Mylan Inc.

Patent Trials and Appeals Board

May 28, 2020

13907028 - (D) (P.T.A.B. May. 28, 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.
13/907,028 05/31/2013 Kevin Ostrander 097693-1002533 9296
122945 7590 05/28/2020
Mylan Pharmaceuticals Inc.
5005 Greenbag Road
Morgantown, WV 26501
EXAMINER
COBANOGLU, DILEK B
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
05/28/2020 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):
mylan_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KEVIN OSTRANDER and JOHN W. DENNY

Appeal 2019-001929
Application 13/907,028
Technology Center 3600
____________

Before BRUCE T. WIEDER, TARA L. HUTCHINGS, and
ROBERT J. SILVERMAN, Administrative Patent Judges.

SILVERMAN, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision rejecting claims 1–10 and 19–27. We have jurisdiction
under 35 U.S.C. § 6(b). An oral hearing was held on May 11, 2020.
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Mylan
Incorporated. Appeal Br. 1.
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ILLUSTRATIVE CLAIM
1. A method of using an emergency medicament device,
the method comprising:
determining a physical location of a mobile device using
a location detection service;
periodically polling an ID tag associated with the
medicament device using the mobile device to determine if the
medicament device is within a predetermined distance from the
mobile device, wherein the predetermined distance is
determined based on a predefined signal strength of a signal
from the ID tag to the mobile device;
generating an alarm on the mobile device upon
determining that the medicament device is not within the
predetermined distance, wherein generating the alarm
comprises playing an audible sound on the mobile device until
the medicament device is within the predetermined distance
from the mobile device;
establishing a connection by reading the ID tag
associated with the medicament device using the mobile device
and periodically receiving medicament device data from the ID
tag upon determining that the medicament device is present;
determining a status of a use sensor of the medicament
device from the received medicament device data;
automatically requesting instructions for using the
medicament device based on the ID tag upon determining an
activated status of the use sensor; and
displaying a video associated with the ID tag to a user of
the mobile device, the video providing instructions for using the
medicament device in accordance with approved labeling of the
medicament device.
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REJECTION2
Claims 1–10 and 19–27 are rejected under 35 U.S.C. § 101 as
ineligible subject matter.
FINDINGS OF FACT
The findings of fact relied upon, which are supported by a
preponderance of the evidence, appear in the following Analysis.
ANALYSIS
Under 35 U.S.C. § 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. Yet, subject matter belonging to any of the statutory
categories may, nevertheless, be ineligible for patenting. The Supreme
Court has interpreted § 101 to exclude laws of nature, natural phenomena,
and abstract ideas, because they are regarded as the basic tools of scientific
and technological work, such that including them within the domain of
patent protection would risk inhibiting future innovation premised upon
them. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S.
576, 589 (2013).
Of course, “[a]t some level, ‘all inventions . . . embody, use, reflect,
rest upon, or apply’” these basic tools of scientific and technological work.
Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 217 (2014). Accordingly,
evaluating ineligible subject matter, under these judicial exclusions, involves
a two-step framework for “distinguish[ing] between patents that claim the
buildin[g] block[s] of human ingenuity and those that integrate the building

