Frederic J. Huser

Patent Trials and Appeals Board

Nov 27, 2019

14860248 - (D) (P.T.A.B. Nov. 27, 2019)

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.
14/860,248 09/21/2015 Frederic J. HUSER 6530.1008A 5947
23280 7590 11/27/2019
Davidson, Davidson & Kappel, LLC
589 8th Avenue
16th Floor
New York, NY 10018
EXAMINER
COBANOGLU, DILEK B
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
11/27/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
ddk@ddkpatent.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
_________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte FREDERIC J. HUSER
____________________

Appeal 2018-001224
Application 14/860,2481
Technology Center 3600
____________________

Before ROBERT E. NAPPI, ERIC S. FRAHM, and MICHAEL T. CYGAN,
Administrative Patent Judges.

FRAHM, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 1–15 and 18–25, which constitute all
the claims pending in this application. Claims 16 and 17 have been canceled
(see Final Act. 2). We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 The instant application on appeal is a continuation application of U.S.
Patent Application Serial No. 13/771,704, abandoned on February 20, 2013,
which claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional
Application 61/601,308 filed February 21, 2012 (see Spec. ¶ 1).
2 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. “The word ‘applicant’ when used in this title refers to the
inventor or all of the joint inventors, or to the person applying for a patent as
provided in §§ 1.43, 1.45, or 1.46.” Appellant identifies the real party in
interest as the inventor, Frederic J. Huser (Appeal Br. 2).
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STATEMENT OF THE CASE
Disclosed Invention and Exemplary Claim
According to Appellant, the present invention “provides a process for
making [a] drug available to the public as an over-the-counter [OTC]
medication, with certain restrictions that the inventor believes would be
acceptable to both FDA and the drug manufacturer/distributor” (Appeal Br.
16). More specifically, Appellant discloses the claimed method as useful
and applicable for drugs with “a long-standing need for an Rx-to-OTC
switch” (Spec. ¶ 5), for example, “cholesterol drugs such as lovastatin and
pravastatin” (id.; see also id. ¶¶ 5, 6, 8, 56), and diabetes and hypertension
drugs (see id. ¶ 56). According to Appellant:
A significant public health benefit could be derived if these
medications were accessible in a more convenient, more
widespread OTC purchase environment. Further, if
prescription drugs for chronic conditions can be made more
broadly and more inexpensively available with appropriate
safeguards, then the population will have better access to these
drugs and be healthier overall.

(Id. ¶ 15.)
[T]he diagnostic actions will be administered only at the point
of sale (“POS”) in Food, Drug, or Mass Merchandiser stores
which have Clinical Laboratories Improvement Act (“CLIA”)
certificates of waiver from the appropriate state and/or federal
regulatory body to conduct CLIA-waived diagnostic tests with
trained healthcare personnel present (such as those in a
pharmacy) and will be conducted by retail store healthcare
personnel to determine before drug use the presence of the
chronic condition and to determine after drug use drug
effectiveness and safety in the individual patient.

