Incept, LLC

Patent Trials and Appeals Board

Mar 19, 2020

15152739 - (D) (P.T.A.B. Mar. 19, 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.
15/152,739 05/12/2016 Peter Jarrett 3516.69US02 5801
62274 7590 03/19/2020
CHRISTENSEN, FONDER, DARDI & HERBERT PLLC
33 South Sixth Street
Suite 4540
Minneapolis, MN 55402
EXAMINER
SOROUSH, LAYLA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
03/19/2020 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):
docket@cfd-ip.com
patents@cfd-ip.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte PETER JARRETT, RAMI EL-HAYEK, TIMOTHY S. JARRETT,
CHARLES D. BLIZZARD, and AMARPREET S. SAWHNEY
____________

Appeal 2019-006533
Application 15/152,739
Technology Center 1600
____________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
ULRIKE W. JENKS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1, 2, 5, 6, 8–13, 16, 17, and 21–29 (see Appeal Br.
3). We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “Incept,
LLC” (Appellant’s January 16, 2019 Appeal Brief (Appeal Br.) 3).
Appeal 2019-006533
Application 15/152,739

2
STATEMENT OF THE CASE
Appellant’s disclosure “relates to drug delivery involving hydrogels as
used for various medical conditions, and includes hydrogels formed in an
eye with extended drug release times” (Spec.2 1: 8–10). Appellant’s claim 1
is reproduced below:
1. A method of delivering a therapeutic agent to a tissue
comprising combining a first precursor and a second precursor
that react with each other in presence of a therapeutic agent to
form a covalently crosslinked hydrogel in situ in an eye with
the therapeutic agent dispersed in the hydrogel, all of the agent
being directly disposed in the hydrogel and having a low
solubility in water, and with the hydrogel being formed with a
spacing between crosslinks that allows diffusion of the agent
through the hydrogel, wherein the hydrogel essentially persists
at least until the agent has been essentially released.
(Appeal Br. 15.)

Ground of rejection before this Panel for review:
Claims 1, 2, 5, 6, 8–13, 16, 17, and 21–293 stand rejected under 35
U.S.C. § 103(a) as unpatentable over Jarrett.4
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?

2 Appellant’s May 12, 2016 Specification.
3 Although Examiner did not include Appellant’s claim 29 in the statement
of the rejection, Appellant does include claim 29 as part of this rejection (see
Examiner’s July 17, 2019 Answer (Ans.); cf. Appeal Br. 3). Therefore, we
included claim 29 in our deliberations.
4 Jarrett et al., US 2013/0071462 A1, published Mar. 21, 2013.
Appeal 2019-006533
Application 15/152,739

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FACTUAL FINDINGS (FF)
FF 1. Appellant discloses that “therapeutic agents require a minimum
concentration to be effective but may have toxic effects at concentrations
that are too high. Therefore the agent must be released quickly and
consistently enough to be effective without being released at too great a rate
through the entire life of the implant” (Spec. 4: 13–16).
FF 2. Appellant discloses “[d]rugs or other therapeutic agents for
delivery,” using its hydrogel (Spec. 37: 1 – 41: 17).
FF 3. Appellant discloses that “[l]ow-solubility is a broad term that means
no more than 200 μg/ml soluble in water at 25°C, the water being pure
water, and the drug being essentially pure or a salt” (Spec. 41: 24–25).
FF 4. Appellant discloses that “hydrogels may be loaded with an agent or
agents that are disposed directly and/or indirectly in the hydrogel,” wherein
“[d]irectly refers to placing the agent in direct contact with the matrix, e.g.,
by forming a matrix in a presence of the agent in solid or soluble form” and
“[a]n indirect loading process is, e.g., placing the agent in particles and
forming the hydrogel around them, so that the agent is inside the particle
and, at the time of formation, is not in direct contact with the matrix” (Spec.
47: 10–17).
FF 5. Jarrett “relates to drug delivery systems and applications, and
includes delivery of drugs using particles entrapped in a hydrogel matrix”
(Jarrett ¶ 1; see id. ¶ 15 (Jarrett discloses a “system [that] involves a
biodegradable hydrophilic hydrogel comprising dispersed lipophilic particles
that contain a water soluble therapeutic agent. The particles may be made
with molecules that have a low water solubility, meaning a water solubility
of less than about 0.1 mg/ml at 20ºC.”)).
Appeal 2019-006533
Application 15/152,739

