Bruce ReinerDownload PDFPatent Trials and Appeals BoardDec 7, 20212021001016 (P.T.A.B. Dec. 7, 2021) Copy Citation 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. 12/213,184 06/16/2008 Bruce Reiner 71486.0062 9346 13155 7590 12/07/2021 Edwards Neils LLC 380 Maple Street #8126 Gallatin, TN 37066 EXAMINER COLEMAN, CHARLES P. ART UNIT PAPER NUMBER 3626 NOTIFICATION DATE DELIVERY MODE 12/07/2021 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): ipgeneral@edwardsneils.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte BRUCE REINER Appeal 2021-001016 Application 12/213,184 Technology Center 3600 ____________ Before MICHAEL C. ASTORINO, JAMES P. CALVE, and MATTHEW S. MEYERS, Administrative Patent Judges. MEYERS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), the Appellant appeals from the Examiner’s non-final decision to reject claims 2–21, 23–43, and 45–51, which are all of the pending claims.1 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Dr. Bruce Reiner as the real party in interest. Appeal Br. 2. Appeal 2021-001016 Application 12/213,184 2 CLAIMED INVENTION Appellant’s claimed invention relates to a qualitative assurance system that “quantitatively rates users that perform and/or participate in medical procedures, particularly in the area of radiology.” Spec. ¶ 3. Claims 2, 27, and 32 are the independent claims on appeal. Claim 2, reproduced below, with modified formatting and bracketed notations, is illustrative of the claimed subject matter. 2. A method of reducing radiation exposure risk to a patient, comprising: [a] performing at least one imaging study on the patient using an imaging device; [b] taking images during said at least one imaging study, using said imaging device, during an imaging examination of the patient; [c] combining, using a merging module, said images of said at least one imaging study with any other imaging studies on the patient, in at least one database, with medical records on the patient; [d] assessing, using a metrics module the processing of said images from said at least one imaging study with said previous imaging studies, in combination with said medical records of the patient; [e] determining a radiation exposure of the patient from previous imaging studies by at least extracting radiation exposure parameters from previous imaging devices; [f] determining a cumulative risk of radiation exposure of the patient from said previous imaging studies and any additional imaging studies; [g] adjusting radiation exposure parameters on one or more imaging devices during any said additional imaging studies to reduce radiation levels, and thereby reduce said cumulative risk of radiation exposure to the patient; and Appeal 2021-001016 Application 12/213,184 3 [h] creating a patient quality assurance score, using said metrics module by assessment of said patient cumulative risk of radiation exposure, said medical records, said imaging studies, including said additional imaging studies, patient surveys, and patient compliance with medical instructions, to measure at least an effectiveness of a utilization of said imaging device to increase patient radiation safety. Appeal Br. 24–25 (Claim App.). REJECTIONS Claims 2, 16, 27, 32, and 40 stand rejected under 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. Claims 2–21, 23–43,2 and 45–51 stand rejected under 35 U.S.C. § 101 as being directed to a judicial exception without significantly more. ANALYSIS Written Description The Examiner rejects independent claims 2, 27, and 32 as failing to comply with the written description requirement because “[t]he subject matter ‘adjusting radiation exposure levels/parameters’ is not properly described in the application as filed.” Non-Final Act. 3. More particularly, the Examiner determines that “[t]he [S]pecification does not describe how imaging devices, merging modules and/or metrics modules, perform the 2 Claims 41 and 42 depend from independent claim 32, but do not recite the same statutory class of invention as that recited by claim 32. We take the change of statutory class to be typographical error. However, should prosecution continue, the Examiner may wish to consider requiring the appropriate correction. Appeal 2021-001016 Application 12/213,184 4 ‘adjusting radiation exposure parameters on one or more imaging devices’ and ‘adjusting radiation exposure levels’ steps of claims 2, 16, 27, 32 and 40.” Id. at 4. According to the Examiner, at most Appellant’s Specification “appears to support recommending radiation exposure levels/parameters adjustment by way of a report (i.e. quality assurance score), or manual radiation exposure levels/parameters adjustment by a human operator, or recording of manual radiation exposure levels/parameters adjustment made by a human operator.” Id. at 3. The Examiner rejects dependent claims 16 and 40 for the same reasons. Id. at 