(Id. ¶ 1.)
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Exemplary independent claim 1 under appeal recites a method of
offering a drug for sale as an OTC product based on real-time diagnostic
results at a point-of-sale location, and is reproduced below with emphases
and bracketed lettering added to key portions of the claim at issue:
1. A method of offering for sale a drug as an over-the-
counter (OTC) product based on the real time diagnostic results
at a point-of-sale location from a specific CLIA-waived
diagnostic test identified in a condition-of-use label for the
drug, comprising
[A] administering a specific CLIA-waived diagnostic test
to a human patient by having a healthcare person obtain a fluid
sample from the patient at a point-of-sale location,
[B] testing the fluid sample in the specific CLIA-waived
diagnostic machine at the point-of-sale location, wherein the
CLIA-waived diagnostic machine analyzes the fluid sample and
delivers results in less than 30 minutes regarding a biomarker,
[C] determining whether the human patient is a candidate
for treatment with a drug by having a healthcare person at the
point-of-sale location analyze the results of the CLIA-waived
diagnostic test to determine if the biomarker is within a
required range as indicated on the condition-of-use label, and
[D] offering to the patient a drug regimen comprising a
plurality of unit doses of the drug only if the results of the
diagnostic test indicate that the patient would benefit from
treatment with the drug.
Appeal Br., Appendix A, A1 (emphases and bracketed lettering added).
Remaining independent claim 15 recites a method of treating a human
patient on an OTC basis with a drug having limitations commensurate in
scope with limitations [A]–[D] of claim 1.
The Examiner’s Rejections
(1) Claims 1, 4, and 24 stand rejected under 35 U.S.C. § 101 as being
directed to non-statutory subject matter (a human being) (Final Act. 2–3).
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Because this rejection has been withdrawn by the Examiner (see Ans. 2), we
do not consider it further herein.
(2) Claims 1–15 and 18–25 stand rejected under 35 U.S.C. § 101 as
being directed to patent-ineligible subject matter (an abstract idea) (Final
Act. 3–6).
(3) Claims 1–15 and 18–25 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Keravich et al. (US 2009/0125324 A1; published
May 14, 2009) (hereinafter, “Keravich”) and Appellant’s Admitted Prior Art
found at paragraphs 58 and 59 of the Specification (hereinafter, “AAPA”)
(Final Act. 7–21).
Appellant’s Contentions
(1) Appellant contends (Appeal Br. 11–23; Reply Br. 4–15) that the
Examiner erred in rejecting claims 1–15 and 18–25 under 35 U.S.C. § 101.
Specifically, Appellant contends the claims are not directed to an abstract
idea (Appeal Br. 11–17; Reply Br. 4–11) and the claimed invention amounts
to significantly more than an abstract idea (Appeal Br. 17–23; Reply Br. 14–
15). Appellant primarily presents arguments as to independent claims 1 and
15 (Appeal Br. 11–23; Reply Br. 4–15), and asserts that the dependent
claims include similar limitations as claims 1 and 15 and are, therefore,
patent eligible for the same reasons. Both method claims 1 and 15 contain
commensurate limitations and are argued for similar reasons. Therefore,
with regard to the patent-eligibility rejection, we select claim 1 as
representative of the group of claims 1–15 and 18–25 pursuant to our
authority under 37 C.F.R. § 41.37(c)(1)(iv).
(2) Appellant contends (Appeal Br. 23–33; Reply Br. 15–22) that the
Examiner erred in rejecting claims 1–15 and 18–25 under 35 U.S.C.
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§ 103(a). Appellant generally contends that Keravich teaches away from the
claimed invention (Appeal Br. 25–26; Reply Br. 17, 19–21), because
Keravich seeks to avoid interaction of a healthcare person at a point of sale,
whereas the recited invention requires the intervention of health care
personnel, in the offering for sale of a drug (see Appeal Br. 25). Appellant
also contends the Examiner’s motivation for combining Keravich and AAPA
is insufficient and uses impermissible hindsight (see Appeal Br. 26; Reply
Br. 19).
Principal Issues on Appeal
Based on Appellant’s arguments in the Appeal Brief (Appeal Br. 11–
33) and Reply Brief (Reply Br. 4–22), the following principal issues are
presented on appeal:
(1) Has Appellant shown the Examiner erred in rejecting claims 1–15
and 18–25 under 35 U.S.C. § 101 as being directed to patent-ineligible
subject matter, because representative claim 1 is directed to an abstract idea
that is not patent eligible, without significantly more?
(2) Has Appellant shown the Examiner erred in rejecting claims 1–15
and 18–25 under 35 U.S.C. § 103(a) because Keravich teaches away from
the invention recited in claim 1?

ANALYSIS
Issue (1): Patent Eligibility Under 35 U.S.C. § 101
We have reviewed the Examiner’s (i) Final rejection (Final Act. 3–6);
and (ii) Advisory Action mailed February 17, 2017 (“Adv. Act.” 2), in light
of Appellant’s contentions in the Briefs that the Examiner erred (Appeal Br.
11–23; Reply Br. 4–15), as well as the Examiner’s response to Appellant’s
