Elanco US Inc. et al.

Patent Trials and Appeals Board

Oct 28, 2020

15887164 - (D) (P.T.A.B. Oct. 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.
15/887,164 02/02/2018 Roger K. Prichard X20592A 8661
159715 7590 10/28/2020
Elanco US Inc.
Patent Division
2500 Innovation Way
Greenfield, IN 46140
EXAMINER
GOLDBERG, JEANINE ANNE
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
10/28/2020 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):
patents@elanco.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ROGER K. PRICHARD, CATHERINE BOURGUINAT,
and TIMOTHY G. GEARY

Appeal 2020-001001
Application 15/887,164
Technology Center 1600
____________

Before ULRIKE W. JENKS, AMEE A. SHAH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

SHAH, Administrative Patent Judge.

DECISION ON APPEAL1

1 In this Decision, we reference the Appeal Brief (“Appeal Br.”), filed Aug.
21, 2019 (as amended Sept. 17, 2019), Reply Brief (“Reply Br.”), filed Nov.
21, 2019, Examiner’s Answer (“Ans.”), mailed Nov. 12, 2019, Final Action
(“Final Act.”), mailed June 24, 2019, and the amended Specification
(“Spec.”), filed Mar. 21, 2018. We note that the pages of the Briefs are not
numbered. We consider the first page of each Brief as page 1 with each
page thereafter numbered sequentially.
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STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), the Appellant2 appeals from the
Examiner’s final decision to reject claims 13 and 17–24.3 We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

CLAIMED SUBJECT MATTER
The Appellant’s invention relates to “genetics related to macrocyclic
lactone (ML) endectocide resistance in nematode parasites (e.g., Dirofilaria
immitis),” “[s]ingle nucleotide polymorphisms within the genome of D.
immitis . . . that, singly or in combination, correlate with reduced
responsiveness of the parasites to MLs,” “methods for detection of these
parasites, methods for treatment of these parasites, and methods and kits for
determination of responsiveness of these parasites to MLs.” Spec. 1,
ll. 14–20.
Claims 13 and 20 are the independent claims on appeal. Claim 13,
reproduced below, is illustrative of the claimed subject matter.
13. An isolated nucleic acid molecule comprising 5 – 300
nucleotides of SEQ ID NO: 118, or a reverse complement
thereof;

2 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. The Appellant identifies the real parties in interest as
“ELANCO US INC.” and “MCGILL UNIVERSITY.” Appeal Br. 3.
3 Claim 37 has been withdrawn by the Examiner “as being drawn to a
nonelected invention, there being no allowable generic or linking claim.”
Final Act. 3.
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wherein the isolated nucleic acid molecule includes a
disclosed polymorphic site that correlates with resistance to a
macrocyclic lactone; and
wherein the isolated nucleic acid molecule further includes
a detectable label.
Appeal Br. 19 (Claims App.). Claim 20 recites a “kit for determining a
genotype of a Dirofilaria spp. nematode, the kit comprising at least” the
elements of claim 13. See id at 19–20.

REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Brennan US 5,474,796 Dec. 12, 1995
Prichard et al. (“Prichard”) US 10,000,811 B2 June 19, 2018
Jeffrey D. Rothstein et al., “Chronic inhibition of superoxide dismutase
produces apoptotic death of spinal neurons,” 91 Proc. Natl. Acad. Sci.
USA, 4155–4159 (May 1994) (“Rothstein”)
Author unknown, “1998/99 Catalog,” pp. 121, 284, New England BioLabs
(1998) (“NEB Catalog”)
Christelle Godel et al., “The genome of the heartworm, Dirofilaria immitis,
reveals drug and vaccine targets,” 26 The FASEB Journal, 4650–4661
(Aug. 15, 2012) (“Godel”)

REJECTIONS
I. Claims 13 and 17–24 stand rejected under 35 U.S.C.
§ 101 as being directed to a judicial exception without significantly
more.
II. Claims 13 and 17–24 stand rejected under 35 U.S.C.
§ 112(a) as failing to comply with the written description requirement.
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III. Claims 13 and 17–24 stand rejected under 35 U.S.C.
§ 112(b) as being indefinite.
IV. Claims 13, 17, and 20–24 are rejected under 35 U.S.C.
§ 102(a)(1) as being anticipated by Brennan.
V. Claims 13, 17, and 20–24 are rejected under 35 U.S.C.
§ 102(a)(1)4 as being anticipated by NEB Catalog.
VI. Claims 13 and 17–24 are rejected under 35 U.S.C.
§ 102(a)(1) as being anticipated by Godel.
VII. Claims 13, 17, and 20–24 stand rejected under pre-AIA
35 U.S.C. § 103 as being unpatentable over NEB Catalog and
Rothstein.
VIII. Claims 13 and 17–24 stand rejected on the ground of
non-statutory double patenting as being unpatentable over claims 1–5
of Prichard.

OPINION
Preliminary Matter
The Appellant argues that the Examiner’s decision to withdraw
claim 37 should be reversed because “there is no reasonable, logical, or legal
basis for Examiner to conclude Claim 37 should be withdrawn from
consideration separately from Claim 20.” Appeal Br. 9. The Examiner
maintains the withdrawal. See Ans. 22–23.

4 We consider the Examiner’s citation to pre-AIA 35 U.S.C. § 102(b) (Final
Act. 18; Ans. 29), which is incorporated into AIA 35 U.S.C. § 102(a)(1),
inadvertent error.
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As the Examiner notes (see id.), matters regarding restriction
requirements are to be resolved via petition to the technology center
Director. See 37 C.F.R. § 1.144; MANUAL OF PATENT EXAMINING
PROCEDURE § 1002.02(C) (“MPEP”). Thus, we consider claim 37
withdrawn and not pending on appeal.

