Biomedical Synergies, Inc.

Patent Trials and Appeals Board

Jul 22, 2020

2019005491 (P.T.A.B. Jul. 22, 2020)

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.
14/192,542 02/27/2014 Duke O. Kasprisin 52914.007 8724
25005 7590 07/22/2020
Intellectual Property Dept.
DeWitt LLP
2 East Mifflin Street
Suite 600
Madison, WI 53703-2865
EXAMINER
TOMASZEWSKI, MICHAEL
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
07/22/2020 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):
IP-DOCKET@dewittllp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DUKE O. KASPRISIN, PAUL E. KOZLOSKI,
SUSAN A. KOZLOSKI, AGNES VERCILLO,
and JEFFREY K. WINSTEAD
____________

Appeal 2019-005491
Application 14/192,542
Technology Center 3600
____________

Before ANTON W. FETTING, BRUCE T. WIEDER, and
AMEE A. SHAH, Administrative Patent Judges.

SHAH, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the
Examiner’s decision to reject claims 1–22, which are all of the pending
claims. The Appellant’s representative appeared for Oral Argument on
July 7, 2020. 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. The Appellant identifies the real party in interest as
Biomedical Synergies, Inc. Appeal Br. 2.
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CLAIMED SUBJECT MATTER
The Appellant states that their invention relates “to a computer
software-based system for ensuring the safe and appropriate handling of
such TM [transplantable materials] and NBI [non-biologic implant
materials] from receipt to their use in surgical procedures and tracing such
TM and NBI later in response to an adverse reaction investigation or recall.”
Spec. 1, ll. 18–20.
Claims 1 and 10 are the independent claims on appeal. Claim 1 is
illustrative of the subject matter on appeal and is reproduced below:
1. A method for tracking the internal processing by a
medical establishment of a piece of transplantable material
provided by a supplier for subsequent transplantation or
implantation into a patient, wherein a computer database,
processor, and software program containing an organized set of
instructions in coded language and having a plurality of graphical
user interfaces are provided for storing and processing
information, such method comprising the steps of:
(a) assigning a unique identification code to the
transplantable material upon its receipt by the medical
establishment from the supplier;
(b) inspecting the transplantable material upon its receipt
from the supplier for an unsafe condition;
(c) providing a comprehensive set of standard operating
procedures adopted by the specific medical establishment
covering at least one step for the login, handling, storage
conditions, reconstitution, or surgical use of the transplantable
material by staff members of the medical establishment in a
manner compliant with prevailing safety regulations and industry
mandates;
(d) entering into the database via a graphical user interface
data required by the standard operating procedures concerning
how the at least one processing step for the login, handling,
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storage conditions, reconstitution or surgical use of the
transplantable material by the staff member was carried out;
(e) processing such data entered into the graphical user
interface by the software program which incorporates the
standard operating procedures to ensure that the step for the
login, handling, storage conditions, reconstitution, or surgical
use of the transplantable material was conducted strictly in a
manner compliant with the standard operating procedures by:
(i) comparing the content of the entered data field
against the contents of the corresponding standard
operating procedures for that processing step for the login,
handling, storage conditions, reconstitution, or surgical
use processing step to determine if compliance with the
standard operating procedure exists, including whether the
data field was not completed;
(ii) if compliance exists, then the software allowing
the staff member access to the next graphical user interface
relating to the next processing step for the login, handling,
storage conditions, reconstitution, or surgical use of the
transplantable material; and
(iii) if compliance does not exist, then the software
not allowing the staff member to access the next graphical
user interface relating to the next step for the login,
handling, storage conditions, reconstitution, or surgical
use of the transplantable material;
(f) assessing the patient after transplantation or
implantation of the transplantable material for evidence of an
adverse effect;
(g) investigating any such adverse effect discovered in the
patient to determine whether it constitutes an adverse reaction;
(h) reporting any such adverse reaction to the supplier that
supplied the transplant material to the medical establishment;
(i) wherein the transplantable material is chosen from the
group consisting of human cells, tissue, or organs intended for
implantation, transplantation, infusion, or transfer to a patient,
including, but not limited to: musculoskeletal tissues like bone,
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tendons, fascia, ligaments, cartilage, and bioengineered bone
products; skin; cardiovascular tissues like heart valves, arteries,
veins, and pericardium; reproductive cells like sperm, semen,
oocytes, fertilized eggs, and embryos; cellular therapies like stem
cells, progenitor cells, cord blood, chondrocytes, bone marrow,
and neural cells; dura mater; breast milk; eyes; corneas; organs;
islet cells; parathyroids; autologous tissue; and synthetic and
xenographic tissue used as replacements for human tissue; as
well as non-biologic implants, including but not limited to:
titanium screws, titanium or carbon-fiber cages or resorbable
cages, fixation systems, saline or silicone breast implants,
synthetic polymers, prosthetic hips, knees and other joint
combinations thereof; as well as surgical instruments,
equipment, reagents, and supplies associated with the
transplanting or implanting of any transplant material into a
patient; and;
(j) wherein the medical establishment is an organization
directed to the storage, research, transplantation, or implantation
of transplantable materials chosen from the group consisting of
hospitals, medical clinics, surgical centers, fertility clinics, tissue
banks, organ donor banks, university and research facilities,
diagnostic laboratories, and willed body programs.
Appeal Br. 17–19 (Claims App.).

THE REJECTION
Claims 1–22 stand rejected under 35 U.S.C. § 101 as being directed to
a judicial exception without significantly more.

