Mark H. Schoenfisch et al.

Patent Trials and Appeals Board

Feb 28, 2020

13157036 - (D) (P.T.A.B. Feb. 28, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/157,036 06/09/2011 Mark H. Schoenfisch 035052/405966 6293
826 7590 02/28/2020
ALSTON & BIRD LLP
BANK OF AMERICA PLAZA
101 SOUTH TRYON STREET, SUITE 4000
CHARLOTTE, NC 28280-4000
EXAMINER
PARK, HAEJIN S
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
02/28/2020 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):
usptomail@alston.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MARK H. SCHOENFISCH, JAE HO SHIN,
and NATHAN STASKO
__________

Appeal 2018-007125
Application 13/157,036
Technology Center 1600
__________

Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
JENNIFER MEYER CHAGNON, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–20, 42–48, and 59–70. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant states that the real party in interest is The
University of North Carolina at Chapel Hill. Appeal Br. 2 (entered January
16, 2018).
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STATEMENT OF THE CASE
This application has been before this Board previously, in Appeal
2014-000405. See Decision entered May 2, 2016 (“Dec.”). In the present
appeal, the following rejections are before us for review:
(1) Claims 1–20, 42–48, and 59–70, under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement
(Final Act. 3–8);2 and
(2) Claims 1–20, 42–48, and 59–70, under 35 U.S.C. § 112, first
paragraph, as lacking enablement for the full scope of the subject matter
encompassed by the claims (Final Act. 9–11).
Appellant’s claim 1 is representative of the subject matter on appeal,
and reads as follows:
1. A nitric oxide-releasing particle, the nitric
oxide-releasing particle comprising a nitric oxide [(NO)]
donor and a core scaffold, wherein a secondary amine of
the core scaffold is converted to the nitric oxide donor,
and wherein the particle has a total releasable nitric oxide
storage of at least 1.2 μmol of NO per milligram of the
nitric oxide releasing particle.
Appeal Br. 23.
WRITTEN DESCRIPTION
The Examiner’s Prima Facie Case
The Examiner determined that Appellant’s claims encompass
NO-releasing particles “of any size and composition,” the particles having
only two required components, (1) “a nitric oxide donor” and (2) a “core
scaffold.” Final Act. 5. The Examiner determined that, in addition to those

2 Final Action entered July 14, 2017.
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components, Appellant’s claims only require that, “during [particle]
preparation a secondary amine of the core scaffold has been converted to the
nitric oxide donor” such that the claimed particles have “‘total releasable
nitric oxide storage’ of at least 1.2 μmol of nitric oxide per milligram
(μmol/mg) of the particle or 1.2 to 36 μmol/mg (independent claims 42, 44,
46, and dependent claim 2).” Id.; see also id. at 7 (“[A]side from the NO
donor and ‘core scaffold’, the genus of particles encompassed by the instant
claims could further comprise any structural components or arrangements as
long as the desired NO-storage attribute is met.”).
The Examiner determined that Appellant’s Specification provides
only “limited support for the claimed genus of nitric oxide-releasing
particles.” Final Act. 5. In particular, after reviewing Appellant’s
Specification, the Examiner determined that, “out of the thirty-eight particles
Applicants disclose, only fourteen or about a third, actually had total
releasable NO storage of at least 1.2 μmol/mg.” Id. at 7. Moreover, the
Examiner noted, the Specification describes “only a few examples of nitric
oxide-releasing particles with total releasable nitric oxide content of at least
1.2 μmol/mg, whose structure and method of preparation, i.e., factors
additional to converting a secondary amine in the core scaffold to a NO-
donor, appear specific and narrowly defined.” Id.