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arguments in the Appeal Brief (see Ans. 3–13), and the evidence of record.
We are not persuaded by Appellant’s contentions that the Examiner erred in
rejecting claims 1–15 and 18–25 under 35 U.S.C. § 101 as being directed to
patent-ineligible subject matter, without significantly more. With regard to
representative claim 1 rejected under 35 U.S.C. § 101, we adopt as our own
(1) the findings and reasons set forth by the Examiner in the Final Office
Action from which this appeal is taken (Final Act. 3–6), as well as the
Advisory Action mailed February 17, 2017 (Adv. Act. 2); and (2) the
reasons set forth by the Examiner in the Examiner’s Answer (Ans. 3–13) in
response to Appellant’s Appeal Brief. We concur with the conclusions
reached by the Examiner, and add the following for emphasis.
Section 101 of the Patent Act provides “[w]hoever invents or
discovers any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement thereof, may
obtain a patent therefor, subject to the conditions and requirements of this
title.” 35 U.S.C. § 101. However, the Supreme Court has long 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 Supreme Court’s two-step 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
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mitigate settlement risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611
(2010) (“Claims 1 and 4 in petitioners’ application explain the basic concept
of hedging, or protecting against risk.”).
Concepts determined to be abstract ideas and, thus, patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219–20; Bilski, 561 U.S. at 611);
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and
mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as “molding rubber products” (Diamond v. Diehr, 450 U.S. 175, 191
(1981)); “tanning, dyeing, making water-proof cloth, vulcanizing India
rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S.
(15 How.) 252, 267–68 (1853))); and manufacturing flour (Benson, 409 U.S.
at 69 (citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Supreme Court held that “a claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
mathematical formula.” Diehr, 450 U.S. at 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 Supreme Court also indicated that a claim “seeking patent
protection for that formula in the abstract . . . is not accorded the protection
of our patent laws, and this principle cannot be circumvented by attempting
to limit the use of the formula to a particular technological environment.”
Id. (citing Benson and Flook); see, e.g., id. at 187 (“It is now commonplace
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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 (internal 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.
The PTO recently published revised guidance on the application of
§ 101. USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance,
84 Fed. Reg. 50 (Jan. 7, 2019) (“Guidance”). Under the Guidance, we first
look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of
abstract ideas (i.e., mathematical concepts, certain methods of
organizing human activity such as a fundamental economic
practice, or mental processes) (Step 2A, Prong 1); and
(2) additional elements that integrate the judicial exception into
a practical application (see MANUAL OF PATENT EXAMINING
PROCEDURE (“MPEP”) §§ 2106.05(a)–(c), (e)–(h)) (9th Ed.,
Rev. 08.2017, 2018) (Step 2A, Prong 2).
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look to
whether the claim:
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(3) adds a specific limitation beyond the judicial exception that
is not “well-understood, routine, conventional” in the field (see
MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional
activities previously known to the industry, specified at a high
level of generality, to the judicial exception (Step 2B).
See Guidance, 84 Fed. Reg. at 54–56.
Even if the claim recites an abstract idea, the Federal Circuit explains
the “directed to” inquiry is not simply asking whether the claims involve a
patent-ineligible concept:
The “directed to” inquiry . . . cannot simply ask whether the
claims involve a patent-ineligible concept, because essentially
every routinely patent-eligible claim involving physical
products and actions involves a law of nature and/or natural
phenomenon—after all, they take place in the physical world.
See Mayo, [566 U.S. at 71] (“For all inventions at some level
embody, use, reflect, rest upon, or apply laws of nature, natural
phenomena, or abstract ideas.”) Rather, 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); see
also Diehr, 450 U.S. at 188 (“In determining the eligibility of respondents’
claimed process for patent protection under § 101, their claims must be
considered as a whole.”); McRO, Inc. v. Bandai Namco Games Am. Inc., 837
F.3d 1299, 1314 (Fed. Cir. 2016) (The question is whether the claims as a
whole “focus on a specific means or method that improves the relevant
technology or are instead directed to a result or effect that itself is the
abstract idea and merely invoke generic processes and machinery”).

