Ex Parte Shah

Patent Trial and Appeal Board

May 31, 2018

14058788 (P.T.A.B. May. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/058,788 10/21/2013 Rajiv R. Shah
94740 7590 06/04/2018
Winthrop & Weinstine, P.A.
Capella Tower, Suite 3500
225 South Sixth Street
Minneapolis, MN 55402
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
16574.4.l.US.U2 4519
EXAMINER
NGUYEN, TRAN N
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
06/04/2018 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):
patent@winthrop.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAJIV R. SHAH
Appeal2016-005106 1
Application 14/058,7882
Technology Center 3600
Before NINA L. MEDLOCK, MATTHEWS. MEYERS, and
ROBERT J. SILVERMAN, Administrative Patent Judges.
MEYERS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's final
rejection of claims 18-24, 26-31, 36, and 37. 3 We have jurisdiction under
35 U.S.C. § 6(b ).
1 Our decision references Appellant's Appeal Brief ("Appeal Br.," filed
June 29, 2015), Reply Brief ("Reply Br.," filed April 8, 2016), the
Examiner's Answer ("Ans.," mailed February 8, 2016), and Final Office
Action ("Final Act.," mailed January 29, 2015).
2 Appellant identifies MyMeds, Inc. as the real party in interest (Appeal
Br. 1).
3 The Examiner indicates that claims 32-35 are presently withdrawn (see
Final Act. 2; Ans. 7, stating "Examiner submits that these claims have been
withdrawn from consideration as being directed towards an impermissible
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We AFFIRM.
CLAIMED INVENTION
Appellant's claimed invention relates generally "to systems and
methods for increasing pharmaceutical competency of patients, by providing
users/patients with a location to track, manage, learn about, and improve
their understanding of the one or more medications they may be taking"
(Spec. ,r 21 ).
Claims 18 and 36 are the independent claims on appeal. Claim 18,
reproduced below with added bracketed notations, is illustrative of the
subject matter on appeal:
18. A computer-based method for managing one or
more medications taken by a user, the method comprising:
[a] receiving as computer readable storage media
medication data from a source, wherein the medication data is
related to the user's prescribed, dispensed, and claimed
medicines;
[b] storing the medication data in a database as non-
transitory computer readable media;
shift in invention that was not elected by original presentation."); see also
Non-Final Office Action, mailed November 3, 2014, at page 3). In contrast,
Appellant indicates that claims 32-35 "remain pending" (Appeal Br. 11; see
also Applicant Arguments, filed January 22, 2015, at pages 6-7), and as
such, asserts that claims 18-24 and 26-37 are presently rejected (see Appeal
Br. 7; see also Reply Br. 5). The propriety of a restriction requirement is
reviewable by petition to the Technology Center Director. See 37 C.F.R.
§ 1.144; MPEP §§ 818.03(c), 1002.02(c)(2), and 1201. Petitionable issues
are not subject to review by the Board. See In re Berger, 279 F.3d 975,
984--85 (Fed. Cir. 2002). Accordingly, we provide no opinion concerning
the propriety of the restriction requirement. Thus, claims 32-35 are not
before us on appeal.
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[ c] associating a unique identification for each user with
the stored medication data for the user using computer
executable instructions;
[d] providing a computer-based user interface, whereby
the stored medication data for the user is accessible to the user
only after the user has provided an authentication; and
[ e] receiving an authentication provided by the user in
computer readable form, the authentication associated with the
user's unique identification;
[f] providing a computer-implemented tutorial that the
user may access from the user interface, wherein, using computer
executable instructions, the tutorial interactively teaches the user
to associate the name of a medication the user is taking with the
clinical condition for which the medication was prescribed in
order to increase the likelihood of the user taking the medication
as prescribed; [ and]
[g] alerting the user via the user interface if two or more
of the medications prescribed, dispensed, or claimed by the user
are contra-indicated.
REJECTIONS
Claims 18-24, 26-31, 36, and 37 are rejected under 35 U.S.C. § 101
as directed to non-statutory subject matter (see Final Act. 6-10).