The Examiner additionally noted that, in affirming a similar written
description rejection in the previous appeal in the present application
(Appeal 2014-000405), the Board found that Appellant’s Specification
“reinforces th[e] unpredictability” as to preparing NO-releasing particles
with the required NO release properties because “the examples fail to reveal
any predictable way to form particles of a variety of materials and sizes that
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meet the NO-release ratio of the broad genus claims.” Final Act 8 (quoting
Dec. 16) (emphasis removed); see also id. (“[B]ecause the art was
unpredictable, we determine that a more detailed disclosure is necessary here
to support the full scope of the claimed subject matter.” (quoting Dec. 16)).
Therefore, the Examiner ultimately reasoned, “[i]n view of the
unpredictability of the art, it is determined th[ere] is not sufficient written
description to inform a skilled artisan that applicant was in possession of the
claimed invention as a whole at the time the application was filed.” Final
Act. 8.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
For the reasons provided below, Appellant does not persuade us that
the preponderance of the evidence fails to support the Examiner’s
determination that Appellant’s claims lack adequate written description.
Our reviewing court has advised that, as to claims that recite a genus
“using functional language to define a desired result, the specification must
demonstrate that the applicant has made a generic invention that achieves the
claimed result and do so by showing that the applicant has invented species
sufficient to support a claim to the functionally-defined genus.” AbbVie
Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1299
(Fed. Cir. 2014) (citations and internal quotations omitted).
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Accordingly, “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. (citations and internal quotations omitted); see also id. at
1299–1300 (“[A]nalogizing the genus to a plot of land, if the disclosed
species only abide in a corner of the genus, one has not described the genus
sufficiently to show that the inventor invented, or had possession of, the
genus.”).
In the present case, using the analogy provided by the court in AbbVie
Deutschland v. Janssen Biotech, we agree with the Examiner that the
disclosed species encompassed by Appellant’s claim 1 only abide in a corner
of the genus encompassed by the claim.
Specifically, Appellant’s claim 1 recites an NO-releasing particle
having only two structural requirements: the particle must include (1) a
“core scaffold” and (2) an NO donor. See Appeal Br. 23. Claim 1 further
specifies that the NO donor must be a secondary amine component of the
core scaffold, the secondary amine having been converted into the NO
donor. See id. Appellant’s Specification explains that secondary amines
may be converted to NO donors by reacting the secondary amines with a
strong base and gaseous NO. See Spec. 27 (“The secondary amine
functional group of the dendrimers [branched polymers] is converted in high
yields to a nitric oxide donor in the presence of a strong base and gaseous
nitric oxide.”).
Beyond the core scaffold and NO donor converted from a secondary
amine, the sole required feature recited in claim 1 for the claimed particles is
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the functional requirement that the particles have “a total releasable nitric
oxide storage of at least 1.2 μmol of NO per milligram of the nitric oxide
releasing particle.” Appeal Br. 23. While Appellant characterizes this
limitation as a structural element (see Appeal Br. 8; Reply Br. 3–4), claim 1
does not include any language that specifically ties the releasable NO
storage limitation to any particular structural feature.
Thus, Appellant’s claim 1 recites a genus that encompasses any
NO-releasing particle composed of a core scaffold that has an NO donor
converted from a secondary amine, as long as the particle has a total
releasable nitric oxide storage of at least 1.2 μmol of NO per milligram of
the particle. That is, the genus of NO-releasing particles recited in claim 1
encompasses any particle composed of a core scaffold with an NO donor
derived from a secondary amine, as long as the particle achieves the
functionally defined desired result of having a total releasable nitric oxide
storage of at least 1.2 μmol of NO per milligram of the particle.
Appellant does not persuade us that the Specification describes a
representative number of species falling within the scope of the claimed
genus. Nor does Appellant persuade us that the Specification describes
structural features common to the genus such that a person skilled in the art
could visualize or recognize the members of the genus.
As to the breadth of the claimed genus, Appellant concedes that the
“claimed core scaffold may be any material that has been sufficiently
functionalized with nitric oxide donors such that the structure of the particle
that comprises the core scaffold and the nitric oxide donors has the claimed
ratio of nitric oxide release to particle mass.” Reply Br. 2.