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Step 1
Under Step 1 of the patent-eligibility inquiry under § 101, we
determine whether a claim is directed to one of the four statutory categories
of invention, i.e., a process, machine, manufacture, or composition of matter.
In the instant case on appeal, independent claims 1 and 15, as well as
claims 2–14 and 18–25 depending respectively therefrom, each recite “[a]
method of offering for sale a drug” (claims 1–14, 22) or “[a] method of
treating a human patient on an over-the-counter (OTC) basis with a drug”
(claims 15, 18–21, 23–25) having several steps for performing a series of
acts, for example, administering a point-of-sale, CLIA-waived diagnostic
test of a human patient, determining if the human patient is a candidate for
treatment, and “offering to the patient a drug regimen” (claims 1, 15).
Therefore, claims 1 and 15, and claims 2–14 and 18–25 depending
respectively therefrom, as method claims, recite at least one of the
enumerated categories (e.g., process) of eligible subject matter in 35 U.S.C.
§ 101.
As a result, as to claims 1–15 and 18–25, we continue our analysis
under Step 2A, Prong 1 of the Guidance to determine whether the claims (1)
recite a judicial exception (a law of nature, natural phenomenon, or subject
matter within the enumerated groupings of abstract ideas above); and (2) are
patent-eligible.
Step 2A, Prong 1
At a high level, representative claim 1 recites a method of offering for
sale a drug after determining if a patient would benefit from treatment with
the drug. According to Appellant, the present invention “provides a process
for making [a] drug available to the public as an over-the-counter [(OTC)]
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medication, with certain restrictions that the inventor believes would be
acceptable to both FDA and the drug manufacturer/distributor” (Appeal Br.
16).
The preamble and limitation [D] of the claim 1 are focused on, and
generally relate to, commercial/sales activities, i.e., offering a drug for sale,
which is a business relation between people (e.g., a patient/customer and a
pharmacy/seller/healthcare person or other business entity) (see generally
Spec. ¶¶ 2–7). As such, the claimed invention recites certain methods of
organizing human activity, which is an abstract idea. The Examiner
determines, and we agree, that claim 1 is “drawn to a method for offering for
sale a drug as an over-the-counter product” (Final Act. 3), and ‘“offering for
sale a drug based on real diagnostic results’” (Ans. 3). Limitations [A] and
[B] are routine data gathering steps, and recite a process for a healthcare
person to administer a diagnostic test to a human patient by obtaining a fluid
sample from a patient for testing of the fluid sample by a diagnostic machine
which outputs biomarker results. In limitation [C], a healthcare person
analyzes the test results to determine if the patient is a candidate for
treatment, and in limitation [D], a drug regimen is offered to the patient if
the test results indicate the patient would benefit, which are mental processes
involving evaluation and judgment. Finally, the correlation between (i)
determining if the patient is a candidate for treatment based on the
biomarker results being within a required range as set forth in limitation [C];
and (ii) the patient being benefited from treatment with the drug as set forth
in limitation [D], describes a natural law.
The method of offering a drug regimen in claim 1 of the instant case
has many similarities to the method of treatment found patent ineligible in
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Mayo. In Mayo, the Supreme Court found that claims covering laws of
nature, such as effective drug treatment regimens/dosages, are not patent
eligible. Mayo, 566 U.S. at 70. Similar to claim 1 in the instant case before
us, “the steps in the claimed processes [in Mayo] (apart from the natural
laws themselves) involve well-understood, routine, conventional activity
previously engaged in by researchers in the field” (id. at 73). As stated in
Mayo, the claimed process steps “simply tell doctors to gather data from
which they may draw an inference in light of the correlations” (id. at 79).
Limitations [A] and [B] set forth in claim 1 of the instant case are no
different – data is gathered in order to assist a healthcare person analyze the
results in limitation [C] in order to determine if the patient would benefit
from treatment with the drug before offering a drug regimen to the patient in
limitation [D]. In the words of the Supreme Court in Mayo:
To put the matter more succinctly, the claims inform a relevant
audience about certain laws of nature; any additional steps
consist of well-understood, routine, conventional activity
already engaged in by the scientific community; and those
steps, when viewed as a whole, add nothing significant beyond
the sum of their parts taken separately.