3–4. Appellant responds that “the Examiner omits the description in the [S]pecification of how the imaging device agent modules 216 gather data on ‘imaging device actions performed such as . . . imaging device parameter adjustments.’” Appeal Br. 10 (emphases omitted) (citing Spec. ¶ 83). Appellant also argues that support for the claim language of limitation [g] is found in the Specification at paragraphs 118, 119, and 126. Appeal Br. 10– 12. Based on these cited portions, Appellant argues that “the QA scorecard program is reducing radiation exposure by either eliminating redundant imaging studies or optimizing techniques and performing radiation adjustment actions.” Appeal Br. 11 (emphases omitted). Appellant explains that “[t]hese are not just ‘recommendations’ as the Examiner has previously asserted, but the [S]pecification clearly states that these optimizing techniques are actions that result in adjustments of radiation levels or elimination of redundant imaging studies.” Id. (emphases omitted). Appeal 2021-001016 Application 12/213,184 5 In response, the Examiner states that paragraph 83 of the Specification “supports at most ‘gather[ing] imaging device monitoring data’ such as ‘imaging device parameter adjustments.’ There is no express recitation that Appellant’s imaging device itself performs parameter adjustments in response to the generation of a quality assurance (QA) scorecard (which itself is mere data).” Ans. 3 (emphases omitted). Whether a specification complies with the written description requirement of 35 U.S.C. § 112, first paragraph (now 35 U.S.C. § 112(a)), is a question of fact and is assessed on a case-by-case basis. See, e.g., Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991)). The disclosure, as originally filed, need not literally describe the claimed subject matter (i.e., using the same terms or in haec verba) in order to satisfy the written description requirement. But the specification must convey with reasonable clarity to those skilled in the art that, as of the filing date, Appellant was in possession of the claimed invention. See id. Here, the Specification discloses that imaging device agent modules 216 may gather image device monitoring data based on user actions performed, such as user login information; imaging modalities; parameters that are selected to perform the imaging modalities, including motion information, positioning information, exposure information, artifact information, collimation information; number of times an imaging exam is performed; data files and databases that are accessed; information that is requested . . . and other user action data. Spec. ¶ 82. The Specification also discloses that Appeal 2021-001016 Application 12/213,184 6 imaging device agent modules 216 may gather imaging device monitoring data based on imaging device actions performed, such as when data is exchanged; the type of input device used; whether reports are printed; when data was saved; an Internet Protocol (IP) address of devices that were communicated with; a location of data storage/retrieval; imaging device parameter adjustments; and other imaging device data. Id. ¶ 83. The Specification further discloses that [b]y providing access to the patient’s records that are stored in the information sources, such as the EMR and/or electronic imaging folder, the QA scorecard program 110 provides users with a tool for eliminating the occurrence of redundant exams. According to one embodiment, eliminating redundant imaging exams increases patient safety by subjecting the patient to less radiation exposures and also saves costs by requiring fewer imaging studies. According to one embodiment, the QA scorecard program 110 may calculate QA metrics for eliminating redundancy in a patient QA scorecard. Id. ¶ 118. The Specification still further discloses that patient exposure to radiation may be reduced by enabling the QA scorecard program 110 to eliminate redundant imaging studies that utilize, for example, ionizing radiation or other radiation sources. According to one embodiment, patient exposure to radiation may be reduced by enabling the QA scorecard program 110 to perform optimizing techniques that includes accessing patient data from the information sources, extracting exposure parameters and corresponding QA scores from all previous imaging studies, and recommending adjustments to radiation levels, among other actions. Id. ¶ 119. Based on these cited paragraphs, we agree with the Examiner that “express support in Appellant’s Specification for Appellant’s allegation that ‘the imaging device itself performs the image device parameter Appeal 2021-001016 Application 12/213,184 7 adjustment[s]’” cannot be found in the cited portions of the Specification. Ans. 3. Here, we note that Appellant’s Specification makes a distinction between imaging device agent modules that “gather