OPINION
The Appellant argues independent claims 1 and 10 and the dependent
claims together. See Appeal Br. 8–15. We thus group these claims together
and select claim 1 as representative of this group, with claims 2–22 standing
or falling therewith. See 37 C.F.R. § 41.37(c)(1)(iv) (2017).
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35 U.S.C. § 101 Framework
A. 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. 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
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 waterproof cloth, vulcanizing India
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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; 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 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. (citation omitted)
(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 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.
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B. USPTO Section 101 Guidance
In January 2019, after the Examiner’s Final Rejection and Answer
were mailed and the Appellant’s Appeal and Reply Briefs filed, the U.S.
Patent and Trademark Office (USPTO) published revised guidance on the
application of § 101. 2019 Revised Patent Subject Matter Eligibility
Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“2019 Revised Guidance”).2 “All
USPTO personnel are, as a matter of internal agency management, expected
to follow the guidance.” Id. at 51; see also October 2019 Update at 1. The
2019 Revised Guidance, by its terms, applies to all applications, and to all
patents resulting from applications, filed before, on, or after January 7, 2019.
84 Fed. Reg. at 50.3
Under the 2019 Revised Guidance and the October 2019 Update, 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) (“Step 2A, Prong One”); and (2) additional
elements that integrate the judicial exception into a practical application (see

2 In response to received public comments, the Office issued further
guidance on October 17, 2019, clarifying the 2019 Revised Guidance.
USPTO, October 2019 Update: Subject Matter Eligibility (the “October
2019 Update”) (available at https://www.uspto.gov/sites/default/files/
documents/peg_oct_2019_update.pdf).
3 The 2019 Revised Guidance supersedes MPEP § 2106.04(II) and also
supersedes all versions of the USPTO’s “Eligibility Quick Reference Sheet
Identifying Abstract Ideas.” See 2019 Revised Guidance, 84 Fed. Reg. at 51
(“Eligibility-related guidance issued prior to the Ninth Edition, R-08.2017,
of the MPEP (published Jan. 2018) should not be relied upon.”).
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MPEP § 2106.05(a)–(c), (e)–(h) (9th ed. Rev. 08.2017, Jan. 2018)) (“Step
2A, Prong Two”).4 2019 Revised Guidance, 84 Fed. Reg. at 52–55.
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. 2019 Revised Guidance, 84 Fed. Reg. at 55.
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. Id. at 56.
Step One of the Mayo/Alice Framework
Under the first step of the Mayo/Alice framework and Step 2A of
USPTO guidance, the Examiner determines that independent claim 1 is
directed to “a method for tracking the internal processing by a medical
establishment of a piece of transplantable material provided by a supplier for
subsequent transplantation or implantation into a patient by assigning” a
code, inspecting material, providing a set of procedures, entering data,
documenting data, assessing a patient, investigating and reporting adverse