Claims 18-24 and 26-31 are rejected under 35 U.S.C. § 112(a) or
35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the
written description requirement (see Final Act. 4--5).
ANALYSIS
Statutory Subject Matter
Independent claims 18 and 36, and dependent claims 19-24, 26-31, and 37
The Supreme Court, in Alice, reiterated the two-step framework
previously set forth in Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 566 U.S. 66 (2012), "for distinguishing patents that claim
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laws of nature, natural phenomena, and abstract ideas from those that claim
patent-eligible applications of those concepts." Alice Corp. Pty. Ltd. v. CLS
Bank Int'!, 134 S. Ct. 2347, 2355 (2014). The first step in that analysis is to
"determine whether the claims at issue are directed to one of those patent-
ineligible concepts." Id. If the claims are not directed to a patent-ineligible
concept, e.g., an abstract idea, the inquiry ends. Otherwise, the inquiry
proceeds to the second step where the elements of the claims are considered
"individually and 'as an ordered combination"' to determine whether there
are additional elements that "'transform the nature of the claim' into a
patent-eligible application." Id. (quoting Mayo, 566 U.S. at 79, 78).
The Court acknowledged in Mayo, that "all inventions at some level
embody, use, reflect, rest upon, or apply laws of nature, natural phenomena,
or abstract ideas." Mayo, 566 U.S. at 71. Therefore, the Federal Circuit has
instructed that claims are to be considered in their entirety to determine
"whether their character as a whole is directed to excluded subject matter."
McRO, Inc. v. Bandai Namco Games Am., Inc., 837 F.3d 1299, 1312
(Fed. Cir. 2016) (quoting Internet Patents Corp. v. Active Network, Inc.,
790 F.3d 1343, 1346 (Fed. Cir. 2015)).
Here, in rejecting claims 18-24, 26-31, 36, and 37 under 35 U.S.C.
§ 101, the Examiner determined that the claims, considered as a whole, are
directed to an abstract idea of "managing medications taken by a person"
without additional elements that transform it into a patent-eligible
application of that idea (Final Act. 6). According to the Examiner,
independent claim 18 is
similar to certain methods of orgamzmg human activities
because the claimed steps, for example, mirror a mental process
that a neurologist should follow when testing a patient for
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nervous system malfunctions. In this claim, the mental process
involves interactively teaching the user about the medicine to
increase the user's likelihood of taking the medication, and
determining which medications are contra-indicated and
determining if an alert should be generated for the user.
(Ans. 6).
In response, Appellant argues that the Examiner errs in rejecting the
claims, because "[ t ]he Examiner did not cite any rule or precedent
discussing what qualifies as 'organizing human activities"' (Appeal Br. 8;
see also Reply Br. 8-15). More particularly, Appellant argues that the
present claims cannot be directed to "organizing human activities" because
they cannot be performed without the use of a machine (Appeal Br. 9). We
cannot agree.
Under step one of the framework set forth in Alice, we agree with the
Examiner that the invention is directed broadly to the concept of "managing
medications taken by a person" (Final Act. 6), and similar to certain methods
of organizing human activities that our reviewing courts have found patent
ineligible, such as "unpatentable mental processes" including "steps [that]
can be performed in the human mind, or by a human using a pen and paper"
in CyberSource Corp. v. Retail Decisions, Inc. 654 F.3d 1366, 1372-73
(Fed. Cir. 2011) and the concept of collecting information, analyzing it, and
displaying certain results of the collection and analysis in Electric Power
Group, LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016).
In making this determination, we note that the present invention "is
directed to systems and methods for increasing the pharmaceutical
competency of patients, by providing users/patients with a location to track,
manage, learn about, and improve their understanding of the one or more
medications they may be taking" (Spec. ,r 21 ). The Specification discloses
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that one problem with our current healthcare system relates to "a patient
seeing two or more doctors or specialists that do not always communicate
with one another" (id. ,r 3) which makes "it is difficult for many people to
feel as though they have a handle on their health care" (id.). The
Specification further discloses that "current methods of obtaining
information about and/or tracking and/or managing one's prescription drug
use may be too complicated, too time consuming, or too expensive" (id.),
and thus, identifies "a need for a user-friendly, easy, informative way to
manage one's prescription drug use" (id.).