image device monitoring data based on user actions performed” (e.g., parameters that are selected to perform the imaging modalities, including exposure information and number of times an imaging exam is performed) and imaging device agent modules that “gather imaging device monitoring data based on imaging device actions performed” (e.g., imaging device parameter adjustments). Spec. ¶¶ 82–83. We also note that imaging device parameter adjustments would not necessarily include radiation exposure parameter adjustments. The Specification makes it clear that the optimizing techniques include “accessing patient data from the information sources, extracting exposure parameters and corresponding QA scores from all previous imaging studies, and recommending adjustments to radiation levels.” Id. ¶ 119 (emphasis added). We are not persuaded by Appellant’s assertion that “the QA scorecard program is reducing radiation exposure by either eliminating redundant imaging studies or optimizing techniques and performing radiation adjustment actions” and that “[t]hese are not just ‘recommendations.’” Appeal Br. 11 (emphases omitted). In addition to the paragraph cited above regarding recommending adjustments to radiation levels, the QA scorecard program is disclosed as “enabl[ing] users to assess redundancy of medical imaging studies, which leads to excessive costs” (Spec. ¶ 108) and as “provid[ing] users with a tool for eliminating the occurrence of redundant exams.” Id. ¶ 118. Appellant argues that “there is no other interpretation of Appeal 2021-001016 Application 12/213,184 8 how the claims are read in context of the entire claim and of the entire [S]pecification” and Appellant “is his own lexicographer here.” Appeal Br. 11. However, the Specification does not lexicographically define “actions” or “recommendations.” Although Appellant may act as their own lexicographer so as to assign a special definition to each claim term, that definition must be “clearly set[] forth” and “explicit.” See Prima Tek II, L.L.C. v. Polypap, S.A.R.L., 318 F.3d 1143, 1148 (Fed. Cir. 2003). Appellant further argues that “the very fact that the computer’s actions to reduce radiation levels at the image device can be ‘manually overridden’, further emphasizes the fact that the actions taken by the computer are not manually performed.” Appeal Br. 12 (citing Spec. ¶ 126) (emphases omitted). However, the Specification discloses that “the QA scorecard program 110 may recommend performing a requested CT examination without intravenous contrast or performing ultrasound” and that “a specialist may decide to override the QA scorecard program 110 recommendation and add intravenous contrast to improve imaging information.” Spec. ¶ 126. The paragraphs proffered by Appellant do not support “the computer’s actions to reduce radiation levels at the image device,” but instead describe providing a recommendation for adjusting a radiation level. Thus, we agree with the Examiner that “adjusting radiation exposure parameters on one or more imaging devices during any said additional imaging studies to reduce radiation levels,” as recited by independent claims 2, 27, and 32, is not reasonably disclosed or described in the Specification. Appeal 2021-001016 Application 12/213,184 9 Accordingly, we sustain the Examiner’s rejection of claims 2, 27, and 32 under 35 U.S.C. § 112 (pre-AIA), first paragraph. We sustain the Examiner’s rejection of claims 16 and 40 for the same reasons. Patent-Ineligible Subject Matter Appellant argues claims 2–21, 23–43, and 45–51 as a group. Appeal Br. 12–22. We select independent claim 2 as representative. The remaining claims stand or fall with claim 2. See 37 C.F.R. § 41.37(c)(1)(iv). 35 U.S.C. § 101 Framework Section 101 An invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. However, the U.S. 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. Pty. Ltd. 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 Court’s two-part framework, described in Mayo 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. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4 Appeal 2021-001016 Application 12/213,184 10 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 (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 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 187, 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 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. at 187 (“It is now commonplace that an application of a law of nature or mathematical formula to a known structure Appeal 2021-001016 Application 12/213,184 11 or process may well be deserving of patent protection.”), 191 (citing Benson and Flook) (citation omitted). 