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. See 2019 Revised Guidance - Section III(A)(2),
84 Fed. Reg. at 54–55.
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effects, and tracing the material back to the supplier, i.e., collecting
information, analyzing the information, and displaying results of the
collecting and analyzing. Final Act. 2–3 (comparing the claim to Electric
Power Grp., LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016)). When
viewed through the lens of the 2019 Revised Guidance, the Examiner’s
analysis depicts the claimed limitations as subject matter comprising
“[m]ental processes—concepts performed in the human mind (including an
observation, evaluation, judgment, opinion)” under Prong One of Revised
Step 2A. 84 Fed. Reg. at 52; see also October 2019 Update 7.
The Examiner further determines that the additional elements of the
claim beyond the abstract idea “amount to no more than a recitation of . . . a
generic computer structure(s) that serves to perform generic computer
functions that serve to merely link the abstract idea to a particular
technological environment (i.e., computers)” and do not “improve[] the
functioning of a computer or improve[] any other technology.” Final
Act. 3–4; see also Ans. 5–6. When viewed through the lens of the 2019
Revised Guidance, Prong Two of Revised Step 2A, the Examiner’s
determinations indicate that the claim’s additional elements do not integrate
the judicial exception into a practical application because they “do[] no more
than generally link the use of a judicial exception to a particular
technological environment or field of use.” 84 Fed. Reg. at 55.
The Appellant disagrees with the Examiner’s characterization and
contends that claim 1 “constitutes a comprehensive tissue management
business method for transplantable materials like tissues and organs stored
or used within a ‘medical establishment’” (Reply Br. 1–2) and
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provide[s] a method in which the software program manipulates
the computer to turn it into a compliance monitor for ensuring
that the staff member is complying with the standard operating
procedures adopted by the hospital or tissue bank employer for
safely processing the transplantable material and properly
documenting those process steps to enable the hospital or tissue
bank to respond to a patient adverse reaction to the transplantable
material or product recall within the industry.
Appeal Br. 8 (emphasis omitted). The Appellant also contends that the
claim “represents a significant advance over the prior art” (id.; see also id.,
e.g., at 11, 12), “improve[s] upon previous known technology for tracking
and tracing transplantable materials” (id. at 13; see also id. at 14; Reply
Br. 2), and “produces a result that could not be achieved via a paper and
pencil tracking system that would have no lockout functionality or self-
auditing feature” (id. at 9; see also id., e.g., at 11, 12). When viewed
through the lens of the 2019 Revised Guidance, the Appellant’s arguments
indicate that the Appellant contends that claim 1 does not recite a mental
process under Prong One and “integrates a judicial exception into a practical
application” under Prong Two because it includes an additional element or
combination of elements that “reflects an improvement in the functioning of
a computer, or an improvement to other technology or technical field.” 84
Fed. Reg. at 54–55. For at least the following reasons, we disagree.
Under the first step of the Mayo/Alice framework and Step 2A
USPTO guidance, we first determine to what claim 1 is directed, i.e.,
whether claim 1 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,
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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,
including the claim language, that claim 1 focuses on an abstract idea, and
not on any improvement to technology and/or a technical field.
Reciting a Judicial Exception
The Specification provides for “TISSUE MANAGEMENT
SYSTEM.” Spec., Title (emphases omitted). In the Field of the Invention
section, the Specification provides that the invention relates “more
specifically to a computer software-based system for ensuring the safe and
appropriate handling of such TM and NBI from receipt to their use in
surgical procedures and tracing such TM and NBI later in response to an
adverse reaction investigation or recall.” Spec. 1, ll. 15–20. The system
“provides for tracking the movement of NBI from receipt into a medical
establishment facility to their use in a surgical procedure.” Id. at 1,
ll. 21–22. In the Background of the Invention section, the Specification
discusses that when incidents related to infections, illness, and/or death in a
transplant patient occurs, “good medical practice and public health policy
requires an immediate investigation of the patient’s condition to determine
whether the infection, illness or death was caused by the tissue, organ, NBI,
or surgical procedure, as opposed to an independent condition in the
patient.” Id. at 4, l. 28–5, l. 12. The investigation can comprise tracing a
faulty surgical procedure to the surgeons and nurses, operating room, and
equipment involved, or tracing a faulty NBI or TM to a supplier or donor.
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See id. at 5, ll. 12–20. “Yet, such a tracing process is frequently impossible
because many hospitals fail to log in the TM and NBI that they receive from
suppliers and track their use in surgical procedures,” leading to patients
receiving contaminated products. Id. at 5, ll. 20–26. Tissue usage
information cards returned by a hospital to an issuing tissue bank allow the
tissue bank to monitor usage of tissue and notify everyone of a recall, but
“hospitals only return 50-85%, of these cards to the tissue banks.” Id. at 5,
ll. 9–13. “Because of these abuses and other safety problems within hospital
and tissue bank environments, regulatory and standard setting agents . . . are
currently implementing mandates for the safe handling, storage, use, and
tracing of TM,” but “provide no instructions or guidelines to the hospital or
tissue bank for how to comply,” leaving to the hospitals and tissue banks
“regulatory and legal liability for their failure to comply, but no tools to use
to comply.” Id. at 6, l. 31–7, l. 8.
The Specification discusses prior art systems of an organ procurement
and transfer system, an organ donor exchange system, a transportation
container, systems that keep track of samples with a laboratory, and systems
for keeping track of the location of supplies that “do not address the proper
handling and storage of those products.” Spec. 7, l. 9–8, l. 12. Further, the
Specification discusses prior art computer systems that “store, monitor, and
track patient information,” “assist[] the administration of medical care,”
“permit[] a user to carry his personal medical records with him,” “monitor a
patient in the field,” “collect data for [a] patient and communicate it back to
a server at the home office for use by a doctor or nurse to tell the field
practitioner what steps to take to treat the patient,” “permit[] a medical
practitioner to carry a patient’s medical records with him in image form in
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the field, consult medical on-line databases, and communicate remotely with
other members of the medical staff,” and “track and monitor the patient’s
symptoms to indicate how the administered drug is affecting the patient.”
Id. at 8, l. 20–10, l. 10.
However, these prior systems do not “address the safety of the organ
or organ match for the patient,” “track[] the safe receipt, handling, or use of
the organ, or tracing its use after surgery,” “prevent unsafe handling, storage,
or treatment by the hospital of the organ,” “ensure the safe handling, storage,
and treatment of the sample within the lab,” and “do not address the proper
handling and storage of those products.” Spec. 7, l. 12–8, l. 12. Further,
these systems can be complex and expensive (see id. at 8, ll. 30–33) and do
not “permit queries directed to TM data,” do not “track the healthcare
institution’s processing and handling of the TM,” “provide[] no mechanism
for prompting or enabling the healthcare institution to investigate an adverse
reaction occurring in the patient,” and are “without any functionality for
tracking the processing and handling of the blood samples” (id. at 10,
ll. 15–25).
Thus, the invention aims to provide “a comprehensive computerized
system that permits the tracking of the appropriate handling, processing,
storage, and use of tissues throughout the tissue bank’s or hospital’s chain of
custody of the materials” that would provide benefits and advantages of
“prompt[ing] staff members of the tissue bank or hospital to record
necessary data and properly handle, process, store, and use the tissue or
organ product,” and of
provid[ing] a search or query functionality that reliably enables
the tracing back of tissues from patient to supplier after an
adverse reaction is detected, or the tracing forward of the TM or
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NBI material from supplier to patient or hospital in the event of
a product recall that is issued by the supplier or the Food and
Drug Administration.
Spec. 10, ll. 26–35. To accomplish this aim, the invention “provides a
comprehensive tissue management system for transplant materials like
tissues, organs, and non-biologic implants” with a tracking portion that
“verifies that staff members of a medical establishment like a hospital have
handled, stored, transported, reconstituted, and used the tissue, non-biologic
implant, or organ materials in a safe and regulatory-compliant manner from
the point of receipt to the point of issuance or surgical use throughout the
hospital’s organization” and that “is preferably computer-based,” “structured
to provide appropriate prompts to the staff members to take the necessary
actions to handle, store, transport, reconstitute and use the tissue or organ
materials in a safe or appropriate manner,” and “will not permit such staff
members to carry out a critical step for handling, storing, transporting,
reconstituting or using such tissue, non-biologic implant, or organ material
unless data has already been entered into the system to verify that a prior
critical step has been taken.” Id. at 11, ll. 7–19.
Corresponding with the disclosure, claim 1 recites “[a] method for
tracking the internal processing by a medical establishment of a piece of
transplantable material provided by a supplier for subsequent transplantation
or implantation into a patient.” Appeal Br. 17 (Claims App.). We consider
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claim 1 as a whole5 giving it the broadest reasonable construction6 as one of
ordinary skill in the art would have interpreted it in light of the
Specification7 at the time of filing. The method of claim 1 comprises the
steps of: (1) assigning a code to material, i.e., “(a) assigning a unique
identification code to the transplantable material upon its receipt by the
medical establishment from the supplier”; (2) inspecting the material, i.e.,
“(b) inspecting the transplantable material upon its receipt from the supplier
for an unsafe condition”; (3) providing procedures data, i.e.,
(c) providing a comprehensive set of standard operating
procedures adopted by the specific medical establishment
covering at least one step for the login, handling, storage
conditions, reconstitution, or surgical use of the transplantable
material by staff members of the medical establishment in a
manner compliant with prevailing safety regulations and industry
mandates;
(4) entering data into a database, i.e., “(d) entering into the database via a
graphical user interface data required by the standard operating procedures
concerning how the at least one processing step for the login, handling,
storage conditions, reconstitution or surgical use of the transplantable

5 “In determining the eligibility of respondents’ claimed process for patent
protection under § 101, their claims must be considered as a whole.” Diehr,
450 U.S. at 188.
6 2019 Revised 101 Guidance, page 52, footnote 14 (“If a claim, under its
broadest reasonable interpretation . . . .”) (Emphasis added.)
7 “First, it is always important to look at the actual language of the claims.
. . . Second, in considering the roles played by individual limitations, it is
important to read the claims ‘in light of the specification.’” Smart Sys.
Innovations, LLC v. Chicago Transit Auth., 873 F.3d 1364, 1378 (Fed. Cir.
2017) (J. Linn, dissenting in part and concurring in part), citing Enfish, 822
F.3d at 1335, among others.

