Ex Parte Lees et al

Patent Trial and Appeal Board

Dec 6, 2018

13581102 (P.T.A.B. Dec. 6, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/581,102 10/11/2012
79158 7590 12/10/2018
STINSON LEONARD STREET LLP (RL Y)
7700 FORSYTH BOULEVARD, SUITE 1100
ST. LOUIS, MO 63105
FIRST NAMED INVENTOR
Inez Lees
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.
RLY 09051.301US 9734
EXAMINER
RONEY, CELESTE A
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
12/10/2018 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):
stl.uspatents@stinson.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte INEZ LEES, KALPESH BIY ANI, ERIC CONNOR,
SCOTT HECKER, HONGMIN ZHANG, MICHAEL JAMES COPE,
ELIZABETH GOKA, ANGELA LEE, DEIDRE MADSEN, JUN SHAO,
and XINNAN ZHANG
Appeal2017-009781
Application 13/581,102
Technology Center 1600
Before DEMETRA J. MILLS, ULRIKE W. JENKS, and JOHN E.
SCHNEIDER, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL 1
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 The Appellants state Relypsa, Inc. is the real party in interest. App. Br. 2.
Appeal2017-009781
Application 13/5 81,102
NATURE OF THE INVENTION
The present invention generally relates to amine
polymers useful to bind bile acids in the gastrointestinal tract of
a patient in need of bile acid removal. These polymers and
pharmaceutical compositions thereof are useful to lower
cholesterol, particularly, non-high density lipoprotein (non-
HDL ), or more particularly, low-density lipoprotein (LDL)
cholesterol, in patients in need thereof.
Spec. ,II.
Many bile acid sequestrants do not have the binding capacity or
binding affinity to reduce the serum LDL-cholesterol concentration
significantly without requiring the patient to take large amounts of the
sequestrant. A large dose requirement reduces patient compliance and
tolerance. Thus, bile acid sequestrants capable of removing a greater amount
of bile salts from the gastrointestinal tract with equal or lower doses are
needed. Spec. ,r 5.
STATEMENT OF CASE
The following claim is representative.
1. An amine polymer comprising repeat units derived
from polymerization of a crosslinking monomer and an
imidazole monomer of formula 1 or a salt thereof
wherein
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R21, R22, R23, and R24 are independently hydrogen, C1 to
C12 alkyl, aryl, or heterocyclo;
provided that at least one of R21, R21, R23, and R14 is -R2-
NH-R26 and the other R groups are less reactive with the
crosslinking monomer than the -R2-NH-R26 nitrogen or the
imidazole nitrogens;
R2 is C2 to C14 alkylene;
R26 is hydrogen, C1 to C16 hydrocarbyl, C1 to C16
substituted hydrocarbyl, or C1 to Cso alkyl wherein the -CH3
group or one or more of the -CH2- groups are replaced with an
amide, a carbonyl, an ether, an ester, a cycloalkyl, an aryl, or a
heterocyclo functional group, or C1 to Cso alkyl wherein the -
CH3 group or one or more of the ---CH2 groups are substituted
with a hydroxy, a halo, an amino, an alkoxy, or an aryloxy; and
wherein the crosslinking monomer is 1,8-dichlorooctane,
1,8-dibromooctane, 1,9- dichlorononane, 1,9-dibromononane,
1, 10-dichlorodecane, 1, 10-dibromodecane, 1, 12-
dichlorododecane, 1, 11-dibromoundecane, 1, 11-
dichloroundecane, 1, 12-dibromododecane, or a combination
thereof.
Grounds of Rejection
Claims 1-3, 5, 6, and 14 stand rejected under pre-AIA 35 U.S.C.
§ 103(a) as being unpatentable over Hildebrandt (US 6,111,056, issued Aug.
29, 2000) in view of Kesseler (US 5,401,498, issued Mar. 28, 1995).
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Final Office
Action at pages 2-5.