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. (alterations in original) (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. USPTO Section 101 Guidance We are also guided by U.S. Patent and Trademark Office (“USPTO”) Guidance, as set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Guidance, 84 Fed. Reg.”), incorporated into the MANUAL OF PATENT EXAMINING PROCEDURE §§ 2104–06, Rev. 10.2019 (“MPEP”) in June 2020. “The guidance sets out agency policy with respect to the USPTO’s interpretation of the subject matter eligibility requirements of 35 U.S.C. [§] 101 in view of decisions by the Supreme Court and the Federal Circuit.” Guidance, 84 Fed. Reg. at 51.3 3 In response to received public comments, the Office issued further guidance on October 17, 2019, clarifying the 2019 Revised Guidance, 84 Fed. Reg. USPTO, October 2019 Update: Subject Matter Eligibility (the Appeal 2021-001016 Application 12/213,184 12 Although “[a]ll USPTO personnel are, as a matter of internal agency management, expected to follow the guidance,” the Guidance “does not create any right or benefit, substantive or procedural, enforceable by any party against the USPTO.” Id. The Guidance, by its terms, applies to all applications, and to all patents resulting from applications, filed before, on, or after January 7, 2019. Id. at 50. Under the USPTO Guidance and October 2019 Update, we first look to whether the claim recites: (1) any judicial exceptions, including laws of nature, natural phenomena, and products of nature (see MPEP §§ 2106.04(II)(A)(1), 2106.04(b)) (“Step 2A, Prong One”); and (2) additional elements that integrate the judicial exception into a practical application (see id. §§ 2106.04(II)(A)(2), 2106.04(d)) (“Step 2A, Prong Two”).4 Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look, under Step 2B, to whether the additional elements, individually or in combination, provide an inventive concept. See MPEP §§ 2106(III), 2106.05. “An inventive concept ‘cannot be furnished by the unpatentable law of nature (or “October 2019 Update”) (available at https://www.uspto.gov/sites/default/ files/documents/peg_oct_2019_update.pdf). 4 This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application, as the term is used in USPTO Guidance. See Guidance — Section III(A)(2), 84 Fed. Reg. at 54–55; MPEP § 2106.04(d). Appeal 2021-001016 Application 12/213,184 13 natural phenomenon or abstract idea) itself.’” Id. § 2106.05 (quoting Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1376 (Fed. Cir. 2016)). Among the considerations in determining whether the additional elements, individually or in combination, amount to significantly more than the exception itself, we look to whether they add a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. MPEP § 2106.05(II); Guidance, 84 Fed. Reg. at 56. Step One of the Mayo/Alice Framework Under the first step of the Mayo/Alice framework and Step 2A, Prong One of USPTO Guidance, the Examiner determines that exemplary independent claim 2 recites broadly “taking images, combining images, assessing images, determining radiation exposures, determining cumulative risks, adjusting radiation exposure parameters, creating patient quality assurance scores.” Non-Final Act. 5. The Examiner characterizes the steps recited by claim 2 as “a method of managing personal behavior or relationships or interactions between people (social activities, teaching, following rules, instructions) and thus grouped as a certain method of organizing human interactions.” Id. (emphases omitted). Under Prong Two of the USPTO Guidance, the Examiner determines that the identified judicial exception is not integrated into a practical application “because the generically recited additional computer elements . . . amount to simply implementing the abstract idea on a computer.” Id. Appeal 2021-001016 Application 12/213,184 14 In response, Appellant asserts that the Examiner is incorrect in determining that the claims are directed to an abstract idea. Appeal Br. 12. According to Appellant, “the present invention requires that radiation exposure risk caused by multiple imaging examinations (i.e., x-rays, MRI’s, etc.) performed on a patient, be quantified for radiation levels, to reduce the risk of future health issues, e.g., cancerous tumors, to the patient.” Id. at 13. Appellant argues that the claims do not merely present the “results of abstract processes of collecting and analyzing information”, but provide significantly more, such as identifying particular tools which are used (i.e., imaging device, metrics module, merging module, etc.), to achieve a “specific improvement,” which is ensuring that a patient is not exposed unnecessarily to excessive radiation with its consequential health risk. Id. at 14. Under the first step of the Mayo/Alice framework and Step 2A of the USPTO Guidance, we first determine to what claim 2 is directed, i.e., whether claim 2 recites an abstract idea and if so, whether claim 1 is directed to that abstract idea. The Federal Circuit has explained that “the ‘directed to’ inquiry applies a stage-one filter to claims, considered in light of the specification, based on whether ‘their character as a whole is directed to excluded subject matter.’” Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016) (quoting Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1346 (Fed. Cir. 2015)). It asks whether the focus of the claim is on a specific improvement in relevant technology or on a process that itself qualifies as an “abstract idea” for which computers are invoked merely as a tool. See id. at 1335–36. Here, it is clear from the Specification, Appeal 2021-001016 Application 12/213,184 15 including the claim language, that claim 2 focuses on an abstract idea, and not on any improvement to technology and/or a technical field. Reciting a Judicial Exception In making this determination, we note that the Specification is titled “METHOD AND APPARATUS FOR GENERATING A PATIENT QUALITY ASSURANCE SCORECARD,” and states that the disclosure relates to a quality assurance (QA) system that “quantitatively rates users that perform and/or participate in medical procedures, particularly in the area of radiology.” Spec. ¶ 3. The Specification states that, [t]he first and foremost priority for any QA program is to improve quality of service. As QA programs are implemented in the medical field, the ultimate goal is to improve patient care. To accomplish this goal, products and/or services should offer procedures for increasing accountability and improving feedback among users that participate in a medical study. Id. ¶ 4. The Specification acknowledges that [d]igital imaging technologies provide digital processing capabilities, such as image capture, image archive, image transfer, and image display that may be shared among users to the medical study. Digital imaging technologies further allow data that is associated with the digital processing operations to be captured and combined with the underlying digital imaging processing operations. Id. ¶ 5. According to the Specification, “a need exists to leverage digital imaging technologies to increase accountability and improve feedback among users that participate in a medical study.” Id. ¶ 6. To address this need, the present invention provides a QA scorecard “framework for developing a comprehensive medical imaging QA program Appeal 2021-001016 Application 12/213,184 16 that defines objective benchmarks.” Spec. ¶ 7. The Specification describes that “medical studies are performed by users that perform discrete tasks in an imaging study workflow sequence,” and that [a] typical workflow sequence includes imaging exam ordering, imaging exam scheduling, imaging exam acquisition, imaging exam processing, imaging exam archiving, imaging exam distribution, imaging exam display, imaging exam navigation, imaging exam interpretation, imaging exam reporting, communication and billing, among other sequences. Id. ¶ 8. Consistent with this disclosure, independent claim 2 recites “[a] method of reducing radiation exposure risk to a patient” including steps for collecting data, i.e., “performing at least one imaging study on the patient” (limitation [a]); “taking images during said at least one imaging study” (limitation [b]); “combining, using a merging module, said images of said at least one imaging study” (limitation [c]); analyzing data, i.e., “assessing, using a metrics module the processing of said images from said at least one imaging study with said previous imaging studies” (limitation [d]); “determining a radiation exposure of the patient” (limitation [e]); “determining a cumulative risk of radiation exposure of the patient” (limitation [f]); manipulating (i.e., updating or recommending) data, i.e., “adjusting radiation exposure parameters on one or more imaging devices” (limitation [g]); and analyzing and outputting additional data, i.e., “creating a patient quality assurance score” (limitation [h]). Appeal Br. 24–25 (Claim App.). Appeal 2021-001016 Application 12/213,184 17 When considered collectively and under the broadest reasonable interpretation, we agree with the Examiner that claim 2, as summarized above, recites broadly a system for “analyzing data and generating QA scorecards” (Ans. 4–6) by a series of steps for collecting, analyzing, and manipulating data with the result of reducing radiation exposure risk to a patient and providing a quality assurance score which may be characterized in the form of certain methods of organizing human activities, i.e., “managing personal behavior or relationships or interactions between people (including . . . following rules or instructions).”5 Guidance, 84 Fed. Reg. at 52; MPEP § 2106.04(a)(2)(II).6 As such, we are unpersuaded by Appellant’s assertion that the present claims “do not merely present the ‘results of abstract processes of collecting and analyzing information’, but provide significantly more, such as identifying particular tools which are used (i.e., imaging device, metrics module, merging module, etc.), to achieve a ‘specific improvement.’” Appeal Br. 14. As discussed more fully below with respect to Prong Two, simply reciting an “imaging device,” “merging module,” and “metrics module” does not change the result that the claim recites an abstract idea. At best, the specific physical elements 5 We note that “[a]n abstract idea can generally be described at different levels of abstraction.” Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1240 (Fed. Cir. 2016). The Board’s “slight revision of its abstract idea analysis does not impact the patentability analysis.” Id. at 1241. 6 We also agree with the Examiner that claim 2 may be characterized as falling under the category of “[m]ental processes—concepts performed in the human mind (including an observation, evaluation, judgment, opinion).” Guidance, 84 Fed. Reg. at 52; MPEP § 2106.04(a)(2)(III). Ans. 5–6. Appeal 2021-001016 Application 12/213,184 18 “limit[] the invention to a technological environment for which to apply the underlying abstract concept.” Intellectual Ventures I LLC v. Capital One Fin. Corp., 850 F.3d 1332, 1340 (Fed. Cir. 2017) (“Capital One Fin.”). Collecting, analyzing, and manipulating data, and generating QA scorecards is similar to the concepts found abstract in University of Florida Research Foundation, Inc. v. General Electric Co., 916 F.3d 1363, 1366–68 (Fed. Cir. 2019) (Claim for standardizing data to be conveyed to a bedside device for graphical display was directed to the abstract idea of “collecting, analyzing, manipulating, and displaying data.”), BSG Tech LLC v. Buyseasons, Inc., 899 F.3d 1281, 1286 (Fed. Cir. 2018) (“considering historical usage information while inputting data”), Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1351–54 (Fed. Cir. 2016) (Claim for detecting events by receiving, detecting, analyzing, displaying, accumulating, and updating data, and deriving a composite indicator from that data was directed to the abstract idea of “collecting information, analyzing it, and displaying certain results of the collection and analysis.”), and In re Salwan, 681 F. App’x 938, 941 (Fed. Cir. 2017) (nonprecedential) (claims to storing, communicating, transferring, and reporting patient health information in a network held as an abstract idea of billing insurance companies and organizing patient health information). Having concluded that claim 2 recites a judicial exception under the Guidance, Step 2A, Prong One, we next consider whether the claim recites additional elements that integrate the judicial exception into a practical application. Appeal 2021-001016 Application 12/213,184 19 Integration into a Practical Application We look to whether the claim “appl[ies], rel[ies] on, or use[s] 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 judicial exception,” i.e., “integrates a judicial exception into a practical application.” Guidance, 84 Fed. Reg. at 54; MPEP § 2106.04(d). Here, the only additional elements recited in claim 2, i.e., elements beyond the abstract idea, are the “imaging device,” “merging module,”7 and “metrics module”8 — elements that, as the Examiner observes, are “merely tools used by Appellant to implement data processing.” Ans. 6. Appellant asserts that the present invention is directed to additional elements (i.e., imaging device, metrics module, merging module, adjusting the imaging device parameters based on the results of the metrics module) which give effect to a particular treatment or medical condition (i.e., reducing patient radiation exposure from imaging devices), used with a particular machine (i.e., imaging device), and which provides information such that the present invention is more than a “drafting effort designed to monopolize the 7 The Examiner finds “merging module” to invoke 35 U.S.C. § 112 (pre- AIA), sixth paragraph (Non-Final Act. 4). Appellant’s Summary of Claimed Subject Matter directs attention to paragraphs 20 and 84 of the Specification to address this limitation. 8 The Examiner finds “metrics module” to invoke 35 U.S.C. § 112 (pre- AIA), sixth paragraph (Non-Final Act. 4). Appellant’s Summary of Claimed Subject Matter directs attention to paragraphs 97 and 98 of the Specification to address this limitation. Appeal 2021-001016 Application 12/213,184 20 exception” (see the 2019 Revised Patent Subject Matter Eligibility Guidance). Appeal Br. 16–17 (emphasis omitted). However, we disagree with Appellant’s assertion. Here, we note that the Specification describes that “the server may include a merging module that receives data from all devices that are networked to the server,” and that “the merging module merges data that is captured during a medical examination, including user action data, client computer action data, imaging device action data, and