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Consistent with Appellant’s broad interpretation of claim 1’s core
scaffold as encompassing any material having an NO donor converted from
a secondary amine, the Specification discloses that a wide variety of
materials may be used to prepare the core scaffold. See Spec. 4 (“[T]he
volume of the interior region [may] at least partially filled by a core selected
from the group consisting of: (a) a metallic cluster; (b) a dentritic [sic,
dendritic] network; (c) a co-condensed silica network; and (d) a combination
thereof.”); id. at 27 (“Suitable dendrimers [dendritic/branched polymers] for
use as core scaffolds of the presently disclosed particles include
polypropylenimine dendrimer; polyamidoamine (PAMAM) dendrimer;
polyaryl ether dendrimer; polylysine dendrimer; polyester dendrimer;
polyamide dendrimer; dendritic polyglycerol; and triazine dendrimers.”).
As Appellant contends, and the Examiner does not dispute, Tables 2
and 6 of Appellant’s Specification describe fourteen examples of particles
composed of a core scaffold having an NO donor converted from a
secondary amine, in which the particles have a total releasable nitric oxide
storage of at least 1.2 μmol of NO per milligram of the particle, as required
by claim 1. See Appeal Br. 7–8; see Final Act. 6 (noting that four of the
particles described in Table 2, and ten of the particles described in Table 6,
meet release limitation of claim 1).
In contrast to the concededly wide breadth of materials encompassed
by claim 1, however, the fourteen exemplified particles having a releasable
NO storage encompassed by claim 1 are composed of only two types of
materials. First, Example 6 of the Specification describes the synthesis of
the four particles shown in Table 2 encompassed by claim 1. See Spec. 56–
57 (describing synthesis of polypropylenimine dendrimer derivatives); see
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also id. at 58 (Table 2 of Example 7 describing tested particles from
Example 6 as “Diazeniumdiolated Species”).
And, second, Example 16 of the Specification describes the synthesis
of the ten particles shown in Table 6 encompassed by claim 1. See Spec.
66–67 (describing synthesis of diazeniumdiolate-modified silica particles).
Thus, while the genus of particles recited in Appellant’s claim 1
concededly encompasses particles composed of “any material” with a
secondary amine-derived NO donor that has a total releasable nitric oxide
storage of at least 1.2 μmol of NO per milligram of the particle (Reply Br.
2), the Specification describes only two types of materials,
diazeniumdiolate-modified polypropylenimine dendrimers and
diazeniumdiolate-modified silica particles, that actually meet the functional
requirement of claim 1. Because the Specification discloses only two types
of materials that provide a releasable NO storage amount encompassed by
claim 1, whereas claim 1 encompasses a wide variety of materials for use as
a core scaffold (see Spec. 4, 27), none of which has been described in the
Specification as providing the releasable NO storage recited in claim 1, we
agree with the Examiner that Appellant’s Specification does not provide
adequate descriptive support for the genus of NO-releasing particles recited
in Appellant’s claim 1.
Although the fourteen particles described in the Specification that are
encompassed by claim 1 may appear to be a significant number, we are not
persuaded that the claim-encompassed particles described in the
Specification are adequately representative of the claimed genus. See
AbbVie Deutschland v. Janssen Biotech, 759 F.3d at 1300 (“Although the
number of the described species appears high quantitatively, the described
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species are all of the similar type and do not qualitatively represent other
types of antibodies encompassed by the genus.”). In particular, as discussed
above, the fourteen claim-encompassed particles described in the
Specification are only composed of two types of materials, whereas claim 1
encompasses numerous types of other materials as the core scaffold and NO
donor, for which no showing has been made as to the claimed level of total
releasable NO storage.