We also note that independent claim 18 is directed generally to "[a]
computer-based method for managing one or more medications taken by a
user," including steps for "receiving ... medication data," "storing the
medication data," "associating a unique identification for each user with the
stored medication data for the user," "providing a ... user interface" for
users to access stored medication data "only after the user has provided an
authentication," "receiving an authentication provided by the user ... , the
authentication associated with the user's unique identification," "providing
a ... tutorial that the user may access from the user interface," and "alerting
the user via the user interface if two or more of the medications prescribed,
dispensed, or claimed by the user are contra-indicated." Here, independent
claim 18 involves nothing more than receiving and storing data, associating
the data with an identifier, providing a user interface to access the data,
providing additional data, i.e., "tutorial," and alerting a user, without any
particular inventive technology- an abstract idea. See Elec. Power Grp.,
830 F.3d at 1354.
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Appellant further argues that independent claim 18 is not directed to
an abstract idea because "[a]ccuracy is critical when determining contra-
indicated medications, and the method of [ c ]laim 18 eliminates the
possibility of human error" (Appeal Br. 10; see also Reply Br. 13-14).
However, Appellant's argument is not persuasive at least because Appellant
does not provide adequate evidence or technical reasoning as to how or why
any efficiencies provided by the claimed invention are necessarily rooted in
computer technology. The fact that "[ c ]laim 18 allows a user to securely
and privately view all of his or her 'prescribed, dispensed, and claimed
medicines' in one computer-based location, and provides important contra-
indication warnings" (Appeal Br. 10) does not make the claimed invention
any less abstract. "[R ]elying on a computer to perform routine tasks more
quickly or more accurately is insufficient to render a claim patent eligible."
OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015).
Step two is "a search for an 'inventive concept'-i.e., an element or
combination of elements that is 'sufficient to ensure that the patent in
practice amounts to significantly more than a patent upon the [ineligible
concept] itself."' Alice, 134 S. Ct. at 2355 (alteration in original) (citing
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1294
(2012)).
And, similar to the situation in Electric Power, we find nothing
sufficient to remove the claims from the class of subject matter ineligible for
patenting. As the court explained in Electric Power, "merely selecting
information, by content or source, for collection, analysis, and display does
nothing significant to differentiate a process from ordinary mental processes,
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whose implicit exclusion from § 101 undergirds the information-based
category of abstract ideas." Elec. Power Grp., 830 F.3d at 1355.
Here, Appellant argues that independent claim 18 recites limitations
that amount to significantly more than "the purported abstract idea of
organizing human activities" because the claim provides limitations which
enable "a user to securely and privately access and manage his or her
medication data for all 'prescribed, dispensed, and claimed medicines"'
(Appeal Br. 16; see also Reply Br. 14--15). However, we agree with the
Examiner that "when viewed as a whole and/or an ordered combination, [the
claims do] not amount to significantly more than the abstract concept
because the computer-implemented steps have been recited with a high level
of generality" (Ans. 7-8). As the Examiner points out, "the claim does not
provide 'specific ways' of using medication data. Instead, the claim makes
use of generic computer technology to implement an abstract concept to
manage medication contraindication" (id. at 8; see also, e.g., Spec. ,r 51 "a
system or any portion thereof may be a personal computer (e.g., desktop or
laptop), tablet computer, mobile device ( e.g., personal digital assistant
(PDA) or smart phone), server"; ,r 31 "[ w ]hile passwords are described,
other authentication and security methods are also contemplated and within
the spirit of the present disclosure."). Thus, the individual steps of
"receiving," "storing," "associating," "providing," "receiving," "providing,"
and "alerting" as recited by independent claim 18 do not supply an inventive
concept because they merely require the application of conventional, well-
known analytical steps. See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709,
716 (Fed. Cir. 2014) ("[T]he claimed sequence of steps comprises only
'conventional steps, specified at a high level of generality,' which is
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insufficient to supply an 'inventive concept."') ( citing Alice, 134 S. Ct. at
2357). There is no indication in the record that any specialized computer
hardware or other non-generic computer components are required.