Rejection I – 35 U.S.C. § 101 – Statutory Subject Matter
The Appellant presents arguments for the claims together. See Appeal
Br. 9–10. We thus group all the claims together and select claim 13 as
representative of the group, with the rejection of the remaining claims
standing or falling therewith. See 37 C.F.R. § 41.37(c)(1)(iv).
35 U.S.C. § 101 Framework
Section 101
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101.
However, the U.S. Supreme Court has long interpreted 35 U.S.C. § 101 to
include implicit exceptions: “[l]aws of nature, natural phenomena, and
abstract ideas” are not patentable. E.g., Alice Corp. v. CLS Bank Int’l,
573 U.S. 208, 216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Court’s two-part framework, described in Mayo and Alice.
Id. 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. If the claim is “directed to” an implicit exception, we turn to the
second step of the Alice and Mayo framework, where “we must examine the
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elements of the claim to determine whether it contains an ‘inventive
concept’ sufficient to ‘transform’ the claimed [exception] into a patent-
eligible application.” Alice, 573 U.S. at 221 (quotation marks omitted); see
also Mayo, 565 U.S. at 78–79. 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. “If a law of nature is not
patentable, then neither is a process reciting a law of nature, unless that
process has additional features that provide practical assurance that the
process is more than a drafting effort designed to monopolize the law of
nature itself.’” Id. at 77.
USPTO Section 101 Guidance
We are also guided by U.S. Patent and Trademark Office (“USPTO”)
Guidance, as set forth in the 2019 Revised Patent Subject Matter Eligibility
Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Guidance”), incorporated into
the MPEP §§ 2104–06, Rev. 10.2019, in June 2020. “The guidance sets out
agency policy with respect to the USPTO’s interpretation of the subject
matter eligibility requirements of 35 U.S.C. § 101 in view of decisions by
the Supreme Court and the Federal Circuit.” Guidance, 84 Fed. Reg. at 51.
Although “[a]ll USPTO personnel are, as a matter of internal agency
management, expected to follow the guidance,” the guidance “does not
create any right or benefit, substantive or procedural, enforceable by any
party against the USPTO.” Id. The Guidance, by its terms, applies to all
applications, and to all patents resulting from applications, filed before, on,
or after January 7, 2019. Id. at 50.
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Under USPTO Guidance, we first look to whether the claim recites:
(1) any judicial exceptions, including laws of nature, natural phenomena,
and products of nature (see MPEP §§ 2106.04(II)(A)(1), 2106.04(b))
(“Step 2A, Prong One”); and (2) additional elements that integrate the
judicial exception into a practical application (see id. §§ 2106.04(II)(A)(2),
2106.04(d)) (“Step 2A, Prong Two”).5
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look, under
Step 2B, to whether the additional elements, individually or in combination,
provide an inventive concept. See MPEP §§ 2106(III), 2106.05. “An
inventive concept ‘cannot be furnished by the unpatentable law of nature (or
natural phenomenon or abstract idea) itself.’” Id. at § 2106.05 (quoting
Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, (Fed. Cir. 2016)).
Among the considerations in determining whether the additional elements,
individually or in combination, amount to significantly more than the
exception itself, we look to whether they add a specific limitation beyond the
judicial exception that is not “well-understood, routine, conventional” in the
field or simply append well-understood, routine, conventional activities
previously known to the industry, specified at a high level of generality, to
the judicial exception. MPEP § 2106.05(II); Guidance, 84 Fed. Reg. at 56.

5 This evaluation is performed by (a) identifying whether there are any
additional elements recited in the claim beyond the judicial exception, and
(b) evaluating those additional elements individually and in combination to
determine whether the claim as a whole integrates the exception into a
practical application. See Guidance - Section III(A)(2), 84 Fed. Reg. at
54–55, MPEP § 2106.04(d).
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Step One of the Mayo/Alice Framework
Under the first step of the Mayo/Alice framework and Step 1 of
USPTO guidance, we determine that claim 13 recites an isolated nucleic
acid molecule, i.e., a composition of matter.
Under the first step of the Mayo/Alice framework and Step 2A, Prongs
One and Two of USPTO guidance, the Examiner determines that claim 13 is
“directed to nucleic acid fragments from the Dirofilaria genome, i.e. known
naturally occurring nucleic acids. Such isolated nucleic acid molecules, that
are identical to fragments of naturally occurring nucleic acid molecules[,]
are not patent eligible subject matter.” Final Act. 4. The Examiner further
finds that “[t]he broadest reasonable interpretation of detectable label
encompasses additional nucleotides . . . [that] may be detected using
hybridization and sandwich assays.” Id. “Thus, these oligonucleotides may
comprise naturally occurring nucleotides that may be detected by
hybridization and sandwich type assays. Probes with nucleotides would be
[sic] therefore be labeled with detectable nucleotides.” Id. The Examiner
also finds that claim 13 “embrace[s] probes and primers that are identical to
naturally occurring gene fragments and clearly read on nature-based
products that themselves do not exhibit markedly different characteristics
from the naturally occurring gene” (id. at 5), that consistent with Ass’n for
Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013)
(“Myriad”), “the primers and probe molecules embraced by the instant
[claims] are not patent eligible compositions of matter regardless of whether
or not they are isolated from the genome” (id. at 6), and as in University of
Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755 (Fed.
Cir. 2014), “the function of the nucleic acids is the same function as the
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relevant portion of the naturally occurring sequence. Just as in nature,
primers and probes utilize the innate ability of DNA to bind to itself” (id.).
The Appellant disagrees and argues that “a person of skill in the art
would not consider a nucleotide label detected by hybridization and
sandwich assays to be an appropriate label for the claimed nucleic acid
molecules.” Appeal Br. 10. The Appellant also argues that “there is no
reasonable or logical basis for Examiner to interpret the claim term
‘detectable label’ to be a naturally-occurring extension of the claimed
nucleic acid molecules.” Id.
We agree with the Examiner that under Prong One, claim 13 recites a
product of nature. Here, the claim recites an isolated nucleic acid molecule
including a polymorphic site and a detectable label. We consider claim 13
as a whole6 giving it the broadest reasonable construction7 as one of
ordinary skill in the art would have interpreted it in light of the
Specification8 at the time of filing. The Specification provides that
an “isolated nucleic acid molecule” may refer to a nucleic acid
molecule that does not occur in nature as part of a larger

