Ex Parte Giftakis et alDownload PDFPatent Trials and Appeals BoardJul 9, 201912236260 - (D) (P.T.A.B. Jul. 9, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/236,260 09/23/2008 71996 7590 07/11/2019 SHUMAKER & SIEFFERT, P.A 1625 RADIO DRIVE, SUITE 100 WOODBURY, MN 55125 FIRST NAMED INVENTOR Jonathon E. Giftakis 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. 1023-803US01 / P0033524.0 CONFIRMATION NO. 7565 EXAMINER PORTER, RACHELL ART UNIT PAPER NUMBER 3626 NOTIFICATION DATE DELIVERY MODE 07/11/2019 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): pairdocketing@ssiplaw.com rs.patents.five@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JONATHON E. GIFTAKIS, PETER J. KOVACH, WARREN W. BALL, JONATHAN C. WERDER, NINA M. GRAVES, DAVID C. ULLESTAD, and SARAH B. ALME 1 Appeal2017-0035142 Application 12/236,260 Technology Center 3600 Before BIBHU R. MOHANTY, KENNETH G. SCHOPPER, and MATTHEWS. MEYERS, Administrative Patent Judges. MEYERS, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING Appellants filed a Request for Rehearing ("Request" or "Req.") under 37 C.F.R. § 41.52 for reconsideration of our Decision ("Decision" or "Dec.") on Appeal mailed March 29, 2019. The Decision affirmed the 1 Appellants identify Medtronic, Inc. as the real party in interest. Appeal Br. 3. 2 Our decision references Appellants' Appeal Brief ("Appeal Br.," filed April 4, 2016) and Reply Brief ("Reply Br.," filed January 2, 2017), and the Examiner's Answer ("Ans.," mailed November 2, 2016) and Final Office Action ("Final Act.," mailed October 28, 2015). Appeal2017-003514 Application 12/236,260 Examiner's rejection of claims 1-22 under 35 U.S.C. § 101 as directed to non-statutory subject matter. 3 We have jurisdiction over the Request under 35 U.S.C. § 6(b). APPELLANTS' ARGUMENT Appellants request we reconsider our Decision affirming the Examiner's rejection of claims 1-22 under 35 U.S.C. § 101 based on recent relevant decisions by the Federal Circuit, as well as based on the 2019 REVISED PATENT SUBJECT MATTER ELIGIBILITY GUIDANCE, 84 Fed. Reg. 50 (Jan. 7, 2019) ("2019 Revised Guidance"). Req. 1-2. Appellants argue that "even if the claims recite a judicial exception, which Appellant[ s] do[] not concede, the claims are patent eligible because the claims integrate the judicial exception identified by the Board in the Decision on Appeal into a practical application." Id. at 4. PRINCIPLES OF LAW A. 35 U.S.C. § 101 We first note "[ w ]hether a [patent] claim is drawn to patent-eligible subject matter is an issue of law that [is] review[ed] de nova." SiRF Tech., Inc. v. Int'! Trade Comm'n, 601 F.3d 1319, 1331 (Fed. Cir. 2010) (emphasis added). An invention is patent-eligible if it claims a "new and useful process, machine, manufacture, or composition of matter." 35 U.S.C. § 101.4 3 The Decision also reversed the Examiner's rejection of claims 1-22 under 35 U.S.C. § 103(a). Appellants have not requested reconsideration of the rejection under§ 103(a). 4 This threshold analysis of whether a claim is directed to one of the four statutory categories of invention, i.e., a process, machine, manufacture, or 2 Appeal2017-003514 Application 12/236,260 However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit exceptions: "[l]aws of nature, natural phenomena, and abstract ideas" are not patentable. E.g., Alice Corp. v. CLS Bankint'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 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. composition of matter, is referred to as "Step l" in the patent-eligibility inquiry under § 101. 3 Appeal2017-003514 Application 12/236,260 252, 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 "[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 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. 4 Appeal2017-003514 Application 12/236,260 B. USPTO Guidance The PTO recently published revised guidance in the Federal Register concerning the application of§ 101. 2019 Revised Guidance. 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 interactions such as a fundamental economic practice, or mental processes); 5 and (2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.0S(a}- ( c), (e }-(h)). 6 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 § 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. 7 See 2019 Revised Guidance. 5 Referred to as "Revised Step 2A, Prong l" in the Guidance (hereinafter "Step 2A(i)"). 6 Referred to as "Revised Step 2A, Prong 2" in the Guidance (hereinafter "Step 2A(ii)"). 7 Items (3) and (4) continue to be collectively referred to as "Step 2B" of the Supreme Court's two-step framework, described in Mayo and Alice. 5 Appeal2017-003514 Application 12/236,260 Step 2A(i) ~ Abstract Idea Informed by our judicial precedent, the recent 2019 Revised Guidance extracts and synthesizes key concepts identified by the courts as abstract ideas to explain that the abstract idea exception includes the following groupings of subject matter, when recited as such in a claim limitation: (a) Mathematical concepts-mathematical relationships, mathematical formulas or equations, mathematical calculations; (b) Certain methods of organizing human activity - fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and ( c) Mental processes----concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Under the 2019 Revised Guidance, if the claim does not recite a judicial exception (a law of nature, natural phenomenon, or subject matter within the enumerated groupings of abstract ideas above), then the claim is patent-eligible at Step 2A(i). This determination concludes the eligibility analysis, except in situations identified in the Guidance. 