And, considered as an ordered combination, the computer components
of Appellant's independent claims 18 and 3 6 add nothing that is not already
present when the limitations are considered separately. Viewed as a whole,
Appellant's claims simply recite to the concept of "managing medications
taken by a person" (Final Act. 6) as performed by a general purpose
computer (see Spec. ,r 51 ). The claims do not, for example, purport to
improve the functioning of the computer itself. Nor do they effect an
improvement in any other technology or technical field. Instead, the claims
at issue amount to nothing significantly more than an instruction to apply the
abstract idea of "managing medications taken by a person" (Final Act. 6),
i.e., receiving and storing data, associating the data with an identifier,
providing a user interface to access the data, providing a "tutorial," and
alerting a user, which under our precedents, is not enough to transform an
abstract idea into a patent-eligible invention. See Alice, 134 S. Ct. at 2360.
Appellant further argues that "[ t ]he allowance of Claim 18 would not
'pre-empt' any field or 'effectively grant a monopoly' over organizing
human activities" (Appeal Br. 18 (citing Alice Corp., 134 S. Ct. at 2354)).
However,
[ t ]he Supreme Court has made clear that the principle of
preemption is the basis for the judicial exceptions to
patentability. Alice, 134 S. Ct. at 2354 ("We have described the
concern that drives this exclusionary principle as one of pre-
emption[.]"). For this reason, questions on preemption are
inherent in and resolved by the § 101 analysis.
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Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379
(Fed. Cir. 2015). Preemption concerns are, thus, fully addressed and
rendered moot where a claim is determined to disclose patent ineligible
subject matter under the two-part framework described in Mayo and Alice.
Although "preemption may signal patent ineligible subject matter, the
absence of complete preemption does not demonstrate patent eligibility"
(id.).
In view of the foregoing, we sustain the Examiner's rejection under
35 U.S.C. § 101 of independent claim 18, and dependent claims 19--24 and
26-31, which are not separately argued.
Appellant argues independent claim 3 6 under a separate heading, but
relies on the arguments for independent claim 18 (see Appeal Br. 20-21; see
also Reply Br. 15). We find no meaningful distinction between independent
method claim 18 and independent system claim 3 6. The claims all are
directed to the same underlying invention. Therefore, we also sustain the
rejection of independent claim 36 and claim 37, dependent therefrom, under
§ 101 for the same reasons. As the Federal Circuit has made clear, "the
basic character of a process claim drawn to an abstract idea is not changed
by claiming only its performance by computers, or by claiming the process
embodied in program instructions on a computer readable medium." See
CyberSource, 654 F.3d at 1375-76 (citing In re Abele, 684 F.2d 902 (CCPA
1982)).
Software Per Se
As discussed above, we agree with the Examiner's determination that
claims 18-24, 26-31, 36, and 37 are directed to subject matter that is not
patent-eligible under 35 U.S.C. § 101. Accordingly, the Examiner's
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alternative rejection of claims 36 and 37 under 35 U.S.C. § 101 is
cumulative and therefore not addressed.
Written Description
In rejecting claims 18-24 and 26-31 under 35 U.S.C. § 112(a) (AIA),
the Examiner finds that the Specification fails to support the "alerting"
limitation wherein "drugs are prescribed and/or dispensed 'by the user,"'
(Final Act. 5; see also Ans. 3--4) because "the user is not both a pharmacist
and a physician. In fact, she is neither. The user is understood to be the
patient ... who can only 'claim' certain medications" (Final Act. 5).
Additionally, the Examiner finds that "there is a single source of
[medication] data. The source could be the user's employer" (id.) for
providing information about medications that were prescribed and dispensed
and the user for providing information about the "claimed" medications
(Final Act. 5; see also Ans. 4--5). However, the Examiner finds that the
Specification discloses at least these two sources of data and not a single
source of data (see Ans. 5). Therefore, the Examiner finds Appellant has
"not yet described a communication process, which allows for the scope of
the added alerts" (see Final Act. 5).
In response, Appellant argues that the Examiner's rejection is
improper, because "[t]he Examiner's assertion that Claim 18 requires that a
user prescribe, dispense, and claim his or her medications is narrow,
unreasonable, and inconsistent with the Applicant's [S]pecification. The
[S]pecification makes continued reference to a doctor prescribing
medications, and to a pharmacy dispensing medication" (Reply Br. 6-7
(citing Spec. ,r,r 3, 25, 29, 41, 42)). Appellant also argues that "the recitation
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of 'a source' in Claim 18 is not restrictive and does not limit the Claim to
including only one source. However, the Specification does make clear that
an employer, for example, may be the source for prescribed, dispensed, and
claimed medication data" (Reply Br. 7 (citing Spec. ,r 32)).
Whether a Specification complies with the written description
requirement of 35 U.S.C. § 112(a) (AIA), is a question of fact and is
assessed on a case-by-case basis. See, e.g., Purdue Pharma L.P. v.
Paulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (citing Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991)). The disclosure, as
originally filed, need not literally describe the claimed subject matter (i.e.,
using the same terms or in haec verba) in order to satisfy the written
description requirement. But the Specification must convey with reasonable
clarity to those skilled in the art that, as of the filing date, Appellant was in
possession of the claimed invention. See id.
At the outset, we agree with Appellant that the Examiner's claim
construction is inconsistent with the Specification. The Specification
indicates that patients "may have more than one doctor prescribing drugs for
them" (Spec. ,r 3). The patient's employer may provide a batch file
containing prescription history for all employees to the Portal Provider
System (PPS), and the specific data provided may include the prescribing
physician information and pharmacy name (see Spec. ,r 25). Furthermore,
"[i]f a new pharmacy is used, the [PPS] may be updated to reflect this"
(Spec. ,r 32). Thus, we agree with Appellant's claim construction that the
"[claim] calls for alerting the user via the interface if two or more
medications prescribed to the user, dispensed to the user, or claimed 'by the
user' are contra-indicated" (Appeal Br. 6). Thus, we find that a person of
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ordinary skill in the art would reasonably understand from the Specification
(including the drawings), as originally filed, that the Specification provides
written description support for the alerting limitations, as presently claimed
(see, e.g., Spec. ,r,r 3, 25, 29, 32, 41, 42).
As to "a source," we agree with Appellant that the claim term "a
source" does not limit the claim to "only one source" (Reply Br. 7). See,
e.g., Tate Access Floors, Inc. v. Inteiface Architectural Res., Inc., 279 F.3d
1357, 1370 (Fed. Cir. 2002) ("It is well settled that the term 'a' or 'an'
ordinarily means 'one or more."'); KCJ Corp. v. Kinetic Concepts, Inc.,
223 F.3d 1351, 1356 (Fed. Cir. 2000). Furthermore, we find that a person of
ordinary skill in the art would reasonably understand from the Specification
(including the drawings), as originally filed, that the Specification provides
written description support for "a source," to be for example, an employer
(Reply Br. 7 citing (Spec. ,r 32) or a user (Spec. ,r 32) as presently claimed.
Therefore, we do not sustain the Examiner's rejection of claims 18-24
and 26-31, under 35 U.S.C. § 112(a) (AIA).
DECISION
The Examiner's rejection of claims 18-24, 26-31, 36, and 37 under
35 U.S.C. § 101 is affirmed.
The Examiner's rejection of claims 18-24 and 26-31 under 35 U.S.C.
§ 112(a) or 35 U.S.C. § 112(a) (AIA), is reversed.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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