6 “In determining the eligibility of respondents’ claimed process for patent
protection under § 101, their claims must be considered as a whole.”
Diamond v. Diehr, 450 U.S. 175, 188 (1981).
7 Revised Guidance, 84 Fed. Reg. at 52 n.14 (“If a claim, under its broadest
reasonable interpretation . . . .”) (emphasis added).
8 “First, it is always important to look at the actual language of the
claims. . . . Second, in considering the roles played by individual limitations,
it is important to read the claims ‘in light of the specification.’” Smart Sys.
Innovations, LLC v. Chicago Transit Authority, 873 F.3d 1364, 1378 (Fed.
Cir. 2017) (J. Linn, dissenting in part and concurring in part) (citing Enfish,
LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016), among
others).
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polynucleotide sequence; and/or may be substantially free from
any other nucleic acid molecules or other contaminants that are
found in its natural environment. As used herein, an “isolated
nucleic acid molecule” may also encompass recombinantly or
synthetically produced nucleic acid molecules.
Spec. 12, ll. 10–15. Further, “the term ‘polymorphic site’ may refer to a
region/ specific location in a nucleic acid at which two or more alternative
nucleotide sequences are observed in a significant number of nucleic acid
samples from a population of individuals.” Id. at 13, ll. 18–21. The
Specification provides that examples of detectable labels “may include
radioactive labels, enzymatic labels and/or fluorescent labels.” Id. at 49,
ll. 18–19.
The Appellant disagrees with the Examiner’s interpretations and
argues, without further explanation, that “a person of skill in the art would
not consider a nucleotide label detected by hybridization and sandwich
assays to be an appropriate label for the claimed nucleic acid molecules”
(Appeal Br. 10) and that such an interpretation “is unreasonably broad
because such an interpretation renders the claimed composition unsuitable
for its intended purpose, as given at least in Claim 22” (Reply Br. 2; see also
Appeal Br. 10).
However, as the Examiner notes, the examples provided in the
Specification for labels are non-limiting. See Final Act. 4; Ans. 24. We
agree with the Examiner’s finding that, under the broadest reasonable
interpretation, “a ‘detectable label’ is additional nucleotides that may be
detected using hybridization and sandwich assays. The detectable labels
may also be barcodes.” Ans. 24; see also Final Act. 4 (finding that the
detectable labels of claim 13 may encompass “naturally occurring
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nucleotides that may be detected by hybridization and sandwich type
assays.”). The Appellant’s statement of what one of ordinary skill in the art
would or would not consider to be a detectable label of an isolated
nucleotide amounts to unsupported attorney argument; the statement is not
supported by reasoning, argument, or evidence that contradicts the
Examiner’s supported finding.
Further, with regard to the Appellant’s statement that the detectable
label is not a naturally-occurring extension (Appeal Br. 10), we note that to
be patent eligible, a “nonnaturally occurring manufacture or composition of
matter” must possess “markedly different characteristics from any found in
nature.” Myriad, 569 U.S. at 590–591 (citing Diamond v. Chakrabarty, 447
U.S. 303, 309 (1980)). Markedly different characteristics can be expressed
as the product’s structure, function, and/or other properties, and are
evaluated based on what is recited in the claim on a case-by-case basis. See
MPEP § 2106.04(c)(II). The Appellant has not established that the
detectable label being part of the claimed nucleic acid does not meet that
requirement in light of the Examiner’s claim construction, which we agree is
a reasonable construction under the applicable prosecution standard. Thus,
we agree with the Examiner and find that the claim recites a judicial
exception, i.e., a product of nature.
Having concluded that claim 13 recites a judicial exception under
USPTO Guidance, Step 2A, Prong One, we next consider whether the claim
recites additional elements that integrate the judicial exception into a
practical application under Step 2A, Prong Two. To do so, we look to
whether the claim “appl[ies], rel[ies] on, or use[s] the judicial exception in a
manner that imposes a meaningful limit on the judicial exception, such that
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the claim is more than a drafting effort designed to monopolize the judicial
exception,” i.e., “integrates a judicial exception into a practical application.”
Guidance, 84 Fed. Reg. at 54–55; MPEP § 2106.04(d). For example,
integration may include using the natural product in a particular treatment or
prophylaxis for a medical condition or a particular manufacture that is
integral to the claims. Guidance, 84 Fed. Reg. at 55; MPEP § 2106.04(d)(2).
Here, claim 13 does not include any particular treatment or
prophylaxis for a medical condition. At best, the isolated nucleic acid
molecule is provided in a kit that is intended to be used to determine a
genotype of a particular nematode (see claim 20), but the patentability of the
product claim centers on the nucleic acid molecule itself, i.e., the product of
nature. Accordingly, we determine that the recited natural product is not
integrated into a practical application.
Thus, we are not persuaded of error in the Examiner’s determination
that claim 13 is directed to a judicial exception of a product of nature.
Step Two of the Mayo/Alice Framework
Under the second step in the Mayo/Alice framework and USPTO
Guidance Step 2B, we “[e]valuat[e] additional elements to determine
whether they amount to an inventive concept [which] requires considering
them both individually and in combination to ensure that they amount to
significantly more than the judicial exception itself.” MPEP § 2106.05(I).
Particularly, we evaluate whether the claims include specific limitations that
are not “well-understood, routine, conventional activity previously engaged
in by scientists who work in the field.” Mayo, 566 U.S. at 79. “A claim that
recites an abstract idea, law of nature, or natural phenomenon must include
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‘additional features’ to ensure ‘that the [claim] is more than a drafting effort
designed to monopolize the [abstract idea, law of nature, or natural
phenomenon].’” Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371,
1377 (Fed. Cir. 2015) (alterations in original) (quoting Mayo, 566 U.S. at
77–78). “[S]imply appending conventional steps, specified at a high level of
generality” to the claimed law does not make it patentable. Mayo, 566 U.S.
at 82.
Here, we note that in claim 13, there are no additional elements apart
from the claimed isolated nucleic acid, which is the natural product. The
Examiner finds that the additional element of a kit (as recited in claim 20) is
not enough because “[t]he fact that these natural products are organized into
a kit with an intended use adds nothing to the judicial exceptions that would
distinguish them from the naturally occurring material.” Final Act. 7.
The Appellant disagrees and argues that “[t]he use of a product should
be considered in determining whether a claim term interpretation is
reasonable.” Appeal Br. 10. However, with respect to claim 13, the claim
recites only a product. It is only the elements recited in a claim that are
material to defining its scope. See Phillips v. AWH Corp., 415 F.3d 1313,
1312 (Fed. Cir. 2005) (en banc) (citing Vitronics Corp. v. Conceptronic,
Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996) (“we look to the words of the claims
themselves . . . to define the scope of the patented invention”). Moreover,
regarding the kit of claim 20, “a preamble is not limiting where a patentee
defines a structurally complete invention in the claim body and uses the
preamble only to state a purpose or intended use for the invention.”
Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed.
Cir. 2002). Such is the case with claim 20. The use of the kit comprising
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the isolated nucleic acid molecule simply generally links the product of
nature to the field of use of determining a genotype of a Dirofilaria spp.
nematode. See MPEP § 2106.05(e). The “determining” is not positively
recited.
As discussed above, there is no evidence on the record to dispute the
Examiner’s findings that the elements of claims 13 and 20 are natural
products. Apart from these natural products, there is no evidence of record
that the independent claims include other, unconventional elements, either
alone or in combination.
Therefore, we are not persuaded of error in the Examiner’s
determination that the limitations of claim 13 (and of claim 20) do not
transform the claim into significantly more than the product of nature.
We sustain the Examiner’s rejection under 35 U.S.C. § 101 of
independent claim 13 and thus also of claims 17–24.

