Robert Jones et al.

Patent Trials and Appeals Board

Aug 13, 2020

2019006449 (P.T.A.B. Aug. 13, 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.
13/825,601 11/08/2013 Robert M. Jones 20750-0160US1 2404
26204 7590 08/13/2020
FISH & RICHARDSON P.C. (ARENA PHARMACEUTICALS)
P.O. BOX 1022
MINNEAPOLIS, MN 55440-1022
EXAMINER
LIEB, JEANETTE M
ART UNIT PAPER NUMBER
1654
NOTIFICATION DATE DELIVERY MODE
08/13/2020 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):
PATDOCTC@fr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte ROBERT M. JONES, JUERG LEHMANN,
WEICHAO CHEN, JEFFREY EDWARDS,
GLEN MARQUEZ, MICHAEL E. MORGAN,
ABU J.M. SADEQUE, and SUN HEE KIM1
________________

Appeal 2019-006449
Application 13/825,601
Technology Center 1600
________________

Before JOHN G. NEW, RICHARD J. SMITH, and RYAN H. FLAX,
Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the term “Appellant” to refer to the “applicant” as defined in
37 C.F.R. § 1.142. Appellant states that the real party-in-interest is Arena
Pharmaceuticals Inc. App. Br. 1.
Appeal 2019-006449
Application 13/825,601

2
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 27 and 60–64 as unpatentable under
U.S.C. § 101 as being directed to unpatentable subject matter.
Claims 63 and 64 also stand rejected as unpatentable under U.S.C.
§ 112, first paragraph as lacking written descriptive support.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

NATURE OF THE CLAIMED INVENTION
Appellant’s invention is directed to compounds and methods useful in
the treatment of, for example, a disorder selected from: a GPR1 19-
receptor-related disorder; a condition ameliorated by increasing secretion of
an incretin; a condition ameliorated by increasing a blood incretin level; a
condition characterized by low bone mass; a neurological disorder; a
metabolic-related disorder; type 2 diabetes; obesity; and complications
related thereto. Abstract.

REPRESENTATIVE CLAIM
Claim 27 is representative of the claims on appeal and recites:
27. A method for increasing the secretion of an incretin in an
individual or increasing a blood incretin level in an individual, or
for treating a disorder selected from a GPR119-receptor-related
disorder; a condition ameliorated by increasing secretion of an
incretin; a condition ameliorated by increasing a blood incretin
level; a condition characterized by low bone mass; a neurological
disorder; a metabolic-related disorder; and obesity; in an
individual; the method comprising prescribing to said individual
Appeal 2019-006449
Application 13/825,601

3
in need thereof, a compound according to claim 2 in combination
with a second pharmaceutical agent.

App. Br. 19–20. Because claim 27 references prescribing a compound as
defined by claim 2, this claim is reproduced below:

2. A compound according to claim 1 selected from 3-fluoro-
4-(5-fluoro-6-(4-(3-(2-fluoropropan-2-yl)-1,2,4-oxadiazol-5-
yl)piperidin-l-yl)pyrimidin-4-ylamino)-N,N-
dimethylbenzamide and pharmaceutically acceptable salts,
solvates, and hydrates thereof.

Id. at 18.
ISSUES AND ANALYSES
We decline to adopt the Examiner’s reasoning and conclusion that the
claims on appeal are directed to nonstatutory subject matter. We similarly
decline to adopt the Examiner’s conclusion that the claims lack written
descriptive support. We address the arguments raised by Appellant below.

A. Rejection of claims 27 and 60–64 as being directed to nonstatutory
subject matter under 35 U.S.C. § 101

Issue
Appellant argues the Examiner erred by concluding that the claims are
directed to a patent ineligible abstract idea. App. Br. 8.

Analysis
The Examiner finds that the claims recite a method or process, and are
therefore directed to one of the statutory classes of patentable subject matter.
Final Act. 4.
Appeal 2019-006449
Application 13/825,601