Id. at 79–80.
Moreover, but for the recitation of a “specific CLIA-waived
diagnostic machine at the point-of-sale location” used for “administering a
specific CLIA-waived diagnostic test to a human patient” (see claim 1,
preamble, limitations [A] and [B]), we find the recited steps or acts, could be
performed as mental steps, or with the aid of pen and paper, by the recited
“healthcare person” (claim 1, limitation [C]). See CyberSource Corp. v.
Retail Decisions, Inc., 654 F.3d 1366, 1375 (Fed. Cir. 2011) (“That purely
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mental processes can be unpatentable, even when performed by a computer,
was precisely the holding of the Supreme Court in Gottschalk v. Benson.”).
Our reviewing court has concluded that abstract ideas include the
concepts of collecting data, recognizing certain data within the collected data
set, and storing the data in memory. Berkheimer v. HP Inc., 881 F.3d 1360,
1366 (Fed. Cir. 2018) (concluding that the acts of parsing, comparing,
storing, and editing data are abstract ideas); Content Extraction &
Transmission LLC v. Wells Fargo Bank, Nat’l Ass’n, 776 F.3d 1343, 1347
(Fed. Cir. 2014) (abstract ideas include the concepts of collecting data,
recognizing certain data within the collected data set, and storing the data in
memory); see also Smart Sys. Innovations, LLC v. Chicago Transit Auth.,
873 F.3d 1364, 1372 (Fed. Cir. 2017) (concluding “claims directed to the
collection, storage, and recognition of data are directed to an abstract idea”).
Therefore, claim 1, which recites collecting and recognizing certain data
(limitations [A]–[C]), sets forth concepts recognized by our reviewing court
to be judicially excepted abstract ideas that are patent ineligible.
Moreover, the further-recited acts of (i) comparing data, such as the
biomarker comparison to a range recited in limitation [C]; and (ii) offering
the patient a drug regimen recited in limitation [D], are acts of observation
and evaluation that can be practically performed in the human mind, and are
therefore abstract ideas. 84 Fed. Reg. at 52. With regard to the biomarker
and range determination/comparison recited in limitation [C], collection of
information and analysis of information (e.g., recognizing certain data
within the dataset) are abstract ideas. Elec. Power, 830 F.3d at 1353. And,
with regard to both limitations [C] and [D], our conclusion that these acts are
part of an abstract mental process is further supported by case law. See
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Berkheimer, 881 F.3d at 1366 (concluding that acts of parsing, comparing,
storing, and editing data are abstract ideas); SAP Am., Inc. v. InvestPic, LLC,
898 F.3d 1161, 1167 (Fed. Cir. 2018)) (“[M]erely presenting the results of
abstract processes of collecting and analyzing information . . . is abstract as
an ancillary part of such collection and analysis.”); Intellectual Ventures I
LLC v. Capital One Fin. Corp., 850 F.3d 1332, 1340 (Fed. Cir. 2017)
(“collecting, displaying, and manipulating data” is an abstract idea);
Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351
(Fed. Cir. 2014) (holding that, without additional limitations, a process that
starts with data, applies an algorithm, and ends with a new form of data is
directed to an abstract idea).
Further, merely combining several abstract ideas (such as a
mathematical concept and a mental process) does not render the combination
any less abstract. RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327
(Fed. Cir. 2017) (“Adding one abstract idea . . . to another abstract idea . . .
does not render the claim non-abstract.”); see also FairWarning IP, LLC v.
Iatric Sys., Inc., 839 F.3d 1089, 1094 (Fed. Cir. 2016) (determining the
pending claims were directed to a combination of abstract ideas).
In this light, the method for offering for sale a drug to a patient,
including determining if treatment is beneficial based on test results and
analysis of a biomarker delivered from testing a fluid sample recited in claim
1, describes (1) a law of nature; (2) certain methods of organizing human
activity such as a fundamental economic practice like offering a drug for
sale; combined with (3) a mental process involving concepts performed in
the human mind (including an observation, evaluation, judgment, opinion)
like analyzing test results. Thus, we conclude claim 1 recites (1) a method
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of offering for sale a drug based on diagnostic results, through performance
of (2) observations and judgments capable of being performed in the human
mind, i.e., which is a mental process; and (3) applying laws of nature, based
on the correlation between (i) determining if the patient is a candidate for
treatment based on the biomarker results being within a required range, and
(ii) the patient being benefited from treatment with the drug. In other words,
claim 1 recites a combination of abstract ideas. We consider these
limitations together to be the recited abstract idea for purposes of the
eligibility analysis. October 2019 Patent Eligibility Guidance Update
(“Update”) at 2 (available at https://www.uspto.gov/sites/default/files/
documents/peg_oct_2019_update.pdf). Claims 2–15 and 18–25 grouped
with claim 1 contain similar subject matter, and similarly recite
combinations of abstract ideas. Because we conclude independent claim 1
and claims 2–15 and 18–25 grouped therewith recite a combination of
abstract ideas, we proceed to Step 2A, Prong 2 of the Guidance to determine
whether claim 1 is “directed to” the judicial exception, by determining
whether additional elements of the claim integrate the abstract idea into a
practical application. Such additional elements may reflect an improvement
to a technology or technical field. See Guidance, 84 Fed. Reg. at 55.
Step 2A, Prong 2 – Practical Application
Under Step 2A, Prong 2, we determine whether the recited judicial
exception is integrated into a practical application of that exception by (a)
identifying whether there are any additional elements recited in the claim
beyond the judicial exception(s); and (b) evaluating those additional
elements individually and in combination to determine whether they
integrate the exception into a practical application. If the recited judicial
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exception is integrated into a practical application, the claim is not directed
to the judicial exception. Thus, we determine whether the claims “focus on
a specific means or method that improves the relevant technology” or are
“directed to a result or effect that itself is the abstract idea and merely invoke
generic processes and machinery.” McRO, 837 F.3d at 1314.
Here, claim 1 recites the additional elements of “a drug,” “a
condition-of-use label,” “a human patient,” “a healthcare person,” “a fluid
sample,” “a point-of-sale location,” “a specific CLIA-waived diagnostic
test,” and a “specific CLIA-waived diagnostic machine” (claim 1).
Considering claim 1 as a whole, none of the additional elements applies or
uses the abstract idea in a meaningful way such that the claim as a whole is
more than a drafting effort designed to monopolize the exception.
Appellant has not shown claim 1 recites additional elements that
integrate the judicial exception into a practical application. In particular,
Appellant has not shown the additional elements (e.g., the CLIA-waived
diagnostic test machine) integrate the judicial exception into a practical
application. Appellant contends (Reply Br. 10) s that the “condition-of-use