We note, moreover, that in reciting that the secondary amine-derived
NO donor has a total releasable nitric oxide storage of “at least” 1.2 μmol of
NO per milligram of the particle (Appeal Br. 23), the genus recited in claim
1 encompasses particles with storages of releasable NO significantly higher
than 1.2 μmol of NO per milligram of the particle. The Examiner found, and
Appellant does not dispute, that the claim-encompassed particle having the
highest releasable NO storage described in the Specification has a total
releasable NO storage of 36 μmol/mg. See Ans. 5–6 (citing Spec., Table 2).
We agree with the Examiner that “a maximum of 36 μmol/mg could not
convey the open-ended range of ‘at least 1.2’, e.g., 50 μmol/mg.” Ans. 6.
We are also persuaded that the Examiner has advanced evidence of
unpredictability that further bolsters a finding that the particles of claim 1
lack adequate written description. In particular, as the Examiner found, and
Appellant does not dispute, at least thirteen particles with a scaffold that
includes a secondary amine-derived NO donor encompassed by claim 1 did
not meet claim 1’s requirement of a total releasable nitric oxide storage of at
least 1.2 μmol of NO per milligram of the particle. See Ans. 8. Indeed,
Appellant concedes that the art is unpredictable. See Appeal Br. 9. Given
the conceded unpredictability as to obtaining particles that meet the
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releasable NO storage recited in claim 1, we are not persuaded that claim 1’s
recitation of a scaffold that includes a secondary amine-derived NO donor
provides a structural feature common to the members of the claimed genus
that allows skilled artisans to visualize or recognize members of the claimed
genus.
In sum, for the reasons discussed, we agree with the Examiner that the
Specification does not provide adequate descriptive support for the genus of
NO-releasing particles recited in Appellant’s claim 1. We therefore affirm
the Examiner’s rejection of claim 1 for lack of written description. Because
they were not argued separately, claims 6–20, 42–48, and 59–70 fall with
claim 1. See 37 C.F.R. § 42.37(c)(1)(iv) (2017).
Appellant’s claim 2 recites “[t]he nitric oxide releasing particle of
Claim 1, wherein the nitric oxide-releasing particle has a total releasable
nitric oxide storage in a range of 1.2 μmol to 36 μmol of NO per milligram
of the nitric oxide releasing particle.” Appeal Br. 23.
Appellant’s claim 3 recites “[t]he nitric oxide-releasing particle of
claim 1, wherein the nitric oxide-releasing particle has a total releasable
nitric oxide storage in a range of 1.2 μmol to 10 μmol of NO per milligram
of the nitric oxide releasing particle.” Id.
For reasons similar to those discussed above as to claim 1, Appellant
does not persuade us that the Examiner erred in determining that the
Specification does not provide adequate descriptive support for the genus of
NO-releasing particles recited in claims 2 and 3. See Appeal Br. 10–11. In
particular, although Appellant’s claims 2 and 3 narrow the open-ended range
of releasable NO storage recited in claim 1, claims 2 and 3 still encompass a
broad genus of NO-releasing particles composed of numerous different
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materials which have not been described in the Specification as providing
the releasable NO storage recited in claims 2 and 3. Accordingly, we also
affirm the Examiner’s rejection of claims 2 and 3 for lack of written
description.
Appellant’s claim 4 recites “[t]he nitric oxide-releasing particle of
claim 1, wherein the nitric oxide-releasing particle comprises a
co-condensed silica network.” Appeal Br. 23. For reasons similar to those
discussed above as to claim 1, Appellant does not persuade us that the
Examiner erred in determining that the Specification does not provide
adequate descriptive support for the genus of NO-releasing particles recited
in claim 4. See id. at 11–12.
Although Appellant’s claim 4 limits the particle to one that includes a
particular type of material (a co-condensed silica network), claim 4 still
recites a genus that encompasses the open-ended range of releasable NO
storage recited in claim 1. As the Examiner points out, and Appellant does
not dispute, the only particles composed of a co-condensed silica network
that have a releasable NO storage encompassed by claims 1 and 4 have an
NO storage ranging from 1.2 to 10.2 μmol/mg. See Ans. 11 (citing Table 6
of Appellant’s Specification). We agree with the Examiner that the
Specification’s description of particles with a NO storage ranging from 1.2
to 10.2 μmol/mg does not provide a representative number of species of
particles encompassed by the open-ended range of at least 1.2 μmol/mg
recited in claims 1 and 4. We therefore affirm the Examiner’s rejection of
claim 4 for lack of written description.