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Application 13/5 81,102
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
Under § 103, "there must be some articulated reasoning with some
rational underpinning to support the legal conclusion of obviousness." KSR
Int'! Co. v. Teleflex, Inc., 550 U.S. 398,418 (2007) (citation omitted). "If a
technique has been used to improve one device, and a person of ordinary
skill in the art would recognize that it would improve similar devices in the
same way, using the technique is obvious unless its actual application is
beyond his or her skill." Id. at 416.
[T]he "motivation-suggestion-teaching" test asks not merely
what the references disclose, but whether a person of ordinary
skill in the art, possessed with the understandings and
knowledge reflected in the prior art, and motivated by the
general problem facing the inventor, would have been led to
make the combination recited in the claims.
In re Kahn, 441 F. 3d 977, 988 (Fed. Cir. 2006). The motivation to combine
references does not have to be identical to the applicants to establish
obviousness. In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996).
Obviousness Rejection
The Examiner finds that
Hildebrandt discloses polymers obtained by reacting primary or
secondary amines with cross linkers that contain at least two groups
that react and alkylate the amines (abstract). Specifically, Hildebrandt
discloses polymers obtained by reacting the amines of imidazole ( e.g.
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Application 13/5 81,102
1-3-aminopropyl imidazole; col 2, lines 34-36) with cross linkers
based on dihalides ( col 4, lines 22-25) ( e.g 1,3-dichloropropane, at col
4, line 29; 1,6-dichlorohexane, at col 4, line 30).
Hildebrandt does not disclose 1, 10-dibromodecane.
Final Act. 2-3. The Examiner relies on Kesseler to make up for the
deficiencies of Hildebrandt. "Kesseler discloses polymers obtained by the
reaction of polyethyleneimines ( e.g. contains secondary amines) with
crosslinking agents as alkylating agents. Suitable crosslinking agents that
alkylate and crosslink the amines include dihaloalkanes, such as 1, 10-
dibromodecane (col 6, lines 4-19)." Final Act. 3.
The Examiner concludes that
it would have been obvious to one of ordinary skill in the art to have
added 1, 10-dibromdecane to Hildebrandt' s invention. An ordinarily
skilled artisan would have been so motivated because crosslinked
amine polymers are formulated with dihalides, where 1, 10-
dibromdecane is a useful dihalide for polymerization, as taught by
Kesseler (Kesseler, col 6, lines 4-19). And, Kesseler provides a
reasonable expectation of success in crosslinking among structurally
obvious compounds ( e.g. the 1,6-dichlorohexane of Hildebrandt and
the 1, 10-dibromodecane of Kessel er) [.]
Final Act. 3.
Appellants contend that the Examiner has failed to set forth a prima
facie case of obviousness. App. Br. 5. In particular, Appellants argue that
the Office has failed to provide any reason why a person of ordinary
skill would have selected the Hildebrandt polymers from the "scope
and content of the prior art." The Hildebrandt reference does not in
any way provide a reason to select the alkylated imidazole monomers
from the universe of possible amine monomers disclosed in the
Hildebrandt reference. In addition, the Hildebrandt reference does not
exemplify amine polymers prepared from alkylated imidazole
monomers. In fact, the Hildebrandt reference discloses a large
number of possible amine monomers and combinations of amine
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Application 13/5 81,102
monomers and crosslinking monomers and neither the Office nor the
references provide a reason why a person of skill in the art would
have selected the alkylated imidazole monomers from this large genus
or why if the alkylated imidazole monomers were selected from this
large genus that the crosslinking monomers would have been
modified to arrive at the claimed polymers. Thus, there is no reason
articulated as to why the polymers of Hildebrandt would have been
selected or modified by a person of ordinary skill in the art.