other data.” Spec. ¶ 20. The Specification also describes that the merging module “may locally store the received data in a storage device 260 and/or may store the received data in an external storage device.” Id. ¶ 84. The Specification further discloses “metrics module 232 for performing prospective and retrospective trending analysis” and “metrics module 232 may automatically tally and record QA scores in a selected database.” Id. ¶¶ 97–98. Thus, Appellant’s conclusory assertions that the merging and metrics modules are “unique module[s] programmed for unique operations by the inventor” (Appeal Br. 13) fail to provide persuasive evidence that the programming related to each of their process steps entails anything atypical from conventional programming. As is clear from the Specification, there is no indication that the processes recited in claim 2 require any specialized computer hardware or other inventive computer components, i.e., a particular machine, invoke any asserted inventive programming, or that the claimed invention is implemented using anything other than generic computer components to perform generic computer functions. See DDR Holdings, LLC v. Appeal 2021-001016 Application 12/213,184 21 Hotels.com, L.P., 773 F.3d 1245, 1256 (Fed. Cir. 2014) (“[A]fter Alice, there can remain no doubt: recitation of generic computer limitations does not make an otherwise ineligible claim patent-eligible.”). Instead, independent claim 2, unlike the claims found non-abstract in prior cases, uses generic computer technology to collect, analyze, and manipulate data for the purposes of reducing radiation exposure risk and measuring an effectiveness of a utilization of an imaging device, and does not recite an improvement to a particular computer technology. See, e.g., Spec. ¶ 53 (“[S]erver 120 may include a processor 121 having a CPU 122 or parallel processor, which may be a server data processing device and an I/O interface 123.”); see also Spec. ¶¶ 41, 54, 56–61, 64, 66–68. Cf. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314–15 (Fed. Cir. 2016) (Finding claims not abstract because they “focused on a specific asserted improvement in computer animation.”). We also find no indication in the Specification that the claimed invention as recited in claim 2 effects a particular treatment or prophylaxis for a disease or medical condition. Appellant further argues that The step of adjusting the radiation exposure parameters during the imaging examination on an imaging device, based on the results determined by the merging module and metrics module[] . . . [is] not [a] step[] that can be performed by the human mind, and [is] not [a] simple abstraction, but rather, [is] directed to specific steps using tangible devices, performed by novel means – which make them more than a simple abstract idea. Appeal Br. 14 (emphases omitted). Appellant explains that “the adjustment takes place automatically by the imaging device.” Id. at 20 (emphases Appeal 2021-001016 Application 12/213,184 22 omitted). However, we find the step of adjusting the radiation exposure parameters to be similar to patent ineligible concepts such as adjusting an alarm limit to an updated alarm limit as in Flook, 437 U.S. at 584 (holding ineligible a method for updating an alarm limit on a process variable, despite the process involving the catalytic chemical conversion of hydrocarbons); comparing new and stored information and using rules to identify options as in SmartGene, Inc. v. Advanced Biological Labs., SA, 555 F. App’x 950 (Fed. Cir. 2014); tracking financial transactions to determine whether they exceed a pre-set spending limit (i.e., budgeting) as in Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367 (Fed. Cir. 2015). The step Appellant relies on is part of the abstract idea, which cannot integrate that abstract idea into a practical application. Under Step 2A, Prong Two, “examiners evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception.” Guidance, 84 Fed. Reg. at 54. As such, features of the abstract idea cannot be relied upon to integrate itself into a practical application. See id. at 55 n.24 (USPTO guidance uses the term “additional features” to refer to claim features beyond the identified abstract idea). Appellant asserts that “the present claims exhibit patent-eligibility since the claims focus on a specific means or method that improves the quality of patient care with an improvement in the treatment of patients during imaging examinations.” Appeal Br. 20. However, the focus of independent claim 2 is not on any technological advancement to the way computers operate, or an imaging device operates; but rather, on the implementation of the abstract idea, “for which computers are invoked Appeal 2021-001016 Application 12/213,184 23 merely as a tool.” See Enfish, 822 F.3d at 1336. Here, the claimed process of reducing