Ex Parte Gore et al

Patent Trial and Appeal Board

Aug 9, 2018

14104663 (P.T.A.B. Aug. 9, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/104,663 12/12/2013
530 7590 08/13/2018
LERNER, DAVID, LITTENBERG,
KRUMHOLZ & MENTLIK
600 SOUTH A VENUE WEST
WESTFIELD, NJ 07090
FIRST NAMED INVENTOR
Ashok Y eshwant Gore
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.
SPHARM 3.0-008 DIV 7822
EXAMINER
SONG, JIANFENG
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
08/13/2018 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):
eOfficeAction@ldlkm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ASHOK YESHWANT GORE, MILIND DIXIT,
RA VI CHAND RAN MAHALINGAM, EDWARD A. SCHAUER,
MATTHEW STEWART, RAJENDRA TANDALE, and
RAMSHARAN SINGH
Appeal2017-007101
Application 14/104,663
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a
lanthanum dioxycarbonate compound. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
1 Appellants identify the Real Party in Interest as Spectrum Pharmaceuticals,
Inc. (see App. Br. 1 ).
2 We have considered and herein refer to the Specification of Feb. 19, 2014
("Spec."); Final Office Action of July 25, 2016 ("Final Action"); Appeal
Brief of Dec. 23, 2016 ("App. Br."); Examiner's Answer of Jan. 31, 2017
("Answer"); and Reply Brief of Mar. 31, 2017 ("Reply Br.").
Appeal2017-007101
Application 14/104,663
Statement of the Case
Background
"Pharmaceutical products for use in the treatment of
hyperphosphatemia are known in the art. These include ... lanthanide
containing compounds including dioxycarbonate ( also referred to herein as
LDOC)" (Spec. ,r 2). The Specification teaches that in the prior art "the
phosphate binding kinetics of lanthanum dioxycarbonate ... was not
consistent at all pHs. As pH tended to increase, as would happen in the
digestive tract of a mammal, the binding kinetics slowed" (Id. ,r 4).
The Claims
Claims 1-20 are on appeal. Claim 1 is representative and reads as
follows:
1. A lanthanum dioxycarbonate compound, comprising:
a polymorph of formula La202C03, a polymorph of
formula La2C05, or combinations thereof,
wherein said lanthanum dioxycarbonate compound
includes 0.75% by weight or less of sodium, and has particles
having spherical morphology.
The Issues
A. The Examiner rejected claims 1-20 under 35 U.S.C. § I03(a) as
unpatentable over Moerck3 and Forquy4 (Final Act. 3-8).
B. The Examiner rejected claims 1-20 on the ground of nonstatutory
double patenting as being unpatentable over claims 1-12 of U.S. Patent No.
7,588,782 in view ofForquy (Final Act. 16).
3 Moerck et al., US 2006/0134225 Al, published June 22, 2006.
4 Forquy et al., US 5,061,670, issued Oct. 29, 1991.
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Application 14/104,663
C. The Examiner rejected claims 1-20 on the ground of nonstatutory
double patenting as being unpatentable over claims 1-70 of U.S. Patent No.
8,715,603 in view ofForquy (Final Act. 16-17).
Because the same issue is dispositive for all of the rejections, we will
consider them together.
The Examiner finds Moerck teaches a "composition comprising
lanthanum dioxycarbonate La202C03 ... as a round particle" but
acknowledges that Moerck does not teach the composition "includes 0.75%
by weight or less of sodium" as recited in claim 1 (Final Act. 3). The
Examiner similarly finds that the claims of the '782 and '603 patents teach
lanthanum dioxycarbonate but also do not teach the composition "includes
0.75% by weight or less of sodium" as recited in claim 1 (Final Act. 16).
The Examiner finds Forquy teaches a process where "[l]anthanum
oxycarbonate [is] obtained by precipitation" using sodium carbonate, and
further teaching the use of potassium carbonate or ammonium carbonate as
alternative carbonate ion sources to sodium carbonate (Final Act. 5; cf Final
Act. 16).
The Examiner finds that it would have been obvious "to replace
potassium carbonate or ammonium carbonate for sodium carbonate to
prepare dioxycarbonate La202C03 including less than about 0.2% of
sodium" because "it is prima facie obvious for simple substitution of one
known element for another to obtain predictable result" (Final Act. 6; cf
Final Act. 16-17).
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Application 14/104,663
The issue with respect to this rejection is: does a preponderance of
evidence of record support the Examiner's conclusion that the prior art
renders the claims obvious?
Findings of Fact
1. Moerck "is directed to lanthanum-based compounds that bind
phosphate and that can be formulated to provide for a reduced pill burden
relative to other phosphate binders" for treatment of "diseases such as End
Stage Renal Disease ... and Chronic Renal Insufficiency" (Moerck ,r 2).
2. Moerck teaches the "lanthanum-based compounds used in the
compositions and formulations of the present invention are typically either
lanthanum carbonate hydroxides or lanthanum oxycarbonates ( e.g.,
lanthanum oxycarbonate 2 hydrate and lanthanum dioxycarbonate )"
(Moerck ,r 25).
3. Example 2 of Moerck teaches synthesis of "anhydrous
lanthanum oxycarbonate La20 2C03" using sodium carbonate (Moerck ,r 51 ).
4. Moerck teaches that a "micrograph shows that the structure in
[the Example 2] compound is made of equidimensional or approximately
round particles of about 100 nm in size. An X-ray diffraction pattern showed
that the product made is an anhydrous lanthanum oxycarbonate written as
La202C03" (Moerck ,r 52).
5. Forquy teaches "a particular process for the preparation of a
catalyst containing at least one metal of the lanthanide group and at least one
alkaline-earth metal, which makes it possible to obtain a catalyst which is
particularly active and selective in the oxidative conversion of methane into
higher hydrocarbons" (Forquy 2:8-14).