4
However, the Examiner finds that the claims recite a judicially-created
exception to Section 101, viz., an abstract idea, and specifically the step of
“prescribing.” Final Act. 5. The Examiner finds that claims 61 and 62 are
also directed to a method of determining, but finds that this is an additional
abstract mental step that is a part of the prescribing step, because the
individual to which the compound is being authorized must be identified in
order to prescribe the compound. Id. The Examiner also finds that the
claims do not recite additional elements that amount to “significantly more”
than the judicial exception. Id.
The Examiner finds that Appellant’s Specification provides no
express definition of the claim term “prescribing” and therefore relies upon
the broadest reasonable definition consistent with the Specification. Final
Act. 8 (citing MPEP § 2111.01). The Examiner finds that the claim term
“prescribe can be defined as to “advise the use of (a medicine, etc.), esp. by
an authorized prescription.” Id. (citing Prescribe, THE POCKET OXFORD
AMERICAN DICTIONARY OF CURRENT ENGLISH 623 (2002). The Examiner
finds that the same source defines the term “advise” as meaning to “give
advice to[,] recommend[, or] inform; notify.” Id. (citing Advise, THE
POCKET OXFORD AMERICAN DICTIONARY OF CURRENT ENGLISH 11 (2002).
The Examiner therefore reasons that the broadest reasonable interpretation
consistent with the specification is that the term “prescribing” means “to
recommend, give advice, inform, or notify (someone) to use a medicine.”
Id.
The Examiner reasons that such a definition does not require that the
prescribing occur in writing and may encompass orally telling an individual
to use a compound, including in combination with another pharmaceutical
Appeal 2019-006449
Application 13/825,601

5
agent (as recited in claim 2). App. Br. 8. The Examiner also finds that this
definition does not require that the individual is administered a compound,
or do anything other than receive a recommendation to take a compound. Id.
Additionally, the Examiner finds that, even if prescribing requires
prior authorization, authorization alone does not impart any additional step.
Id. The Examiner points to both Appellant’s arguments and the Board’s
Decision from a prior appeal from this same application (the “Prior
Decision,” mailed March 17, 2017) as adopting as the definition of
“prescribing”: “advis[ing] and author[izing] the use of (a medicine or
treatment) for someone, especially in writing”). Id. at 8–9 (citing Prior Dec.
4, 7–8). The Examiner finds that this definition encompasses only the
(authorized) advising or recommending to an individual in need thereof to
use a compound according to claim 2 and/or in combination with another
pharmaceutical agent and is merely the giving of an instruction or advice
that does not require any other steps or actions to practice the claimed
method. Id. at 9. As such, the Examiner argues, the step of “prescribing”
recited in the claims does not require, explicitly or implicitly, the act of
administering a composition. Id. at 10.
The Examiner analogizes the step of “prescribing” to our reviewing
court’s holding that rules (i.e., instructions) for playing a wagering game are
an abstract idea. Final Act. 10 (citing In re Smith, 815 F.3d 816, 819 (Fed.
Cir. 2016). Additionally, the Examiner notes, the court concluded in Smith
that additional steps of physically shuffling and dealing cards do nothing
more than append conventional steps to an abstract idea, and are insufficient
to transform the claimed subject matter into a patent eligible application of
the abstract idea. Id.
Appeal 2019-006449
Application 13/825,601

6
Similarly, the Examiner reasons, in the claims on appeal, the act of
prescribing is nothing more than the (authorized) instructing,
recommending, or advising someone to do a particular thing (i.e., take a
drug or drug combination, or authorizing one to dispense or provide that
drug), and prescribing must similarly be an abstract idea. Final Act. 10.
Appellant first points out that the issue of whether claims 27 and 60
recite patent-eligible subject matter was decided by the Board in the Prior
Decision. App. Br. 8 (citing Prior Dec. 3–11).
Appellant contends that, contrary to the Examiner’s conclusion,
claims 27 and 60–64 are not directed to a law of nature, a natural
phenomenon, or an abstract idea. App. Br. 9. Appellant disputes the
Examiner’s reliance upon the dictionary definition of “prescribing” that
ignores the context in which the term is used. Id. According to Appellant,
the term “prescribing” is used in the context of claims that recite a method of
treatment to achieve particular therapeutic effects in an individual who is in
need of the treatment, which is carried out by “prescribing” a specific, novel
compound (as defined in claim 2). Id. Appellant argues that a skilled
artisan would understand that it would be impossible for the therapeutic
effects recited in these claims to be achieved unless the prescribing results in
the compound actually being administered to an individual, because the
therapy depends on the pharmacological properties of the compound of
claim 2. Id. at 9–10.
Appellant argues that a person of ordinary skill in the art would
comprehend how treating a patient having a specific disorder with a specific
medication works, and that it is not an abstract process. App. Br. 10.
Appellant asserts that prescribing is therefore a process that initiates and
Appeal 2019-006449
Application 13/825,601