2 The Final Office Action (page 2) rejects claims 1–10 and 24–27 under
35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA), second paragraph. This
rejection is withdrawn. Answer 3.
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blocks into something more, thereby transform[ing] them into a patent-
eligible invention.” Id. (citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 88–89 (2012)) (internal quotation marks omitted).
The first step determines whether the claim is directed to judicially excluded
subject matter (such as a so-called “abstract idea”); the second step
determines whether there are any “additional elements” recited in the claim
that (either individually or as an “ordered combination”) amount to
“significantly more” than the identified judicially excepted subject matter
itself. Id. at 217–18.
In 2019, the USPTO published revised guidance on the application of
§ 101, in accordance with judicial precedent. See 2019 Revised Patent
Subject Matter Eligibility Guidance, 84 Fed. Reg. 50, 52 (Jan. 7, 2019)
(“2019 Revised Guidance”). Under the 2019 Revised Guidance, a claim is
“directed to” an abstract idea, only if the claim recites any of
(1) mathematical concepts, (2) certain methods of organizing human
activity, and (3) mental processes — without integrating such abstract idea
into a “practical application,” i.e., without “apply[ing], rely[ing] on, or
us[ing] 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.” Id. at 52–55. The
considerations articulated in MPEP § 2106.05(a)–(c) and (e)–(h) bear upon
whether a claim element (or combination of elements) integrates an abstract
idea into a practical application. Id. at 55. A claim that is “directed to” an
abstract idea constitutes ineligible subject matter, unless the claim recites an
additional element (or combination of elements) amounting to significantly
more than the abstract idea. Id. at 56.
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The 2019 Revised Guidance stands “[i]n accordance with judicial
precedent” (id. at 52), but enumerates the analytical steps somewhat
differently than the Supreme Court’s Alice opinion. Step 1 of the 2019
Revised Guidance addresses whether the claimed subject matter falls within
any of the statutory categories of § 101. Id. at 53–54. Step 2A, Prong One,
concerns whether the claim at issue recites ineligible subject matter and, if
an abstract idea is recited; Step 2A, Prong Two, addresses whether the
recited abstract idea is integrated into a practical application. Id. at 54–55.
Unless such integration exists, the analysis proceeds to Step 2B, in order to
determine whether any additional element (or combination of elements)
amounts to significantly more than the identified abstract idea. Id. at 56.
In the present Appeal, as to Step 1 of the 2019 Revised Guidance, the
Examiner determines that all claims in the Appeal (claims 1–10 and 19–27)
are within the statutory categories of § 101. Final Action 3.
With regard to the Examiner’s analysis corresponding to Step 2A,
Prong One, of the 2019 Revised Guidance, we are persuaded, for the
following reasons, that none of the independent claims (claims 1, 19, and 24)
recites a judicial exception.
The Final Office Action and Answer provide various characterizations
of the independent claims. As to the first such characterization, the
Examiner states:
Claims 1–10, 19–27 are directed to an abstract idea of
“determining whether a medicament device is in a
predetermined distance from the mobile device, if it is within a
predetermined distance from the mobile device, providing an
instructions video to the mobile device, if it is not in a
predetermined distance from the mobile device, then generating
an alarm.”
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Final Action 3. See also Answer 3.
The Examiner states that this position would be “explained in detail”
(Final Action 3); yet, the remainder of the Final Office Action does not
explain why the activities described above would constitute an abstract idea.
Moreover, this description does not fit any of the abstract-idea categories
employed by the Office. See 2019 Revised Guidance, 84 Fed. Reg. at 52.
The foregoing description provides no “mathematical relationships,
mathematical formulas or equations, [or] mathematical calculations” (id.); as
such, it does not constitute a mathematical concept. The Examiner’s
description also does not manifest any method of organizing human activity,
as it does not exhibit any “fundamental economic principles or practices,”
“commercial or legal interactions,” or “managing personal behavior or
relationships or interactions between people.” Id. Nor may the Examiner’s
description be characterized as a mental process — i.e., a “concept[ ]
performed in the human mind” (id.) — particularly as to the features in the
Examiner’s description of “providing an instructions video to the mobile
device” and “generating an alarm” (Final Action 3).
The Examiner likens the claimed subject matter to another abstract-
idea characterization, based upon the following paraphrasing of certain
limitations of claim 1:
[D]etermining a physical location of a mobile device, polling an
ID tag associated with the medicament device using a mobile
device to determine if the medicament device [is] within a
predetermined distance from the mobile device, generating an
alarm on the mobile device upon determining that the
medicament device is not within a predetermined distance from
the mobile device, establishing a connection by reading the ID
tag associated with the medicament device using the mobile
device, determining status of a use sensor of the medicament
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device from the received medicament device data,
automatically requesting instructions for using the medicament
device based on the ID tag upon determining an activated status
of the use sensor, and displaying an instructions video
associated with the ID tag to a user of the mobile device.
Final Action 3–4. According to the Examiner, these limitations “correspond
to concepts identified as abstract ideas by the courts, such as ‘an idea of
itself,’” for example “the concept of ‘delivering user-selected media content
to [a] portable device.’” Id. at 4 (citing Affinity Labs of Tex., LLC v.
Amazon.com Inc., 838 F.3d 1266 (Fed. Cir. 2016)).
Yet, the referenced abstract-idea characterization, from the Affinity
Labs decision, does not fairly represent the purportedly corresponding
language of claim 1. In particular, the characterization of “delivering user-
selected media content to [a] portable device” (id.) fails to account for
numerous of the identified claim features that appear in claim 1, for
example, such as “determining a physical location of a mobile device,”
“determin[ing] if the medicament device is within a predetermined distance
from the mobile device,” “generating an alarm on the mobile device upon
determining that the medicament device is not within the predetermined
distance,” and “determining a status of a use sensor of the medicament
device from the received medicament device data.” Thus, the Examiner’s
analysis oversimplifies the substance of claim 1, “by looking at [it] generally
and failing to account for the specific requirements of the claim[ ].” McRO,
Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1313 (Fed. Cir. 2016)
(citing In re TLI Commc’ns LLC Patent Litig., 823 F.3d 607, 611 (Fed. Cir.
2016) and Diamond v. Diehr, 450 U.S. 175, 189 n.12 (1981)). Therefore,
we agree with the Appellant’s argument (see Appeal Br. 11–14), insofar as
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the identified subject matter of claim 1 does not recite an abstract idea
corresponding to “delivering user-selected media content to [a] portable
device” in Affinity Labs, 838 F.3d at 1269.
A similar problem affects the Examiner’s further characterization of
claim 1. In the Final Office Action, the Examiner refers to the following
excerpt of the claim language:
establishing a connection by reading the ID tag associated with
the medicament device using the mobile device and periodically
receiving medicament device data from the ID tag upon
determining that the medicament device is present; determining
a status of a use sensor of the medicament device from the
received medicament device data; automatically requesting
instructions for using the medicament device based on the ID
tag upon determining an activated status of the use sensor; and
displaying a video associated with the ID tag to a user of the
mobile device, the video providing instructions for using the
medicament device in accordance with approved labeling of the
medicament device.
Final Action 4. The foregoing claim language3 is said to correspond to the
concept of “collecting information, analyzing it, and displaying certain
results of the collection and analysis,” which was called an abstract idea in
Electric Power Grp., LLC v. Alstom, S.A., 830 F.3d 1350, 1353 (Fed. Cir.
2016). Id. In the Answer, the Examiner invokes the same characterization
from Electric Power Group, stating that the following excerpt of claim 1
also corresponds to the concept of “collecting information, analyzing the
information, and displaying certain results of the collection and analysis”:
[D]etermining a physical location of a mobile device using a
location detection service; periodically polling an ID tag