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Application 14/104,663
6. Forquy teaches that in generating the catalyst, the "source of
carbonate ions may be chosen from the various carbonates which are water-
soluble in the concentrations employed, especially alkali metal carbonates
such as sodium carbonate and potassium carbonate, ammonium carbonate
and quaternary ammonium carbonates" (Forquy 3:8-13).
7. F orquy teaches, in Example 6, formation of a lanthanum
oxycarbonate catalyst:
Product C: Lanthanum oxycarbonate obtained by precipitation,
by mixing equal volumes of a 0.2M aqueous solution of
LaCb.6H20 and of a 0.2M aqueous solution of sodium
carbonate, followed in succession by isolating the precipitate by
filtration, washing the precipitate with distilled water until, the
chlorides were eliminated, drying at 60° C. for 24 hours and
finally calcination at 600° C. for 4 hours in air to provide
lanthanum oxycarbonate, La20(C03)2.
(Forquy 7:55---63).
8. Claim 1 of US 7,588,782 is reproduced below:
A method of treating hyperphosphatemia in a mammal, wherein
the method comprises administering an effective amount of a
composition comprising a lanthanum compound of the formula
La202C03 having a phosphate binding capacity of at least 50
mg P04/g of the lanthanum compound.
('782 21:24--28).
9. Claim 1 of US 8,715,603 is reproduced below:
A rare earth compound selected from the group consisting of
crystalline La202C03, crystalline La20s, and crystalline
LaC030H, wherein the rare earth compound has a BET specific
surface area of at least about 10 m2/g and exhibits a phosphate
binding of at least 40% of an initial phosphate content after 10
minutes at an initial pH of about 3 and wherein the rare earth
compound is in the form of particles with a porous structure.
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Application 14/104,663
(' 603 21: 1 7-24 ).
Principles of Law
A prima facie case for obviousness requires a "reason that would have
prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does." KSR Int 'l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
Appellants contend "the carbonate sources discussed in F orquy are
used to make the catalyst of Forquy. The catalyst of Forquy is not a
lanthanum dioxycarbonate as recited in Moerclc' (App. Br. 3). Appellants
contend "[t]here is no line of reasoning for the Office to conclude that [the
Forquy carbonate] sources can be used as equivalents to produce the
lanthanum dioxycarbonate of Moerk, other than hindsight reasoning" (id. at
5). Appellants contend
[T]here would have been no reason for one of ordinary skill in
the art to incur the additional time and expense of using a non-
alkali metal carbonate or reducing sodium content to be less
than 0.75% by weight because the cited art fails to recognize
the problem of phosphate binding kinetics over a range of pH
when sodium carbonate is used.
(id. at 7). Appellants contend "[t]here is no motivation to use the carbonate
source of Forquy even if it were technically possible" (id. at 7).
The Examiner responds "Forquy is relied on for teaching carbonates,
such as potassium carbonate or ammonium carbonate as alternative to
sodium carbonate, to make lanthanum oxycarbonate, a close variant to
claimed compound lanthanum dioxycarbonate" (Ans. 14). The Examiner
finds "Forquy teaches potassium carbonate or ammonium carbonate as
alternative to sodium carbonate as source of carbonate ions, to make
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Application 14/104,663
lanthanum oxycarbonate, a close variant to claimed compound lanthanum
dioxycarbonate" (id.).
We agree with Appellants that the rejection lacks a convincing reason
to modify the lanthanum dioxycarbonate of Moerck, used for treatment of
end stage renal disease (FF 1-2), with different carbonate ion sources
suggested by Forquy as useful in making lanthanum catalysts including
lanthanum oxycarbonate for oxidative conversion of methane into higher
hydrocarbons (FF 5-7). That the carbonate ion sources are equivalent, at
least according to Forquy, in lanthanum catalysts for chemical synthesis of
hydrocarbons does not necessarily support the Examiner's implicit finding
that the carbonate ion sources would have been expected to be equivalent in
a pharmaceutical treatment of hyperphosphatemia.
On the flip side, while Forquy clearly teaches that lanthanum
oxycarbonate may use different carbonate sources, Forquy does not suggest
that the claimed compound, lanthanum dioxycarbonate, would be functional
as a catalyst for the oxidative conversion of methane into higher
hydrocarbons and Moerck lacks any such teaching. The Examiner provides
no reason to replace Forquy's lanthanum oxycarbonate with Moerck's
lanthanum dioxycarbonate in the methane conversion reaction.
Therefore, in the absence of any reason to make the specific changes
based on these references in very different fields of endeavor, we agree with
Appellants that the cited prior art does not render the claims obvious.
Conclusion of Law
A preponderance of evidence of record does not support the
Examiner's conclusion that the prior art renders the claims obvious.
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Application 14/104,663
SUMMARY
In summary, we reverse the rejection of claims 1-20 under 35 U.S.C.
§ 103(a) as unpatentable over Moerck and Forquy.
We reverse the rejection of claims 1-20 on the ground of nonstatutory
double patenting as being unpatentable over claims 1-12 of U.S. Patent No.
7,588,782 in view ofForquy.
We reverse the rejection of claims 1-20 on the ground of nonstatutory
double patenting as being unpatentable over claims 1-70 of U.S. Patent No.
8,715,603 in view of Forquy.
REVERSED
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