radiation exposure risk to a patient by collecting, analyzing, and manipulating information is recited without any technological details on how the steps are performed technologically other than using a conventional image device and a conventional computer in its ordinary capacity to perform data analysis. See, e.g., Spec. ¶¶ 16, 53–54. Any improvement in the quality of patient care or treatment of patients during imaging examinations is not a technical or technological improvement; but rather a business improvement. See, e.g., id. ¶¶ 99, 101, 103, 108–109. OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015) (Holding that claims are directed to “the abstract idea of offer-based price optimization.”); Enfish, 822 F.3d at 1336 (Focusing on whether the claim is “an improvement to [the] computer functionality itself, not on economic or other tasks for which a computer is used in its ordinary capacity.”). See also Bridge & Post, Inc. v. Verizon Commc’ns, Inc., 778 F. App’x 882, 893 (Fed. Cir. 2019) (“The ability to run a more efficient advertising campaign, even if novel, and even if aided by conventional computers, is an advance ‘entirely in the realm of abstract ideas,’ which we have repeatedly held to be ineligible.”). Thus, we are not persuaded of error in the Examiner’s determination that the additional elements of claim 2 do not integrate the judicial exception into a practical application, as the term is used in USPTO Guidance, and we are not persuaded of error in the Examiner’s determination that claim 2 is directed to an abstract idea. Appeal 2021-001016 Application 12/213,184 24 Step Two of the Mayo/Alice Framework Under the second step in the Alice framework and USPTO Guidance Step 2B, we “[e]valuat[e] additional elements to determine whether they amount to an inventive concept [which] requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” MPEP § 2106.05(I). Here, the Examiner determines [t]he claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations (i.e., processor, etc.) only store and retrieve information, and these are well-understood, routine, conventional computer functions. Non-Final Act. 5 (citing MPEP § 2106.05(d)(II)). We agree with the Examiner. See also Elec. Power, 830 F.3d at 1355 (gathering, sending, monitoring, analyzing, selecting, and presenting information does not transform the abstract process into a patent-eligible invention); OIP Techs, 788 F.3d at 1363 (noting that storing data is well-understood, routine, and conventional and does not render claims eligible); In re TLI Commc’ns LLC Patent Litig., 823 F.3d 607, 613 (Fed. Cir. 2016) (“[T]he claims’ recitation of a ‘telephone unit,’ a ‘server’, an ‘image analysis unit,’ and a ‘control unit’ fail to add an inventive concept sufficient to bring the abstract idea into the realm of patentability”). In response, Appellant argues that the steps recited “go beyond ‘well-understood, routine, conventional activit[ies]’ and render the invention patent- eligible” (see Bascom [Glob. Internet Servs., Inc. v. AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016)]), since there is no Appeal 2021-001016 Application 12/213,184 25 existing system or method which allows radiation risk exposure to be reduced during an imaging examination by adjusting the parameters on the image device(s). Appeal Br. 18 (emphases omitted). However, an abstract idea does not transform into an inventive concept just because the prior art does not disclose or suggest it. See Mayo, 566 U.S. at 78. Indeed, “[t]he ‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.” Diehr, 450 U.S. at 188–89; see also Mayo, 566 U.S. at 91 (rejecting “the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101”). We are not persuaded, on the present record, that the Examiner erred in rejecting independent claim 2 under 35 U.S.C. § 101. Therefore, we sustain the Examiner’s rejection of independent claim 2, and claims 3–21, 23–43, and 45–51, which fall with independent claim 2. Rejection of claims 32–43, 45, 47, 49, and 51 under 35 U.S.C. § 101 as being directed to signals In rejecting independent claim 32, the Examiner finds claim 32 is also directed to non-statutory subject matter because a computer readable medium “covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media.” Non-Final Act. 6–7. See also Spec. ¶ 64. Appellant does not challenge the Examiner’s rejection. See generally Appeal 2021-001016 Application 12/213,184 26 Appeal Br. Therefore, the rejection under 35 U.S.C. § 101 as being directed to signals is summarily sustained. CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 2, 16, 27, 32, 40 112, first paragraph Written Description 2, 16, 27, 32, 40 2–21, 23–43, 45–51 101 Eligibility 2–21, 23–43, 45–51 Overall Outcome 2–21, 23–43, 45–51 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 Copy with citationCopy as parenthetical citation