Appellant’s claim 5 recites “[t]he nitric oxide-releasing particle of
claim 1, wherein the nitric oxide-releasing particle comprises a dendritic
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network.” Appeal Br. 23. For reasons similar to those discussed above as to
claims 1 and 4, Appellant does not persuade us that the Examiner erred in
determining that the Specification does not provide adequate descriptive
support for the genus of NO-releasing particles recited in claim 5. See id. at
12.
Although Appellant’s claim 5 limits the particle to one that includes a
particular type of material (a dendritic network), claim 5 still recites a genus
that encompasses the open-ended range of releasable NO storage recited in
claim 1. As the Examiner points out, and Appellant does not dispute, the
only particles composed of a dendritic network that have a releasable NO
storage encompassed by claims 1 and 5 have a NO storage ranging from 3.2
to 36 μmol/mg. See Ans. 11 (citing Table 2 of Appellant’s Specification).
We agree with the Examiner that the Specification’s description of
particles with a NO storage ranging from 3.2 to 36 μmol/mg does not
provide a representative number of species of particles encompassed by the
open-ended range of at least 1.2 μmol/mg recited in claims 1 and 5. We
note, moreover, that the sole species of dendritic network-containing
particles that meet the claimed NO storage requirement are composed of
diazeniumdiolate-modified polypropylenimine dendrimers (see Spec. 55–
58), whereas the term dendritic network in claim 5 encompasses a wide
variety of different branched polymers (see id. at 27), which have not been
described in the Specification as providing the claimed NO storage capacity.
We therefore affirm the Examiner’s rejection of claim 5 for lack of written
description.
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ENABLEMENT
The Examiner’s Prima Facie Case
The Examiner rejected claims 1–20, 42–48, and 59–70 as lacking
enablement for the full scope of the subject matter encompassed by the
claims. Final Act. 9–11. In particular, the Examiner concluded that
although the Specification enabled the fourteen exemplified embodiments of
NO-releasing particles mentioned above, the Specification nonetheless did
not enable
all nitric oxide-releasing particles comprising a nitric oxide
donor and a core scaffold, wherein a secondary amine of the
core scaffold has been converted to the nitric oxide donor, and
having a total releasable NO storage of at least at least 1.2 μmol
or 1.2 to 36 μmol/mg of nitric oxide per milligram (μmol/mg)
of the particle.
Id. at 9.
The Examiner noted that Table 2 of the Specification disclosed four
examples of particles with NO release amounts encompassed by the claims,
and also that Table 6 disclosed ten examples of particles with NO release
amounts encompassed by the claims. See id. at 9–10.
The Examiner reasoned that, despite the fourteen examples of
particles encompassed by Appellant’s claims, the Specification, nonetheless,
did not enable the full scope of claim-encompassed subject matter:
In sum, out of the thirty-eight particles Applicants
disclose, only fourteen or about a third, actually had total
releasable NO storage of at least 1.2 μmol/mg. The fourteen
also had varying types of “core scaffold” and different ligands,
and thus any extrapolation of the limited examples, i.e., to
achieve higher NO storage, seems unwarranted. Furthermore
only one of the thirty-eight particles had NO storage of 36
μmol/mg, with the next highest at 13 μmol/mg. Thus
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Applicant’s disclosure fails to provide direction or guidance,
but for the discrete examples that did, on attaining at least 1.2
μmol or 1.2 to 36 μmol/mg of releasable nitric oxide per
milligram of the particle.
Id. at 10.