Rejection II – 35 U.S.C. § 112(a) – Written Description
The Appellant presents arguments for the claims together. See Appeal
Br. 10–13. We thus group all the claims together and select claim 13 as
representative of the group, with the rejection of the remaining claims
standing or falling therewith. See 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner rejects claims 13 and 17–24 as failing to comply with
the written description requirement of 35 U.S.C. § 112(a), because the
Specification does not describe, in a way to reasonably convey to one of
ordinary skill in the art at the time the application was filed, that the
Appellant had possession of the claimed invention. See Final Act. 9–10
(citing Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336 (Fed. Cir.
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2010) (“Ariad”) and Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir.
1991)). In particular, the Examiner determines that the Specification as filed
does not have adequate written description support for
why position 151 of SEQ ID NO: 118 is associated with
responsiveness to a macrocyclic lactone. Given the guidance in
the specification and what was taught in the art prior to the
invention, the skilled artisan would be unable to predictably
correlate structural changes in SEQ ID NO: 118 with
responsiveness to a macrocyclic lactone, simply based on their
existence.
Id. at 11. The Examiner further determines that
the polymorphism is not representative of the genus of any
polymorphic site in a nucleic acid molecule of elected SEQ ID
NO: 118 associated with resistance to a macrocyclic lactone
because it is not clear which polymorphisms in SEQ ID NO: 118
would have the same affect [sic]. Therefore the specification
fails to teach how to distinguish members of the claimed genus
of polymorphisms and variants which possess the claimed
functionality from non members.
Id. at 12. The Examiner also finds that specific guidance is needed and
“[s]ince the disclosure fails to describe the common attributes or
characteristics that identify members of the genus, and because the genus is
highly variant, any polymorphic site in a nucleic acid molecule of elected
SEQ ID NO: 118 alone is insufficient to describe the genus.” Id. at 12–13.
The Appellant contends that “the claim element a ‘disclosed
polymorphic site that correlates with resistance to a macrocyclic lactone’ has
the meaning given in Figures 1–28 and pages 19–49 of the amended
Specification as filed (i.e. the section entitled ‘Disclosed SNPs’).” Appeal
Br. 10. Specifically, the Appellant
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maintains the Specification contains adequate written description
for the term “disclosed polymorphic site” and the Specification
adequately discloses that, when applied to SEQ ID NO: 118, the
term refers to a polymorphism at position 151. Examiner's
conclusion that “[t]he current claims encompass a large genus of
polymorphic sites which comprise variants at any position of
SEQ ID NO: 118” is clear error and is not consistent with the
plain meaning of the claims. Thus, the term and the claim-as-a-
whole, satisfy the written description.
Id. at 12–13. The Appellant also contends that
The Specification can satisfy the written description requirement
by disclosing the existence of a correlation between function (i.e.
macrocyclic lactone sensitivity/resistance) and structure (i.e. the
disclosed polymorphisms). Ex parte Grosmaire. Disclosing a
theory of how the structure affects the function is not a
requirement for patentability.
Id. at 13. The Appellant argues that the “Examiner fails to consider the
Specification as whole, and instead takes passages out of their intended
context.” Reply Br. 2. The Appellant provides no further evidence or
technical reasoning to rebut the Examiner’s specific findings.
The written description requirement “ensures that when a patent
claims a genus by its function or result, the specification recites sufficient
materials to accomplish that function - a problem that is particularly acute in
the biological arts.” Ariad, 598 F.3d at 1352–53. Thus, a “sufficient
description of a genus . . . requires the disclosure of either a representative
number of species falling within the scope of the genus or structural features
common to the members of the genus so that one of skill in the art can
‘visualize or recognize’ the members of the genus.” Id. at 1350 (quoting
Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559,
1568–69 (Fed. Cir. 1997)). “[A]n adequate written description requires a
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precise definition, such as by structure, formula, chemical name, physical
properties, or other properties, of species falling within the genus sufficient
to distinguish the genus from other materials.” Id. Although “functional
claim language can meet the written description requirement when the art
has established a correlation between structure and function,” “merely
drawing a fence around the outer limits of a purported genus is not an
adequate substitute for describing a variety of materials constituting the
genus and showing that one has invented a genus and not just a species.” Id.
Here, the Specification provides that “[i]n one example, genetic
markers from D. immitis include the sequences below (SEQ ID NOs: 1-109),
where the underlined nucleotides (i.e., the polymorphic sites) indicate the
nucleotide position within the fragment that correlates with resistance to
MLs (i.e., the alternative nucleotide).” Spec. 19, ll. 22–25. “Figures 1–28
illustrate the genotype frequencies for the SNP within each of the indicated
markers, for susceptible and LOE isolates. The graphs are representative of
markers that are also designated as SEQ ID NOs: 1-109 within the
application.” Id. at 5, ll. 23–26. “In another example, genetic markers from
D. immitis include the sequences below (SEQ ID NOs: 110-127), where the
underlined nucleotides (i.e., the polymorphic sites) indicate the SNP
nucleotide position within the fragment that correlates with resistance to
MLs (i.e., the alternative nucleotide).” Id. at 44, ll. 21–24. In these
sequences, which include SEQ ID NO: 118, “the nucleotide at the SNP
position in the indicated sequence correlates with resistance to MLs. In the
heading for each sequence, the nucleotide change from wild-type to the
alternative nucleotide (alternative nucleotide correlates with ML resistance)
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at the polymorphic site is shown.” Id. at 44, ll. 28–32. The SNP position for
SEQ ID NO: 118 is indicated at position 151. Id. at 46, ll. 26–31.
Claim 13 recites a genus of an isolated nucleic acid molecule
comprising 5 – 300 nucleotides of SEQ ID NO: 118 with a disclosed
polymorphic site that correlates with resistance to a macrocyclic lactone.
This genus encompasses any polymorphic site, i.e., any change in the
sequence. The Specification, however, discusses only one possible change
at position 151 for sequence 118, which gives certain resistance. See supra.
It does not, however, describe structural features common to members of the
genus such that one can visualize or recognize members thereof that would
achieve resistance to a macrocyclic lactone. Nor is there an indication that
the art has established such a correlation between structure and function.
The Appellant’s contentions that the claim is clear in its meaning and
that because the Specification “adequately discloses that, when applied to
SEQ ID NO: 118, the term refers to a polymorphism at position 151”
(Appeal Br. 12–13), do not persuade us that the Examiner’s rejection is in
error. We note that though the claim is read in light of the Specification,
limitations from the Specification are not incorporated into the claim,
particularly when the Specification describes a particular species but the
claim recites a broader genus. See Superguide Corp. v. DirecTV
Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“Though
understanding the claim language may be aided by explanations contained in
the written description, it is important not to import into a claim limitations
that are not part of the claim. For example, a particular embodiment
appearing in the written description may not be read into a claim when the
claim language is broader than the embodiment.”). Although it is true that
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the Appellant’s Specification discloses a polymorphism at position 151 of
SEQ ID NO: 118 that gives rise to the claimed resistance, the claim is not
limited to a polymorphism at position 151 of SEQ ID NO: 118. Rather
claim 13 recites that the isolated nucleic acid molecule comprising 5–300
nucleotides of SEQ ID NO: 118, or a reverse complement thereof, “includes
a disclosed polymorphic site that correlates with resistance to a macrocyclic
lactone.” The term “disclosed” has no reference point that is recited in the
claim, thus the claim is reasonably understood to include any polymorphic
site. We note that the Appellant has refused the Examiner’s suggestions to
amend the claims to specifically recite that the claims comprise position 151
of SEQ ID NO: 118. See Final Act. 13; Ans. 26.
Regarding the Appellant’s argument that “[d]isclosing a theory of
how the structure affects the function is not a requirement for patentability”
(Appeal Br. 13), while the Federal Circuit has recognized that “the written
description requirement can in some cases be satisfied by functional
description,” it has made clear that “such functional description can be
sufficient only if there is also a structure-function relationship known to
those of ordinary skill in the art.” In re Wallach, 378 F.3d 1330, 1335 (Fed.
Cir. 2004); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 964 (Fed.
Cir. 2002) (“Enzo”). “One needs to show that one has truly invented the
genus, i.e., that one has conceived and described sufficient representative
species encompassing the breadth of the genus. Otherwise, one has only a
research plan, leaving it to others to explore the unknown contours of the
claimed genus.” AbbVie Deutschland GmbH v. Janssen Biotech, Inc., 759
F.3d 1285, 1300 (Fed. Cir. 2014). The Appellant’s Specification leaves it to
others to explore the unknown contours of polymorphisms that might meet
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the claimed function of resistance to a macrocyclic lactone. The
Specification discusses a primary structure, i.e., SEQ ID NO: 118 with a
change at position 151, but does not discuss the relationship of that primary
structure change to the claimed function of resistance, and how one of
ordinary skill in the art could reasonably predict other primary structure
changes that would give rise to the ultimate functional change required,
which may be due to particular secondary or tertiary structure changes.
And, the Appellant does not provide evidence to dispute the Examiner’s
findings that “[n]o structural limitations or requirements which provide
guidance on the identification of sequences which meet the functional
limitations of responsiveness to a macrocyclic lactone is provided” (Final
Act. 12), i.e., that the correlation between the function and structure is not
sufficiently known (see Enzo, 323 F.3d at 965).
Accordingly, we sustain the Examiner’s rejection under 35 U.S.C.
§ 112(a) of claim 13 and thus also of claims 17–24.