8 However, if the claim recites a judicial exception (i.e., an abstract idea enumerated above, a law of nature, or a natural phenomenon), the claim 8 In the rare circumstance in which an Examiner believes a claim limitation that does not fall within the enumerated groupings of abstract ideas should nonetheless be treated as reciting an abstract idea, the procedure described in the Guidance for analyzing the claim should be followed. See Guidance, Section III.C. 6 Appeal2017-003514 Application 12/236,260 requires further analysis for a practical application of the judicial exception in Step 2A(ii). Step 2A(ii) ~ Practical Application If a claim recites a judicial exception in Step 2A (i), we determine whether the recited judicial exception is integrated into a practical application of that exception in Step 2A(ii) 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. The seven identified "practical application" sections of the MPEP, 9 cited in the 2019 Revised Guidance under Step 2A(ii), are: (1) MPEP § 2106.05(a) Improvements to the Functioning of a Computer or To Any Other Technology or Technical Field (2) MPEP § 2106.05(b) Particular Machine (3) MPEP § 2106.05( c) Particular Transformation (4) MPEP § 2106.05(e) Other Meaningful Limitations (5) MPEP § 2106.05(±) Mere Instructions To Apply An Exception ( 6) MPEP § 2106.05(g) Insignificant Extra-Solution Activity (7) MPEP § 2106.05(h) Field of Use and Technological Environment If the recited judicial exception is integrated into a practical application as determined under one or more of the MPEP sections cited 9 See MPEP § 2106.05(a}-(c), (e}-(h). Citations to the MPEP herein refer to revision [R-08.2017]. 7 Appeal2017-003514 Application 12/236,260 above, then the claim is not directed to the judicial exception, and the patent- eligibility inquiry ends. If not, then analysis proceeds to Step 2B. Step 2B - "Inventive Concept" or "Significantly More" Under our precedent, it is possible that a claim that does not "integrate" a recited judicial exception under Step 2A(ii) is nonetheless patent eligible. For example, the claim may recite additional elements that render the claim patent eligible even though a judicial exception is recited in a separate claim element. 10 The Federal Circuit has held claims eligible at the second step of the Alice/Mayo test (USPTO Step 2B) because the additional elements recited in the claims provided "significantly more" than the recited judicial exception ( e.g., because the additional elements were unconventional in combination). 11 Therefore, if a claim has been determined to be directed to a judicial exception under Revised Step 2A, we must evaluate the additional elements individually and in combination under Step 2B to determine whether they provide an inventive concept (i.e., whether the additional elements amount to significantly more than the exception itself). 12 10 See, e.g., Diehr, 450 U.S. at 187. 11 See, e.g., Amdocs (Israel), Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1300, 1304 (Fed. Cir. 2016); BASCOM Global Internet Services, Inc. v. AT&T Mobility LLC, 827 F.3d 1341, 1349-52 (Fed. Cir. 2016); DDR Holdings, LLC v. Hotels.com L.P., 773 F.3d 1245, 1257-59 (Fed. Cir. 2014). 12 We note the patent eligibility inquiry may contain underlying issues of fact. Mortg. Grader, Inc. v. First Choice Loan Servs. Inc., 811 F .3d 1314, 1325 (Fed. Cir. 2016). In particular, "[t]he question of whether a claim element or combination of elements is well-understood, routine and conventional to a skilled artisan in the relevant field is a question of fact." Berkheimer v. HP Inc., 881 F.3d 1360, 1368 (Fed. Cir. 2018). 8 Appeal2017-003514 Application 12/236,260 Under the 2019 Revised Guidance, we must consider in Step 2B whether an additional element or combination of elements: (1) "Adds a specific limitation or combination of limitations that are not well- understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present;" or (2) "simply appends well- understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present." See 2019 Revised Guidance, III.B. 13 In the Step 2B analysis, an additional element ( or combination of elements) is not well-understood, routine or conventional unless the examiner finds an evidentiary basis, and expressly supports a rejection in writing with, one or more of the following: 1. A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element( s ). 2. A citation to one or more of the court decisions discussed in MPEP § 2106.05( d)(II) as noting the well- 13 In accordance with existing Step 2B guidance, an Examiner's conclusion that an additional element ( or combination of elements) is well understood, routine, conventional activity must be supported with a factual determination. For more information concerning evaluation of well- understood, routine, conventional activity, see MPEP § 2106.05( d), as modified by the USPTO Berkheimer Memorandum (USPTO Commissioner for Patents Memorandum dated Apr. 9, 2018, "Changes in Examination Procedure Pertaining to Subject Matter Eligibility, Recent Subject Matter Eligibility Decision (Berkheimer v. HP, Inc.)" (hereinafter "Berkheimer Memo"). 9 Appeal2017-003514 Application 12/236,260 understood, routine, conventional nature of the additional element( s ). 3. A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element( s ). 4. A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element( s). See Berkheimer Memo. The analysis in Step 2B further determines whether an additional element or combination of elements: (a) Adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or (b) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present. 2019 Revised Guidance, see Berkheimer Memo. If the Examiner or the Board determines under Step 2B that the element ( or combination of elements) amounts to significantly more than the exception itself, the claim is eligible, thereby concluding the eligibility analysis. However, if a determination is made that the element and combination of elements does not amount to significantly more than the exception itself, the claim is ineligible under Step 2B, and the claim should be rejected for lack of subject matter eligibility. 10 Appeal2017-003514 Application 12/236,260 ANALYSIS 14 In the Decision, with respect to Step 2A(i), we stated that we agree with the Examiner that independent claim 1 is directed broadly to "comparing new and stored information and using rules to identify options and a formula for updating alarm limits" (Final Act. 2; Ans. 21 ). And, when viewed through the lens of the 2019 Revised Guidance, the Examiner's analysis depicts the claimed subject matter as one of the ineligible "[ m ]ental processes" that include "concepts performed in the human mind (including an observation, evaluation, judgment, opinion)," and thus an abstract idea. See 2019 Revised Guidance, 52; See also Flook, 437 U.S. at 595 ("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." (internal citations omitted)). Dec. 8. And, with respect to Step 2A(ii), we concluded that exemplary independent claim 1 failed to integrate the judicial exception into a practical application of that exception. See id. at 8-14. However, upon reconsidering our Decision regarding Step 2A(ii), we agree with Appellants' that independent claim 1 does integrate the judicial exception into a practical application at least because it includes "an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition." See 2019 Revised Guidance, 84 Fed. Reg. at 55. In this regard, we agree with Appellants that 14 We selected independent claim 1 as representative for claims 1-10 in the Decision. See Dec. 3. Although Appellants argued remaining claims 11-22 separately, Appellants' arguments were based on the same reasons put forth with respect to independent claim 1. See id. at 16. We maintain that independent claim 1 is representative. 11 Appeal2017-003514 Application 12/236,260 claim 1 applies or uses the alleged mental process to effect a particular treatment or prophylaxis for a disease or medical condition, such as by reciting "adjusting, with the processor, therapy delivered by a medical device to the patient, ... wherein adjusting therapy comprises: ... initiating the on-cycle if the medical device is in the off-cycle at the time the event marker is generated ... ; and with the processor, restarting the on-cycle if the medical device is in the on-cycle at the time the event marker is generated. Req. 6. Here, after further consideration, we disagree with the Examiner that the claims are simply "directed to a process of treating a patient by receiving information regarding event marker has been triggered, and adjusting treatment or therapy/treatment based upon whether the received data indicates that the patient was not receiving therapy (i.e. off-cycle) for therapy." Final Act. 2; Ans. 21. Instead, we find the claims use the received information, i.e., an "event marker," to direct subsequent operations- namely, to control "whether a medical device is in an off-cycle or an on- cycle of a therapy cycle implemented by the medical device at a time an event marker is generated." Req. 3. We agree with Appellants that "'initiating the on-cycle if the medical device is in the off-cycle at the time the event marker is generated' and 'restarting the on-cycle if the medical device is in the on-cycle at the time the event marker is generated' result in different dosages of the therapy." Id. (citations omitted). Thus, Appellants' claims are like those in Vanda. In Vanda, the court distinguished claims involving using acquired patient information to modify a drug administration regimen from the claims at issue in Mayo, which involved acquiring patient information, but did not require any particular use of the acquired information. Vanda Pharms. Inc. v. West-Ward Pharms. 12 Appeal2017-003514 Application 12/236,260 Int'! Ltd., 887 F.3d 117, 1134--35 (Fed. Cir. 2018). The court found the claims in Vanda were not directed to an abstract idea, under Alice step one, because they involved using the acquired data to direct a treatment program. Similarly, in this case, the claims involve the use of acquired data, i.e., an "event marker," to direct operation of a medical device. As such, these claims are not directed to an abstract idea and, accordingly, the claims survive Alice step one. Thus, we conclude that there are meaningful limitations in the claims that transform the judicial exception into a patent-eligible application such that the claim amounts to significantly more than the judicial exception itself. CONCLUSION In view of the above, we modify our Decision and reverse the Examiner's rejection of claims 1-22 under§ 101. DECISION We grant Appellants' Request and modify our Decision with respect to reversing the rejection under 35 U.S.C. § 101 of claims 1-22. Our decision is final for purposes of judicial review. See 37 C.F.R. § 4I.52(a)(l). REQUEST FOR REHEARING GRANTED 13 Copy with citationCopy as parenthetical citation