Ex Parte Schoenfisch et al

Patent Trial and Appeal Board

Apr 28, 2016

13157036 (P.T.A.B. Apr. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/157,036 06/09/2011
826 7590 05/02/2016
ALSTON & BIRD LLP
BANK OF AMERICA PLAZA
101 SOUTH TRYON STREET, SUITE 4000
CHARLOTTE, NC 28280-4000
FIRST NAMED INVENTOR
Mark H. Schoenfisch
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
035052/405966 6293
EXAMINER
PARK, HAEJIN S
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
05/02/2016 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 STASK0 1
Appeal2014-000405
Application 13/157,036
Technology Center 1600
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to nitric
oxide-releasing particles that have been rejected as failing to comply with
the written description requirement, as indefinite, and as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm-in-part.
1 Appellants identify the Real Party in Interest as the University of North
Carolina at Chapel Hill. (Appeal Br. 2.)
Appeal2014-000405
Application 13/157,036
STATEMENT OF THE CASE
The invention relates to "particles that release nitric oxide in a
controlled and targeted manner, thereby prolonging the therapeutic effects of
nitric oxide and improving the specificity of nitric oxide delivery to targeted
cells and/or tissues." (Spec. 1.)
Claims 1-20 and 42-70 are on appeal. The following independent
claims are illustrative.
1. A nitric oxide-releasing particle, the nitric oxide-
releasing particle comprising a nitric oxide donor and a core
scaffold, the particle having a particle size of at least 2 nm and a
total releasable nitric oxide storage of at least 1.2 µmol of NO
per milligram of the nitric oxide releasing particle.
49. An amorphous nitric oxide-releasing particle that has
a particle size of at least 2 nm and releases at least 1.2 µmol of
NO per milligram of the nitric oxide releasing particle.
52. ii:\. particle comprising means for releasably storing at
least 1.2 µmol of NO per milligram of the particle and a means
for providing a particle having a size of at least 2 nm.
(Appeal Br. 38 (Claims App'x).)
The rejections are as follows:
Claims 1-20, 42--48, and 58-702 are rejected under 35 U.S.C. § 112,
first paragraph, for lack of adequate written description on a first ground.
(Final Act. 4--5.)
2 The Examiner listed claim 49 in the Final Office Action, but removed
claim 49 in the Answer with respect to this rejection. (Compare Final Act. 3
with Ans. 3.) We agree with Appellants (Appeal Br. 6, n. 1) that inclusion
of claim 49 in this rejection appears to be unintentional error. Claim 58,
2
Appeal2014-000405
Application 13/157,036
Claims 1-20, 42-56, 60, 62, 64, 65 and 703 are rejected under
35 U.S.C. § 112, first paragraph, for lack of adequate written description on
a second ground. (Final Act. 5---6.)
Claims 52-57 are rejected as indefinite under 35 U.S.C. § 112, second
paragraph. (Final Act. 6-7.)
Claims 49, 50, 52, 53, and 55 are rejected under 35 U.S.C. § 103(a) as
obvious based on Arnold.4 (Final Act. 8-9.)
Claims 1-3, 5, 7-12, 14, 17-20, 42-50, 52-55, and 65-68 are rejected
under 35 U.S.C. § 103(a) as obvious based on Arnold as evidenced by
Hrabie.5 (Final Act. 8-9.)
Claims 1, 5, and 6 are rejected under 35 U.S.C. § 103(a) as obvious
based on Arnold in view of Hermann. 6 (Final Act. 12.)
Claims 1, 10, and 13 are rejected under 35 U.S.C. § 103(a) as obvious
based on Arnold in view of Saavedra.7 (Final Act. 12-13.)
which depends from claim 49, remains included, but also appears to have
been included by error.
3 As Appellants note, it appears the Examiner intended to include
independent claims 52 and 65 among those claims subject to the second
written description rejection. (Appeal Br. 15, n. 3.) For example, although
claim 65 is absent in the heading, claim 65 is expressly identified in the body
of the rejection. (Final. Act. 5.) Like Appellants, we therefore treat claims
52 and 65 as included within the second written description rejection.
4 Arnold et al., U.S. 6,673,338 Bl, issued Jan. 6, 2004 ("Arnold").
5 Joseph A. Hrabie and Larry K. Keefer, Chemistry of the Nitric Oxide-
Releasing Diazeniumdiolate ("Nitrosohydroxylamine '') Functional Group
and Its Oxygen-Substituted Derivatives, CHEM. REV. 102, 1135-1154 (2002)
("Hrabie").
6 Hermann, U.S. 2006/0095120 Al, published May 4, 2006 ("Hermann").
7 Saavedra et al., U.S. 6,610,660 Bl, issued Aug. 26, 2003 ("Saavedra").
3
Appeal2014-000405
Application 13/157,036
Claims 1-20 and 42-70 are rejected under 35 U.S.C. §103(a) as
obvious based on Arnold in view of Schoenfisch8 as evidenced by Hrabie.
(Final Act. 13-15.)
Issues
I - WRITTEN DESCRIPTION
The two grounds of rejection are summarized as follows:
• The Examiner rejects claims 1-20, 42--48, and 58-70 to nitric
oxide-releasing particles comprising a "core scaffold," a phrase
the Examiner contends is (i) undefined and (ii) illustrated by