Rejection III – 35 U.S.C. § 112(b) – Indefiniteness
The Appellant presents arguments for the claims together. See Appeal
Br. 14. We thus group all the claims together and select claim 13 as
representative of the group, with the rejection of the remaining claims
standing or falling therewith. See 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner rejects claims 13 and 17–24 as being indefinite under
35 U.S.C. § 112(b), because the requirement of a “disclosed polymorphic
site that correlates with resistance to a macrocyclic lactone” is unclear as to
“whether the polymorphic site is limited to the site disclosed in the
specification or whether the claim encompasses any polymorphic site
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disclosed. Furthermore, it is unclear whether the claim encompasses either
the mutant or wild-type nucleotide as the polymorphic site.” Final Act. 15.
The Examiner notes that “[p]aragraph 136 of the specification further
provides that the disclosure is not limited to the specific details, the
representative apparatus, the illustrative examples show and described,” and
as such, “while Applicant appears to argue the claims are limited to a
particular disclosed position, the specification itself appears to broaden this
disclosure.” Id. at 16 (citing Spec. 67, ll. 1–12).
The Appellant “affirmatively states the claim element a ‘disclosed
polymorphic site that correlates with resistance to a macrocyclic lactone’ has
the meaning given in Figures 1-28 and pages 19-49 of the amended
Specification as filed (i.e. the section entitled ‘Disclosed SNPs’)” and
“argues there is no reasonable or logical basis for Examiner to interpret the
claim term ‘disclosed polymorphic site’ to be anything other than the
definition provided in the Specification as filed.” Appeal Br. 14. The
Appellant does not state exactly what that definition is.
As discussed above with reference to Rejections I and II, the
Specification does not provide a particular definition for a “disclosed
polymorphic site that correlates with resistance to a macrocyclic lactone,” as
recited in the claim. Rather, the Specification broadly “defines” that “the
term ‘polymorphic site’ may refer to a region/ specific location in a nucleic
acid at which two or more alternative nucleotide sequences are observed in a
significant number of nucleic acid samples from a population of individuals”
(Spec. 13, ll. 18–21), and provides examples of sites that correlated with
resistance to a macrocyclic lactone in the form of position 151 of SEQ ID
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NO: 118 (see id. at 44, 46). This definition and examples are not limiting,
and thus other positions or sites may be included.
To the extent the Appellant argues that the claim is clear in that the
Specification provides the example of position 151 for the site, as also
discussed above with respect to Rejection II, the specific example of
position 151 cannot be read into the claim when the claim recites a broader
genus. Here as well, the Appellant has refused the Examiner’s suggestions
to amend the claims to specifically recite that the claims comprise position
151 of SEQ ID NO: 118. See Final Act. 15; Ans. 26. Thus, we agree with
the Examiner that one of ordinary skill in the art would not understand the
metes and bounds of claim 13, i.e., “whether the polymorphic site is limited
to the site disclosed in the specification or whether the claim encompasses
any polymorphic site disclosed” and “whether the claim encompasses either
the mutant or wild-type nucleotide as the polymorphic site.” Final Act. 15.
Accordingly, we sustain the Examiner’s rejection under 35 U.S.C.
§ 112(b) of claim 13 and thus also of claims 17–24.
For purposes only of addressing the pending rejections under
35 U.S.C. §§ 102 and 103 (Rejections IV–VII), we will interpret the claims
as requiring a polymorphic site at position 151 of SEQ ID NO: 118.

