CELATOR PHARMACEUTICALS INC. et al.

Patent Trials and Appeals Board

Aug 26, 2020

13905015 - (D) (P.T.A.B. Aug. 26, 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.
13/905,015 05/29/2013 Lawrence D. MAYER 53255-20015.01 1036
25225 7590 08/26/2020
MORRISON & FOERSTER LLP
12531 HIGH BLUFF DRIVE
SUITE 100
SAN DIEGO, CA 92130-2040
EXAMINER
WESTERBERG, NISSA M
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
08/26/2020 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):
EOfficeSD@mofo.com
PatentDocket@mofo.com
pair_mofo@firsttofile.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte LAWRENCE D. MAYER, ROBERT K. PRUD’HOMME,
CHRISTINE J. ALLEN, and WALID S. SAAD
____________

Appeal 2019-006848
Application 13/905,0151
Technology Center 1600
____________

Before FRANCISCO C. PRATS, TAWEN CHANG, and DAVID COTTA,
Administrative Patent Judges.

COTTA, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 relating to particulate
constructs stabilized by an amphiphilic compound and comprising at least
one active agent coupled through a linker to a hydrophobic moiety. Spec.
¶ 2. The Examiner rejected the claims on appeal as obvious under 35 U.S.C.
§ 103(a) and under 35 U.S.C. § 112 as indefinite, as failing to comply with

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. According to Appellant, the real party in interest is
Celator Pharmaceuticals, Inc., which is wholly owned by Jazz
Pharmaceuticals, PLC. Appeal Br. 2.
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the written description requirement, and as introducing new matter. A
hearing was held on May 11, 2020.2 We affirm-in-part.
STATEMENT OF THE CASE
The Specification discloses that “[t]he present invention provides
particulate constructs that can be adapted to the release of active agents of
various types useful in both pharmaceutical and non-pharmaceutical
applications.” Spec. ¶ 24. According to the Specification, “[t]hese delivery
systems provide high loading capacity for active compounds as well as
provide a means for controlled release of the active, reduction in toxicity
where relevant, and, if desired, selective delivery to a target site.” Id.
Claims 1, 3, 4, 7–9, 13, and 16–24 are on appeal. Claim 1 is
representative and reads as follows:
1. A composition comprising particles obtained by mixing

a) an amphiphilic stabilizer,

b) a conjugate of the formula

(active – linker)n – hydrophobic moiety (1)

wherein n is an integer of 1–100;

“active” refers to a first therapeutic agent;

“linker” is a divalent residue of an organic
molecule which comprises a bond that is selectively
cleavable by reduction or hydrolysis to control the rate of
release of said active from the particle free of said
hydrophobic moiety or portion thereof; and

2 A transcript from the hearing has been entered into the record (“Tr.”).
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“hydrophobic moiety” refers to the residue of an
organic molecule that is insoluble in aqueous solution;
and

c) a second therapeutic agent different from the first
therapeutic agent,

wherein said first and second therapeutic agents are
present in the composition at a nonantagonistic ratio

said conjugate and particles constructed so that the
release of the first therapeutic agent from the particles is
coordinated with the release of the second therapeutic
agent so that the administered ratio of said first
therapeutic agent to said second therapeutic agent in said
composition is maintained when said composition is
administered parenterally to a subject, as measured in the
plasma of the subject, and

wherein the hydrophobic moiety is a polymer
having a molecular weight between 800 and 200,000
g/mole or is a natural product, and

the amphiphilic stabilizer is a copolymer having a
hydrophilic region and a hydrophobic region wherein
said copolymer is a graft, block or random copolymer
and has a molecular weight between 1,000 g/mole and
50,000 g/mole.