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material by the staff member was carried out”; (5) processing data by
comparing information and allowing or disallowing access to data based on
the comparison,
(e) processing such data entered into the graphical user
interface by the software program which incorporates the
standard operating procedures to ensure that the step for the
login, handling, storage conditions, reconstitution, or surgical
use of the transplantable material was conducted strictly in a
manner compliant with the standard operating procedures by:
(i) comparing the content of the entered data field
against the contents of the corresponding standard
operating procedures for that processing step for the login,
handling, storage conditions, reconstitution, or surgical
use processing step to determine if compliance with the
standard operating procedure exists, including whether the
data field was not completed;
(ii) if compliance exists, then the software allowing
the staff member access to the next graphical user interface
relating to the next processing step for the login, handling,
storage conditions, reconstitution, or surgical use of the
transplantable material; and
(iii) if compliance does not exist, then the software
not allowing the staff member to access the next graphical
user interface relating to the next step for the login,
handling, storage conditions, reconstitution, or surgical
use of the transplantable material;
(6) assessing the patient, i.e., “(f) assessing the patient after transplantation
or implantation of the transplantable material for evidence of an adverse
effect”; (7) investigating results of the assessment, i.e., “(g) investigating
any such adverse effect discovered in the patient to determine whether it
constitutes an adverse reaction”; and (8) reporting the results of the
investigation, i.e., “(h) reporting any such adverse reaction to the supplier
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that supplied the transplant material to the medical establishment.” See id.
at 17–19 (Claims App.).
Limitations (i) and (j) of claim 1 simply narrow the type of
transplantable material and the type of medical establishment. The preamble
provides for “a computer database, processor, and software program
containing an organized set of instructions in coded language and having a
plurality of graphical user interfaces are provided for storing and processing
information.” Appeal Br. 17. Other than limitation (e) of processing data by
the software program, the remaining limitations of assigning, inspecting,
providing, entering, assessing, investigating, and reporting are not recited as
being performed by a computer. These limitations are recited functionally
without any implementation details on how, technologically or by what
algorithm, the assigning, inspecting, entering, assessing, investigating, and
reporting steps are performed, and can all be performed manually and
mentally. The Specification supports this finding. For example, the
Specification discusses that a supplier can assign a unique identification
number (see Spec. 26, l. 15), and hospital staff perform the actions of
logging in material that “includes a unique identification number for each
piece . . . (specially assigned where necessary)” (id. at 25, ll. 5–7), entering
information into the system (see id. at 25, l. 20–26, l. 14), inspecting the
material (see id. at 26, l. 24–27, l. 9), “creat[ing] specific policies and
procedures regarding how it should handle, store, and transplant the
transplantable material” (id. at 27, ll. 10–12), and performing a post-
operative assessment and determining whether an adverse effect has
occurred, after which the hospital notifies the tissue bank and enters data
into a system (see id. at 16, ll. 5–14; 17, ll. 9–15). See also id. at 31,
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ll. 19–29; 33, ll. 10–15. The Specification makes clear, “[a] critical
component for the comprehensive tissue management method 26 of the
present invention is the hospital staff 202. As shown in Fig, 3, a trained staff
member must be designated with responsibility for each of the process steps
described above.” Spec. 30, ll. 8–10; see also id. at 38, ll. 21–25.
When considered collectively and under the broadest reasonable
interpretation, the limitations of claim 1 recite a method for tracking
processing of transplantable material to ensure compliance with procedures
by assigning, providing, entering, processing, and limiting access to data,
inspecting the material, assessing a patient, investigating the results of the
assessment, and reporting the results of the investigation.8 This is an
abstract idea comprising “[m]ental processes—concepts performed in the
human mind (including an observation, evaluation, judgment, opinion)” and
a “[c]ertain method[] of organizing human activity— . . . managing personal
behavior or relationships or interactions between people (including social
activities, teaching, and following rules or instructions).” 2019 Revised
Guidance, 84 Fed. Reg. at 52. We note that under the Appellant’s
characterization of claim 1 reciting a method for compliance (see Appeal
Br. 8), the claim still recites an abstract idea of a mental process and a
method of organizing human activity of managing personal behavior.
The courts have held similar concepts to be abstract. For example, the
Federal Circuit has held abstract the concepts of the “simple information