Rejection IV – 35 U.S.C. § 102 – Anticipated by Brennan
The Appellant presents arguments for the claims together. See Appeal
Br. 15–16. We thus group all the claims together and select claim 13 as
representative of the group, with the rejection of the remaining claims
standing or falling therewith. See 37 C.F.R. § 41.37(c)(1)(iv).
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The Appellant contends that the Examiner’s rejection is in error
because Brennan does not disclose “isolated nucleic acid molecules
including a disclosed polymorphic site that correlates with resistance to a
macrocyclic lactone.” Appeal Br. 15. Specifically, the Appellant argues
that Brennan teaches “a plurality of oligonucleotides of random sequence,”
the oligonucleotides being “attached to a solid surface.” Id. And, even “[i]f
the claimed sequence is inherently present (although not explicitly disclosed)
in Brennan . . ., then that sequence is not substantially free of other nucleic
acids and could not be used in the claimed kits.” Id.
The Examiner finds that Brennan teaches “oligonucleotides having 10
nucleotides each (10-mers). The oligonucleotides represent every possible
permutation of the 10-mer oligonucleotide.” Final Act. 17. The Examiner
further finds that “Brennan inherently teaches 10-mers comprising position
151 of SEQ ID NO: 118. Specifically, Brennan inherently teaches
GTTTTTGAAT and GTTTTCTATG.” Id. The Examiner notes that the
Specification’s definition of isolated nucleic acid molecule (as discussed
above with reference to Rejection I) and finds that “[t]he nucleic acid
molecules of Brennan are substantially free from any other contaminants
that are found in its natural environment. The nucleic acids are not in cells
or with proteins and cellular material. Thus, they are isolated as defined by
the specification.” Id. at 17–18; see also Ans. 28. The Examiner maintains
that “[a] 10-mer comprising position 151 of SEQ ID NO: 118 is not distinct
from the 10-mer Brennan inherently teaches GTTTTTGAAT and
GTTTTCTATG,” and that the Appellant provides “no evidence that the
10-mers of Brennan are not encompassed within the instant claims.”
Ans. 28.
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The Examiner’s position is supported. Here, the claim does not
require “that [the] sequence is not substantially free of other nucleic acids
and could not be used in the claimed kits.” Appeal Br. 15. As discussed
above with reference to Rejection I, the Specification provides that an
isolated nucleic acid molecule may mean a nucleic acid that is not part of a
larger polynucleotide, “and/or may be substantially free from any other
nucleic acid molecules or other contaminants that are found in its natural
environment.” Spec. 12, ll. 10–15 (emphasis added). And, the claim recites
the molecule comprising 5-300 nucleotides of SEQ ID NO. 118, but does
not recite that the molecule is free of other molecules, which means it may
include additional nucleotides, so long as the recited portion of SEQ ID NO:
118 is also present. See Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501
(Fed. Cir. 1997) (“‘Comprising’ is a term of art used in claim language
which means that the named elements are essential, but other elements may
be added and still form a construct within the scope of the claim.”); see also
In re Crish, 393 F.3d 1253, 1257 (Fed. Cir. 2004) (holding that the term
“comprising” can include other nucleotides). Given the alternative nature of
the definitions in the Specification for “isolated nucleic acid molecule,” the
claimed isolated nucleic molecule does not need to be free of other nucleic
acids or other components, such as a solid support, and it does not exclude a
full-length sequence.
Brennan discloses “apparatus and methods for sequencing
oligonucleotides and for identifying the amino acid sequence of peptides that
bind to biologically active macromolecules.” Brennan, Abstract. Figure 1
illustrates the “[h]ybridization analysis using arrays of trimers,” with
“[i]ndividual dots that have bound the DNA fragment . . . underlined” (id. at
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col. 3, ll. 42–44), and “depicts a sequencing arrangement based on a matrix
of trimer oligonucleotides bound to the array plate” (id. at col. 10, ll. 6–7).
FIG. l(a) is the basic matrix consisting of the four nucleotides.
FIG. 1(b) is the complete trimer matrix, representing each of the
43 trimer permutations. The underlined elements in the array
represent sites to which the target nucleic acid is bound. FIG.
1(c) depicts how a sequence complementary to the target nucleic
acid is constructed from the known sequences of the sites to
which the target nucleic acid is bound.
Id. at col. 10, ll. 9–18. Figure 1b shows a matrix with permutations
comprising 5 G’s or 5 T’s in a row. “The array contains oligonucleotides
having 10 nucleotides each (10-mers).” Id. at col 9, ll. 48–49. The synthesis
is carried out in a way such that “the total array represents every possible
permutation of the 10-mer oligonucleotide.” Id. at col. 9, ll. 49–55.
In other words, Brennan teaches oligonucleotides attached to 10-mers.
As the Examiner finds, these are isolated nucleic acid molecules because
they are free from cell contents and thus free from nucleic acids not found in
nature. See Ans. 28. That the oligonucleotides are attached to a support (see
Appeal Br. 15) does not alter these facts. Thus, the Examiner’s finding that
Brennan “inherently teaches 10-mers comprising position 151 of SEQ ID
NO: 118” in “inherently teach[ing] GTTTTTGAAT and GTTTTCTATG”
(Final Act. 17) is supported.
Accordingly, we sustain the Examiner’s rejection under 35 U.S.C.
§ 102(a) as anticipated by Brennan of claim 13 and thus also of claims 17
and 20–24.

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Rejection V – 35 U.S.C. § 102 – Anticipated by NEB Catalog
The Appellant presents arguments for the claims together. See Appeal
Br. 15–16. We thus group all the claims together and select claim 13 as
representative of the group, with the rejection of the remaining claims
standing or falling therewith. See 37 C.F.R. § 41.37(c)(1)(iv).
The Appellant contends that the Examiner’s rejection is in error
because NEB does not disclose “isolated nucleic acid molecules including a
disclosed polymorphic site that correlates with resistance to a macrocyclic
lactone.” Appeal Br. 15. Specifically, the Appellant argues that “the NEB
product contains a mixture of oligonucleotides.” Id. And, even “[i]f the
claimed sequence is inherently present (although not explicitly disclosed)
in. . . NEB, then that sequence is not substantially free of other nucleic acids
and could not be used in the claimed kits.” Id.
The Examiner finds that “[t]he NEB catalog offered for sale a random
primer mix of 12mer and 24mer nucleotide primers.” Final Act. 19. The
Examiner notes that “[t]he claims encompass a large genus of possible
nucleic acid probes and primers with no particular base composition or
length” and finds that “[t]he NEB catalog kits will inherently and necessarily
contain 12 and 24 nucleotides primers encompassed by the claimed
recitation. NEB inherently teaches 12-mers comprising position 151 of SEQ
ID NO: 118. Specifically, NEB inherently teaches GTTTTTGAATAT and
TAGTTTTCTATG.” Id. at 20. The Examiner maintains that “[a] 12-mer
comprising position 151 of SEQ ID NO: 118 is not distinct from the 12-mer
NEB inherently teaches GTTTTTGAAT and GTTTTCTATG,” and that the
Appellant provides “no evidence that the 12-mers of NEB are not
encompassed within the instant claims.” Ans. 29–30.
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“A reference may anticipate inherently if a claim limitation that is not
expressly disclosed ‘is necessarily present, or inherent, in the single
anticipating reference’. . . ‘[i]nherency . . . may not be established by
probabilities or possibilities.’” In re Montgomery, 677 F.3d 1375, 1379–80
(Fed. Cir. 2012) (citations omitted). Although the Examiner is correct in
that the NEB Catalog “offer[s] for sale a random primer mix of 12mer and
24mer nucleotide primers,” the Examiner has not adequately explained that
these primers inevitably comprise 5 – 300 nucleotides of SEQ ID NO. 118.
The Examiner’s position is effectively that one of ordinary skill could take
DNA in general and arrive at any sequence, including sequence 118. Even,
assuming arguendo, the Examiner’s position is correct, the Examiner has not
shown how NEB necessarily discloses the primers having at least 5 – 300
nucleotides of SEQ ID NO: 118 to anticipate the claim or how position 151
of SEQ ID NO: 118 is necessarily present (as discussed above with
reference to Rejection III). That one may eventually arrive at the sequence
is not enough for anticipation.
Accordingly, based on the record before us — because an anticipation
rejection requires a finding in a single reference of each and every limitation
as set forth in the claims — we do not sustain the rejection under 35 U.S.C.
§ 102(a) as anticipated by NEB Catalog of claim 13 and thus also of
claims 17 and 20–24.