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FF 6. Examiner finds that Jarrett discloses “a biodegradable hydrophilic
hydrogel comprising dispersed lipophilic particles that comprise a
therapeutic agent, wherein the lipophilic particles have a low water solubility
in physiological saline at physiological temperature,” including water
soluble agents, such as “axitinib,” wherein the hydrogel is made from
crosslinked precursors (see Ans. 4–5; see also Jarrett ¶¶ 42, 51, and 94–97
(describing “Drugs or Other Therapeutic Agents for Delivery” using Jarrett’s
hydrogel delivery system)).
FF 7. Examiner finds that Jarrett discloses “that it is possible to construct a
hydrogel with a desired degradation profile, from a few days to many
months, using a degradable segment” (Ans. 4; see Jarrett ¶ 85).
FF 8. Examiner finds that Jarrett’s drug delivery system “may be used for
[t]reatment of neovascular (wet) age-related macular degeneration” (Ans. 4;
see Jarrett ¶ 100).
FF 9. Examiner finds that “[a] visualization agent may be used
with . . . [Jarrett’s] hydrogel,” wherein the visualization agent “may or may
not become chemically bound to the hydrogel” (Ans. 4; see Jarrett ¶¶ 90–92
(describing “Visualization Agents” useful in Jarrett’s hydrogel delivery
system)).
FF 10. Jarrett discloses that “[v]isualization agents may be selected from
among any of the various non-toxic colored substances suitable for use in
medical implantable medical devices, such as FD&C BLUE dyes 3 and 6,
eosin, methylene blue, indocyanine green, or colored dyes normally found in
synthetic surgical sutures” (Jarrett ¶ 92; see id. ¶ 93 (Jarrett discloses that the
visualization “agent tends to mark the location of the particle and provides
an indication of its presence and dissolution rate”)).
Appeal 2019-006533
Application 15/152,739

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ANALYSIS
Based on Jarrett, Examiner concludes that, at the time Appellant’s
invention was made, it would have been prima facie obvious to deliver a
therapeutic agent using Jarrett’s hydrogel (see Ans. 6). In this regard,
Examiner reasons that because Jarrett’s hydrogel can comprise a water
soluble therapeutic agent, having lipophilic particles with a low water
solubility in physiological saline at physiological temperature” a person of
ordinary skill in this art “would have had [a] reasonable expectation of
successfully achieving similar efficacy and results” as Appellant obtained
when delivering a therapeutic agent to a tissue (see id.; see also id. at 7). We
are not persuaded.
As Appellant explains, Jarrett discloses a delivery system wherein the
therapeutic agent is indirectly loaded into a hydrogel, whereas the
therapeutic agent of Appellant’s claimed invention is directly deposited in
the hydrogel (see Appeal Br. 9; see also id. at 11 and 15; FF 4 (describing
the difference between direct and indirect process of loading a hydrogel); cf.
FF 5 (Jarrett describes an indirect process of loading a hydrogel, wherein
particles, containing a water soluble therapeutic agent, are dispersed in a
hydrogel)). Examiner does not dispute Appellant’s characterization of
Jarrett’s disclosure as it relates to the indirect process of loading therapeutic
agent into a hydrogel (see Ans. 7). Thus, Examiner failed to establish an
evidentiary basis on this record to support a conclusion that Jarrett makes
obvious a delivery system wherein a therapeutic agent is directly deposited
in the hydrogel.
Examiner instead asserts that Jarrett discloses that a visualization
agent may be directly deposited into a hydrogel and “Appellant’s broad
Appeal 2019-006533
Application 15/152,739

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claims do not specify the therapeutic agent to exclude such visualization
agents” (Ans. 7–8; see also id. at 4). We are not persuaded. Jarrett itself
describes visualization agents separately from therapeutic agents (see FF 9–
10; cf. FF 6). Thus, Examiner failed to establish an evidentiary basis on this
record to support conclusion that a person of ordinary skill in the art would
have reasonably considered Jarrett’s visualization agent to be within the
scope of a therapeutic agent as that term is used by both Jarrett and
Appellant (see FF 2). In addition, as Appellant explains, Examiner failed to
establish an evidentiary basis on this record to support a conclusion that
Jarrett’s visualization agents meet the solubility requirement of the
therapeutic agent set forth in Appellant’s claimed invention (see Appeal Br.
12–13; FF 10; cf. Appeal Br. 15; FF 3). In sum, Examiner failed to provide
an evidentiary basis on this record to support a conclusion that a person of
ordinary skill in this art would have reasonably considered that Jarrett’s
visualization agents fall within the scope of the therapeutic agents required
by Appellant’s claimed invention (see Ans. 7–8).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 1, 2, 5, 6, 8–
13, 16, 17, and 21–29 under 35 U.S.C. § 103(a) as unpatentable over Jarrett
is reversed.

Appeal 2019-006533
Application 15/152,739

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 2, 5, 6,
8–13, 16,
17, 21–28
103 Jarrett 1, 2, 5, 6,
8–13, 16,
17, 21–28
REVERSED