8 We note that this characterization is similar to the Examiner’s, and 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.
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exchange” of “keeping track of deadlines for clients and carrying out two-
way communications with clients relevant to meeting those deadlines [and]
using computers and networks to do so” in WhitServe LLC v. Donuts Inc.,
809 F. App’x 929, 933 (Fed. Cir. 2020), “collecting information, analyzing
it, and displaying certain results of the collection and analysis” in Electric
Power, 830 F.3d at 1353, “cataloging labor data” to ensure compliance with
jurisdictional rules in Shortridge v. Found. Constr. Payroll Serv., LLC, 655
F. App’x 848, 850–52 (Fed. Cir. 2016), tracking and storing information on
financial transactions for budgeting purposes in Intellectual Ventures I LLC
v. Capital One Bank (USA), 792 F.3d 1363, 1365–67 (Fed. Cir. 2015), and
“controlling access to resources” in Ericsson Inc. v. TCL Commc’n Tech.
Holdings Ltd., 955 F.3d 1317, 1327 (Fed. Cir. 2020). As such, we disagree
with the Appellant’s contentions that claim 1 does not recite an abstract idea
similar to that of Electric Power. See Appeal Br. 7; Reply Br. 4–5.
Having concluded that claim 1 recites a judicial exception, i.e., an
abstract idea, in determining whether the claim is directed to this abstract
idea, we next consider whether the claim recites additional elements that
integrate the judicial exception into a practical application.
Integration into a Practical Application
Under Step 2A, Prong Two of the 2019 Revised Guidance (84 Fed.
Reg. at 54), 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.” Here, the only additional elements recited in
claim 1 beyond the abstract idea are “a computer database, processor, and
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software program containing an organized set of instructions in coded
language and having a plurality of graphical user interfaces,” elements that,
as the Examiner observes (see Final Act. 4), are described in the
Specification as generic computing elements. For example, the
Specification describes a system that “comprises a general programmable
computer 42 having a central processing unit (“CPU”) 44 controlling a
memory unit 46, a storage unit 48, an input/output (“I/O”) control unit 50,
and at least one monitor 52,” and “may also include clock circuitry, a data
interface, a network controller, and an internal bus,” along with “other
peripheral components such as printers, drives, keyboards, mice, barcode
scanners, and the like.” Spec. 16, ll. 26–33; Fig. 2. “Additionally, one
skilled in the art will recognize that the programmable computer 42 can
utilize known hardware, software, and the like configurations of varying
computer components to optimize the storage and manipulation of the data
and other information contained within the comprehensive tissue
management system 10.” Id. at 16, l. 34–17, l. 7. The computer system also
“includes a software program 54 having a plurality of graphic user interfaces
(“GUIs”) that permit the input of data” and the display of data. Id. at 17,
ll. 9–11, 21. “The computer system on which the system resides may be a
standard PC, laptop, server, handheld wireless device, or any automated data
processing equipment capable of running software for monitoring the
progress of the transplantable material.” Id. at 18, ll. 12–14. See also id.
at 18, ll. 14–31 (describing generic computer components).
We find no indication in the Specification, nor does the Appellant
direct us to any indication, that the operations recited in claim 1 require any
specialized computer hardware or other inventive computer components,
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i.e., a particular machine, invoke any asserted inventive programming, or
that the claimed invention is implemented using other than generic computer
components to perform generic computer functions. See DDR Holdings,
LLC v. 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.”).
The Appellant contends that claim 1 “provide[s] a method in which
the software program manipulates the computer to turn it into a compliance
monitor for ensuring that the staff member is complying with the standard
operating procedures adopted by the hospital or tissue bank employer for
safely processing the transplantable material and properly documenting
those process steps to enable the hospital or tissue bank to respond to a
patient adverse reaction to the transplantable material or product recall
within the industry.” Appeal Br. 8; see also Reply Br. 5. We disagree.
Rather, the claim recites steps that are mostly performed manually/mentally
and uses a computer in its ordinary capacity to receive, process, and display
information. At best, the additional elements outside the abstract idea link
the need for complying with the use of standard operating procedures (id.) to
the particular technological environment of the Internet and computers. See
Alice, 573 U.S. at 223 (holding that attempting to limit the use of an abstract
idea to a particular technological environment does not make a claim patent-
eligible) (quoting Bilski, 561 U.S. at 610–11); Affinity Labs of Tex., LLC v.
DIRECTV, LLC, 838 F.3d 1253, 1259 (Fed. Cir. 2016) (“[M]erely limiting
the field of use of the abstract idea to a particular existing technological
environment does not render the claim[] any less abstract”).
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The Appellant also contends that claim 1’s “software program with its
‘lock-out’ functionality makes the methods for properly tracking and tracing
the transplantable materials self-auditing,” and “elevates the methods to
something more than an abstract idea” and improves a “computerized
system.” Appeal Br. 8, 11.9 We disagree. Claim 1 does not recite
limitations reciting tracing, a “lock-out” function, or “self-auditing.” To the
extent the Appellant relies on limitation (e) reciting the conditional allowing
of a staff member to the next graphical interface (see Reply Br. 4), we note
that controlling access to data based on criteria is part of the abstract idea,
i.e., not an additional element, and is an abstract idea itself. Dropbox, Inc. v.
Synchronoss Techs., Inc., No. 2019-1765, 2020 WL 3400682, at *3 (Fed.
Cir. June 19, 2020); Smartflash LLC v. Apple Inc., 680 F. App’x 977, 982
(Fed. Cir. 2017) (holding abstract controlling access to content data).
Ericsson, 955 F.3d at 1327 (holding that controlling access to resources is a
process that “can be performed in the human mind, or by a human using a
pen and paper” that long predates the claimed invention and “is pervasive in
human activity”). To the extent the Appellant relies on limitations (d) and
(e) reciting entering into a database data regarding how the processing of
login, handling, storage, reconstitution, or surgical use was carried out by a
staff member, and processing the data by comparing it to standard auditing
procedures, entering and comparing data are also part of the abstract idea
and do not recite steps describing “self-auditing.”