App. Br. 31.
The Examiner rejected the claims as follows:
Claims 1, 3, 4, 7–9, 13, and 16–24 were rejected under 35 U.S.C.
§ 112 as failing to comply with the written description requirement.
Claims 1, 3, 4, 7–9, 13, and 16–24 were rejected under 35 U.S.C.
§ 112 as indefinite.
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Claims 17–24 were rejected under 35 U.S.C. § 103(a) as obvious over
the combination of Oh,3 Soppimath,4 McLeod,5 and Muggia.6
Claims 17–24 were rejected under 35 U.S.C. § 103(a) as obvious over
the combination of Oh, Soppimath, McLeod, Muggia, and Johnson.7
Claims 1, 3, 4, 7–9, and 16–24 were rejected under 35 U.S.C. § 103(a)
as obvious over the combination of Oh, Soppimath, McLeod, Muggia, and
Tardi.8
OBVIOUSNESS
The same issue is dispositive with respect to all three obviousness
rejections. Accordingly, we address all three rejections together.
Oh discloses “a molecular sustained controlled release system
constructed by the conjugation of molecules to be released with
biodegradable polyester polymer via covalent bond.” Oh Abstract.
The “drug release rate” from Oh’s controlled release system is taught to be
“proportional to [the] mass erosion rate of the biodegradable microspheres,
nanoparticles, and films.” Id. at 7:35–41. The Examiner nonetheless finds
that Oh discloses linkers that “control the rate of release,” as recited in the

3 Oh et al., US Patent No. 6,589,548 B1, issued July 8, 2003 (“Oh”).
4 Soppimath et al., Biodegradable Polymeric Nanoparticles as Drug
Delivery Devices, 70 Journal of Controlled Release 1–20 (2001)
(“Soppimath”).
5 McLeod et al., Synthesis and Chemical Stability of Glucocorticoid-Dextran
Esters: Potential Prodrugs for Colon-Specific Delivery, 92 International
Journal of Pharmaceutics, 105–114 (1993) (“McLeod”).
6 Muggia et al., Phase III Randomized Study of Cisplatin Versus Paclitaxel
Versus Cisplatin and Paclitaxel in Patients with Suboptimal Stage III or IV
Ovarian Cancer: A Gynecologic Oncology Group Study, 18(1) Journal of
Oncology 106–115 (2000) (“Muggia”).
7 Johnson et al., WO 02/078674 A1, published Oct. 10, 2002 (“Johnson”).
8 Tardi et al., WO 03/028696 A2, published April 10, 2003 (“Tardi”).
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claims, because “there is a significant overlap between the types of linkers
disclosed by Oh and those included in the definition of linker in the instant
specification.” Ans. 28. According to the Examiner “[b]onds such as the
carbamate bond in examples 6 and 7 of Oh and other exemplified bonds
such as esters, amides, anhydrides, ureas, urethanes, carbonates, imines,
thioesters, disulfides, and carbamates include bonds that are cleaved by
hydrolysis as required by the instant claims.” Id. (internal citation omitted).
The Examiner finds that the claims encompass biodegradation and states that
she was “unable to locate any evidence either in Oh itself or in the
prosecution history that all drug release from the particles occurs in a form
in which the carbamate bond between the active and the polymer remains
intact.” Id. We are not persuaded.
As Appellant points out, in order for the “linker” to “control the rate
of release of said active,” as recited in the claims, the “rate of cleavage of the
bond contained in the linker must be faster than the rate of disintegration of
the hydrophobic moiety and the amphiphilic stabilizer.” Reply Br. 5; see
also, Torchilin Decl.9 ¶ 6. Otherwise the rate of release would be controlled
by the rate of disintegration of the hydrophobic moiety and the amphiphilic
stabilizer.
The Examiner appears to contend that the linkers used in Oh would
inherently have this property because the types of bonds disclosed in Oh are
the same types of bonds as disclosed in the Specification. Ans. 28.
However, Oh itself suggests that this is not the case. Oh describes a study in
which the release profiles of two nanoparticles was compared. Oh, 16:14–