label for the drug” recited in claim 1 is not merely an intended use of the
method. Appellant further contends (id. at 13–14) that the label provides
technical improvement in the form of improving compliance of patients with
the requirements of a label of a drug, and improving public access of the
drug, thereby confining the claims to a particular useful application of the
abstract idea.
We are not persuaded Appellant has shown that the recited label
provides any improvement to a technology. Appellant’s alleged
improvements relate to restricting which users may purchase drugs based on
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the suitability of the drug for the user based upon an associated suitability
test, and alleged reductions in cost due to the removal of a prescription
requirement and its associated costs. Reply Br. 13. However, Appellant
characterizes these alleged benefits as being due to regulatory change, rather
than any particular technological improvement. Id. (a “mandatory” test; “the
FDA should permit the switch”); Spec. ¶¶ 2 (“drug labeling is regulated by
the U.S. Food and Drug Administration (‘FDA’)),” 3 (“[a]ll such
combination [of drug with a particular test] labels heretofore approved by
the FDA are for Rx drugs only).” Appellant further characterizes the
improvement as providing “certain restrictions that the inventor believes
would be acceptable to both FDA and the drug manufacturer/distributor.”
Appeal Br. 16. Accordingly, we agree with the Examiner’s conclusion that
the additional limitations of the claims provide an improvement to a
technology or technical field. Ans. 13.
Additionally, the claimed invention administers and analyzes a test to
generate a biomarker. The Supreme Court in Mayo has determined that
steps of administering a drug to a patient in need of that drug merely defines
the relevant audience, and is not sufficient to transform the nature of the
claim into a patent-eligible claim. Mayo, 566 U.S. at 77–78. Further, the
step of determining the level of a relevant marker in a patient, by whatever
process the doctor or the laboratory wishes to use, is merely telling the
practitioner to engage in well-understood, routine, conventional activity
previously engaged in by those who work in the field, and as such, does not
provide significantly more to the identified judicial exception. Id. The
Court further stated that a limitation providing only that informing a medical
practitioner of the relevant natural laws, while trusting them to use those
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laws appropriately in their decision-making; e.g., by prescribing appropriate
drugs for a condition, does not, without more, provide eligibility to an
otherwise ineligible claim. Id. at 78. Thus, to the extent that the condition
of use label informs the practitioner of the relevant drug, or the relevant test
that may be applied, such is not considered to provide eligibility under
Mayo. As such, based on the record before us, we determine that the
claimed invention is not integrated into a practical application.
For the reasons discussed above, we conclude Appellant’s claim 1
(and claims 2–15 and 18–25 grouped therewith) invokes generic diagnostic
components merely as a tool in which the healthcare person applies the
judicial exception and, thus, the abstract idea is not integrated into a
practical application. Because claim 1 recites a judicial exception (laws of
nature, the abstract idea of a method of organizing human activity and a
mental process) that is not integrated into a practical application, in
accordance with the Guidance, we conclude claim 1 and claims 2–15 and
18–25 grouped therewith, are directed to an abstract idea under Step 2A, and
the eligibility analysis with regard to claims 1–15 and 18–25 proceeds to
Step 2B.
Step 2B – Inventive Concept
Having determined claim 1 and claims 2–15 and 18–25 grouped
therewith are directed to an abstract idea that is not integrated into a practical
application, we now evaluate whether the additional elements add a specific
limitation that is not well-understood, routine, or conventional activity in the
field, or simply append well-understood, routine, conventional activities
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previously known to the industry, specified at a high level of generality, to
the abstract idea. See Guidance.
In the instant case on appeal, the additional elements recited in claim
1 do not “contain[] an ‘inventive concept’ sufficient to ‘transform’ the
claimed abstract idea into a patent-eligible application.” Alice, 573 U.S. at
221 (internal quotation marks omitted), or “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). Instead, claim 1 merely recites well-understood, routine, or
conventional activity in the field previously known to the industry, specified
at a high level of generality, to the abstract idea.
For example, the “specific CLIA-waived diagnostic test to a human
patient” obtained from a fluid sample of the patient recited in claim 1 is
disclosed as being performed by a conventional and well-known device,
such as “a POS, CLIA-waived diagnostic machine” (Spec. ¶ 58), or a “table-
top diagnostic test equipment (the Piccolo Xpress)” which can deliver results
“in under 15 minutes” (id. ¶ 59). Thus, we agree with the Examiner that (i)
the claimed “CLIA-waived diagnostic machine is a well-known device that
analyzes the tests for the patients and it[]s functions . . . are well-understood,
routine and conventional activities previously known to the pertinent
industry” (Final Act. 5; see also Ans. 11); and (ii) “[t]he claims do not
include additional elements that are sufficient to amount to significantly
more than the judicial exception because the additional elements when
considered both individually and as an ordered combination do not amount
to significantly more than the abstract idea” (Ans. 11). We also agree with
the Examiner (see id. at 7–8) that paragraph 61 of Appellant’s Specification
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describes the Piccolo Xpress as being a well-known table-top diagnostic test
machine routinely used in the healthcare field for analyzing patient fluid
samples. Finally, Appellant discloses that the test machine itself is generic,
and “[t]he present invention is not limited by any particular diagnostic test
equipment,” and “currently available diagnostic equipment other than that
which is specifically described herein [(e.g., the Piccolo Express)] may be
used” (Spec. ¶ 62).
Thus, Appellant’s Specification only describes well-understood,
routine, conventional computerized and diagnostic testing device
components in a manner that indicates the components and the functions
they perform were well-known in the art. See Hybritech Inc. v. Monoclonal
Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986) (explaining that “a
patent need not teach, and preferably omits, what is well known in the
art”); see also Intellectual Ventures I LLC v. Erie Indem. Co., 850 F.3d
1315, 1331 (Fed. Cir. 2017) (“The claimed mobile interface is so lacking in
implementation details that it amounts to merely a generic component
(software, hardware, or firmware) that permits the performance of the
abstract idea, i.e., to retrieve the user-specific resources.”).
Appellant further argues that obtaining the claimed “condition-of-use
label,” either as explicitly set forth in claim 15, or as allegedly inherently
required in claim 1, is not routine, conventional, or well-understood.3 Reply