3 The Examiner might rely upon the underlined portions only, but the reason
for such underlining is not explained in the Final Office Action. Including
or excluding the non-underlined text has no effect upon the analysis herein.
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associated with the medicament device using the mobile device
to determine if the medicament device is within a
predetermined distance from the mobile device; generating an
alarm on the mobile device upon determining that the
medicament device is not within the predetermined distance;
determining a status of a use sensor of the medicament device
from the received medicament device data; automatically
requesting instructions for using the medicament device based
on the ID tag upon determining an activated status of the use
sensor.
Answer 5.
However, neither of the identified excerpts from claim 1 aligns with
Electric Power Group’s activities of collecting, analyzing, and displaying
data. Significantly, the claims addressed in Electric Power Group are
remarkable for their lack of detail, particularly as to what constitutes the
claimed “analyzing” and “displaying.” Elec. Power Grp., 830 F.3d at 1352.
The Federal Circuit points out that the Electric Power Group claims fail to
recite what type of “analy[sis]” would be performed and how this might be
accomplished, nor did the claims delineate any particular technique or
instrumentality for “displaying” the results:
Though lengthy and numerous, the claims do not go beyond
requiring the collection, analysis, and display of available
information in a particular field, stating those functions in
general terms, without limiting them to technical means for
performing the functions that are arguably an advance over
conventional computer and network technology.
Id. at 1351. See also id. at 1355 (“The claims in this case do not even
require a new source or type of information, or new techniques for analyzing
it.”) (citations omitted). Additionally, our reviewing court explains:
a large portion of the lengthy claims is devoted to enumerating
types of information and information sources available within
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the power-grid environment. But merely selecting information,
by content or source, for collection, analysis, and display does
nothing significant to differentiate a process from ordinary
mental processes, whose implicit exclusion from § 101
undergirds the information-based category of abstract ideas.
Id. at 1355. Accordingly, the court in Electric Power Group, in describing
the shortcomings of the claims at issue in that case, repeatedly invokes the
caveat “without more,” in order to emphasize the unusually spare nature of
the claims before the court — in regard to the very features that would need
to be more fulsome, in order to avoid the pitfall of subject-matter
ineligibility. Id. at 1354 (“[W]e have treated analyzing information by steps
people go through in their minds, or by mathematical algorithms, without
more, as essentially mental processes within the abstract-idea category”;
“[W]e have recognized that merely presenting the results of abstract
processes of collecting and analyzing information, without more (such as
identifying a particular tool for presentation), is abstract as an ancillary part
of such collection and analysis”; “Most obviously, limiting the claims to the
particular technological environment of power-grid monitoring is, without
more, insufficient to transform them into patent-eligible applications of the
abstract idea at their core.”) (emphasis added).
In contrast, each of the Examiner’s selected excerpts from claim 1, of
the present Appeal, contains more than mere unarticulated “analyzing”
feature, which the Federal Circuit described in Electric Power Group.
Instead, the claim language referenced on page 4 of the Final Office Action
recites, for example, “determining a status of a use sensor of the medicament
device from the received medicament device data.” Similarly, the claim
language referenced on page 5 of the Answer recites, for example,
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“determine if the medicament device is within a predetermined distance
from the mobile device.” Therefore, we agree with the Appellant’s
argument (see Appeal Br. 15–18, Reply Br. 6–7), insofar as the identified
subject matter of claim 1 does not recite an abstract idea corresponding to
“collecting information, analyzing it, and displaying certain results of the
collection and analysis,” as in Electric Power Group, 830 F.3d at 1353. The
Examiner’s comparison of claim 1 to the subject matter claimed in Electric
Power Group relies upon an oversimplified understanding of the claim
language at issue. See McRO, 837 F.3d at 1313.
Because the Examiner relies on the analysis, discussed above, as to all
the independent claims, we are persuaded of error in the rejection of
independent claims 1, 19, and 24, without needing to address Step 2A, Prong
Two, or Step 2B of the 2019 Revised Guidance. Accordingly, we do not
sustain the rejection of claims 1–10 and 19–27 under 35 U.S.C. § 101.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–10, 19–27 101 Eligibility 1–10, 19–27

REVERSED