9 We acknowledge that many of the Appellant’s arguments may be properly
evaluated under Step 2 of Alice/Mayo (Step 2B of 2019 Revised Guidance).
Solely for purposes of maintaining consistent treatment within the Office,
we evaluate these arguments under Step 1 of Alice/Mayo (Step 2A of 2019
Revised Guidance). See 2019 Revised Guidance, 84 Fed. Reg. at 55.
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The Appellant argues that, similar to DDR Holdings, claim 1 does not
“recite the performance of a business practice known from the pre-Internet
world along with the requirement that it be performed on the Internet,” but
rather recites “an innovative computer-implemented software system that
produces a result that could not be achieved via a paper and pencil tracking
system that would have no lock-out functionality or self-auditing feature.”
Appeal Br. 9; Reply Br. 6. However, the Appellant does not provide
reasoning or evidence, and we do not see from the claim, how the limitations
claim a technological solution to computer-based problem, i.e., a solution
“necessarily rooted in computer technology in order to overcome a problem
specifically arising in the realm of computer networks.” DDR Holdings, 773
F.3d at 1257; cf. Appeal Br. 9, 15. The Appellant does not specify what
problem is being addressed by the inventors. See Appeal Br. 9–15. At best,
the Appellant contends, and the Specification indicates, that the invention
addresses the problems of “individual hospitals and tissue banks all too often
ignor[ing] these mandates [regarding documentation] in practice, and their
staff members ignor[ing] the necessary steps for properly handling and
documenting transplantable materials through ignorance or lack of
commitment.” Appeal Br. 15. Further, “employer institutions had to rely
upon periodic human auditing of their human staff members’ actions for
treating the transplantable materials and documenting such steps to ensure
compliance with their standard operating procedures (to the extent that they
even existed).” Id.; see also Reply Br. 11–12 (discussing previous problems
related to infections and recall difficulties); Spec. 8, l. 13–10, l. 25; supra.
However, as the Appellant acknowledges, ensuring compliance with
standard procedures and providing adequate documentation are not problems
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rooted in technology, but existed prior to the internet. See Appeal Br. 15;
Spec. 8, l. 13–10, l. 25.
Further, the purported solution comprises a generic computer
operating in its ordinary and conventional capacity. See supra; see also
Alice, 573 U.S. at 224–26. The Appellant does not contend that they
invented any of the claimed components or their basic functions or that those
components, claimed generally, were unknown in the art as of time of the
invention. See Affinity Labs, 838 F.3d at 1270. The “focus” of the claim is
not “on the specific asserted improvement in computer capabilities” (Enfish,
822 F.3d at 1336), but rather on using a computer to implement the abstract
idea of tracking the processing of a transplantable material to ensure
compliance to procedures.
Regarding the Appellant’s references to McRO, Inc. v. Bandai Namco
Games Am. Inc., 837 F.3d 1299 (Fed. Cir. 2016) and Thales Visionix Inc. v.
United States, 850 F.3d 1343 (Fed. Cir. 2017) (see Appeal Br. 10, 13–14;
Reply Br. 10–11), the claims there were directed to a specific improvement
in computer technology. In McRO, the claims were directed to computer
animation and used rules to automate a subjective task of humans to create a
sequence of synchronized, animated characters. See McRO, 837 F.3d at
1314–15. Unlike Flook, Bilski, and Alice, it was not the use of the computer,
but the incorporation of the rules that improved an existing technological
process. Id. at 1314. In finding the claims patent-eligible, McRO noted that
the “abstract idea exception has been applied to prevent patenting of claims
that abstractly cover results where ‘it matters not by what process or
machinery the result is accomplished.’ [O’Reilly v. Morse, 56 U.S. (15
How.) 62, 113 (1853)]; see also Mayo, [566 U.S. at 85].” Id. In Thales, the
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claims were directed to a physical tracking system that used mathematical
equations that were “dictated by the placement of the inertial sensors and
application of laws of physics” to determine the orientation of a tracked
object relative to a moving platform. Thales, 850 F.3d at 1348. In other
words, the improvement was to the technology in a physical tracking system.
Here, there is no such improvement to technology or a technological
process.
The Appellant does not assert an improvement in the technical or
technological aspects of the assigning, inspecting, providing, entering,
processing/comparing, assessing, investigating, and reporting steps. Here,
the steps are not limited to how they are accomplished, but rather recite the
result of whatever process is used to generate (i.e., assign), organize (i.e.,
enter), and analyze (i.e., inspect, process, and assess) data, and perform an
action based on the results of the analyses (i.e., investigate and report). As
discussed above, these limitations say little about how these functions are
performed. See SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1167 (Fed.
Cir. 2018) (explaining that the claims in McRO “avoided being ‘abstract’ in
another sense reflected repeatedly in our cases” because “they had the
specificity required to transform a claim from one claiming only a result to
one claiming a way of achieving it”). Although the Appellant states the
claim incorporates “rules” (Appeal Br. 12), these rules are part of the
analysis of comparing data and allowing access based on that comparison.
The Appellant also does not direct our attention to anything in the
Specification to indicate that the invention provides a technical
improvement, such as incorporating rules to automate a subjective task of
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humans to improve a technical field, similar to those in McRO, or to an
improvement to a physical tracking system as in Thales.
The Appellant’s comparisons with Enfish (see Appeal Br. 10–11) are
also unpersuasive of Examiner error. In Enfish, the court held that the focus
of the claims was to “a specific improvement to the way computers operate,
embodied in the self-referential table.” 822 F.3d at 1336. Specifically, “the
claims [were] not simply directed to any form of storing tabular data, but
instead [were] specifically directed to a self-referential table for a computer
database.” Id. at 1337. The Specification provided that “the self-referential
table function[ed] differently than conventional database structures” (id.)
and improved “the way a computer stores and retrieves data in memory” (id.
at 1339). Here, however, the claim receives information and at best,
organizes it into a conventional database, but does not use or create an
unconventional database structure. The focus of the claim is unrelated to
how databases and tables function, and the Appellant does not purport to
have invented the claimed database. The claim does not recite any
improvement to the way in which the database stores or organizes
information analogous to the self-referential table in Enfish.
The Appellant repeatedly argues that claim 1 is not directed to an
abstract idea because it improves prior art systems. See Appeal Br. 8
(arguing the invention “represents a significant advance over the prior art
known before 2006 in the medical industry where staff members had to rely
upon standard operating procedures written down on paper (to the extent that
they existed at all), and in many cases failed to adhere to those standard
operating procedures in their own actions and paper documentation with the