As to unpredictability, the Examiner again cited the Board’s
affirmance of a written description rejection in the previous appeal in the
present application (Appeal 2014-000405), where the Board found that
Appellant’s Specification “reinforces th[e] unpredictability” as to preparing
NO-releasing particles with the required NO release properties because “the
examples fail to reveal any predictable way to form particles of a variety of
materials and sizes that meet the NO-release ratio of the broad genus
claims.” Final Act. 8 (quoting Dec. 16; emphasis by Examiner); see also id.
(“[B]ecause the art was unpredictable, we determine that a more detailed
disclosure is necessary here to support the full scope of the claimed subject
matter.” (quoting Dec. 16)).
Analysis
For the reasons provided below, Appellant does not persuade us that
the Examiner erred in determining that Appellant’s Specification fails to
enable the full scope of the subject matter recited in the rejected claims.
When evaluating the issue of enablement, the well-known factors to
be considered in determining whether experimentation would be undue
include:
(1) the quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art, (7) the
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predictability or unpredictability of the art, and (8) the breadth
of the claims.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Appellant initially contends that each of the independent claims
recites a “NO-releasing particle that is described by a particular structure”
and that the last Wands factor, therefore, “weighs in favor of enablement.”
Appeal Br. 13. We are not persuaded.
Representative claim 1 recites only two specific materials: (1) a “core
scaffold” and (2) an NO donor, “wherein a secondary amine of the core
scaffold is converted to the [NO] donor.” Appeal Br. 23.
Appellant concedes that a core scaffold
may be any material that has a secondary amine of the core
scaffold that has been converted to a NO donor, and that has
been sufficiently functionalized with nitric oxide donors such
that the structure of the particle that comprises the core and the
nitric oxide donors has the claimed nitric oxide storage.
Appeal Br. 14. Consistent with the breadth of claim 1 conceded by
Appellant, the NO donor of Appellant’s claim 1 may be any NO-donating
moiety converted from, i.e., derived from, a secondary amine. See id. at 23.
Thus, contrary to Appellant’s contention that claim 1 provides
breadth-narrowing structural limitations, the claim encompasses any
material that includes an NO donor derived from a secondary amine, with no
specific limitation as to the structure of the NO donor. As noted above,
Appellant’s Specification discloses that a wide variety of different materials
may be used to prepare the core scaffold and NO donor. See Spec. 4 (core
scaffold may be composed of a metallic cluster, dendritic network, a
co-condensed silica network, or combination thereof); id. at 27 (core
scaffolds may include polypropylenimine dendrimer, polyamidoamine
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(PAMAM) dendrimer, polyaryl ether dendrimer, polylysine dendrimer,
polyester dendrimer, polyamide dendrimer, dendritic polyglycerol, and
triazine dendrimers).
Because claim 1 encompasses a particle composed of essentially any
material that includes an NO donor (of any structure) derived from a
secondary amine, as long as the particle has a total releasable NO storage of
at least 1.2 μmol/mg, we agree with the Examiner that the subject matter
encompassed by claim 1 has considerable breadth. Indeed, as the Examiner
found, claim 1’s open-ended range of total releasable NO storage of at least
1.2 μmol/mg encompasses values many orders of magnitude higher than 1.2
μmol/mg.
Given the considerable breadth of claim 1, Appellant does not
persuade us that the scope of claim 1 weighs in favor of a conclusion of
enablement. Indeed, given claim 1’s considerable breadth in relation to the
potential materials that may be used to obtain the claimed level of releasable
NO storage, we agree with the Examiner that a significant quantity of
experimentation would have been necessary to determine which
encompassed materials would be useful for preparing a particle meeting the
claim’s functional NO storage requirement.
Appellant also does not persuade us that the state of the art weighs in
favor of a conclusion of enablement. Appellant concedes that “[p]rior to
Appellants’ present invention, approaches that combined nitric oxide donors
with other structures, such as proteins, fumed silica or polymethacrylate, had
limited ability to store large amounts of nitric oxide per unit mass. See, e.g.,
Specification, Example 8 and Table 3, page 58, lines 2-11.” Appeal Br. 14.