Rejection VI – 35 U.S.C. § 102 – Anticipated by Godel
The Appellant presents arguments for the claims together. See Appeal
Br. 15–16. We thus group all the claims together and select claim 13 as
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representative of the group, with the rejection of the remaining claims
standing or falling therewith. See 37 C.F.R. § 41.37(c)(1)(iv).
The Appellant contends that the Examiner’s rejection is in error
because “Godel does not explicitly or impliedly disclose a polymorphic site
that correlates with resistance to a macrocyclic lactone, nor does Godel
disclose a [sic] isolated nucleic acid molecule of the claimed sequence that
further includes a detectable label.” Appeal Br. 16. Specifically, the
Appellant argues that “Godel discloses nematode sequences but does not
disclose an isolated nucleic acid molecule of SEQ ID NO: 118 including a
disclosed polymorphic site that correlates with resistance to a macrocyclic
lactone and further including a detectable label.” Id. at 15. The Appellant
also argues that the “Examiner clearly uses improper hindsight to compare
the sequences to find the polymorphic site.” Id. at 15–16.
The Examiner finds that “Godel teaches the final assembly are
described on http://www.dirofilaria.org,” which “teaches a region in
Dirofilaria immitis, nuclear genome assembly 2.2 surrounding position 151
of elected SEQ ID NO; 118.” Final Act. 22. The Examiner notes that “[t]he
claim does not require any particular allele is present at position 151, only
that the nucleic acid includes a polymorphic site. Here, Godel teaches an ‘a’
allele as position 151 of SEQ ID NO: 118.” Ans. 30. The Examiner
maintains that “the art teaches the sequence. Even if Godel didn’t recognize
or appreciate the sequence correlates with resistance to a macrocyclic
lactone, the art teaches the claimed sequence.” Id. at 31. The Examiner also
notes that “impermissible hindsight” applies only “in the context of 103
rejections.” Id. (citing MPEP § 2145(IX)(A).
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Godel discloses “[c]omparing the proteome of D. immitis with other
nematodes and with mammalian hosts . . . [to] identify families of potential
drug targets, immune modulators, and vaccine candidates.” Godel 4650,
Abstract. “Genome sequence was generated from single individuals of D.
immitis isolated from naturally infected dogs.” Id. at 4652. “The
mitochondrial and Wolbachia wDi genomes were assembled
independently.” Id. The final nuclear assembly including the D. immitis and
wDi genomes, annotations, technical details, and analyses “are available
through a dedicated genome browser (http://www.dirofilaria.org).” Id.
at 4652–53.
The Appellant does not contest the Examiner’s finding that “[u]sing
the BLAST search on the cited www.dirofilaria.org website, the art teaches a
region in Dirofilaria immitis, nuclear genome assembly 2.2 surrounding
position 151 of elected SEQ ID NO; 118” that includes 5 T’s in a row. Final
Act. 22; Ans. 30. Rather, the Appellant argues that this does not disclose a
polymorphic site with resistance to a macroclyclic lactone and a detectable
label. See Appeal Br. 15–16. However, the claimed isolated nucleic
molecule does not exclude a naturally occurring sequence of DNA so long
as it comprises 5 – 300 nucleotides of SEQ ID NO. 118, position 151 of that
sequence, and a label that can comprise naturally occurring nucleotides.
Importantly, with respect to this rejection, the claim does not require a
sequence that confers resistance to a macrocylic lactone, just that it include a
position that is polymorphic such that it would, with a certain nucleotide,
confer such resistance.
The Appellant’s argument amounts to a contention that the
Examiner’s rejection is in error because Godel does not disclose a change at
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position 151 and is, instead, a naturally occurring nucleotide sequence.
However, as the Examiner finds, “[t]he claim does not require any particular
allele is present at position 151.” Moreover, it does not require a particular
nucleotide that confers resistance to a macrocylic lactone. Thus, whether or
not Godel recognized that position 151 is susceptible to polymorphism in the
first place, or that a particular polymorphic change correlates to resistance to
a macrocyclic lactone is not material to whether Godel anticipates the claim.
Godel discloses a gene that has the nucleotide sequence 118 including
position 151. That Godel may not include a particular nucleotide at position
151 that confers resistance to a macrocyclic lactone does not establish lack
of anticipation. That is because, as just explained, the claim does not require
a sequence that confers resistance to a macrocylic lactone, just that it include
a position that is polymorphic such that it would, with a certain nucleotide,
confer such resistance.
The Appellant does not dispute the Examiner’s finding that “Godel
teaches an ‘a’ allele as position 151 of SEQ ID NO: 118” (Ans. 30), and thus
teaches a sequence that includes position 151 of SEQ ID NO: 118 was
known and described by the prior art. In light of the foregoing, we are also
not persuaded of error by the Appellant’s argument that “[t]he Examiner
clearly uses improper hindsight to compare the sequences to find the
polymorphic site.” Appeal Br. 15–16 (emphasis added).
Accordingly, we sustain the Examiner’s rejection under 35 U.S.C.
§ 102(a) as anticipated by Godel of claim 13 and thus also of claims 17–24.