result that adverse reaction investigations and product recalls floundered”);
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9 (citing DDR Holdings and arguing that the invention “incorporat[es]
instead an innovative computer-implemented software system that produces
a result that could not be achieved via a paper and pencil tracking system
that would have no lock-out functionality or self-auditing feature.”); 11–12
(citing BASCOM Glob. Internet Servs., Inc. v. AT&T Mobility LLC, 827 F.3d
1341 (Fed. Cir. 2016) and arguing claim 1 “define[s] the associated tissue
tracking and tracing system via the lock-out functionality and self-auditing
features of the software run on a computer system that makes significant
improvements over the prior art computer inventory control systems . . . and
certainly over pen and paper systems otherwise known in the prior art”); 12
(citing Trading Tech. Int'l, Inc. v. CQG, INC., 675 F. App’x 1001 (Fed. Cir.
2017) and arguing “[h]ere, Applicant’s method claims are directed to a
software-implemented computerized tissue tracking and tracing system that
adds compliance monitoring via the lock-out functionality and self-auditing
features that were previously unavailable in and improve upon prior art
systems. [The] Examiner . . . has already determined that Applicant’s
method claims are patentable under Sections 102 and 103, so the claims
should be patent-eligible under Section 101 too.”); 13–14 (arguing
“Applicant has improved upon previous known technology for tracking or
tracing transplantable materials by providing a method embodying software
that both teaches the staff member what needs to be properly done with
regard to the piece of transplantable material, and self-monitors and enforces
the follow through by that staff member in accordance with the standard
operating procedures.”); Reply Br. 5–6, 8, 11. However, a claim is not
abstract and does not “integrate the [abstract idea] into a practical
application” (as the term is used in the 2019 Revised Guidance, 84 Fed. Reg.
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at 55) just because the prior art does not disclose or suggest it. See Mayo,
566 U.S. at 78. “Groundbreaking, innovative, or even brilliant discovery
does not by itself satisfy the § 101 inquiry.” Ass’n for Molecular Pathology
v. Myriad Genetics, Inc., 569 U.S. 576, 591 (2013). 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”). As discussed above, the claim does not
purport to improve a technological system or technical area, but simply uses
a computer to implement a process that was previously performed manually
and mentally.
We disagree that claim 1 here is similar to those of Trading
Technologies. See Appeal Br. 12; see also Reply Br. 9. In Trading
Technologies, the Federal Circuit affirmed the district court’s denial of
CQG’s motion for judgment as a matter of law and determined that “the
claimed subject matter is ‘directed to a specific improvement to the way
computers operate,’ . . . for the claimed graphical user interface method
imparts a specific functionality to a trading system ‘directed to a specific
implementation of a solution to a problem in the software arts.’” 675
F. App’x at 1006 (citations omitted). Specifically, the Federal Circuit held
that the district court’s conclusion that “the specific structure and concordant
functionality of the graphical user interface are removed from abstract ideas,
as compared to conventional computer implementations of known
procedures” was in “accord with precedent.” Id. at 1004. In contrast, here,
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the Appellant does not identify how the claim solves a problem in the
software arts. Here, a generic computer is used to receive and present data,
claim 1 provides no details on the technological specifics of the graphical
user interface(s), and there is no indication that claim 1 improves the
functioning of the computer, makes it operate more efficiently, or solves a
technological problem with a solution rooted in computer technology. Here,
there is no improvement to the existing display or graphical user interface.
Rather, the claim here is similar to those of Trading Tech. Int’l., Inc. v. IBG
LLC, 921 F.3d 1084, 1095 (Fed. Cir. 2019) that did not “solve any purported
technological problem.”
Regarding the Appellant’s further argument that the claim is similar to
those of BASCOM (see Appeal Br. 1–12; Reply Br. 9), the Appellant does
not show how the claim here is similar to BASCOM’s “particular
arrangement of elements [that] is a technical improvement over prior art
ways of filtering such content” (827 F.3d at 1350). The patent at issue in
BASCOM “claim[ed] a technology-based solution (not an abstract-idea-
based solution implemented with generic technical components in a
conventional way) to filter content on the Internet that overcomes existing
problems with other Internet filtering systems.” Id. at 1351. The court
determined that “[b]y taking a prior art filter solution (one-size-fits-all filter
at the ISP server) and making it more dynamic and efficient (providing
individualized filtering at the ISP server), the claimed invention represents a
‘software-based invention[ ] that improve[s] the performance of the
computer system itself.’” Id. Here, there is no such improvement.
Although the claim recites the structural element of a computer with a
database, processor, and program, as discussed above, there is no claimed
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technological improvement to these structures or arrangement of these
structures. Any improvement in the invention lies in the abstract idea itself,
i.e., tracking processing of transplantable material to ensure compliance with
procedures.
The Appellant further argues that claim 1 is similar to the claims held
patent-eligible in Finjan, Inc. v. Blue Coat Systems, Inc., 879 F.3d 1299
(Fed. Cir. 2018) and Core Wireless Licensing, S.A.R.L. v. LG Electronics,
Inc., 880 F.3d 1356 (Fed. Cir. 2018). Reply Br. 7–8. However, in both of
those cases, as the Appellant acknowledges (id.), the court found that the
claims recited a specific improvement in computer technology – by
“employ[ing] a new kind of file that enables a computer security system to
do things it could not do before” in Finjan (879 F.3d at 1305) and “an
improved user interface for electronic devices, particularly those with small
screens” in Core Wireless (880 F.3d at 1363). Here, as discussed above,
there is no improvement to computer technology; rather, claim 1 merely uses
a computer as a tool to apply the “comprehensive tissue management
business method for transplantable materials” (Reply Br. 1–2).
Accordingly, we conclude claim 1 does not contain an element or
combination of elements that imposes a meaningful limit on the abstract idea
that integrates the abstract idea into a practical application.
Thus, we are not persuaded of error in the Examiner’s determination
that claim 1 is directed to an abstract idea.
Step Two of the Mayo/Alice Framework
Under the second step in the Mayo/Alice framework (corresponding to
Step 2B of the 2019 Revised Guidance), we find supported the Examiner’s
determination that claim 1’s limitations, taken individually or as an ordered
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combination, do not amount to significantly more than the judicial
exception. See Final Act. 3–4.
The Appellant contends that claim 1 “require[s] a computer software
program that incorporates those adopted standard operating procedures for
leading the staff member user through those steps” (Appeal Br. 13) and
“produce[s] real-time compliance monitoring and enforcement of specific
standard operating procedures” (Reply Br. 13). However, simply requiring a
computer for “real-time” processing is not enough to transform an abstract
idea into a patent-eligible invention. See Ultramercial, Inc. v. Hulu, LLC,