two species that are "not sufficient to demonstrate that
Applicants had possession of the invention as broadly as
claimed." (Final Act. 4.)
• The Examiner rejects claims 1-20, 42-56, 60, 62, 64, 65 and
70; which recite particles of "at least 2 nm" - an "open-ended
range" that "finds no basis in Applicants' disclosure." (Final
Act. 5-6.) According to the Examiner, the disclosed species do
not reasonably convey possession of the broad genus of
particles claimed, especially where numerous particles
disclosed do not meet the other claim elements and the few that
do reflect a small "fraction" within a vast range. (Id.)
Appellants contend that the claims, including the terms "core
scaffold" and "at least 2 nm" are fully supported, and that the examples
8 Schoenfisch et al., WO 2004/009253 Al, published Jan. 29, 2004
("Schoenfisch").
4
Appeal2014-000405
Application 13/157,036
provided in the Specification show particles that meet the size and nitric
oxide-releasing properties of the claims. (Appeal Br. 6-11, 15-17.)
The issue is whether, for each of the two grounds of rejection, the
Examiner has established by a preponderance of the evidence that the claims
fail to satisfy the written description requirement of§ 112, first paragraph.
Findings of Fact
1. The Specification discloses
In some embodiments, the "core" of the presently disclosed
particles comprises a material selected from the group
including, but not limited to: (a) a metallic cluster; (b) a
dendritic network; and ( c) a co-condensed silica (i.e., siloxane-
bonded) network possessing variable silane functionality.
(Spec. 25, 11. 8-11.)
2. The Specification describes testing of certain particles with a
metallic core (i.e., functionalized monolayer protected gold nanoparticles).
(Spec. 53, Example 4, Table 1.) Table 1 above shows the total nitric oxide
released from the monolayer protected gold nanoparticles per milligram of
the particle (e.g., 87,000 pmol/mg = 0.087 µmol/mg, which was the largest
amount of NO released and well below 1.2 µmol/mg). The core diameter of
the particles was 2.1 ± 0.9 nm. (Id. at 52, 11. 9-11.)
5
Appeal2014-000405
Application 13/157,036
3. The Specification describes testing of certain particles with a
dendrimer core.
Table 2. Summary of Nitric Oxide Release from Amine Derivatized Dendrimers
Diazeniumdiolated NO Released Tm(min} moles·------·----··;;\inine·---·····
Species (mmol NO/g) NO/mol Structure
dendrimer
j-.rm--mm"""""""""""""""""""""" """"""""°'""""""""""""""""-""""""""""" """"""""""""""--· ---· • , """"""""-•"""·~----i
DAB-Ac-16 0J)l6 L4 0J)4 capped
DAB·Ac-64 0.02 2.5 0-22
DAB··C7-l6
DAB.C7-64
DA B~Pr:o~ l 6
DAB-Pro-64
0.44
0,69
3A
3.2
r~ .)
36
12 0,74
29 4.94
80 l2
90 45
150 42
117 480
secondary
secondary
(Spec. at 55-58, Example 6-7, Table 2.) Table 2 above shows the total
nitric oxide relased per milligram of these particles (e.g., 0.02 mmol/g =
0.02 µmol/mg). The maximum NO release/storage for these particles was
36 µmol/mg. The Specification does not disclose the size of the particles in
Table 2.
4. The Specification describes testing of certain particles with a co-
condensed silica core.
6
Appeal2014-000405
Application 13/157,036
1)1f1e 4' NO Relea~e.Pr()penles'oTsWica Pari'ic!C~"pj-epared 'based. on-the Co--condensatlon of l
NO Donor Precursors~ I ------------ -------------- ------------------------------------------------------------------ ---------------------------------------------~
Ligand Mo!%.• t[NOJ ! t~·.Z [NO]m I t m I
Type {nmol/mg) I (h) (ppb/mg) I (h) l
' ' '
I --~
_0:~~~----------'-0--1-_141_ :t 1 o ....... L_ .. 12 ~:L ......... _____ t:t~J ....... ~ _ ..... !.~ __ ! ________ J
AEP3 l3 392 ± 15 ! 6 J. l.5 9:2 ± 5 4 ± I 1
AEP3 17 600 ± 25 3.4 ± 0.4 140 :± lO 2. ! ± 0.3
AHAPJ 10 380 ± 20 0.85 ± f)J)S 370 ± tO I 0.35 ± 0.05
I
AEMP3
l AEMP3
I I AEMP3
! AEMP3
l(!
l'' .)
17
20
53±3 6,0 ;t !).2
81 ±3 6.5 ± 0.3
118 ± 5 5.7 ± 0.5
170± lO 5.4 ± 0.3
hjfff) ~---1(-1 -~120±5' ____ _ 4.0±0.2
'·311 is at least 3.
!0±1
22±2
32 ± 2
40± 3
22±2
I o.t2 ± 0.01
I 0.10~~0.01
I OJI ±0.02
I
I o. 1 b: n.01
I
I L6±0J ]
(Spec. 61, Examples 12-13, Table 4.) Table 4 above shows the total nitric
oxide released per milligram of these particles (e.g., 145 nmol/mg = 0.145
µmol/mg). The maximum NO releasee for these particles was 0.600
µmol/mg. The Specification discloses the sizes of some of the particles in
Table 4. For example, the particle with 10 mol% AEP3 is disclosed as
having a diameter of 500 ± 45 nm. With 17 mol% AEP3, the diameter
decreased to 92 ± 16 nm. The particle with 10 mol% AHAP3 has a diameter
of 20 ± 2 nm. (Id. at 61, 11. 15-23.)
5. The Specification describes testing of certain particles with a co-
condensed silica core prepared "via the pre-charging approach."
7
Appeal2014-000405
Application 13/157,036
Table 6. NO Release. Pmverties of PartklesJ:rS?~~~~i f~£!~. Pt£:fh