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Rejection VII – 35 U.S.C. § 103 –
Obviousness over NEB Catalog and Rothstein
The Appellant presents arguments for the claims together. See Appeal
Br. 16–17. We thus group all the claims together and select claim 13 as
representative of the group, with the rejection of the remaining claims
standing or falling therewith. See 37 C.F.R. § 41.37(c)(1)(iv).
The Appellant contends that the Examiner’s rejection is in error
because “NEB’s random sequences cannot possibly be interpreted to provide
a reasonable expectation of success in arriving at all limitations of the
claimed compositions and kits containing those compositions. The addition
of means of detecting nucleic acids from Rothstein cannot correct the many
deficiencies of the NEW [sic] catalogue.” Appeal Br. at 17.
The Examiner relies on NEB Catalog for teaching the limitations of
claim 13 but for a fluorescent label, for which the Appellant relies on
Rothstein. See Final Act. 23–25.
Because we find, as discussed above with reference to Rejection V,
that the Examiner has not adequately shown how NEB Catalog discloses the
claimed isolated nucleic acid molecule comprising 5 – 300 nucleotides of
SEQ ID NO. 118 with a polymorphic site at position 118, we are persuaded
by the Appellant’s argument that Examiner has not adequately shown how
the proposed combination teaches all of the claimed limitations.
Thus, based on the record before us, we do not sustain the Examiner’s
rejection under 35 U.S.C. § 103 as obvious over NEB Catalog and Rothstein
of claim 13 and thus also of claims 17 and 20–24.

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Double Patenting over Prichard
The Examiner rejects claims 13 and 17–24 under the doctrine of non-
statutory double patenting under 35 U.S.C. § 101 over claims 1–5 of
Prichard. Specifically, the Examiner notes that “[a]lthough the claims at
issue are not identical, they are not patentably distinct from each other”
(Final Act. 28) and that “[c]laims 13, 17-24 of the instant application is
generic to all that is recited in claims 1-5 of [Prichard]” (id. at 29).
The Appellant argues that “under 35 USC §101 methods (i.e.
processes) are patentably distinct from compositions of matter” and that as
the effective filing dates of both the instant application and the patent are
identical, “the parent patent cannot qualify as a prior art reference against the
pending claims under either 35 USC §§102 or 103.” Appeal Br. 18; see also
Reply Br. 3.
Obviousness-type double patenting is a judicially-created
doctrine designed to “prevent claims in separate applications or
patents that do not recite the ‘same’ invention, but nonetheless
claim inventions so alike that granting both exclusive rights
would effectively extend the life of patent protection.” Perricone
v. Medicis Pharm. Corp., 432 F.3d 1368, 1373 (Fed. Cir. 2005)
(citation omitted). It prohibits the issuance of claims in a second
patent that are “not patentably distinct from the claims of the first
patent.” In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985)
(citations omitted). A later patent claim “is not patentably
distinct from an earlier claim if the later claim is obvious over,
or anticipated by, the earlier claim.” Eli Lilly & Co. v. Barr
Labs., Inc., 251 F.3d 955, 968 (Fed.Cir.2001) (citations omitted)
In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013).
Here, the Examiner finds that the instant claims are not identical to the
patented claims in that the instant claims are “generic to all that is recited in
[patented] claims 1-5.” Final Act. 29. The Appellant does not disagree, but
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merely argues, without support, that because the instant claims and patented
claims are different statutory classes, they are patentably distinct. See
Appeal Br. 18; Reply Br. 3. We agree with the Examiner that “[t]here is no
per se rule to suggest methods and compositions are patentably distinct.”
Ans. 33. See In re Freeman, 166 F.2d 178, 180 (C.C.P.A. 1948) (“since the
product in each of the appealed claims is defined essentially in terms of the
method by which it is made, the fact that the claims of the patent and the
application are, technically, in different statutory classes, is not in itself,
enough to avoid a rejection on the ground of double patenting”). Indeed, a
method of use was found to be an obvious variant of a claimed composition
in Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353, 1363 (Fed. Cir.
2008). Here, the Appellant does not provide evidence or technical reasoning
how the instant composition and product (kit) claims for determining a
genotype of a Dirofilaria spp. comprising the isolated nucleic acid molecule
comprising 5 – 300 nucleotides of SEQ ID NO: 118 are patentably distinct
from the patented method for determining a genotype of a Dirofilaria
immitis nematode comprising contacting “a Dirofilaria immitis nucleic acid
molecule with at least one oligonucleotide having a length of 15-300
nucleotides of SEQ ID NO: 118” and detecting a G nucleotide at position
151 of SEQ ID NO: 118. Prichard, claim 1.
We are further not persuaded of error by the Appellant’s argument
that “the parent patent cannot qualify as a prior art reference against the
pending claims under either 35 USC §§102 or 103,” and thus, ostensibly,
cannot qualify as art for double patenting purposes. Appeal Br. 18. In In re
Land, the court made “the observation that ‘double patenting’ is normally
applied as a ground of rejection when the patent used to support the double
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patenting rejection is not available as a reference to show ‘prior art’ under
35 U.S.C. §§ 102 or 103.” 368 F.2d 866, 868 (C.C.P.A. 1966). To the
extent the Appellant argues that Prichard cannot qualify as “prior art” for
double patenting because the instant application is a continuation of Prichard
(see Appeal Br. 18 (“the effective filing dates (35 USC § 100(i)) of the
pending claimed subject matter and the patented claims of the parental
application are identical”)), our reviewing court has held “that the protection
afforded by section 121 to applications (or patents issued therefrom) filed as
a result of a restriction requirement is limited to divisional applications.”
Pfizer, 518 F.3d at 1362. The application here is not a divisional of
Prichard. The prosecution history of Prichard reveals that there was a
restriction requirement between claims directed to the species of SEQ ID
NO. 1–127. Requirement for Restriction 4 (mailed May 26, 2017). The
Appellant elected SEQ ID NO. 118, the same sequence claimed in the
pending application. Response to Restriction Requirement 1 (filed July 5,
2017). Thus, we agree with the Examiner (see Ans. 33) that as a
continuation of Prichard and claiming the same sequence, there is no
protection afforded to the current application by 35 U.S.C. § 121.
Accordingly, we sustain the Examiner’s rejection under the doctrine
of double patenting of claims 13 and 17–24.

CONCLUSION
The Examiner’s decision to reject claims 13 and 17–24 is sustained.
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In summary:
Claims
Rejected
35 U.S.C. § References/
Basis
Affirmed Reversed
13, 17–24 101 Eligibility 13, 17–24

13, 17–24 112(a) Written
Description
13, 17–24
13, 17–24 112(b) Indefiniteness 13, 17–24
13, 17, 20–24 102(a)(1) Brennan 13. 17, 20–24
13, 17, 20–24 102(a)(2) NEB Catalog 13, 17, 20–24
13, 17–24 102(a)(1) Godel 13, 17–24
13, 17, 20–24 103(a) NEB Catalog,
Rothstein
13, 17, 20–24
13, 17–24 Double
Patenting
Prichard 13, 17–24
Overall
Outcome
13, 17–24

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