772 F.3d 709, 722–23 (Fed. Cir. 2014) (claims requiring “a substantial and
meaningful role for the computer” did no more than instruct the practitioner
to implement the abstract idea on a generic computer); Customedia Techs.,
LLC v. Dish Network Corp., 951 F.3d 1359, 1364 (Fed. Cir. 2020) (“We
have held that it is not enough, however, to merely improve a fundamental
practice or abstract process by invoking a computer merely as a tool.”)
(citing cases).
The Appellant also argues that claim 1’s features of lock-out
functionality and self-auditing “provide that ‘something extra’ that converts
the system, even should it be determined to represent an abstract idea, into
subject matter that is eligible for patent protection under Section 101,”
similar to Berkheimer v. HP, Inc., 881 F.3d 1360 (Fed. Cir. 2018). Appeal
Br. 14. The Berkheimer decision arose in the context of District Court
patent infringement litigation and stands for the unremarkable proposition
that 35 U.S.C. § 101 eligibility issues are not always amenable to disposition
in district court on pre-trial motions under the Federal Rules of Civil
Procedure such as Rule 56 motions for summary judgment due to the need to
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resolve disputed issues of fact. In Berkheimer, the parties disputed whether
there were improvements to computer functionality captured in the claims.
Berkheimer, 881 F.3d at 1369. For some claims, the court held that
conventional limitations of “parsing data, analyzing and comparing the data
to previously stored data, and presenting the data for reconciliation when
there is a variance . . . amount to no more than performing the abstract idea
of parsing and comparing data with conventional computer components” and
do not capture an inventive concept. Id. at 1369–70. However, for some
claims, the Specification provided support for purported “benefits that
improve computer functionality” and thus, a genuine issue of material fact
existed to make summary judgment inappropriate for these claims. Id.
at 1370. In contrast, as discussed above, here there is no support in the
Appellant’s Specification that the claim, including the features of lock-out
functionality and self-auditing, captures improvements to computer
technology.
As discussed above, under Step 2B, we look to whether the additional
elements beyond the abstract idea, individually or in combination, provide
an inventive concept. 84 Fed. Reg. at 55. Alice is clear, as described above,
that under step two of the Mayo/Alice framework, the elements of each claim
are considered both individually and “as an ordered combination” to
determine whether the additional elements, i.e., the elements other than the
abstract idea itself, “transform the nature of the claim” into a patent-eligible
application. Alice, 573 U.S. at 217; see also Mayo, 566 U.S. at 72–73
(requiring that “a process that focuses upon the use of a natural law also
contain other elements or a combination of elements, sometimes referred to
as an ‘inventive concept,’ sufficient to ensure that the patent in practice
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amounts to significantly more than a patent upon the natural law itself”). In
other words, the inventive concept under step two of the Mayo/Alice
framework cannot be the abstract idea itself: “It is clear from Mayo that the
‘inventive concept’ cannot be the abstract idea itself, and Berkheimer . . .
leave[s] untouched the numerous cases from this court which have held
claims ineligible because the only alleged ‘inventive concept’ is the abstract
idea.” Berkheimer v. HP Inc., 890 F.3d 1369, 1374 (Fed. Cir. 2018) (Moore,
J., concurring); see also BSG Tech LLC v. Buyseasons, Inc., 899 F.3d 1281,
1290 (Fed. Cir. 2018) (“It has been clear since Alice that a claimed
invention’s use of the ineligible concept to which it is directed cannot supply
the inventive concept that renders the invention ‘significantly more’ than
that ineligible concept.”) (citation omitted).
To the extent the Appellant argues that claim 1 recites elements that
amount to significantly more than the abstract idea because the claim is
novel over the prior art (see supra; Appeal Br. 15 (“there were no previously
well-known business practices or technology available within the industry
for achieving these laudable goals”), as discussed above, 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.
Here, the Examiner considers the only additional element beyond the
abstract idea to be the computer database, processor, and software program.
See Final Act. 4. We note that, as discussed above with respect to Step 1 of
the Alice/Mayo framework, claim 1 simply recites the functional results to
be achieved manually or by a conventional computing system. The claims
“provide[] only a result-oriented solution[] with insufficient detail for how a
computer accomplishes it. Our law demands more.” Intellectual Ventures I
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LLC v. Capital One Fin. Corp., 850 F.3d 1332, 1342 (Fed. Cir. 2017). The
claimed functions of providing procedures, entering data, processing data by
comparing it, allowing access based on the results of the comparison, i.e.,
the “lock-out functionality” (see, e.g., Appeal Br. 15) are part of the abstract
idea itself; they are not additional elements to be considered when
determining whether claim 1 includes additional elements or a combination
of elements that is sufficient to amount to significantly more than the
judicial exception.
As discussed above, the only claim elements beyond the abstract idea
are the computer database, processor, and software program with graphical
user interfaces, recited generally, and that the Specification indisputably
shows were conventional at the time of filing. See supra; Spec.
16, l. 26–18, l. 31; Fig. 2. The Appellant does not provide any supported
reasoning or explanation that the functions of assigning a code, inspecting
material, providing procedures data, entering data, processing data by
comparing data, allowing or disallowing access to data based on the
comparison, assessing a patient, investigating based on the assessment, and
reporting the results of the investigation are not well-understood, routine,
and conventional. Cf. Intellectual Ventures I LLC, 792 F.3d at 1369–71
(holding that “the entry of data into a computer database, the breakdown and
organization of that data according to some criteria, . . . and the transmission
of information derived from that entered data to a computer user, all through
the use of conventional computer components, such as a database and
processors, operation in a conventional manner” did not transform a patent-
ineligible process into something more); Elec. Power, 830 F.3d at 1355
(gathering, sending, monitoring, analyzing, selecting, and presenting
Appeal 2019-005491
Application 14/192,542

35
information does not transform the abstract process into a patent-eligible
invention); FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1095
(Fed. Cir. 2016) (generating a rule related to accessing information, applying
the rule, and storing and announcing the result did not transform the abstract
idea into a patent-eligible invention).
Thus, we are not persuaded of error in the Examiner’s determination
that the limitations of claim 1 do not transform the claim into significantly
more than the abstract idea.
For at least the reasons above, we sustain the Examiner’s rejection
under 35 U.S.C. § 101 of independent claim 1 and of claims 2–22, the
rejection of which stands with claim 1.

CONCLUSION
The Examiner’s decision to reject claims 1–22 under 35 U.S.C. § 101
is sustained.
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–22 101 Eligibility 1–22

TIME PERIOD FOR RESPONSE
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)(l)(iv).

AFFIRMED