3 We note that Appellant has stated that the FDA has never issued a
condition of use over the counter drug label requiring the use of a CLIA-
waived diagnostic test for any drug. Reply Br. 11. Because it was not raised
by the Examiner, we do not take a position on the issue of whether
Appellant’s Specification as filed demonstrates possession of obtaining such
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Br. 12, 14. However, the step of obtaining a condition-of-use label is part of
the abstract idea, and not an additional limitation to the abstract idea. Final
Act. 4–5. An inventive concept “cannot be furnished by the unpatentable
law of nature (or natural phenomenon or abstract idea) itself.” Genetic
Techs. v. Merial L.L.C., 818 F.3d 1369, 1376 (Fed. Cir. 2016); see
also Alice, 573 U.S. at 217 (citing Mayo, 566 U.S. at 78 (after determining
that a claim is directed to a judicial exception, “we then ask, ‘[w]hat else is
there in the claims before us?’”) (emphasis added)); RecogniCorp, 855 F.3d
at 1327 (“Adding one abstract idea (math) to another abstract idea (encoding
and decoding) does not render the claim non-abstract”).
Therefore, based on the record before us, we are not persuaded of
error in the Examiner’s determination that claim 1 is directed to patent-
ineligible subject matter, without significantly more. Accordingly, we
affirm the Examiner’s decision to reject claim 1, as well as claims 2–15 and
18–25 grouped therewith, as directed to patent-ineligible subject matter.
Preemption
Appellant’s arguments (Reply Br. 14–15), that the present claims do
not block innovation and pose no risk of preemption for the field of
prescription drugs that are switched to OTC status, are unpersuasive.
Preemption is not the sole test for patent eligibility, and any questions on
preemption in the instant case have been resolved by the Examiner’s Alice
analysis. As our reviewing court has explained: “questions on preemption
are inherent in and resolved by the § 101 analysis,” and, although
“preemption may signal patent ineligible subject matter, the absence of