9 Declaration of Dr. Vladimir P. Torchilin submitted under 37 C.F.R.
§ 1.132, dated June 5, 2015 (“Torchilin Decl.”).
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15. One of the nanoparticles studied was a doxorubicin-PLGA conjugate in
which the doxorubicin was linked to the PLGA by a carbamate bond. Id. at
16:15–24. Oh teaches that “the carbamate linkage between doxorubicin and
PLGA was not easily cleaved in the aqueous medium.” Id. at 16:24–25. As
a result, and as Oh explains, the release of doxorubicin was controlled by the
degradation of the polymer rather than the cleavage of the linker:
The sustained release action was caused by the gradual
chemical degradation of conjugated PLGA backbone and
subsequent controlled liberation of water soluble doxorubicin-
PLGA oligomer conjugates in the incubation medium. Their
release rate was solely dependent on how fast the conjugated
PLGA chains were hydrolyzed to reach the critical MW.
Id. at 16:25–30 (emphasis added).
We acknowledge that certain of the linkers disclosed by Oh overlap
with those disclosed in the specification. Compare Spec. ¶ 40 (identifying
“esters, carbonates, carbamates, disulfides and hydrazones” as linkers
forming “hydrolysable or enzymatically cleavable bonds”) with Oh, 3:66–
4:3 (“This invention provides the system employing the ester bond, amide
bond, anhydride bond, urea bond, urethane bond, carbonate bond, imine
bond, thioester bond, disulfide bond or carbamate bond for conjugation of
molecules with biodegradable polyester polymers.”). However, the
Examiner has not identified persuasive evidence that any of the types of
linkers disclose in Oh would necessarily cleave faster than the polymer
degrades, as required in order for the linker to control the rate of release of
the active. In contrast, Appellant directs us to evidence that “the same type
of bond, such as a carbamate[,] will have a cleavage rate depending on its
surroundings not simply on its own nature.” Reply 5 (citing Torchilin Decl.
¶ 7).
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In sum, the evidence does not support that Oh discloses the conjugates
inherently having the claimed property that the linker controls the release
rate because: 1) Oh teaches that the release rate in one of its nanoparticles
was controlled solely by the hydrolyzation of its biodegradable polymer, 2)
the Examiner has not identified persuasive evidence that the cleavage rate of
the linkers disclosed in Oh is inherently faster than the degradation of the
polymers to which they linked, and 3) Appellant has provided evidence that
the release rate of a linker depends on more than just the constitution of the
linker. As the Examiner has not persuasively articulated a reason why it
would have been obvious to use a linker that controls the release rate, as
claimed, we reverse the Examiner’s three obviousness rejections.
WRITTEN DESCRIPTION
The Examiner rejected claims 1, 3, 4, 7– 9, 13, and 16–24 for failure
to comply with the written description requirement. In doing so, the
Examiner articulated three rationales, each applying to a different group of
claims. We reverse the only one of the Examiner’s rationales that applies to
all of the pending claims. We also reverse the rationale that applies only to
claims 17–24. We affirm the rationale that applies only to claims 1, 3, 4, 7–
9, 13, and 16. In addition, we find that the Examiner has not established that
all of the pending claims include new matter. Our analysis of all three of the
Examiner’s rationales, as well as the Examiner’s finding that all of the
pending claims recite new matter, is set forth below.

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Rationale 1: “selectively cleavable bond”
All of the pending claims require a bond that is “selectively cleavable
by reduction or hydrolysis to control the rate of release of said active from
the particle free of said hydrophobic moiety or portion thereof.”10 The
Examiner found that the claims fail to comply with the written description
requirement because the Specification does not describe “the bonds that are
suitable for this function.” Ans. 6–7. We are not persuaded.
The Specification teaches that “the invention concerns particulate
constructs stabilized by an amphiphilic compound and comprising at least
one active agent coupled through a linker to a hydrophobic moiety, which
agent can be released from the construct by cleavage of the linker.” Spec.
¶ 2. The Specification also discloses linkers that it asserts can perform this
function. Id. ¶ 52; see also, generally, id. ¶¶ 49–63. The Examiner does not
provide reason to doubt these assertions. In re Alton, 76 F.3d 1168, 1175
(Fed. Cir. 1996) (“If. . . the specification contains a description of the
claimed invention, albeit not in ipsis verbis (in the identical words), then the
examiner . . . , in order to meet the burden of proof, must provide reasons
why one of ordinary skill in the art would not consider the description
sufficient.”). Accordingly, the Examiner has not carried its burden to
establish that claims 1, 3, 4, 7–9, 13, and 16–24 fail to comply with the
written description requirement on the basis that they do not describe bonds
suitable as linkers.

10 The quoted language is from claim 1. Claim 17 uses the plural “particles”
rather than the singular “particle” recited in claim 1. This difference does
not substantively impact our analysis.
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Rationale 2: “Nano Precipitation”
Claim 17, and the claims depending therefrom, require that the
claimed composition be obtained using a “Nano Precipitation process.” The
Examiner rejected these claims for failing to comply with the written
description requirement on the basis that the Specification does not describe
the “particular method steps” relating to this term. Ans. 6–7. We are not
persuaded.
The Specification teaches that “Nano Precipitation” is term of art that
describes a known method for forming particulate constructs. It states:
A number of methods can be used to form the particulate
constructs of the invention. One particularly useful method is a
process termed “Nano Precipitation” as described by Johnson,
B. K., et al., AIChE Journal (2003) 49:2264-2282 and U.S.
2004/0091546 incorporated herein by reference.
Spec. ¶ 75. The Examiner does not direct us to persuasive evidence that the
ordinary artisan would not have known what the method steps of Nano
Precipitation were, or would not have understood Appellant to be in
possession of a composition comprising particles obtained using Nano
Precipitation. Accordingly, the Examiner has not carried its burden to
establish that claims 17–24 fail to comply with the written description
requirement on the basis that they do not describe the “Nano Precipitation
process.”
Rationale 3: “the administered ratio . . . is maintained”
Appellant argues the rejection of claims 1, 3, 4, 7–9, 13, and 16 under
rational 3 (i.e., the rationale that the Specification does not disclose
“maintain[ing]” the “administered ratio” as claimed) together. We designate
claim 1 as representative.
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Claim 1 requires that two therapeutic agents be “present in the
[claimed] composition in a non-antagonistic ratio,” and that “the release of
the first therapeutic agent from the particles is coordinated with the release
of the second therapeutic agent so that the administered ratio of said first
therapeutic agent to said second therapeutic agent in said composition is
maintained when said composition is administered parenterally.” The
Examiner finds that the Specification does not provide written description
support for this limitation because the components of the composition are
“broad in scope,” and “[t]he specification does not provide any examples of
particles that contain a non-antagonistic ratio maintained for any length of
time with the structures that provide such a function.” Ans. 5–6. The
Examiner points to Example 16 as describing nanoparticles containing
cisplatin and paclitaxel (two therapeutic agents) that were administered to
mice but notes that no results were provided and that the example concludes
with the statement that “[t]he experiment is repeated at various
paclitaxel:cisplatin ratios for various polymer compositions until the
synergistic ratio is maintained after i.v. injection.” Id. at 6. From this, the
Examiner concludes that, “whatever the initial formulation was in this
example, maintenance of the synergistic ration was not present and . . .
further experimentation was required to provide particles in which a
synergistic ratio was maintained.” Id. The Examiner thus concluded that
the Specification provided “no indication as to the structure and/or
composition of the nanoparticles that resulted in maintenance of the
synergistic ratio of the drug.” Id.
We agree with the Examiner that Appellant’s disclosure does not
show that Appellant was in possession of compositions having the claimed
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function of maintaining a non-antagonistic ratio between therapeutic agents
when administered parenterally. This function is, according to Appellant’s
counsel, novel to the claimed composition. Tr. 6:22–7:3. (“Prior to the
current invention, it was impossible to deliver two drugs to the correct ratio
and maintain that ratio since different drugs had different solubility
profiles.”).
We begin by considering the scope of the claim. The structural
components of claim 1 are very broadly defined. See e.g., Spec. ¶¶ 45–48
(stating that “[a] wide variety of therapeutic agents can be included” and
providing a long list of exemplary therapeutic agents); 50–62 (describing
and providing examples of linkers), 66–69 (stating that “[t]he hydrophobic
moiety may include polymers or natural products” and providing a long list
of exemplary moieties), 70–74 (describing and providing a long list of
exemplary amphiphilic stabilizers). Indeed, in its Reply Brief, Appellant
states that the claims encompass “thousands of combinations of hydrophobic
components, linkers and amphiphilic stabilizers that would achieve the
intended result.” Reply Br. 2; see also, Purd’homme Decl.11 ¶ 3 (testifying
that “the skilled artisan would have a wide variety of choices too numerous
to be listed with any completeness . . . in order to construct . . . particles
containing the conjugate”); Mayer Decl.12 ¶ 3 (testifying that “there is a vast
number of possible combinations that will result in particulate constructs
meeting the requirements of the claims”).

11 Declaration of Robert K. Prud’homme submitted under 37 U.S.C. § 1.132,
signed February 26, 2017 (“Prud’homme Decl.”).
12 Declaration of Lawrence D. Mayer submitted under 37 U.S.C. § 1.132,
signed February 27, 2017 (“Mayer Decl.”).

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In support of this broad genus of functionally defined compositions,
Appellant does not identify, and we do not find in the Specification, a single
composition that has this functional characteristic. Nor do we find evidence
in the Specification that the genus is identified by structural features
common to members of the genus. This supports the Examiner’s
determination that the Specification does not provide written description
support for claim 1. See, Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.,
598 F.3d 1336, 1350. (“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.”).
We recognize that the portions of the Specification cited above
provide descriptions of each of the individual components of the claimed
composition. What is missing is a disclosure of a correlation between
inclusion of each of the recited components in the claimed composition and
the claimed function of maintaining the ratio of therapeutic agents. See Enzo
Biochem Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (holding
that the written description requirement is met for a functional claim
limitation where the function is “coupled with a disclosed correlation
between that function and a structure that is sufficiently known or
disclosed”). Here, rather than provide a correlation between structure and
function, the Specification suggests arriving at the claimed structure by trial
and error experimentation.
In particular, Example 16, which Appellant cites as providing support
for the claimed function (Appeal Br. 16), describes investigating
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“[n]anoparticles containing both cisplatin and paclitaxel . . . for in vivo
release rates” by injecting a composition comprising the nanoparticles into
mice. Spec. ¶¶ 162–163. It concludes with the statement: “[t]he experiment
is repeated at various paclitaxel:cisplatin ratios for various polymer
compositions until the synergistic ratio is maintained after i.v. injection.” Id.
¶ 163.13 We agree with the Examiner that this statement suggests that
Appellant did not have possession of a composition having the claimed
functional characteristic at the time Experiment 16 was described in the
application.14 Ans. 6. In addition, this statement suggests identifying
polymers that perform the claimed function (when used in combination with
the other components of the composition) not by relying on a correlation
between the structure of the polymer and the claimed function, but by brute
force repetition with “various . . . polymer compositions until the synergistic
ratio is maintained.” Id.
Appellant argues that the claims themselves provide the structure
required to satisfy the written description requirement. Appeal Br. 8. More
specifically, Appellant contends that the claim structurally and functionally
defines “the sizes of the conjugate, the linker, the hydrophobic moiety, the
amphipathic stabilizer, as well as the function of the linker, the ratio of the
two drugs and the timing of drug release.” Id. We are not persuaded.
Although Appellant is correct that claim 1 defines certain structural
aspects of the claimed composition, including, e.g., a range of molecular

13 We understand the “polymer composition” referenced in Exhibit 16 to
correspond to the “hydrophobic moiety” component of claim 1. See Spec. ¶
66 (teaching that the hydrophobic moiety “may include polymers”).
14 We note that Example 16 describes the experiment in present tense and is
therefore a prophetic, rather than a working, example.
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weights for the hydrophobic moiety and the amphiphilic stabilizer, we are
not persuaded that the recited structure provides written description support
for the recited function. As discussed above, Appellant does not direct us to
persuasive evidence that these structural features correlate with maintaining
the claimed release profile. See Enzo Biochem Inc., 323 F.3d at 964.
Indeed, at least with respect to the ratio of agents and the identity of the
hydrophobic moiety, Example 16 (discussed above) suggests using trial and
error rather than structural correlation to identify appropriate components.
Further, Example 16 makes clear Appellant’s expectation that compositions
having the claimed components may lack the recited function of maintaining
the ratio of therapeutic agents.
In addition, the evidence supports that obtaining a particular release
rate for the first therapeutic agent – one aspect of maintaining the claimed
ratio of therapeutic agents – depends on more than just the identity of the
linker. See Prud’homme Decl. ¶¶ 6–7 (“the rate of hydrolysis of the linkage
depends not only on the nature of the cleavable bond itself but other factors
such as its distance from the polymer backbone, the hydrophilicity of the
surrounding groups and steric crowding around the center of reaction”).
Accordingly, we are not persuaded that the broad recitation of structure in
the claims is sufficient to show possession of a composition having the
claimed function.
Appellant argues that the Specification teaches “how to form the
nanoparticles, how to attach the linkers to the drug and hydrophobic
moieties, how to determine non-antagonistic ratios, and how to test for
effective drug combination[s].” Appeal Br. 9 (internal citations omitted).
According to Appellant, the Specification also provides examples showing
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“conjugation with active drugs and polymers/hydrophobic moieties,
formation of conjugates into nanoparticles, combination therapies, and
controlled delivery, among other things.” Id. (internal citations omitted).
Finally, Appellant points to the Specification, certain references, and two
Declarations as showing that “the science has matured to a degree that it is
predictable and can be relied on to show Written Description of the present
invention.” Id. at 10. We are not persuaded.
The evidence cited by Appellant goes to whether the ordinary artisan
would be able to make and use the claimed composition, not whether the
Appellant has provided a written description of the invention. See e.g.,
Prud’Homme Decl. ¶ 8 (“In summary, the skilled artisan would readily be
able to construct particles with the requirements of the claims without
further description from that in the specification”); Meyer Decl. ¶ 5 (“Thus,
it [(i.e., the information provided in the Specification)] is in fact sufficient to
inform the skilled artisan that the nature of the hydrophobic moiety and the
nature of the cleavable bond should be such that the cleavable bond controls
the release of the coupled agent free of the hydrophobic moiety or portions
thereof to enable the skilled artisan to construct the claimed particles.”); see
also, Appeal Br. 11 (“There is ample evidence of record that the skilled
artisan, once advised of the inventive concept, could, without further
instruction[,] combine the known elements that lead to the claimed
function.”). Appellant does not direct us to persuasive evidence that the
ordinary artisan would have understood Appellant to possess any particular
composition having the claimed function.
Even crediting that the evidence submitted by Appellant does, in fact,
teach the ordinary artisan how to make and use the claimed composition,
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that alone does not satisfy the written description requirement. Ariad, 598
F.3d at 1344 (holding that 35 U.S.C. § 112 “contains two separate
description requirements: a ‘written description [i] of the invention, and [ii]
of the manner and process of making and using [the invention’].”
(alterations in original)); Goeddel v. Sugano, 617 F.3d 1350, 1356 (Fed. Cir.
2010) (“The question is not whether one skilled in this field of science might
have been able to produce mature hFIF by building upon the teachings of the
Japanese Application, but rather whether that application ‘convey[ed] to
those skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date.’”). As our reviewing court explained,
“[o]ne shows that one is ‘in possession’ of the invention by describing the
invention, with all its claimed limitations, not that which makes it obvious.”
Lockwood v. American Airline, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997).
Accordingly, we affirm the Examiner’s rejection of claims 1, 3, 4, 7–
19, 13, and 16 under 35 U.S.C. § 112 as failing to comply with the written
description requirement.
New Matter
The Examiner found that claims 1, 3, 4, 7–9, 13, and 16–24 contain
new matter because they require a linker that is “selectively cleavable by
reduction or hydrolysis to control the rate of release of said active from the
particle free of said hydrophobic moiety or portion thereof.” Ans. 3.
According to the Examiner, while the linker is taught to control the rate of
release from the hydrophobic moiety, it is not taught that the linker controls
“the rate of release of the drug from the particle.” Id. at 4. As discussed
above, the Specification teaches that “the invention concerns particulate
constructs stabilized by an amphiphilic compound and comprising at least
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one active agent coupled through a linker to a hydrophobic moiety, which
agent can be released from the construct by cleavage of the linker.” Spec. ¶
2 (emphasis added). The Specification also discloses linkers that it asserts
can perform this function. Id. ¶ 52; see also, generally, id. ¶¶ 49–63.
Accordingly, we do not agree with the Examiner’s conclusion that claims 1,
3, 4, 7–9, 13, and 16–24 comprise new matter.
INDEFINITENESS
Claims 1, 3, 4, 7–9, 13, and 16
Claims 1, 3, 4, 7–9, 13, and 16 require that the conjugate and particles
be “constructed so that the release of the first therapeutic agent from the
particles is coordinated with the release of the second therapeutic agent so
that the administered ratio of said first therapeutic agent to said second
therapeutic agent in said composition is maintained when said composition
is administered parenterally.” The Examiner found that these claims were
indefinite because neither the claims nor the Specification “provide a link
between the structure(s) that provide the claimed function of coordinated
release of the first and second therapeutic agents such that the non-
antagonistic ratio of the two drug is maintained following parenteral
administration.” Ans. 8. The Examiner notes that the claims encompass “all
means or methods of resolving the problem” but contends that because
“[t]he specification fails to provide examples of the structures that provide
this function, . . . one of ordinary skill in the art would not be able to draw a
clear boundary between what is and is not covered by the claims.” Id. We
are not persuaded.
The Examiner does not provide persuasive evidence or argument to
support that the ordinary artisan would not have been able to determine what
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was meant by the requirement that the ratio of the first therapeutic agent to
the second therapeutic agent be maintained when the composition
administered parenterally. Put another way, the current record does not
support that, for any given composition, the ordinary artisan would be
unable to ascertain whether that composition met the requirement for
coordinating the release of therapeutic agents. Thus, although we agree with
the Examiner that claims 1, 3, 4, 7–9, 13, and 16 are potentially quite broad
in encompassing a wide range of compositions that provide the claimed
function, and that the Specification does not provide examples of
compositions that provide the claimed function, we do not agree with the
Examiner that the ordinary artisan would “not be able to draw a clear
boundary between what is and is not covered by the claims.” Id.; In re
Miller, 441 F.2d 689, 693 (CCPA 1971) (“[B]readth is not to be equated
with indefiniteness.”). Accordingly, we reverse the Examiner’s rejection of
claims 1, 3, 4, 7–9, 13, and 16 as indefinite.
Claims 17–24
Claim 17 requires a composition comprising particles that are
“obtained from fast mixing according to the Nano Precipitation process.”
The Examiner rejected claim 17, and the claims depending therefrom, as
indefinite on the basis that the term “Nano Precipitation process” lacked
antecedent basis. Ans. 9. According to the Examiner, “[n]o particular
method steps are recited in the body of the claim to further define the
process referenced in the preamble of the claim and . . . [t]herefore the scope
of the process that is used to prepare the nanoparticles in claim 17 is
unclear.” We are not persuaded.
Appeal 2019-006848
Application 13/905,015

19
As discussed above with respect to written description, the
Specification teaches that “Nano Precipitation” is term of art describing a
known method for forming particulate constructs. Spec. ¶ 75. The
Examiner does not direct us to persuasive evidence that the ordinary artisan
would not have known what the method steps of Nano Precipitation were, or
would otherwise not have understood what was meant by the term “Nano
Precipitation.” Accordingly, we reverse the Examiner’s rejection of claims
17–24 as indefinite.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Basis/Reference  Affirmed Reversed
1, 3, 4, 7–9,
13, 16–24
112 Written
description 
1, 3, 4, 7–9,
13, 16
17–24
1, 3, 4, 7–9,
13, 16–24
112 Indefiniteness 1, 3, 4, 7–9,
13, 16–24
1, 3, 4, 7–9,
16–24
103 Oh, Soppimath,
McLeod,
Muggia, Tardi
1, 3, 4, 7–9,
16–24
17–24 103 Oh, Soppimath,
McLeod,
Muggia
17–24
17–24 103 Oh, Soppimath,
McLeod,
Muggia,
Johnson
17–24
Overall
Outcome
1, 3, 4, 7–9,
13, 16
17–24

Appeal 2019-006848
Application 13/905,015

20
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). See, 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED-IN-PART