Given that a releasable NO storage amount encompassed by representative
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claim 1 was not routinely achieved using prior art methods and materials,
Appellant does not persuade us that the state of the art suggests that only
routine experimentation, as opposed to undue experimentation, would be
required to practice the full scope of the subject matter encompassed by
claim 1.
As to the level of predictability in the art, Appellant contends that,
“[w]hile the art at the time of the invention was unpredictable, as described
above and in the specification, it was known in art how to combine and
prepare NO donors with various structures including small molecules and
larger structures such as proteins.” Appeal Br. 15; see also id. at 16–17
(contending that in light of the high skill level in the art, the Specification
includes sufficient examples and guidance to enable a skilled artisan to
practice the full scope of the claimed subject matter notwithstanding the art’s
acknowledged unpredictability). We are not persuaded.
Although Appellant contends that the Specification provides a
generalized scheme for preparing NO-releasing particles encompassed by
the claims, that scheme only provides a method for synthesizing
NO-releasing N-diazeniumdiolates, from specific types of starting materials.
See Appeal Br. 15 (citing Scheme 1). And, as discussed above, Table 6
cited by Appellant (see id. at 16–17) only discloses data relating to
diazeniumdiolate-modified silica particles. Rather than being limited to
N-diazeniumdiolates and specific starting materials, however, claim 1
encompasses essentially any material composed of a secondary amine-
derived NO donor that has a total releasable NO storage of at least 1.2
μmol/mg. The fact that particles having a releasable NO storage within the
range of claim 1 can be prepared by a specialized synthetic approach using
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limited types of materials does not persuade us that a skilled artisan would
expect to be able to use, predictably, the full scope of materials
encompassed by claim 1 to prepare particles having the releasable NO
storage required by the claim, particularly given claim 1’s open-ended NO
storage range.
Indeed, as the Examiner found, the Specification discloses numerous
examples of particles with secondary amine-derived NO donors structurally
encompassed by claim 1, but which do not meet the functional NO storage
requirement of claim 1. See Final Act. 10 (citing Tables 1–4 and 6 of the
Specification as disclosing that “out of the thirty-eight particles Applicants
disclose, only fourteen or about a third, actually had total releasable NO
storage of at least 1.2 μmol/mg”); see also Ans. 8 (Examiner finding that at
least thirteen particles with a scaffold that includes a secondary amine-
derived NO donor encompassed by claim 1 did not meet claim 1’s
requirement of a total releasable nitric oxide storage of at least 1.2 μmol of
NO per milligram of the particle).
We acknowledge Appellant’s contention that at least four of the
allegedly inoperative embodiments identified by the Examiner in the
Specification do not have NO donors derived from secondary amines. See
Appeal Br. 17. We also acknowledge, as our reviewing court has explained,
that “[e]ven if some of the claimed combinations [are] inoperative, the
claims are not necessarily invalid.” Atlas Powder Co. v. E.I. du Pont de
Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984) (emphasis added).
Nonetheless, when “the number of inoperative combinations becomes
significant, and in effect forces one of ordinary skill in the art to experiment
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unduly in order to practice the claimed invention, the claims might indeed be
invalid.” Id. at 1576–77.
In the present case, given the Specification’s undisputed disclosure
that a significant portion of particles that meet claim 1’s broad structural
requirements do not achieve claim 1’s NO storage requirement, and given
the unpredictability in the art conceded by Appellant, we find that the
balance of the evidence supports the Examiner’s determination that a skilled
artisan would have had to engage in undue experimentation to practice the
full scope of the claimed invention. While we acknowledge that the
Specification discloses fourteen particles encompassed by both the structural
and functional requirements of claim 1, the Examiner has conceded that the
Specification is enabling for those embodiments, as noted above.