7
results in treatment by causing the medication to be provided and
subsequently administered to the individual in need of treatment. Id.
Appellant points to the Board’s finding in the Prior Decision that
“prescribing” goes beyond a communication advising an individual to take
the medication, and also includes a component of authorizing a particular
medication to be dispensed (provided) to the individual in need of treatment,
thereby ensuring that the medication is provided to an individual only when
an appropriately qualified person has determined that the treatment is
appropriate. Id.; see Prior Dec. 10. Appellant contends that, when a
medical practitioner prescribes a specific medicine to a specific patient to
treat a specific condition, the practitioner initiates treatment by causing the
medication to be provided for administration to the individual. App. Br. 10.
In our Prior Decision, we reversed the Examiner’s rejection of claims
27 and 60 under Section 101. The Examiner has repeated the rejection, and
we are again persuaded by Appellant’s reasoning and reverse the rejection in
view of Supreme Court precedent and current USPTO Guidelines.
Specifically, in performing an analysis of patentability under 35 U.S.C. §
101, we follow the framework set forth by the Supreme Court in Mayo
Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). We are
also mindful of, and guided by, the United States Patent and Trademark
Office’s 2019 Revised Patent Subject Matter Eligibility Guidance, 84(4)
Fed. Reg. 50 (January 7, 2019) (the “2019 Guidance”).
Appellant’s independent claim 27 recites: “A method for increasing
the secretion of an incretin in an individual or increasing a blood incretin
level in an individual ….” Following the first step of the Mayo analysis, we
find that the claims are directed to a process or method, and therefore fall
Appeal 2019-006449
Application 13/825,601

8
into one of the broad statutory categories of patent-eligible subject matter
under 35 U.S.C. § 101.
In the next step of the Mayo analysis, we determine whether the claim
at issue is directed to a nonstatutory, patent-ineligible concept, i.e., a law of
nature, a phenomenon of nature, or an abstract idea. Mayo, 566 U.S. at 70–
71. If the claim is so directed, we next consider the elements of the claim
both individually and “as an ordered combination” to determine whether
additional elements “transform the nature of the claim” into a patent-eligible
application. Id. at 78–79; see also Ariosa Diagnostics, Inc. v. Sequenom,
Inc., 788 F.3d 1371, 1375 (Fed. Cir. 2015). Specifically, the Supreme Court
considered this second step as determining whether the claim recites 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.” Mayo, 566 U.S. at 72–73.
More specifically, in this second step of the Mayo analysis, we look to
whether the claim recites one of the judicially-created exceptions to
35 U.S.C. § 101, i.e., an abstract idea, a law of nature, or a natural
phenomenon. See 2019 Guidance 54 (Step 2A, Prong 1). If we determine
that the claim recites a judicial exception, we then determine whether the
limitations of the claim reciting the judicial exception are integrated into a
practical application. Id. (Step 2A, Prong 2).
Finally, if we determine that the claim is directed to a judicially-
created exception to Section 101, we evaluate the claim under the next step
of the Mayo analysis, considering the elements of each claim both
individually and “as an ordered combination” to determine whether
additional elements “transform the nature of the claim” into a patent-eligible
Appeal 2019-006449
Application 13/825,601

9
application. Mayo, 566 U.S. at 78–79; see also 2019 Guidance 56 (Step
2B).
Claim 27 recites “prescribing to said individual in need thereof, a
compound according to claim 2 in combination with a second
pharmaceutical agent.” The compound recited in claim 2 is “selected from
3-fluoro-4-(5-fluoro-6-(4-(3-(2-fluoropropan-2-yl)-l, 2, 4-oxadiazol-5-yl)
piperidin-l-yl) pyrimidin-4-ylamino)-N, N-dimethylbenzamide and
pharmaceutically acceptable salts, solvates, and hydrates thereof.”
The Examiner concludes that the claim term “prescribing” renders the
process recited in the claims on appeal an abstract idea, analogizing to the
rules of a wagering game as in Smith. See 815 F.3d at 819. We disagree.
As an initial matter, and for the same reasons we set forth in our Prior
Decision, we employ our prior definition of the claim term “prescribing” as
meaning “advis[ing] and authoriz[ing] the use of (a medicine or treatment)
for someone, especially in writing.” See Prior Dec. 8.
In our Prior Decision we held that:
Abstract ideas have been identified by the courts as including, by
way of example, fundamental economic practices, certain
methods of organizing human activities, an “idea of itself,” and
mathematical relationships or formulae. Interim Guidance 13
(citing Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347,
2355-56 (2014). Examples of such abstract ideas have included
mitigating settlement risk, hedging, creating a contractual
relationship, using advertising as an exchange or currency,
processing information through a clearinghouse, comparing new
and stored information and using rules to identify options, using
categories to organize, store and transmit information,
organizing information through mathematical correlations,
managing a game of bingo [See, e.g., Smith], the Arrhenius
equation for calculating the cure time of rubber, a formula for
updating alarm limits, a mathematical formula relating to
Appeal 2019-006449
Application 13/825,601

10
standing wave phenomena, and a mathematical procedure for
converting one form of numerical representation to another. See
[Interim Guidance on Patent Subject Matter Eligibility
(December 10, 2014), subsequently updated in 2015 and 2016
(the “Interim Guidance”)] 13–15 (citing cases).

We find that the language of Appellants’ claims reciting
prescribing to said individual in need thereof, a compound
according to claim 2 in combination with a second
pharmaceutical agent” does not correspond to any of these
examples. Rather, we find that it corresponds to a concrete and
definable process, viz., the prescribing of a compound of claim 2
to an individual in need thereof, and not simply an abstract idea.

We agree with Appellants that the limitation, when read in
view of their Specification, represents more than a mere
transmission of information from one individual to another.
Rather, it represents “advis[ing] and authoriz[ing] the use of (a
specific medicine or treatment)” by a person who is competent
to do so. Moreover, the act of prescribing recited in claims 27
and 60 is directed to a specific audience (caregivers authorized
to treat a patient for a specific disorder), a specific class of
compounds (i.e., those of claim 2), and to a specific class of
patients (i.e., individuals in need of treatment for a GPR 119-
receptor-related disorder). We therefore disagree with the
Examiner’s conclusion that the claims are impermissibly
directed to an abstract idea, and we agree with Appellants that
the claims are directed to patentable subject matter under
35 U.S.C. § 101.

Prior Dec. 9–11.
We adopt the same reasoning in this appeal. Furthermore, nothing in
the law of the Federal Circuit, nor of that of the Supreme Court, issued in the
interim between the Prior Decision and the present appeal, suggests, let
alone compels, a different outcome to the same findings and conclusions
made by the Examiner.
Appeal 2019-006449
Application 13/825,601

11
Having determined that the claims do not recite a judicially-created
exceptions to 35 U.S.C. § 101, i.e., an abstract idea (Step 2A, prong 1), we
end our analysis at this step. We consequently reverse the Examiner’s
rejection of claims 27 and 60–64 upon this ground.

B. Rejection of claims 63 and 64 as lacking written descriptive support
under 35 U.S.C. § 112, first paragraph

Issue
Appellant argues that the Examiner erred in finding that written
descriptive support is lacking for the limitation reciting “wherein the
prescribing causes the prescription to be administered to said individual,”
which the Examiner argues “constitutes new matter.” App. Br. 4 (quoting
Final Act. 3)

Analysis
The Examiner finds Appellant’s Specification does not provide a
definition for the term “prescribing,” and based on what the Examiner finds
is the plain and ordinary meaning of prescribing, which does not include the
step of causing administration. Final Act. 3. The Examiner adopts the same
definition of the claim term “prescribing” described in the preceding section
supra, viz., “to recommend, give advice, inform, or notify [a person] to use a
medicine.” Id. The Examiner finds that there is no support in Appellant’s
Specification for the definition of prescribing to include to concept that
prescribing a compound to a subject causes administration of the compound
to the subject to occur. Id. at 3–4. The Examiner finds that this concept
goes beyond what one would consider to fall under the scope of the
Appeal 2019-006449
Application 13/825,601

12
definition of prescribing, and is not supported by the Specification, absent
language linking the administration step to the prescribing step. Id. at 4.
The Examiner notes that the claim term “prescribing” appears in the
Specification four times. Final Act. 4 (citing Spec. 14, 26, 29). The
Examiner finds that, in each of these instances, the prescribing step is only
discussed in the context of the hoped for result, such as “increasing the
secretion of an incretin.” Id. (citing Spec. 29). However, the Examiner
finds, Appellant’s Specification is silent as to any causal link between the
prescribing step and an administering step. Id.
Appellant argues that the relevant question with respect to the written
description of Section 112 is not whether the person of skill in the art would
understand that causing administration is necessarily included in the
definition of prescribing, but whether the inventors had possession of an
invention of a method of treatment that includes prescribing medication
wherein the prescribing causes the medication to be administered. App. Br.
5. Appellant argues that a person of ordinary skill in the art would have
understood that a medication cannot have a pharmacological or therapeutic
effect unless it is actually administered. Id.
Appellant asserts that it would therefore have been evident to a skilled
artisan that the inventors had contemplated and were in possession of an
invention of a method of treatment that includes prescribing medication
wherein the prescribing causes the medication to be administered. Id.
According to Appellant, it would not make sense to suggest that a person of
ordinary skill in the art would have understood that the inventors had
contemplated a method of treatment that is accomplished by prescribing
Appeal 2019-006449
Application 13/825,601

13
medication, but had no conception that the prescribing would cause the
medication to be actually administered. Id.
Appellant argues further that, even if the Specification does not
expressly state that prescribing causes the compound of the invention to be
administered to an individual in need of treatment, the application clearly
implicitly and inherently teaches that prescribing the compound causes it to
be administered to the patient. App. Br. 5. Indeed, contends Appellant, a
skilled artisan would have understood that the methods of treatment that
comprise “prescribing” medication could not possibly be effective unless the
medication is administered to the patient. Id. Appellant asserts that a person
of ordinary skill in the art would have understood that causing a medication
to be administered to a patient, so that the medication can exert its beneficial
therapeutic effects, is the very purpose of prescribing a medication. Id.
Appellant argues that, because a patent does not need to teach, and
preferably omits, what is well known in the art, the Specification’s silence as
to a causal link between prescribing and administration of the medication
does not mean that the introduction of a claim expressly reciting that such
causation occurs lacks written descriptive support.
We agree with Appellant. With respect to the written description
requirement, our reviewing court has held that “the test for sufficiency is
whether the disclosure of the application relied upon reasonably conveys to
those skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010). We decline to employ the
Examiner’s definition of the claim term “prescribing,” employing instead
our definition from our Prior Decision, viz., “advis[ing] and authoriz[ing] the
Appeal 2019-006449
Application 13/825,601

14
use of (a medicine or treatment) for someone, especially in writing.” See
supra (quoting Prior Dec. 8). We agree with Appellant that, at the time of
invention, a person of ordinary skill in the art would have understood that
advising and authorizing the use of (a specific medicine or treatment) by a
person who is competent to do so, would necessarily imply that the specific
medicine or treatment would be administered to the patient, by a medical
professional or self-administered by the person seeking treatment. This is
because a skilled artisan would have understood that practicing a “method
for increasing the secretion of an incretin in an individual or increasing a
blood incretin level in an individual, or for treating a disorder selected from
a GPR 119-receptor-related disorder” necessarily requires that the
compound prescribed be administered to the subject in need thereof.
For example, Appellant’s Specification discloses:
One aspect of the present invention pertains to methods for
modulating the activity of a GPR119 receptor, comprising
administering to an individual in need thereof: a therapeutically
effective amount of a compound of the present invention; a
composition of the present invention; or a pharmaceutical
product of the present invention.

One aspect of the present invention pertains to methods for
modulating the activity of a GPR119 receptor, comprising
prescribing to an individual in need thereof: a therapeutically
effective amount of a compound of the present invention; a
composition of the present invention; or a pharmaceutical
product of the present invention.

Spec. 14 (emphasis added). We find, and not least from the parallel usage in
this example, that a person of ordinary skill in the art would have
comprehended that Appellant, at the time of filing, was in possession of a
method comprising “prescribing to said individual in need thereof, a
Appeal 2019-006449
Application 13/825,601

15
compound selected from … wherein the prescribing causes the compound to
be administered to the individual,” as recited in claim 63.
We consequently reverse the Examiner’s rejection of claims 63 and
64.

DECISION
The Examiner’s rejection of claims 27 and 60–64 as unpatentable
under 35 U.S.C. § 101 is reversed.
The Examiner’s rejection of claims 63 and 64 as unpatentable under
35 U.S.C. § 102(b) is reversed.

REVERSED

Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
27, 60–64 101 Non-statutory
subject matter

27, 60–64
63, 64 112, first
paragraph
Written
description
63–64
Overall
Outcome
27, 60–64