a condition-of-use label at the time the application, or the provisional to
which it claims priority, was filed.
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complete preemption does not demonstrate patent eligibility.” Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015);
cf. OIP Techs. Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1362–63 (Fed. Cir.
2015) (“[T]hat the claims do not preempt all price optimization or may be
limited to price optimization in the e-commerce setting do not make them
any less abstract.”). As a result, Appellant’s preemption arguments are not
persuasive.
In view of the foregoing, we determine claim 1 does not recite an
inventive concept because claim 1 simply appends well-understood, routine,
conventional activities previously known to the prescription, healthcare, and
over-the-counter industry, specified at a high level of generality, to the
abstract idea.
Summary
Therefore, under the USPTO’s Revised Patent Eligibility Guidance,
informed by our governing case law concerning 35 U.S.C. § 101, Appellant
has not shown the Examiner erred in concluding claim 1 and claims 2–15
and 18–25 grouped therewith are directed to a judicial exception, i.e., an
abstract idea, without significantly more, and thus, are patent-ineligible
under § 101. In view of the foregoing, we sustain the Examiner’s § 101
rejection of claims 1–15 and 18–25 as being directed to patent-ineligible
subject matter.

Issue (2): Obviousness Under 35 U.S.C. § 103
With regard to the obviousness rejection, we have reviewed
Appellant’s arguments in the Briefs (Appeal Br. 23–33; Reply Br. 15–22),
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the Examiner’s rejection (Final Act. 7–21), and the Examiner’s response
(Ans. 13–14) to Appellant’s arguments in the Appeal Brief.
In rejecting claims under 35 U.S.C. § 103, it is incumbent upon the
Examiner to establish a factual basis to support the legal conclusion of
obviousness. See In re Fine, 837 F.2d 1071, 1073 (Fed. Cir. 1988). The
Examiner’s articulated reasoning in the rejection must possess a rational
underpinning to support the legal conclusion of obviousness. In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006). The USPTO “must examine the
relevant data and articulate a satisfactory explanation for its action including
a rational connection between the facts found and the choice made.” Motor
Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S.
29, 43 (1983) (internal quotation marks and citation omitted); see Synopsys,
814 F.3d at 1322 (stating that, as an administrative agency, the PTAB “must
articulate logical and rational reasons for [its] decisions” (internal quotation
marks and citation omitted)); see also In re Nuvasive, Inc., 842 F.3d 1376,
1383 (Fed. Cir. 2016).
The claimed invention is not obvious if a person of ordinary skill
would not select and combine the prior art references to reach the claimed
invention. Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369,
1379 (Fed. Cir. 2006) (“[T]o establish a prima facie case of obviousness
based on a combination of elements in the prior art, the law requires a
motivation to select the references and to combine them in the particular
claimed manner to reach the claimed invention”).
The determination of obviousness must consider, inter alia, whether a
person of ordinary skill in the art would have been motivated to combine the
prior art to achieve the claimed invention and whether there would have
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been a reasonable expectation of success in doing so. Brown & Williamson
Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1125 (Fed. Cir. 2000);
see also In re Rosuvastatin Calcium Pat. Litig., 703 F.3d 511, 517 (Fed. Cir.
2012); Takeda Chem. Indus., Ltd. v. Alphapharm Pty., 492 F.3d 1350, 1361–
62 (Fed. Cir. 2007). “[A] reference will teach away if it suggests that the
line of development flowing from the reference’s disclosure is unlikely to be
productive of the result sought by the applicant.” W.L. Gore & Assoc., Inc.
v. Garlock, Inc., 721 F.2d 1540, 1550–51 (Fed. Cir. 1983). Further, our
reviewing court has held that “[a] reference may be said to teach away when
a person of ordinary skill, upon reading the reference, would be discouraged
from following the path set out in the reference, or would be led in a
direction divergent from the path that was taken by the applicant.” Ricoh
Co. v. Quanta Computer, Inc., 550 F.3d 1325, 1332 (Fed. Cir. 2008)
(quoting Kahn, 441 F.3d at 990); In re Gurley, 27 F.3d 551, 553 (Fed. Cir.
1994); see also Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1354
(Fed. Cir. 2012) (quoting Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157,
1165 (Fed. Cir. 2006) (alterations omitted)) (A reference teaches away when
it “‘suggests that the line of development flowing from the reference’s
disclosure is unlikely to be productive of the result sought by the
applicant.’”).
In this light, in the instant case on appeal, we agree with Appellant that
(i) paragraphs 16, 20 through 23, and 77 through 79 of Keravich (see Appeal
Br. 25); and (ii) paragraphs 3 and 164 of Keravich (see Reply Br. 19–21),
discourage interaction between a drug purchaser and a healthcare person at a
point of sale as recited in the claims. In view of Keravich’s teachings of a
drug vending machine that “eliminate[s] the need for interaction between the
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purchaser and a licensed practitioner” (Keravich ¶ 3; see also ¶¶ 16, 20–23,
164), “a person of ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference, or would be led
in a direction divergent from the path that was taken by the applicant.”
Ricoh, 550 F.3d at 1332 (internal quotations omitted). Therefore, the
Examiner has not (i) articulated a satisfactory explanation including a
rational connection between the facts found and the choice made (see Motor
Vehicle Mfrs., 463 U.S. at 43), (ii) shown a reasonable expectation of success
(see Brown, 229 F.3d at 1125), and/or (iii) articulated how any modification
of Keravich would be productive of the result sought by Appellant’s claims
(see W.L. Gore, 721 F.2d at 1550–51).
Therefore, Appellant’s main contention, that Keravich teaches away
from the claimed invention (Appeal Br. 25–26; Reply Br. 17, 19–21),
because Keravich seeks to avoid interaction of a healthcare person at a point
of sale, whereas the recited invention requires the intervention of health care
personnel, in the offering for sale of a drug (see Appeal Br. 25), is
persuasive. Appellant’s argument that Keravich “does not contemplate body
fluids being obtained, e.g., at a point of sale – it merely contemplates
biometric data being inputted by the purchaser” (id. at 25), and therefore,
Keravich’s disclosed self-service procedure teaches the exact opposite of the
claimed invention which requires health care professional intervention (see
id. at 26), is also persuasive. Keravich (see ¶¶ 3, 16, 20–23, 164)
discourages against providing interaction with a healthcare person, as
required by the claims (see, e.g., claim 1, limitations [A], [C]), and,
therefore, teaches away from Appellant’s claimed invention. Keravich
expressly teaches a drug “vending machine” (id. ¶¶ 3, 22, 23) that is for
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avoiding any interaction with a healthcare person or licensed practitioner
(see id. ¶¶ 3, 16, 20, 79, 164).
In view of the foregoing, we agree with Appellant’s contentions that
Keravich teaches away from the claimed invention (Appeal Br. 25–26;
Reply Br. 17, 19–21), because Keravich seeks to avoid interaction of a
healthcare person at a point of sale, whereas the recited invention requires
the intervention of health care personnel, in the offering for sale of a drug
(see Appeal Br. 25). Therefore, Appellant has shown the Examiner erred in
rejecting representative claim 1, and thus, claims 2–15 and 18–25, under
35 U.S.C. § 103(a) because Keravich teaches away from the invention
recited in claim 1.
As a result, based on the record before us, we cannot sustain the
Examiner’s obviousness rejection of independent claims 1 and 15, as well as
claims 2–14 and 18–25 depending respectively therefrom, over the
combination of Keravich and AAPA.

CONCLUSIONS
As explained above, Appellant has not shown the Examiner erred in
rejecting claims 1–15 and 18–25 as being directed to patent-ineligible
subject matter, and we sustain the rejection of claims 1–15 and 18–25 under
35 U.S.C. § 101. And, because Appellant has shown the Examiner erred in
rejecting claims 1–15 and 18–25 over the combination of Keravich and
AAPA, we do not sustain the Examiner’s obviousness rejection of claims 1–
15 and 18–25 over the combination of Keravich and AAPA.
Therefore, we affirm the Examiner’s decision to reject claims 1–15
and 18–25, because at least one ground of rejection has been affirmed for
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each claim. See 37 C.F.R. § 41.50(a)(1) (“The affirmance of the rejection of
a claim on any of the grounds specified constitutes a general affirmance of
the decision of the examiner on that claim, except as to any ground
specifically reversed.”).

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–15, 18–
25
101 Eligibility 1–15, 18–
25

1–15, 18–
25
103(a) Keravich, AAPA

1–15, 18–
25
Overall
Outcome
1–15, 18–
25

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED