the application must provide something inventive, beyond mere 'well-understood, routine, conventional activity.'"). Appellants do not dispute the Examiner's finding that the additional tangible elements recited in the claim, such as a processor and insulin delivery device, are all well-known, routine, and conventional. Ans. 10. Based on the foregoing analysis, we conclude that the claims are directed to a judicial exception without significantly more, and therefore not eligible for patent protection. NEW GROUNDS OF REJECTION As discussed above, in addition to affirming the Examiner's determination that the claims are directed to an abstract idea, we also determine that the claims are directed to a law of nature. As our reasoning differs from the Examiner's analysis, we designate our affirmance as a new ground of rejection to preserve Appellants' procedural safeguards. 37 C.F.R. § 4I.50(b). Rule 37 C.F.R. § 4I.50(b) states that "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review." Further, §4I.50(b) also provides that Appellants, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise on of the following 16 Appeal2017-008254 Application 13/634,040 options with respect to the new grounds of rejection to avoid termination of the appeal as to the rejected claims: ( 1) Reopen Prosecution. Submit an appropriate amendment of the claims so rejected or new [e]vidence relating to the claims so rejected or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner .... (2)Request rehearing. Request that the proceeding be reheard under § 51.52 by the Board upon the same record .... No time period for taking any subsequent action in connection with this appeal may be extended under 3 7 C.F .R. § 1.13 6( a )(1 )(iv). SUMMARY We affirm the rejection under 35 U.S.C. § 101, and designate our affirmance a new ground of rejection. AFFIRMED 17 Copy with citationCopy as parenthetical citation