App. Br. 5. More particularly, Appellants argue that
, the Office has not provided any reason why Kesseler would have
been selected from the universe of references disclosing possible
crosslinkers for reaction with amine monomers to prepare amine
polymers. The Office's general statements that 1, 10-dibromodecane
is a "useful dihalide for polymerization" and that Kesseler' s 1, 10-
dibromodecane is structurally similar to Hildebrandt's 1,6-
dichlorohexane do not provide a cogent technical reason to combine
the references. In fact, similar to Ex parte Meagher, such a general
statement for the reason for combining the references does not address
the specific claim elements, e.g., why one would select the cited
references from the multitude of references describing amine
polymers as used in pharmaceutical compositions especially when
Hildebrandt is not directed to pharmaceutical compositions. The
Hildebrandt polymers worked for their intended purpose and there is
no indication that the polymers need modification or improvement.
App. Br. 7 (footnotes omitted). Appellants argue that
The Hildebrandt reference is directed to an improved laundry
detergent and the Kesseler reference is directed to bile acid binding
polymers. Thus, the cited references do not relate to the same problem
and would not have provided a reason for a person of ordinary skill in
the art to systematically vary the Hildebrandt polymers with the
crosslinkers of Kesseler to arrive at the claimed composition. The
goal of preparing a different amine polymer is not specific enough to
for a person of ordinary skill in the art to select and combine the
Hildebrandt and Kesseler references. Thus, there is no reason to
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Application 13/5 81,102
combine the references in the manner that the Office has and claims 1-
3, 5, 6, and 14 are nonobvious over the cited references.
App. Br. 8.
ANALYSIS
There is an election of species in this application. 2 Appellants elected
aminopropylimidazole as the monomer and 1, 10-dibromodecane as the
cross-linking agent. When the Examiner has required the applicant to elect
single chemical species for examination, the issue on appeal is the
patentability of the single elected species. It is appropriate to limit
discussion to that single issue and take no position respecting the
patentability of the broader generic claims, including the remaining, non-
elected species. See, Ex parte Ohsaka, 2 USPQ2d 1461 (Bd. Pat. App. Int.
1987).
We find that the Examiner has provided evidence to support a prima
facie case of obviousness of the elected species for the reasons of record.
The present claims are directed to a cross-linked amine polymer, and not a
method of use of a specific polymer made by a specific process as a bile acid
sequestrant. Hildebrandt teaches that it is known in the art of making
chemical polymers to make cross-linked amine polymers by reacting a
polymer having the claimed aminopropyl imidazole structure ( col. 2, 11. 34-
3 6) with a crosslinking agent based on dihalides ( col. 4, 11. 22-25). Kesseler
also discloses it is known in the art to make cross-linked amine polymers by
reacting a compound having an amine polymer with a dihaloalkane
2 Requirement for Restriction, dated September 27, 2013, with Appellants'
election dated October 28, 2013.
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crosslinking agent, including the claimed 1, 10-dibromodecane crosslinking
agent ( col 6, lines 4-19).
Appellants argue that Hildebrandt and Kesseler are directed to amine
polymers with different intended uses, and thus there is no motivation to
combine the cited references. App. Br. 8. Hildebrandt is directed to cyclic
amine based polymers that can be used as additives in detergents. Col. 7, 11.
45-52. In particular, Hildebrandt describes
treating of fabrics and textiles in aqueous washing or treating
solutions which contain an effective amount of the cyclic amine based
polymer of the invention, followed by rinsing and drying, imparts
fabric appearance benefits to the fabric and textile articles so treated.
Such benefits can include improved overall appearance, pill/fuzz
reduction, antifading, improved abrasion resistance, and/ or enhanced
softness.
Col 7, 11. 45-52. Kesseler also relates to cross-linked amine polymers
which have been crosslinked using a well known dihaloalkane crosslinking
agent. In particular, the intended use of Kesseler's polymers is as
pharmaceuticals which are polyhydroxymethylene derivatives and to their
use for the treatment of dyslipoproteinemias. Col. 1, 11. 6-8.
Appellants specifically argue that
if, for argument's sake, the alkylated imidazole monomers were
selected from the Hildebrandt reference, the Office has not provided
any reason why Kesseler would have been selected from the universe
of references disclosing possible crosslinkers for reaction with amine
monomers to prepare amine polymers.
App. Br. 7. We are not persuaded. Even Appellants' own specification
provides a "laundry list" of almost 2 pages of well known crosslinking
agents which are appropriate for preparing cross-linked amine polymers.
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Application 13/5 81,102
Spec. ,r 26. While Hildebrant exemplifies 1,6 dichlorohexane as a possible
dihalo crosslinking agent, Hildebrandt also includes general disclosure
regarding crosslinkers which may be used with its amine compounds. For
example, Hildebrandt discloses:
1. At least one crosslinker selected from the group consisting of at
least one compound containing two reactive groups and mixtures
of at least one compound containing two reactive groups with at
least one compound containing at least three reactive groups. Col.
1, 1. 57----62, emphasis added.
2. The crosslinker based on compounds containing two reactive
groups is selected from the group consisting of alkylene dihalides,
epihalohydrins, bis(halohydrins) of dials, bis(halohydrins) of
polytetrahydrofuran, bisepoxides. Col. 4, 11. 23-30.
3. Examples of alkylene dihalides which may have 2 to 6 carbon
atoms in the alkylene group are 1,2-dichloroethane, 1,2-
dichloroproane, 1,3-dichloropropane, 1,4-dichlorobutane, 1, 6-
dichlorohexane ... Col. 4, 11. 27-30, emphasis added.
A prior art disclosure is not limited only to its preferred embodiments,
but is available for all that it discloses and suggests to one of ordinary skill
in the art. In re Lamberti, 545 F.2d 747, 750 (CCPA 1976); In re Mills, 470
F.2d 649,651 (CCPA 1972) ("All the disclosures in a reference must be
evaluated ... a reference is not limited to the disclosure of specific working
examples"). Thus, Hildebrandt provides general disclosure to select dihalo
crosslinking agents for use with aminopropylimidazole monomers. Kessler
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Application 13/5 81,102
merely discloses that one specific, well known dihalo crosslinking monomer
for amines is 1, 10-dibromodecane.
Furthermore, "[ r ]eading a list and selecting a known compound to
meet known requirements is no more ingenious than selecting the last piece
to put into the last opening in a jig-saw puzzle. It is not invention." Sinclair
& Carroll Co. v. Interchemical Corp., 325 U.S. 327, 335 (1945); see also,
Merck & Co. Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed.
Cir. 1989) ("Disclos[ ure of] a multitude of effective combinations does not
render any particular formulation less obvious").
It is also "well settled that the recitation of a new intended use for an
old product does not make a claim to that old product patentable." In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Intended uses of a claimed
product do not serve to distinguish the product from prior art products
inherently capable of performing the claimed function. See id. at 14 78-79.
Furthermore, the motivation to combine references does not have to be
identical to the applicants to establish obviousness. In re Kemps, 97 F.3d
1427, 1430 (Fed. Cir. 1996).
We agree with the Examiner that it would have been prima facie
obvious to one of ordinary skill in the amine polymer chemistry art to
choose or substitute one well known class of dihalo crosslinking agent such
as those disclosed, and useful with the amine polymer in Hildebrand, for
another specific, well known, dihalo alkane crosslinking agent, such as the
1, 10-dibromodecane, that is useful with amine polymers, as disclosed in
Kesseler.
We are not persuaded that Unigene Laboratories Inc. v. Apotex Inc.,
655 F3d 1352 (Fed. Cir. 2011) or KSR Int'! Co. v. Teleflex Inc., 127 S.Ct.
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Application 13/5 81,102
1727, 1739 (2007) suggest a different outcome here. App. Br. 5-7. In
Unigene there was significant data with respect to unexpected results, which
are not present here, and the Unigene claims was to a pharmaceutical
composition of narrow claim scope. In the present case, claim 1 is to an
amine polymer generally, not to a pharmaceutical composition, and
Appellants do not argue or rely on unexpected results in the Appeal Brief.
Therefore, we find that the Examiner has provided a specific reason to
combine the cited references, and the obviousness rejection is affirmed for
the reasons of record.
CONCLUSION OF LAW
The cited references support the Examiner's obviousness rejection,
which is affirmed for the reasons of record.
AFFIRMED
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