In sum, for the reasons discussed, Appellant does not persuade us that
the preponderance of the evidence fails to support the Examiner’s
conclusion of non-enablement as to representative claim 1. We therefore
affirm the Examiner’s rejection of claim 1 for lack of enablement. Because
they were not argued separately, claims 6–20, 42–48, and 59–70 fall with
claim 1. See 37 C.F.R. § 42.37(c)(1)(iv).
For reasons similar to those discussed above as to claim 1, Appellant
does not persuade us that the Examiner erred in determining that the
Specification does not enable the full scope of NO-releasing particles
encompassed by claims 2 and 3. See Appeal Br. 19–20. In particular,
although Appellant’s claims 2 and 3 narrow the open-ended range of
releasable NO storage recited in claim 1, claims 2 and 3 still encompass
NO-releasing particles composed of numerous different materials, which
have not been taught or suggested to provide the releasable NO storage
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recited in claims 2 and 3. Accordingly, given the claims’ breadth, the lack
of examples, and the conceded unpredictability in the art, we also affirm the
Examiner’s rejection of claims 2 and 3 for lack of enablement.
For reasons similar to those discussed above as to claim 1, Appellant
also does not persuade us that the Examiner erred in determining that the
Specification does not enable the full scope of NO-releasing particles
encompassed by claim 4. See Appeal Br. 20. Although Appellant’s claim 4
limits the particle to one that includes a particular type of material (a
co-condensed silica network), claim 4 does not narrow the open-ended range
of at least 1.2 μmol/mg releasable NO storage recited in claim 1, from which
claim 4 depends. Claim 4, therefore, encompasses releasable NO storage
values many orders of magnitude higher than 1.2 μmol/mg.
As the Examiner points out, and Appellant does not dispute, the
highest releasable NO storage value disclosed in the Specification for
particles composed of a co-condensed silica network is only 10.2 μmol/mg.
See Ans. 15 (citing Table 6 of Appellant’s Specification). We agree with the
Examiner that the Specification’s disclosure of particles having, at most, a
releasable NO storage of 10.2 μmol/mg does not provide an enabling
disclosure of particles encompassed by the full scope of claim 4, given that
claim 4 encompasses releasable NO storage values significantly higher than
10.2 μmol/mg. Accordingly, given the claim’s breadth, the lack of
examples, and the conceded unpredictability in the art, we also affirm the
Examiner’s rejection of claim 4 for lack of enablement.
For reasons similar to those discussed above as to claim 1, Appellant
also does not persuade us that the Examiner erred in determining that the
Specification does not enable the full scope of NO-releasing particles
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encompassed by claim 5. See Appeal Br. 20–21. Although Appellant’s
claim 5 limits the particle to one that includes a particular type of material (a
dendritic network), claim 5 does not narrow the open-ended range of at least
1.2 μmol/mg releasable NO storage recited in claim 1, from which claim 5
depends. Claim 5, therefore, encompasses releasable NO storage values
many orders of magnitude higher than 1.2 μmol/mg.
As the Examiner points out, and Appellant does not dispute, the
highest releasable NO storage value disclosed in the Specification for
particles composed of a dendritic network is only 36 μmol/mg. See Ans.
15–16 (citing Table 2 of Appellant’s Specification). We agree with the
Examiner that the Specification’s disclosure of particles having, at most, a
releasable NO storage of 36 μmol/mg does not provide an enabling
disclosure of particles encompassed by the full scope of claim 5, given that
claim 5 encompasses releasable NO storage values significantly higher than
36 μmol/mg. Accordingly, given the claim’s breadth, the lack of examples,
and the conceded unpredictability in the art, we also affirm the Examiner’s
rejection of claim 5 for lack of enablement.
CONCLUSION
In summary:
Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–20, 42–48, 59–70 112, first
paragraph
Written Description 1–20, 42–48,
59–70

1–20, 42–48, 59–70 112, first
paragraph
Enablement 1–20, 42–48,
59–70

Overall Outcome 1–20, 42–48,
59–70

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

AFFIRMED